dosing and monitoring: children and adolescents buspar: 20–60 carbamazepine: ... hydroxyzine...

34 • PsychoPharmacology Bulletin: Vol. 48 · No. 2

Educational REviEw

Dosing and Monitoring: Children and Adolescents

By Glenn S. Hirsch

IntroductIon

American culture places a great value on our children. In accordance with this, parents seek out the best health care, wanting to ensure the well-being of their children. Despite this, physicians have been forced to treat children with medica-tions lacking FDA indications for pediatric use. Off-label use to treat childhood disorders has been the rule rather than the exception, with clinicians relying on limited literature or clinical lore to make important medical decisions.

The treatment of psychiatric disorders in children has been no exception. Medications approved for adults gradually make their way into the armamen-tarium of child and adolescent psychiatrists, often without adequate dosing guidelines. The past two decades have seen a dramatic increase in the number of studies looking specifically at pediatric psychopharmacology, but there have been difficulties in obtaining funding for such work. Pediatric studies have also been hampered by the lack of understanding of the biologic nature of many psychiatric disorders.

Numerous factors have worked together to begin changing these problems. In 1994, the FDA enacted the Pediatric Labeling Regulation, which encouraged pharmaceutical firms to submit applications for a change in labeling for pediatric indications if a review of the literature showed that enough data existed to war-rant a pediatric indication.

As part of the Food and Drug Administration Modernization Act of 1997 (enacted in 1998), pediatric exclusivity could be extended by 6 months for medi-cations whose manufacturers submitted pediatric studies in compliance with the act’s regulations. In addition, the Pediatric Rule, effective April 1999, required certain manufacturers—namely those of products that would either be used in a “substantial” number of pediatric patients or provide children a meaningful

Journal name: Psychopharmacology BulletinVolume no: 48Issue no: 2Year: 2018Article designation: Educational ReviewRunning heading title: Dosing and Monitoring: Children and Adolescents

Dr. Hirsch is Vice Chair for Clinical Affairs, Department of Child and Adolescent Psychiatry and Child Study Center of the Hassenfeld Children’s Hospital at NYU Langone and Associate Professor of Child and Adolescent Psychiatry, Psychiatry, and Pediatrics.To whom correspondence should be addressed: James M. La Rossa Jr., Publisher, 2205 Rockefeller Lane, Bldg. B, Redondo Beach, CA 90278. Phone: 310.374.1300; Fax: 424.398.0067; E-mail: [email protected]

Psychopharmacol Bull. 2018;48(2):34–92.

PB-Child & Adolescent Dosing.indd 34 05-02-2018 16:02:25

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35Hirsch and Stephen

PsychoPharmacology Bulletin: Vol. 48 · No. 2

therapeutic benefit over existing treatments—to conduct studies that would be adequate to provide labeling for pediatric indications.

In addition, the NIMH funded the Research Units in Pediatric Psychopharmacology (RUPP) network. RUPP is composed of research units in academic centers across the country devoted to conduct-ing studies to test the efficacy and safety of medications commonly used by practitioners to treat children and adolescents but not yet adequately tested.

The number of pediatric studies and submissions to the FDA has subsequently increased dramatically. Clearly this has allowed new fund-ing sources to assist in the development of pharmacological trials. It has also assisted in allaying the resistance that is often seen toward treatment studies in young children. As public awareness of psychiatric disorders has grown, resistance toward research has begun to diminish.

As our knowledge of pediatric psychopharmacology increa ses, it becomes increasingly difficult to keep track of the available options for treatment. While it is beyond the scope of this book to cover all the factors that make the treatment of children different from that of adults, we have attempted to compile a practical guide for those “in the trenches.” Medications commonly used in children and adolescents, as well as general dosing guidelines, have been provided.

In addition to the dosing and monitoring tables that follow, there are a number of overarching “principles” to keep in mind in treating this vul-nerable population. The latest recommendations for use of psychotro-pic medication from the American Academy of Child and Adolescent Psychiatry (AACAP) greatly expanded guidelines for clinicians. These guidelines for dosing and monitoring in children and adolescents will follow the AACAP’s lead.

Psychiatrists, pediatric neurologists, and pediatricians whose patients may present on a medication they are less familiar with will hopefully find this guide helpful.

We hope the following will enhance the ease with which you practice, and we look forward to your suggestions for future updates.

— Editorial Director, James M. La Rossa Jr.,contributed to the 2018 update of this work


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TABLE 1

Psychotropic Agents (by Generic)

GENERIC BRAND NAMEDOSAGE RANGE*

(mg/day)Alprazolam Xanax

Xanax XR1–4

Amantadine Symmetrel 100–300Amisulpride Soilan 400–1200Amitriptyline Elavil 50–300Amoxapine Asendin 200–600Amphetamine-D Dexedrine 5–40Amphetamine/

dextroamphetamineAdderallAdderall Xr

5–40

Aripiprazole AbilifyAbilify Maintena (Injectable)

2–30

Armodafinil Nuvigil 150–250Asenapine Saphris 10–20Atomexetine Strattera 40–100b

Benztropin Cogentin 0.5–6Biperiden Akineton 2–24Blonanserin Lonasen 8–16Brexpiprazole Rexulti 2–4Buprenorphine Suboxon (w/Naloxone)

Probuphine Implant8–32

Bupropion WellbutrinWellbutrin SRWellbutrin XL

200–450

Buspirone BuSpar 20–60Carbamazepine Tegretol

Tefgretol XRCarbatrol

400–1,600

Cariprazine Vraylar 1.5–6Chlordiazepoxide Librium

LimibitrolLibrax

15–40

Chlorpromazine Thorazine 200–800Citalopram Celexa 20–40Clomipramine Anafranil 100–250Clonazepam Klonopin 0.5–4Clonidine Catapres

KapvayIntunivDuraclon (Injectable)

0.1–0.4

Clorazepate AzeneTranxene

15–60

Clozapine ClozarilLeponexVersacloz (oral suspension)Fazaclo ODT (oral tablets)

25–700

(Continued)


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(mg/day)Desipramine Norpramin 100–300Desvenlafaxine Prestiq 50–100Dextromethorphan Nuedexta 10–20Diazepam Valium 4–40Diphenhydramine Benadryl

Sominex injection:50

10–50D-methamphetamine Desoxyn 20–25Disulfiram Antabuse 250–500Donepezil Aricept 5–10Doxepin Sinequan

Silenor75–150

Droperidol Inapsine 2.5–15Duloxetine Cymbalta 60–120Escitalopram Lexapro 10–40Estazolam ProSom 1–4Eszopiclone Lunesta 1–3Ethosuximide Zarontin 15–40Flibanserin Addyi 100Fluoxetine Prozac

Sarafem20–80

Flupenthixol Depixol 3–6Fluphenazine Prolixin 1–40Fluphenazine decanoate Prolixin Decanaote 1–20Flurazepam Dalmane 15–30Fluvoxamine Luvox

Luvox CR100–300

Gabapentin NeurontinGralise (XR)Horizant (XR)

900–3,600

Galantamine ReminylRazadyne

16–24

Haloperidol Haldol 1–40Haloperidol decanoate Haldol Decanaote 50–100 mg/mLHydroxyzine Atarax

MaraxVistaril

50–100

Iloperidone Fanapt 12–32Imipramine Tofranil 150–300Imipramine Pamoate Tofranil-PM 150–300Intuniv XR

(Guanfacine XR )IntunivTenex

1–4

Isocarboxazid Marplan 40–60Lamotrigine Lamictal

Lamictal ODTLamictal XR

100–400

TABLE 1 (Continued)


(Continued)


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(mg/day)Levetiracetam Keppra

Keppra XR1,000–3,000

Levomilnacipran Fetzima 40–120Lisdexamfetamine Vyvanse 30–70Lithium carbonate Eskalith

Eskalith CRLithobid (slow release)

600–1,800

Lofepramine DeprimylGamanil

140–210

Lorazepam Ativan 1–6Loxapine Loxitane, Adasuve 20–250Lurasidone Latuda 20–80Maprotiline Ludiomil 75–225Memantine Namenda

Namenda XR5–28

Mesoridazine SerentilLidanil

100–400

Methylphenidate ConcertaRitalin, Ritalin-SRRitalin LA, Metadate ER Metadate CD Methylin (chewable)Methylin ERDaytrana (Trans. Patch)Quillichew ERContempla XR-ODTFocalinFocalin XR

18–7210–60

20–60

5–3010–40

Mianserin Lerivon 30–90Milnacipran Savella

IxelToledomin

100–200

Mirtazapine Remeron 15–45Moclobemide Aurorix

ArimaManerix

300–600

Modafinil ProvigilAlertecModiodal

50–800

Molindone Moban 40–225Naltrexone Revia

Vivitrol (injection)50–150

380 mg/4 wksNaltrexone-Buproprion Contrave 16/180 bidNefazodone Serzone 300–600Nortriptyline Pamelor 50–300

TABLE 1 (Continued)


(Continued)


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(mg/day)Olanzapine Zyprexa

Symbyax (olanzapine-fluoxetine)

5–206–12/25–50

Oxazepam Serax 15–120Oxcarbazepine Trileptal

Oxtellar XR600–2,400

Paliperidone Paliperidone palmitate

InvegaInvega Sustenna

6–12

Paroxetine (Paxil CR) Paxil 20–50Perphenazine Trilafon 12–64Phenelzine Nardil 45–90Pimavanserin Nuplazid 34Pimozide Orap 1–10Pregabalin Lyrica 150–600Procyclidine Kemadrin 5–20Propranolol Inderal

InnoPran XL40–400

Protriptyline TriptilVivactil

15–60

Quazepam Doral 7.5–30Quetiapine Seroquel

Seroquel XR50–800

Ramelteon Rozerem 8Reboxetine Norebox

Erdonax2–10

Risperidone RisperdalRisperdal M-TabRisperdal Consta

2–16

Rivastigmine Exelon 6–12Selegiline Eldepryl

Emsam (patch)20–60

Sertindole Serdolect 12–24Sertraline Zoloft 50–200Sodium Oxybate Xyrem 6–9 g/nightSulpiride Dolmatil 150–2,400Suvorexant Belsomra 10–20Tasimelteon Hetilioz 20Temazepam Restoril 15–30Thioridazine Mellaril 200–800Thiothixene Navane 5–60Tiagabine Gabitril 4–56Tianeptine Coaxil

StablonTatinol

37.5

TABLE 1 (Continued)


(Continued)


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(mg/day)Topiramate Topamax

Qudexy XRTrokendi XR

200–400

Tranylcypromine Parnate 30–60Trazodone Desyrel 150–600Trazadone XR Oleptro 150–375Triazolam Halcion 0.125–0.5Trifluoperazine Stelazine 2–6Trihexyphenidyl Artane 2–30Trimipramine Maleate Surmontil 50–300Valproic Acid/750–4,200 Valproate sodiumDivalproex sodium

DepakeneDepaconDepakote

500–1,500

Venlafaxine Effexor,Effexor XR

75–375

Varenicline Chantix 0.5–4Vilazodone Viibryd 40Vortioxetine Trintellix 10–20Zaleplon Sonata 10–20Ziprasidone Geodon 40–200Zolpidem Ambien

Ambien-CR5–10

Zonisamide ZonegranExcegran

100–600

Zopiclone Imovane 7.5Zotepine Lodopin

Zoleptil75–300

Zuclopenthixol Clopixol 20–60

TABLE 1 (Continued)



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Psyc

ho

tr

oPI

c c

rIt

erIa

fo

r c

hIl

dr

en a

nd

ad

ole

scen

ts (

ta

bles

2–7

)TA

BLE

2

Com

bina

tion

Ant

ipsy

chot

ic/A

ntid

epre

ssan

t

DRUG

BRA

ND

NAM

E/GE

NER

IC N

AME

FDA

APPR

OVED

AGE/INDICATION*

PEDI

ATRI

C DO

SAGE

/SER

UM

LEVE

L W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION

Sym

byax

fluox

etine

& ol

anza

pine

Bipo

lar d

epre

ssio

n:

10 a

nd o

lder

3 m

g/25

mg–

12 m

g/

50 m

g da

ilyBl

ack B

ox W

arni

ngs:

1) U

sage

incr

ease

d th

e ris

k of

suici

dal t

hink

ing

and

beha

vior

s in

child

ren

and

adol

esce

nts w

ith m

ajor d

epre

ssiv

e di

sord

er a

nd

othe

r psy

chia

tric

diso

rder

s. 2)

Incr

ease

d m

orta

lity

in e

lder

ly p

atie

nts w

ith

dem

entia

-rela

ted

psyc

hosis

.W

arni

ngs a

nd p

reca

ution

s: 1)

Avo

id a

brup

t with

draw

al. 2

) Low

er st

artin

g do

ses r

ecom

men

ded

for t

hose

with

hep

atic

impa

irmen

t or p

oten

tial

for s

lowe

d m

etab

olism

and

thos

e pr

edisp

osed

to h

ypot

ensiv

e re

actio

ns.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant w

omen

.La

ctatio

n: B

oth

fluox

etin

e an

d ol

anza

pine

are

exc

rete

d in

hum

an b

reas

t m

ilk. S

tudi

es o

f flu

oxet

ine

have

show

n ad

vers

e ef

fect

s in

brea

stfed

in

fant

s, su

ch a

s cry

ing,

sleep

dist

urba

nces

, vom

iting

, and

wat

ery

stool

s. It

is re

com

men

ded

that

wom

en n

ot b

reas

tfeed

whi

le ta

king

Sym

byax

.N

ote:

*Adu

lt do

sing:

10-

20 m

g/da

y (o

ral o

r int

ram

uscu

lar),

6-12

mg

olan

zapi

ne, 2

5-50

mg

fluox

etin

e (o

lanza

pine

/fluo

xetin

e co

mbi

natio

n)


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TAB

LE 3

Ant

ipsy

chot

ics

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION

ANTI

PSYC

HOTI

C M

EDIC

ATIO

NS

Abi

lify

arip

ipra

zole*

(SG

A)Ir

ritab

ility

ass

ocia

ted

with

au

tistic

diso

rder

: 6 a

nd o

lder

Tour

ette

’s di

sord

er: 6

and

ol

der

Bipo

lar I

diso

rder

, man

ic or

mix

ed e

piso

des,

mon

othe

rapy

or a

s an

adj

unct

to li

thiu

m:

10 a

nd o

lder

Schi

zoph

reni

a: 13

and

old

er

2–15

mg

daily

(irr

itabi

lity

with

au

tistic

diso

rder

)<

50 k

g: 2

–10

mg

daily

>50

kg:

2–2

0 m

g da

ily

(Tou

rette

’s)2–

30 m

g da

ily (B

ipol

ar I,

m

anic

or m

ixed

, m

onot

hera

py o

r adj

unct

to

lithi

um)

2–30

mg

daily

(sch

izop

hren

ia)

Addi

tiona

l Bla

ck B

ox W

arni

ng: I

ncre

ased

risk

of s

uicid

al th

inki

ng a

nd b

ehav

iors

in sh

ort-

term

stud

ies i

n ch

ildre

n, a

doles

cent

s, an

d yo

ung

adul

ts ta

king

an

tidep

ress

ants.

Mon

itor f

or w

orse

ning

and

em

erge

nce

of su

icida

l tho

ught

s and

beh

avio

rs.

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

ext

rapy

ram

idal

diso

rder

, som

nolen

ce, t

rem

or, f

atig

ue, n

ause

a, ak

athi

sia,

blur

red

visio

n, e

xces

sive

saliv

a, se

datio

n, d

rool

ing,

decr

ease

d ap

petit

e, let

harg

y, fe

ver,

head

ache

, inc

reas

ed

appe

tite,

naso

phar

yngi

tis, a

nd d

izzi

ness

. 2) P

atie

nts

can

expe

rienc

e in

tens

e ur

ges f

or g

ambl

ing

and

othe

r co

mpu

lsive

beh

avio

rs (s

hopp

ing,

eatin

g, se

xual

urge

s, et

c.). 3

) Abi

lify

Mai

nten

a, an

d A

rista

da—

long

-act

ing

injec

tabl

e ve

rsio

ns o

f thi

s pro

duct

—ar

e no

t app

rove

d in

ped

iatri

c po

pulat

ions

.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pr

egna

nt w

omen

. In

anim

al stu

dies

, arip

ipra

zole

dem

onstr

ated

dev

elopm

enta

l tox

icity,

inclu

ded

poss

ible

tera

toge

nic

effe

cts.

Lacta

tion:

Arip

ipra

zole

is e

xcre

ted

in h

uman

br

east

milk

.


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(Con

tinue

d)

Saph

risas

enap

ine*

(SG

A)Bi

polar

man

ia: 1

0–17

2.5–

10 m

g tw

ice d

aily

War

ning

s and

pre

caut

ions:

1) C

an ca

use

QT

pro

long

atio

n,

seizu

res,

som

nolen

ce, d

izzin

ess,

naus

ea, i

ncre

ased

ap

petit

e, we

ight

gain

, fat

igue

, met

allic

taste

in m

outh

, an

d or

al tin

glin

g. 2)

Con

train

dica

ted

in th

ose

with

se

vere

hep

atic

impa

irmen

t. 3)

Effi

cacy

of a

sena

pine

was

N

OT

dem

onstr

ated

in c

linica

l tria

ls of

adol

esce

nts a

ged

12–1

7 wi

th sc

hizo

phre

nia.

4) A

sena

pine

is a

subl

ingu

al ta

blet

. It s

houl

d no

t be

swall

owed

but

shou

ld b

e pl

aced

un

der t

he to

ngue

and

left

to d

issol

ve co

mpl

etely

. The

ta

blet

will

diss

olve

in sa

liva

with

in se

cond

s. Ea

ting

and

drin

king

shou

ld b

e av

oide

d fo

r 10

min

utes

afte

r ad

min

istra

tion.

5) A

vaila

ble

in b

lack

cher

ry fl

avor

.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pr

egna

nt w

omen

.La

ctatio

n: It

is n

ot k

nown

if a

sena

pine

is e

xcre

ted

in

hum

an b

reas

t milk

. It i

s exc

rete

d in

the

milk

of r

ats

durin

g lac

tatio

n.R

exul

tibr

expi

praz

ole

(SG

A)

18 a

nd o

lder

N/A

Addi

tiona

l Bla

ck B

ox W

arni

ngs:

1) A

ntid

epre

ssan

ts in

crea

se th

e ris

k of

suici

dal t

houg

hts a

nd b

ehav

iors

in

patie

nts a

ged

24 y

ears

and

you

nger

. Mon

itor f

or c

linica

l wo

rseni

ng a

nd e

mer

genc

e of

suici

dal t

houg

hts a

nd

beha

vior

s. 2)

Saf

ety

and

effe

ctive

ness

of R

EXU

LTI

have

not

bee

n es

tabl

ished

in p

ediat

ric p

atien

ts.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es

in p

regn

ant w

omen

. No

adve

rse

deve

lopm

enta

l or

tera

toge

nic

effe

cts w

ere

seen

in a

nim

al stu

dies

.La

ctatio

n: It

is n

ot k

nown

if b

rexp

ipra

zole

and

its

met

abol

ites a

re e

xcre

ted

in h

uman

bre

ast m

ilk. I

t is

excr

eted

in


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Vray

lar

carip

razi

ne (S

GA)

18 a

nd o

lder

N/A

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

preg

nant

wom

en. N

o te

rato

geni

c effe

cts w

ere

seen

in

anim

al stu

dies

, but

ther

e we

re re

ports

of m

alfor

mat

ions

an

d de

velo

pmen

tal t

oxici

ties i

n ra

t pup

s.La

ctatio

n: It

is n

ot k

nown

if c

arip

razi

ne is

exc

rete

d in

hu

man

bre

ast m

ilk. I

t is e

xcre

ted

in th

e m

ilk o

f rat

s du

ring

lacta

tion.

Tho

razi

ne

chlor

prom

azin

e†

(FG

A)

Seve

re b

ehav

iora

l pro

blem

s m

arke

d by

com

bativ

enes

s an

d/or

exp

losiv

e hy

pere

xcita

ble

beha

vior

an

d sh

ort-

term

trea

tmen

t of

hyp

erac

tive

child

ren

who

show

exc

essiv

e m

otor

ac

tivity

with

acc

ompa

nyin

g co

nduc

t diso

rder

s con

sistin

g of

som

e or

all

of th

e fo

llowi

ng sy

mpt

oms:

impu

lsivi

ty, d

ifficu

lty

susta

inin

g at

tent

ion,

ag

gres

sion,

moo

d lab

ility,

an

d po

or fr

ustra

tion

toler

ance

: 6 m

os a

nd o

lder

Out

patie

nts:

0.25

mg/

lb b

ody

weig

ht e

very

4–6

hou

rs a

s ne

eded

Hos

pita

lized

pat

ient

s: sta

rt wi

th lo

w do

ses a

nd

incr

ease

gra

duall

y. In

seve

re

beha

vior

diso

rder

s, hi

gher

do

sage

s may

be

nece

ssar

y;

50–1

00 m

g da

ily. 2

00 m

g da

ily in

old

er c

hild

ren.

(se

vere

beh

avio

ral p

robl

ems)

**The

re is

littl

e ev

iden

ce th

at

beha

vior

impr

ovem

ent i

n se

vere

ly d

istur

bed

men

tally

re

tard

ed p

atie

nts i

s fur

ther

en

hanc

ed b

y do

ses b

eyon

d

War

ning

s and

pre

caut

ions:

1) M

ay a

lter c

ardi

ac c

ondu

ctio

n an

d ca

use

seda

tion,

Neu

rolep

tic M

align

ant S

yndr

ome,

and

weig

ht g

ain.

2) U

se c

autio

n wi

th re

nal d

iseas

e, se

izur

e di

sord

ers,

resp

irato

ry d

iseas

e, an

d in

acu

te

illne

ss. 3

) Sho

uld

gene

rally

not

be

used

in p

edia

tric

patie

nts u

nder

6 m

onth

s of a

ge e

xcep

t whe

n po

tent

ially

life

savi

ng.

Preg

nanc

y: Sa

fety

for t

he u

se o

f chl

orpr

omaz

ine

durin

g pr

egna

ncy

has n

ot b

een

esta

blish

ed. R

epro

duct

ive

studi

es in

rats

have

dem

onstr

ated

pot

entia

l for

em

bryo

toxi

city,

incr

ease

d ne

onat

al m

orta

lity,

and

decr

ease

d pe

rform

ance

in o

ffspr

ing.

The

pos

sibili

ty o

f pe

rman

ent n

euro

logi

cal d

amag

e ca

nnot

be

exclu

ded.

Lacta

tion:

Chl

orpr

omaz

ine

is ex

cret

ed in

hum

an

brea

st m

ilk.

TAB

LE 3

(Continued

)

Ant

ipsy

chot

ics

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




Nau

sea

and

vom

iting

: 6 m

os

and

olde

rPr

esur

gica

l app

rehe

nsio

n:

6 m

onth

s and

old

er

500

mg

per d

ay**

(Sev

ere

beha

vior

al pr

oblem

s) 0.

25 m

g/lb

bod

y we

ight

(a

djus

t dos

age

and

frequ

ency

bas

ed o

n se

verit

y of

sym

ptom

s and

resp

onse

of

the

patie

nt) (

Nau

sea

and

vom

iting

) 0.2

5 m

g/lb

2–

3 ho

urs b

efor

e op

erat

ion

(pre

surg

ical a

ppre

hens

ion)

Clo

zaril

clo

zapi

ne* (

SGA)

18 a

nd o

lder

N/A

Blac

k Box

War

ning

s: 1)

Agr

anul

ocyt

osis

2) S

eizu

res

3) M

yoca

rditi

s and

car

diom

yopa

thy

4) A

dver

se

card

iova

scul

ar a

nd re

spira

tory

effe

cts.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

preg

nant

wom

en. A

nim

al st

udie

s rev

ealed

no

evid

ence

of

impa

ired

ferti

lity

or h

arm

to th

e fe

tus.

Lacta

tion:

Clo

zapi

ne is

pre

sent

in h

uman

bre

ast m

ilk.

Hald

ol

halop

erid

ol† (F

GA)

Schi

zoph

reni

a: 3

and

olde

rTo

uret

te’s

synd

rom

e, an

d di

srup

tive

beha

vior

diso

rder

an

d A

DH

D: 3

and

old

er

0.05

–0.1

5 m

g/kg

/day

(sc

hizo

phre

nia)

0.05

–0.0

75 m

g/kg

/day

(T

oure

tte’s

and

AD

HD

)

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

seda

tion,

or

thos

tatic

hyp

oten

sion,

pho

tose

nsiti

vity,

con

stipa

tion,

dr

y m

outh

, and

pro

lactin

ele

vatio

n. 2

) Hald

ol

deca

noat

e, th

e lo

ng-a

ctin

g in

jecta

ble

vers

ion

of th

is pr

oduc

t, is

not a

ppro

ved

in p

edia

trics

.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pr

egna

nt w

omen

. Ani

mal

studi

es sh

ow h

alope

ridol

m

ay h

arm

fetu

s.La

ctatio

n: In

fant

s sho

uld

not b

e nu

rsed

whi

le on

ha

lope

ridol

(Con

tinue

d)


NOT FOR R

EPRINT




Fana

pt

ilope

ridon

e* (S

GA)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

pro

long

ed Q

Tc

inte

rval

and

pria

pism

. 2) N

ot re

com

men

ded

for

patie

nts w

ith se

vere

live

r im

pairm

ent

Preg

nanc

y: T

he li

mite

d av

ailab

le da

ta in

pre

gnan

t wom

en

is no

t suf

ficie

nt to

info

rm a

dru

g as

socia

ted

risk

for

majo

r def

ects

and

misc

arria

ge.

Lacta

tion:

It is

not

kno

wn if

ilop

erid

one

and

its

met

abol

ites a

re e

xcre

ted

in h

uman

milk

. It i

s exc

rete

d in

the

milk

of r

ats d

urin

g lac

tatio

n.Lo

xita

ne

loxap

ine†

(FG

A)18

and

old

erN

/AW

arni

ngs a

nd p

reca

ution

s: 1)

Sho

uld

be u

sed

in e

xtre

me

caut

ion

in p

atie

nts w

ith a

hist

ory

of c

onvu

lsive

di

sord

ers s

ince

it lo

wers

seiz

ure

thre

shol

d. 2

) Use

in

caut

ion

in th

ose

with

car

diov

ascu

lar d

iseas

e.Pr

egna

ncy:

Safe

use

in p

regn

ancy

has

not

bee

n es

tabl

ished

.La

ctatio

n: T

he e

xten

t of e

xcre

tion

in h

uman

milk

is

not k

nown

; how

ever

, lox

apin

e an

d its

met

abol

ites

have

bee

n sh

own

to b

e tra

nspo

rted

into

the

milk

of

lacta

ting

dogs

. Adm

inist

ratio

n to

nur

sing

wom

en

shou

ld b

e av

oide

d if

clini

cally

pos

sible.

Ada

suve

lox

apin

e† (F

GA)

18 a

nd o

lder

N/A

Addi

tiona

l Bla

ck B

ox W

arni

ng: C

an c

ause

bro

ncho

spas

m,

which

has

the

pote

ntia

l to

lead

to re

spira

tory

dist

ress

an

d re

spira

tory

arre

st. A

dmin

ister

Ada

suve

onl

y in

an

enro

lled

healt

hcar

e fa

cility

that

has

imm

edia

te a

cces

s on

-site

to e

quip

men

t and

per

sonn

el tra

ined

to m

anag

e

TAB

LE 3

(Continued

)

Ant

ipsy

chot

ics

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




(Con

tinue

d)

acut

e br

onch

ospa

smW

arni

ngs a

nd p

reca

ution

s: 1)

Ada

suve

is a

n in

haled

form

of

loxa

pine

. 2) I

s onl

y av

ailab

le th

roug

h a

restr

icted

pr

ogra

m u

nder

a R

isk E

valu

atio

n an

d M

itiga

tion

Stra

tegy

(REM

S) c

alled

Ada

suve

REM

SPr

egna

ncy:

Base

d on

ani

mal

data

, may

cau

se fe

tal h

arm

.La

ctatio

n: It

is n

ot k

nown

whe

ther

loxa

pine

is p

rese

nt

in h

uman

bre

ast m

ilk. L

oxap

ine

and

its m

etab

olite

s ar

e pr

esen

t in

the

brea

st m

ilk o

f lac

tatin

g do

gs.

Disc

ontin

ue d

rug

or n

ursin

g, ta

king

into

con

sider

atio

n im

porta

nce

of d

rug

to m

othe

r.La

tuda

lu

rasid

one (

SGA)

Schi

zoph

reni

a: 13

and

old

er40

–80

mg

daily

Addi

tiona

l Bla

ck B

ox W

arni

ngs:

Incr

ease

d ris

k of

su

icida

l thi

nkin

g an

d be

havi

or in

shor

t-te

rm st

udie

s in

chi

ldre

n, a

doles

cent

s, an

d yo

ung

adul

ts ta

king

an

tidep

ress

ants.

Mon

itor f

or w

orse

ning

and

em

erge

nce

of su

icida

l tho

ught

s and

beh

avio

rs.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

pre

gnan

t wom

en. N

o ad

vers

e de

velo

pmen

tal o

r te

rato

geni

c ef

fect

s wer

e se

en in

ani

mal

studi

es.

Lacta

tion:

It is

not

kno

wn if

lura

sidon

e an

d its

m

etab

olite

s are

exc

rete

d in

hum

an b

reas

t milk

. It

is e

xcre

ted

in th

e m

ilk o

f rat

s dur

ing

lacta

tion.

Mob

an

moli

ndon

e† (F

GA)

Schi

zoph

reni

a: 12

and

old

er15

mg–

225

mg

daily

de

pend

ing

on th

e se

verit

y of

the

diso

rder

and

resp

onse

to

trea

tmen

t

War

ning

s and

pre

caut

ions:

Dro

wsin

ess i

s the

mos

t fre

quen

tly o

ccur

ring

adve

rse

effe

ct.

Preg

nanc

y: A

nim

al re

prod

uctiv

e stu

dies

hav

e no

t de

mon

strat

ed a

tera

toge

nic

pote

ntia

l. The

ben

efits

m

ust b

e we

ighe

d ag

ains

t the

unk

nown

risk

s to

the

fetu

s if u

sed

in p

regn

ant p

atie

nts.


NOT FOR R

EPRINT




Lacta

tion:

It is

not

kno

wn if

mol

indo

ne is

exc

rete

d in

hu

man

bre

ast m

ilk.

Zyp

rexa

ola

nzap

ine*

(SG

A)Sc

hizo

phre

nia

and

bipo

lar I

diso

rder

, man

ia o

r mix

ed

episo

des:

13 a

nd o

lder

2.5–

20 m

g da

ilyW

arni

ngs a

nd p

reca

ution

s: 1)

May

cau

se se

datio

n,

incr

ease

d ap

petit

e, we

ight

gai

n, d

izzi

ness

, abd

omin

al pa

in, f

atig

ue, d

ry m

outh

, and

hea

dach

e. 2)

Zyp

rexa

R

elpre

v, th

e lo

ng-a

ctin

g in

jecta

ble

form

ulat

ion,

is n

ot

appr

oved

in p

edia

trics

.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pr

egna

nt w

omen

.La

ctatio

n: O

lanza

pine

is e

xcre

ted

in h

uman

bre

ast m

ilk.

Inve

ga

palip

erid

one*

(SG

A)Sc

hizo

phre

nia:

12 a

nd o

lder

<51

kg:

3–6

mg

daily

⩾

51 k

g: 3

–12

mg

daily

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

som

nolen

ce,

akat

hisia

, tre

mor

, dys

toni

a, co

gwhe

el rig

idity

, anx

iety,

we

ight

gai

n, a

nd ta

chyc

ardi

a. 2)

Use

can

cau

se a

n in

crea

se in

the

QT

inte

rval.

3) I

nveg

a Su

stenn

a an

d In

vega

Trin

za, l

ong-

actin

g in

jecta

ble

form

ulat

ions

, are

no

t app

rove

d in

ped

iatri

cs.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

preg

nant

wom

en. I

n an

imal

repr

oduc

tion

studi

es, t

here

we

re n

o in

crea

ses i

n fe

tal a

bnor

mali

ties.

Lacta

tion:

Pali

perid

one

is ex

cret

ed in

hum

an b

reas

t milk

.Tr

ilafo

n pe

rphe

nazi

ne†

(FG

A)

Schi

zoph

reni

a: 12

and

old

erA

dult

dosa

ges b

elow.

Se

e ad

ditio

nal i

nfor

mat

ion

note

in th

e ne

xt b

ox.

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

dys

toni

a, ne

urol

eptic

mali

gnan

t syn

drom

e, or

thos

tatic

hy

pote

nsio

n, w

eigh

t gai

n, e

ndoc

rine

chan

ges a

nd

TAB

LE 3

(Continued

)

Ant

ipsy

chot

ics

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




Ora

l: 2–

64 m

g da

ily (1

2–24

mg

is av

erag

e dail

y do

se)

Injec

tion:

5 m

g pe

r dos

e. In

jectio

n ca

n be

repe

ated

ev

ery

6 ho

urs,

not t

o ex

ceed

15

mg

in a

mbu

lator

y pa

tient

s or 3

0 m

g in

ho

spita

lized

pat

ient

s per

day

alter

atio

ns in

car

diac

con

ditio

n. 2

) Acc

ordi

ng to

the

label,

ped

iatri

c do

sage

s hav

e no

t bee

n es

tabl

ished

, but

th

ey re

com

men

ded

that

ped

iatri

c pat

ient

s ove

r 12

year

s m

ay re

ceiv

e th

e lo

west

limit

of a

dult

dosa

ge.

Preg

nanc

y: Sa

fe u

se in

pre

gnan

cy h

as n

ot b

een

esta

blish

ed.

Lacta

tion:

Saf

e us

e du

ring

lacta

tion

has n

ot b

een

esta

blish

ed.

Ora

p pi

moz

ide†

(FG

A)To

uret

te’s

diso

rder

: 12

and

olde

r⩾

12 y

rs: 0

.05

mg/

kg–

0.2

mg/

kg; n

ot to

exc

eed

10 m

g da

ily

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

dys

kine

sias,

dry

mou

th, c

onsti

patio

n, p

rolac

tin e

leva

tion,

and

pro

long

ed

QTc

inte

rval.

2) A

void

abr

upt w

ithdr

awal.

3) A

small

, op

en-la

bel s

tudy

(36

child

ren)

in c

hild

ren

ages

2–

12 d

emon

strat

ed th

at p

imoz

ide

has a

sim

ilar s

afet

y pr

ofile

in th

is ag

e gr

oup

as in

old

er p

atie

nts a

nd th

ere

were

no

safe

ty fi

ndin

gs th

at w

ould

pre

clude

its u

se in

th

is ag

e gr

oup.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

preg

nant

wom

en.

Lacta

tion:

It is

not

kno

wn w

heth

er p

imoz

ide

is ex

cret

ed

in h

uman

bre

ast m

ilk.

Sero

quel

queti

apin

e* (S

GA)

Bipo

lar I

diso

rder

: 10

and

old

erSc

hizo

phre

nia:

13 a

nd o

lder

25–6

00 m

g da

ily

25–8

00 m

g da

ilyW

arni

ngs a

nd p

reca

ution

s: 1)

May

cau

se d

yski

nesia

s, dr

y m

outh

, con

stipa

tion,

pro

lactin

ele

vatio

n, a

nd

prol

onge

d Q

Tc in

terv

al. 2

) Avo

id a

brup

t with

draw

al.

3) A

small

, ope

n-lab

el stu

dy (3

6 ch

ildre

n) in

chi

ldre

n ag

es 2

–12

dem

onstr

ated

pim

ozid

e ha

s a si

mila

r saf

ety

prof

ile in

this

age

grou

p as

in o

lder

pat

ient

s and

ther

e we

re n

o sa

fety

find

ings

that

wou

ld p

reclu

de it

s use

in

this

age

grou

p.(C

ontin

ued)


NOT FOR R

EPRINT




Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

preg

nant

wom

en.

Lacta

tion:

It is

not

kno

wn w

heth

er p

imoz

ide

is ex

cret

ed

in h

uman

bre

ast m

ilk.

Sero

quel

XR

queti

apin

e* (S

GA)

Bipo

lar I

diso

rder

: 10

and

olde

rSc

hizo

phre

nia:

13 a

nd o

lder

50–6

00 m

g da

ily

50–8

00 m

g da

ilyAd

ditio

nal B

lack

Box

War

ning

: Inc

reas

ed ri

sk o

f sui

cidal

thou

ghts

and

beha

vior

s in

child

ren,

ado

lesce

nts,

and

youn

g ad

ults

taki

ng a

ntid

epre

ssan

ts. M

onito

r for

wo

rsen

ing

and

emer

genc

e of

suici

dal t

houg

hts a

nd

beha

vior

s.W

arni

ngs a

nd p

reca

ution

s: M

ay c

ause

som

nolen

ce,

dizz

ines

s, fa

tigue

, inc

reas

ed a

ppet

ite, n

ause

a, vo

miti

ng,

dry

mou

th, t

achy

card

ia, a

nd w

eigh

t gai

n.Pr

egna

ncy:

Lim

ited

hum

an d

ata.

Base

d on

ani

mal

data

, m

ay c

ause

feta

l har

m.

Lacta

tion:

Que

tiapi

ne is

exc

rete

d in

hum

an b

reas

t milk

.R

isper

dal

rispe

ridon

e* (S

GA)

Irrit

abili

ty a

ssoc

iate

d wi

th

autis

tic d

isord

er: 5

and

old

erBi

polar

man

ia: 1

0 an

d ol

der

Schi

zoph

reni

a: 13

and

old

er

<20

kg:

0.2

5–3

mg

daily

>

20 k

g: 0

.5–3

mg

daily

0.

5–6

mg

daily

0.5

–6 m

g da

ily

War

ning

s and

pre

caut

ions:

1) R

isper

dal C

onsta

, the

lo

ng-a

ctin

g in

jecta

ble

form

ulat

ion,

is n

ot a

ppro

ved

in p

edia

trics

. 2) D

oses

abo

ve 2

.5 m

g da

ily in

bip

olar

m

ania

and

3 m

g da

ily in

schi

zoph

reni

a pr

ovid

ed n

o ad

ditio

nal c

linica

l ben

efit

in st

udie

s.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pr

egna

nt w

omen

. Bas

ed o

n an

imal

data

, may

cau

se

feta

l har

m.

TAB

LE 3

(Continued

)

Ant

ipsy

chot

ics

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




Lacta

tion:

Risp

erid

one

and

its m

etab

olite

are

pre

sent

in

hum

an b

reas

t milk

.M

ellar

ilth

iorid

azin

e†

(FG

A)

Trea

tmen

t ref

ract

ory

schi

zoph

reni

a: (a

ge n

ot

spec

ified

)

0.5–

3 m

g/kg

/day

Addi

tiona

l Bla

ck B

ox W

arni

ng: D

ose-

relat

ed p

rolo

ngat

ion

of Q

Tc in

terv

al m

ay c

ause

tors

ade

de p

oint

es-t

ype

arrh

ythm

ias a

nd su

dden

dea

th. U

se re

strict

ed to

sc

hizo

phre

nia

resis

tant

to st

anda

rd a

ntip

sych

otic

drug

s.W

arni

ngs a

nd p

reca

ution

s: FD

A la

bel d

oes n

ot in

clude

a

spec

ific

age.

It st

ates

med

icatio

n ca

n be

use

d in

ped

iatri

c pa

tient

s with

schi

zoph

reni

a wh

o ar

e un

resp

onsiv

e to

oth

er a

gent

s.Pr

egna

ncy:

No

tera

toge

nic

effe

cts r

epor

ted

in p

rodu

ct

labeli

ng.

Lacta

tion:

It is

not

kno

wn w

heth

er th

iorid

azin

e is

excr

eted

in h

uman

bre

ast m

ilk.

Nav

ane

thiot

hixe

ne†

(FG

A)Sc

hizo

phre

nia:

12 a

nd o

lder

6–60

mg

daily

War

ning

s and

pre

caut

ions:

May

cau

se C

NS

colla

pse,

CN

S de

pres

sion,

blo

od d

yscr

asia

s.Pr

egna

ncy:

Safe

use

of t

hiot

hixe

ne d

urin

g pr

egna

ncy

has

not b

een

esta

blish

ed.

Lacta

tion:

It is

not

kno

wn w

heth

er th

ioth

ixen

e is

excr

eted

in

hum

an b

reas

t milk

.St

elazi

ne

trifl

uope

razi

ne†

(FG

A)

Beha

vior

al di

sord

ers:

no a

ge

spec

ified

Psyc

hosis

: 6 a

nd o

lder

1–2

mg

daily

dep

endi

ng o

n th

e siz

e of

the

child

1–15

mg

daily

(som

e ol

der

child

ren

with

seve

re

sym

ptom

s may

requ

ire, a

nd

be a

ble

to to

lerat

e, hi

gher

do

sage

s)

War

ning

s and

pre

caut

ions:

May

cau

se C

NS

colla

pse,

CN

S de

pres

sion,

blo

od d

yscr

asia

s, bo

ne m

arro

w de

pres

sion,

an

d he

patic

impa

irmen

t.Pr

egna

ncy:

Stud

ies i

n pr

egna

nt w

omen

show

ed n

o ca

sual

relat

ions

hip

betw

een

the

drug

and

con

geni

tal

malf

orm

atio

ns.

Lacta

tion:

The

re is

evi

denc

e th

at tr

ifluo

pera

zine

is

excr

eted

in th

e m

ilk o

f nur

sing

mot

hers

.

(Con

tinue

d)


NOT FOR R

EPRINT




Geo

don

zipr

asid

one*

(SG

A)18

and

old

erN

/AW

arni

ngs a

nd p

reca

ution

s: 1)

Dos

es sh

ould

be

adm

inist

ered

with

food

. 2) U

se c

an c

ause

pro

long

ed

QTc

inte

rval.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

preg

nant

wom

en. I

n an

imal

studi

es, z

ipra

sidon

e de

mon

strat

ed d

evelo

pmen

tal t

oxici

ty, in

cludi

ng fe

tal

struc

tura

l abn

orm

alitie

s and

pos

sible

tera

toge

nic

effe

cts

at d

oses

sim

ilar t

o hu

man

ther

apeu

tic d

oses

.La

ctatio

n: It

is n

ot k

nown

whe

ther

zip

rasid

one

or it

s m

etab

olite

s are

exc

rete

d in

hum

an b

reas

t milk

. It

is re

com

men

ded

that

wom

en re

ceiv

ing

zipr

asid

one

shou

ld n

ot b

reas

tfeed

.N

otes

: Bla

ck B

ox W

arni

ng fo

r all

atyp

ical/s

econd

gene

ratio

n an

tipsy

chot

ics (S

GA)

: Inc

reas

ed m

orta

lity

in e

lder

ly p

atie

nts w

ith d

emen

tia-r

elate

d ps

ycho

sis.

*Pre

caut

ions w

hich

app

ly to

all

atyp

ical o

r seco

nd-g

ener

ation

ant

ipsy

chot

ics (S

GA)

: Neu

rolep

tic m

align

ant s

yndr

ome,

tard

ive

dysk

ines

ia, h

yper

glyc

emia

, dia

bete

s, we

ight

gai

n, a

kath

isa, a

nd

dysli

pide

mia

. As s

uch,

pat

ient

s on

thes

e dr

ugs s

houl

d ha

ve th

eir w

eigh

t, bl

ood

pres

sure

, glu

cose

, and

lipi

ds c

heck

ed b

efor

e sta

rting

thes

e m

edica

tions

and

rech

ecke

d at

12

week

s, on

e ye

ar, a

nd a

t lea

st on

ce a

nnua

lly a

fter t

hat.

† Preca

ution

s tha

t app

ly to

all

typi

cal o

r firs

t-ge

nera

tion

antip

sych

otics

(FG

A): E

xtra

pyra

mid

al sy

mpt

om, t

ardi

ve d

yski

nesia

.Pr

ecaut

ions t

hat a

pply

to a

ll an

tipsy

chot

ics: N

eona

tes e

xpos

ed to

ant

ipsy

chot

ic dr

ugs d

urin

g th

e th

ird tr

imes

ter o

f pre

gnan

cy a

re a

t risk

for e

xtra

pyra

mid

al an

d/or

with

draw

al sy

mpt

oms

TAB

LE 3

(Continued

)

Ant

ipsy

chot

ics

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




TAB

LE 4

Ant

idep

ress

ants

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM

LEVE

L W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION

Elav

il am

itrip

tylin

e‡ (tr

icycli

c [TC

A])

18 a

nd o

lder

N/A

War

ning

s and

preca

ution

s: A

ccor

ding

to th

e lab

el, th

e saf

ety a

nd ef

ficac

y of

amitr

ipty

line i

n pe

diat

ric p

atien

ts ha

s not

bee

n es

tabl

ished

. It i

s re

com

men

ded

that

this

drug

not

be u

sed

in p

atien

ts un

der 1

2 ye

ars o

f age

du

e to

lack

of ex

perie

nce w

ith th

e use

of t

his d

rug

in p

ediat

ric p

atien

ts.Pr

egna

ncy:

Am

itrip

tylin

e ha

s bee

n sh

own

to c

ross

the

plac

enta

. The

re

have

bee

n a

few

repo

rts o

f adv

erse

eve

nts,

inclu

ding

CN

S ef

fect

s, lim

b de

form

ities

, or d

evelo

pmen

tal d

elay

in in

fant

s who

se m

othe

rs to

ok

amitr

ipty

line

in p

regn

ancy

.La

ctatio

n: A

mitr

ipty

line

is ex

cret

ed in

to b

reas

t milk

. Bec

ause

of t

he

pote

ntia

l for

serio

us a

dver

se re

actio

ns in

nur

sing

infa

nts f

rom

am

itrip

tylin

e, a

decis

ion

shou

ld b

e m

ade

whet

her t

o di

scon

tinue

nu

rsin

g or

disc

ontin

ue th

e dr

ug.

Ase

ndin

am

oxap

ine‡ (

TCA)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

Mos

t com

mon

adv

erse

eve

nts a

re d

rows

ines

s, dr

y m

outh

, con

stipa

tion,

and

blu

rred

visio

n.Pr

egna

ncy:

No

tera

toge

nic

effe

cts w

ere

obse

rved

in m

ice, r

at, a

nd ra

bbit

studi

es. A

mox

apin

e sh

ould

onl

y be

use

d du

ring

preg

nanc

y if

bene

fit

outw

eigh

s risk

to fe

tus.

Lacta

tion:

Am

oxap

ine i

s exc

rete

d in

hum

an b

reas

t milk

. Cau

tion

shou

ld b

e ex

ercis

ed w

hen

used

in n

ursin

g wo

men

.W

ellbu

trin,

Well

butri

n SR

, Well

butri

n X

L,

Zyb

anbu

prop

ion (a

min

oketo

ne cl

ass)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

1) C

ontra

indi

cate

d in

thos

e wi

th se

izur

e di

sord

ers o

r a cu

rrent

or p

rior d

iagno

sis o

f bul

imia

or a

nore

xia.

2) C

an

incr

ease

blo

od p

ress

ure.

3) C

an c

ause

false

pos

itive

urin

e te

st re

sults

for

amph

etam

ines

.(C

ontin

ued)


NOT FOR R

EPRINT




Preg

nanc

y: D

ata

from

Inte

rnat

iona

l Bup

ropi

on P

regn

ancy

Reg

istry

(6

75 fi

rst-

trim

este

r pat

ient

s) an

d a

retro

spec

tive

coho

rt stu

dy u

sing

the

Uni

ted

Hea

lthca

re D

atab

ase

(121

3 fir

st-tri

mes

ter e

xpos

ures

) did

not

sh

ow a

n in

crea

sed

risk

for m

alfor

mat

ions

. Ani

mal

data

did

not

show

in

crea

sed

risk

of te

rato

geni

city.

Lacta

tion:

Bup

ropi

on a

nd it

s met

abol

ites a

re e

xcre

ted

in h

uman

bre

ast

milk

.C

elexa

cital

opra

m* (

SSRI

)18

and

old

erN

/APr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wom

en.

Ani

mal

repr

oduc

tion

studi

es h

ave s

hown

neg

ative

cons

eque

nces

on

feta

l and

pos

tnat

al de

velo

pmen

t, in

cludi

ng te

rato

geni

c effe

cts w

hen

adm

inist

ered

at d

oses

gre

ater

than

hum

an th

erap

eutic

dos

es.

Lacta

tion:

Cita

lopr

am is

exc

rete

d in

hum

an b

reas

t milk

. The

re h

ave

been

re

ports

of i

nfan

ts ex

perie

ncin

g ex

cess

ive

seda

tion,

dec

reas

ed fe

edin

g, an

d we

ight

loss

in a

ssoc

iatio

n wi

th b

reas

tfeed

ing.

Cau

tion

shou

ld b

e ex

ercis

ed a

nd b

reas

tfeed

ing

infa

nts s

houl

d be

obs

erve

d fo

r sid

e ef

fect

s wh

en g

iven

to a

nur

sing

wom

an.

Ana

frani

lclo

mip

ram

ine‡ (

TCA)

OC

D: 1

0 an

d ol

der

25–2

00 m

g da

ily o

r 3

mg/

kg/d

ay,

which

ever

is

less

War

ning

s and

pre

caut

ions:

1) T

he m

ost c

omm

only

obs

erve

d ad

vers

e ev

ents

are

gastr

oint

estin

al co

mpl

aint

s (in

cludi

ng d

ry m

outh

, con

stipa

tion,

na

usea

, dys

peps

ia, a

nore

xia,

trem

or, d

izzi

ness

, and

ner

vous

ness

). 2)

Se

izur

e wa

s the

mos

t sig

nific

ant r

isk o

f clo

mip

ram

ine

use

in p

rem

arke

t ev

aluat

ion.

3) U

se w

ith c

autio

n in

pat

ient

s with

a h

istor

y of

seiz

ures

or

pred

ispos

ing

fact

ors s

uch

as b

rain

dam

age.

Preg

nanc

y: N

o te

rato

geni

c effe

cts w

ere o

bser

ved

in m

ice an

d ra

t stu

dies

. W

ithdr

awal

sym

ptom

s—in

cludi

ng ji

tterin

ess,

trem

or, a

nd se

izure

s—ha

ve

TAB

LE 4

(Continued

)

Ant

idep

ress

ants

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM

LEVE

L W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




been

repo

rted

in n

eona

tes w

hose

mot

hers

hav

e ta

ken

clom

ipra

min

e un

til d

elive

ry. C

lom

ipra

min

e sh

ould

be

used

dur

ing

preg

nanc

y on

ly if

th

e be

nefit

out

weig

hs th

e ris

k to

the

fetu

s.La

ctatio

n: C

lom

ipra

min

e is

excr

eted

in h

uman

bre

ast m

ilk.

Prist

iqde

sven

lafa

xine

∞¥

(SN

RI)

18 a

nd o

lder

N/A

Preg

nanc

y: N

o ad

equa

te a

nd w

ell-c

ontro

lled

studi

es in

pre

gnan

t wom

en.

Base

d on

ani

mal

data

, des

venl

afax

ine

may

cau

se fe

tal h

arm

.La

ctatio

n: D

esve

nlaf

axin

e is

excr

eted

in h

uman

bre

ast m

ilk.

Sine

quan

do

xepi

n† (T

CA)

18 a

nd o

lder

N/A

War

ning

s and

prec

autio

ns: W

hile

the s

afet

y an

d ef

fect

ivene

ss in

the p

ediat

ric

popu

latio

n ha

ve n

ot b

een

esta

blish

ed, t

he p

rodu

ct la

belin

g sp

ecifi

cally

sa

ys u

se o

f dox

epin

in ch

ildre

n un

der 1

2 ye

ars o

f age

is n

ot re

com

men

ded

beca

use s

afe c

ondi

tions

for i

ts us

e hav

e not

bee

n es

tabl

ished

. Any

one

cons

ider

ing

the u

se o

f dox

epin

in a

child

or a

doles

cent

mus

t bala

nce t

he

risk

versu

s the

ben

efit.

Preg

nanc

y: Sa

fety

in p

regn

ancy

has

not

bee

n es

tabl

ished

.La

ctatio

n: T

here

hav

e be

en re

ports

of a

pnea

and

dro

wsin

ess o

ccur

ring

in

nurs

ing

mot

hers

taki

ng d

oxep

in.

Cym

balta

du

loxeti

ne∞

¥ (S

NRI

)

Gen

erali

zed

anxi

ety

diso

rder

(G

AD

):

7 an

d ol

der

30–1

20 m

g da

ilyPr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wom

en;

use

in p

regn

ancy

onl

y if

the

pote

ntia

l ben

efit

justi

fies t

he p

oten

tial r

isk

to th

e fe

tus.

Lacta

tion:

Dul

oxet

ine

is ex

cret

ed in

hum

an b

reas

t milk

.

Lexa

pro

escit

alop

ram

* (S

SRI)

Majo

r dep

ressi

ve

diso

rder

(M

DD

):

12 an

d ol

der

10–2

0 m

g da

ilyPr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wom

en;

use

in p

regn

ancy

onl

y if

the

pote

ntia

l ben

efit

justi

fies t

he p

oten

tial r

isk

to th

e fe

tus.

Lacta

tion:

Esc

italo

pram

is e

xcre

ted

in h

uman

bre

ast m

ilk. T

here

hav

e be

en

repo

rts o

f inf

ants

expe

rienc

ing

exce

ssive

seda

tion,

dec

reas

ed fe

edin

g, an

d we

ight

loss

in a

ssoc

iatio

n wi

th b

reas

tfeed

ing.

Cau

tion

shou

ld b

e ex

ercis

ed a

nd b

reas

tfeed

ing

infa

nts s

houl

d be

obs

erve

d fo

r sid

e ef

fect

s wh

en e

scita

lopr

am is

give

n to

a n

ursin

g wo

man

.(C

ontin

ued)


NOT FOR R

EPRINT




Proz

ac

fluox

etine

* (S

SRI)

MD

D: 8

and

ol

der

Obs

essiv

e co

mpu

lsive

di

sord

er

(OC

D):

7

and

olde

r

10–2

0 m

g da

ily (M

DD

) 10

–60

mg

daily

(O

CD

)

Preg

nanc

y: T

he e

ffect

on

labor

and

deli

very

in h

uman

s is u

nkno

wn.

Proz

ac d

oes c

ross

the

plac

enta

so th

ere

is a

poss

ibili

ty th

at it

may

hav

e ad

vers

e ef

fect

s on

the

newb

orn.

Pro

zac

shou

ld b

e us

ed in

pre

gnan

cy

only

if th

e po

tent

ial b

enef

it ju

stifie

s the

pot

entia

l risk

s to

the

fetu

s.La

ctatio

n: F

luox

etin

e is

excr

eted

in h

uman

bre

ast m

ilk. N

ursin

g wh

ile

taki

ng fl

uoxe

tine

is no

t rec

omm

ende

d.

Luvo

x flu

voxa

min

e*

(SSR

I)

OC

D: 8

and

ol

der

25–2

00 m

g da

ily (k

ids

over

age

11

may

nee

d do

ses u

p to

300

mg

daily

)

War

ning

s and

pre

caut

ions:

1) L

uvox

CR

is n

ot in

dica

ted

in c

hild

ren/

adol

esce

nts.

2) D

ecre

ased

app

etite

and

wei

ght l

oss h

ave

been

obs

erve

d wi

th p

edia

tric

use.

Reg

ular

mon

itorin

g of

wei

ght a

nd g

row

th is

re

com

men

ded.

Preg

nanc

y: T

he e

ffect

on

labor

and

deli

very

in h

uman

s is u

nkno

wn.

Lacta

tion:

Flu

voxa

min

e is

excr

eted

in h

uman

bre

ast m

ilk so

the

decis

ion

of w

heth

er to

disc

ontin

ue n

ursin

g or

disc

ontin

ue th

e dr

ug sh

ould

take

in

to a

ccou

nt th

e po

tent

ial f

or se

rious

adv

erse

effe

cts f

rom

exp

osur

e to

flu

voxa

min

e in

the

nurs

ing

infa

nts a

s well

as t

he p

oten

tial b

enef

it of

th

erap

y to

the

mot

her.

Tofra

nil

imip

ram

ine‡

(TC

A)

Bedw

ettin

g: 6

an

d ol

der

Age

s 6–1

1: 2

5–50

mg

daily

Age

s 12

and

olde

r:

25–7

5 m

g da

ily*D

o no

t exc

eed

2.

5 m

g/kg

/day

*

War

ning

s and

pre

caut

ions:

1) T

he m

ost c

omm

on a

dver

se e

ffect

s in

child

ren

with

bed

wetti

ng a

re n

ervo

usne

ss, s

leep

diso

rder

s, tir

edne

ss, a

nd m

ild

stom

ach

distu

rban

ces.

The

adv

erse

eve

nts u

suall

y di

sapp

ear d

urin

g co

ntin

ued

use

or w

hen

the

dosa

ge is

dec

reas

ed. 2

) Im

ipra

min

e sh

ould

on

ly b

e us

ed fo

r sho

rt-te

rm, a

dd-o

n th

erap

y. 3)

Tof

rani

l-PM

is n

ot

indi

cate

d in

child

ren.

It is

gen

erall

y re

com

men

ded

that

Tof

rani

l-PM

sh

ould

not

be

used

in ch

ildre

n be

caus

e of

the

incr

ease

d po

tent

ial fo

r

TAB

LE 4

(Continued

)

Ant

idep

ress

ants

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM

LEVE

L W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




*Giv

e on

e ho

ur b

efor

e be

dtim

e*ac

ute o

verd

ose d

ue to

the h

igh

unit

pote

ncy (

75, 1

00, 1

25, a

nd 1

50 m

g).

Any

one c

onsid

erin

g th

e use

Tof

rani

l-PM

(im

ipra

min

e pam

oate

) in

a ch

ild o

r ado

lesce

nt m

ust b

alanc

e the

pot

entia

l risk

s with

the c

linica

l nee

d.Pr

egna

ncy:

Shou

ld n

ot b

e us

ed in

wom

en w

ho a

re o

r mig

ht b

ecom

e pr

egna

nt, a

s the

re h

ave

been

clin

ical r

epor

ts of

con

geni

tal

malf

orm

atio

ns a

ssoc

iate

d wi

th th

e us

e of

imip

ram

ine.

Lacta

tion:

Lik

ely

to b

e ex

cret

ed in

hum

an b

reas

t milk

.M

arpl

an

isoca

rbox

azid

(M

AOI)

18 a

nd o

lder

N/A

War

ning

s and

preca

ution

s: 1)

The

safe

ty an

d ef

fecti

vene

ss in

ped

iatric

po

pulat

ions

has

not

bee

n de

mon

strat

ed, b

ut th

e pro

duct

labeli

ng sp

ecifi

cally

sa

ys m

arpl

an is

not

reco

mm

ende

d fo

r use

in p

atien

ts un

der 1

6 ye

ars o

f age

. 2)

Bec

ause

of a

dver

se re

actio

ns an

d nu

mer

ous d

rug

inte

racti

ons,

mar

plan

is

cons

ider

ed a

seco

nd li

ne ag

ent i

n th

ose w

ho h

ave f

ailed

oth

er ag

ents.

Preg

nanc

y: Sa

fety

in p

regn

ancy

has

not

bee

n es

tabl

ished

.La

ctatio

n: L

evels

of e

xcre

tion

into

bre

ast m

ilk a

nd e

ffect

s on

nurs

ing

infa

nts i

s unk

nown

.Fe

tzim

a lev

omiln

acip

ran

(S

NRI

)

18 a

nd o

lder

N/A

Preg

nanc

y: Sa

fety

in p

regn

ancy

has

not

bee

n es

tabl

ished

.La

ctatio

n: It

is n

ot k

nown

if le

vom

inalc

ipra

n is

excr

eted

in h

uman

bre

ast

milk

. Stu

dies

hav

e sh

own

that

it is

pre

sent

in th

e m

ilk o

f lac

tatin

g ra

ts.Lu

diom

il m

apro

tilin

e‡ (T

CA)

18 a

nd o

lder

N/A

Preg

nanc

y: Sa

fety

in p

regn

ancy

has

not

bee

n es

tabl

ished

.La

ctatio

n: M

apro

tilin

e is

excr

eted

in h

uman

bre

ast m

ilk. C

autio

n sh

ould

be

exe

rcise

d wh

en g

iven

to a

nur

sing

mot

her.

Rem

eron

m

irtaz

apin

e (te

tracy

clic)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

1) T

wo tr

ials

in 2

58 p

edia

tric

patie

nts w

ith

depr

essio

n we

re c

ondu

cted

by

the

man

ufac

ture

r and

the

data

was

not

su

fficie

nt to

supp

ort a

clai

m fo

r use

. 2) D

o no

t tak

e if

an M

AO

I was

us

ed w

ithin

the

past

14 d

ays.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant w

omen

. T

here

wer

e no

tera

toge

nic

effe

cts s

een

in a

nim

al stu

dies

.La

ctatio

n: M

irtaz

apin

e m

ay b

e ex

cret

ed in

to h

uman

bre

ast m

ilk so

ca

utio

n sh

ould

be

exer

cised

whe

n ad

min

ister

ed to

nur

sing

wom

en.

(Con

tinue

d)


NOT FOR R

EPRINT




Pam

elor

nort

ripty

line‡

(TC

A)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

Safe

ty a

nd e

ffect

iven

ess i

n th

e pe

diat

ric

popu

latio

n ha

s not

bee

n es

tabl

ished

. How

ever

, the

pac

kage

labe

ling

did

prov

ide

dosin

g fo

r ado

lesce

nts:

30–5

0 m

g/da

y (n

o sp

ecifi

c ag

e wa

s giv

en fo

r “ad

oles

cent

”).

Preg

nanc

y: Sa

fe u

se d

urin

g pr

egna

ncy h

as n

ot b

een

esta

blish

ed. A

nim

al stu

dies

hav

e yiel

ded

inco

nclu

sive r

esul

ts.La

ctatio

n: S

afe

use

durin

g lac

tatio

n ha

s not

bee

n es

tabl

ished

. Ani

mal

studi

es h

ave

yield

ed in

conc

lusiv

e re

sults

.Pa

xil,

Paxi

l CR

pa

roxe

tine*

(S

SRI)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

1) T

hree

plac

ebo

cont

rolle

d tri

als in

75

2 pa

tient

s with

dep

ress

ion

were

con

duct

ed w

ith p

arox

etin

e, an

d th

e da

ta w

ere

not s

uffic

ient

to su

ppor

t a c

laim

for u

se in

ped

iatri

c pa

tient

s. 2)

May

cau

se n

ause

a, so

mno

lence

, swe

atin

g, tre

mor

, abn

orm

al ph

ysica

l we

akne

ss o

r lac

k of

ene

rgy,

dry

mou

th, i

nsom

nia,

sexu

al dy

sfunc

tion,

co

nstip

atio

n, d

iarrh

ea, a

nd d

ecre

ased

app

etite

.Pr

egna

ncy:

Preg

nanc

y C

ateg

ory

D a

s a re

sult

of sc

ient

ific

evid

ence

of

posit

ive

tera

toge

nic

effe

cts,

parti

cular

ly c

ardi

ovas

cular

malf

orm

atio

ns.

Paro

xetin

e sh

ould

be

avoi

ded

in p

regn

ancy

if p

ossib

le.La

ctatio

n: P

arox

etin

e is

excr

eted

in h

uman

bre

ast m

ilk.

Nar

dil

phen

elzin

e (M

AOI)

18 a

nd o

lder

N/A

Preg

nanc

y: Sa

fety

in p

regn

ancy

has

not

bee

n es

tabl

ished

.La

ctatio

n: S

afet

y in

lact

atio

n ha

s not

bee

n es

tabl

ished

.V

ivac

til

prot

ripty

line‡

(TC

A)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

Safe

ty a

nd e

ffect

iven

ess i

n th

e pe

diat

ric

popu

latio

n ha

s not

bee

n es

tabl

ished

. How

ever

, the

pac

kage

labe

ling

does

pro

vide

dos

ing

guid

eline

s for

ado

lesce

nts:

5 m

g th

ree

times

dai

ly,

incr

ease

gra

duall

y if

nece

ssar

y (n

o sp

ecifi

c ag

e wa

s giv

en fo

r

TAB

LE 4

(Continued

)

Ant

idep

ress

ants

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM

LEVE

L W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




(Con

tinue

d)

“ado

lesce

nt” a

nd m

axim

um d

oses

wer

e no

t giv

en).

Em

sam

(pat

ch)

seleg

iline

(M

AO-B

inhi

bito

r/ph

eneth

ylam

ine c

lass)

18 a

nd o

lder

N/A

Preg

nanc

y: Sa

fety

in p

regn

ancy

has

not

bee

n es

tabl

ished

.La

ctatio

n: S

afet

y in

lact

atio

n ha

s not

bee

n es

tabl

ished

.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wom

en.

Lacta

tion:

It is

not

kno

wn if

seleg

iline

is e

xcre

ted

in h

uman

bre

ast m

ilk.

Stud

ies h

ave

show

n th

at it

is p

rese

nt in

the

milk

of l

acta

ting

rats.

Zol

oft

sertra

line*

(S

SRI)

OC

D: 6

and

ol

der

25–2

00 m

g da

ilyW

arni

ngs a

nd p

reca

ution

s: 1)

Sol

utio

n co

ntai

ns 1

2% a

lcoho

l. 2)

Stu

dies

in

dep

ress

ion

were

not

suffi

cient

to su

ppor

t an

indi

catio

n fo

r ped

iatri

c us

e.Pr

egna

ncy:

Ove

rall,

ava

ilabl

e pu

blish

ed st

udie

s sug

gest

no d

iffer

ence

in

majo

r birt

h de

fect

risk

. No

tera

toge

nicit

y wa

s obs

erve

d in

ani

mal

studi

es.

Lacta

tion:

Ser

tralin

e is

excr

eted

in h

uman

bre

ast m

ilk. I

n a

publ

ished

po

oled

ana

lysis

of 5

3 m

othe

r-in

fant

pai

rs in

whi

ch in

fant

s wer

e ex

clusiv

ely

fed

hum

an m

ilk, n

o ad

vers

e re

actio

ns w

ere

foun

d in

the

brea

stfed

infa

nts.

Parn

ate

trany

lcypr

omin

e (M

AOI)

18 a

nd o

lder

N/A

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant w

omen

. A

nim

al re

prod

uctiv

e stu

dies

show

that

tran

ylcy

prom

ine

pass

es th

roug

h th

e pl

acen

tal b

arrie

r to

the

fetu

s of r

ats.

Lacta

tion:

Tra

nylcy

prom

ine i

s exc

rete

d in

hum

an b

reas

t milk

.D

esyr

el, O

leptro

tra

zodo

ne

(sero

toni

n an

tago

nist

an

d re

upta

ke in

hibi

tor

[SAR

I] cla

ss)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

1) S

houl

d no

t be

used

with

in 1

4 da

ys o

f MA

OI

treat

men

t. 2)

Mon

itor f

or e

mer

genc

e of

man

ia/h

ypom

ania

. 3) M

ay

caus

e pr

olon

gatio

n of

the

QT

/QTc

inte

rval,

incr

ease

d ris

k of

blee

ding

, pr

iapi

sm, a

nd p

ossib

le hy

pona

trem

ia.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant w

omen

. So

me

rat a

nd ra

bbit

studi

es sh

ow a

dver

se e

ffect

s on

the

fetu

s at d

oses

hi

gher

than

the

max

imum

hum

an d

ose.

Lacta

tion:

Tra

zodo

ne a

nd it

s met

abol

ites a

re fo

und

in th

e m

ilk o

f lac

tatin

g ra

ts.


NOT FOR R

EPRINT




Surm

ontil

tr

imip

ram

ine‡

(TC

A)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

Tho

ugh

safe

ty a

nd e

ffect

iven

ess i

n th

e pe

diat

ric

popu

latio

n ha

s not

bee

n es

tabl

ished

, the

FD

A la

belin

g pr

ovid

es d

osin

g re

com

men

datio

ns fo

r ado

lesce

nt p

atie

nts o

f an

initi

al do

se o

f 50

mg

daily

with

gra

dual

incr

ease

s up

to 1

00 m

g pe

r day

(no

age

rang

e wa

s gi

ven

for “

adol

esce

nt”)

.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wom

en.

Trim

ipra

min

e ha

s sho

wn e

vide

nce

of e

mbr

yoto

xicit

y an

d/or

incr

ease

d in

ciden

ce o

f majo

r ano

mali

es in

rats

or ra

bbits

with

dos

es b

eyon

d th

ose

appr

oved

in h

uman

s.La

ctatio

n: E

ffect

s in

the

nurs

ing

infa

nt a

re u

nkno

wn.

Effe

xor,

Effe

xor X

R

venl

afax

ine∞

(S

NRI

)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

Acc

ordi

ng to

the

FDA

labe

ling,

two

plac

ebo-

cont

rolle

d tri

als in

766

ped

iatri

c pa

tient

s with

dep

ress

ion

and

two

plac

ebo

cont

rolle

d tri

als in

793

ped

iatri

c pa

tient

s with

anx

iety

hav

e be

en c

ondu

cted

with

Effe

xor X

R, a

nd th

e da

ta w

ere

not s

uffic

ient

to

supp

ort a

clai

m fo

r use

in p

edia

tric

patie

nts.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant w

omen

. R

at a

nd ra

bbit

studi

es d

id n

ot sh

ow te

rato

geni

city.

Effe

cts o

n lab

or a

nd

deliv

ery

in h

uman

s are

unk

nown

.La

ctatio

n: V

enlaf

axin

e is

excr

eted

in h

uman

bre

ast m

ilk.

Viib

ryd

vila

zodo

ne

(aty

pica

l ant

idep

ressa

nt)

18 a

nd o

lder

N/A

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant w

omen

. The

re

were

no

tera

toge

nic e

ffect

s see

n wh

en g

iven

to p

regn

ant r

ats o

r rab

bits.

Lacta

tion:

No

data

on

the

pres

ence

of v

ilazo

done

in h

uman

bre

ast m

ilk,

the

effe

cts o

n br

eastf

ed in

fant

s, or

the

effe

cts o

f the

dru

g on

milk

pr

oduc

tion.

It is

pre

sent

in th

e m

ilk o

f lac

tatin

g ra

ts.

TAB

LE 4

(Continued

)

Ant

idep

ress

ants

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM

LEVE

L W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




Trin

telli

x Vo

rtiox

etine

(a

typi

cal a

ntid

epre

ssant

–ser

oton

in m

odul

ator

)

18 a

nd o

lder

N/A

War

ning

s and

pre

caut

ions:

Prod

uct u

nder

went

a n

ame

chan

ge fr

om

Brin

telli

x to

Trin

telli

x on

5/2

/16

to d

ecre

ase

the

risk

of p

resc

ribin

g an

d di

spen

sing

erro

rs d

ue to

nam

e co

nfus

ion

with

Bril

anta

, an

antip

latele

t m

edica

tion.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant w

omen

. Ba

sed

on a

nim

al da

ta, v

ortio

xetin

e m

ay c

ause

feta

l har

m. V

ortio

xetin

e ca

used

dev

elopm

enta

l dela

ys w

hen

adm

inist

ered

to p

regn

ant r

ats a

nd

rabb

its. T

here

wer

e no

tera

toge

nic

effe

cts s

een

in ra

ts or

rabb

its.

Lacta

tion:

It is

not

kno

wn w

heth

er v

ortio

xetin

e is

excr

eted

in h

uman

br

east

milk

. It i

s pre

sent

in th

e m

ilk o

f lac

tatin

g ra

ts.N

otes

: ◊∞‡ B

lack

Box

War

ning

that

app

lies t

o all

antid

epre

ssant

s: In

crea

sed

risk

of su

icida

l thi

nkin

g an

d be

havi

ors i

n ch

ildre

n, a

doles

cent

s, an

d yo

ung

adul

ts (1

8–24

) with

majo

r dep

ress

ive

diso

rder

and

oth

er p

sych

iatri

c di

sord

ers.

Mon

itor f

or w

orse

ning

and

em

erge

nce

of su

icida

l tho

ught

s and

beh

avio

rs.

‡Tric

yclic

ant

idep

ress

ants

(TC

As)

are

not t

he d

rugs

of c

hoice

for p

edia

tric

patie

nts w

ith d

epre

ssio

n; th

ere

is lac

k of

hig

h-qu

ality

dat

a to

supp

ort e

ffica

cy a

nd sa

fety.

Mon

itorin

g of

ca

rdia

c fun

ctio

n is

wise

whe

n T

CA

s are

use

d in

child

ren.

◊∞Pr

ecau

tions

that

app

ly to

all

selec

tive

sero

toni

n-re

upta

ke in

hibi

tors

(SSR

Is) a

nd a

ll se

roto

nin

and

nore

pine

phrin

e re

upta

ke in

hibi

tors

(SN

RI) a

ntid

epre

ssan

ts: A

ctiv

atio

n of

man

ia/

hypo

man

ia, d

iscon

tinua

tion

synd

rom

e, in

crea

sed

risk

of b

leedi

ng a

nd u

se in

com

bina

tion

with

mon

oam

ine

oxid

ase

inhi

bito

rs (M

AO

Is).

◊∞¥ P

reca

ution

s tha

t app

ly to

all

SNRI

s: U

sed

in c

ombi

natio

n wi

th M

AO

Is, a

ctiv

atio

n of

man

ia/h

ypom

ania

, disc

ontin

uatio

n sy

ndro

me,

incr

ease

d ris

k of

blee

ding

.G

ener

al p

reca

ution

s for

MAO

Is: T

his c

lass i

s usu

ally

rese

rved

for p

atie

nts f

or w

hom

oth

er a

gent

s hav

e fa

iled

beca

use

of st

rict d

ieta

ry re

strict

ions

and

side

effe

cts.

Patie

nts m

ust a

void

food

s hi

gh in

tyra

min

e an

d alc

ohol

. Thi

s med

icatio

n sh

ould

not

be

used

if a

noth

er M

AO

I has

bee

n pr

evio

usly

pre

scrib

ed. S

erio

us, l

ife-t

hrea

teni

ng si

de e

ffect

s can

occ

ur if

isoc

arbo

xazi

d is

cons

umed

bef

ore

anot

her M

AO

I has

clea

red

from

the

body

.Pr

egna

ncy e

ffects

for S

SRIs/

SNRI

s: Ba

bies

exp

osed

to S

SRIs

and

SN

RIs l

ate

in th

e th

ird tr

imes

ter h

ave

deve

lope

d co

mpl

icatio

ns re

quiri

ng p

rolo

nged

hos

pita

lizat

ion,

resp

irato

ry su

ppor

t, an

d tu

be fe

edin

g. Su

ch c

ompl

icatio

ns c

an a

rise

imm

edia

tely

upo

n de

liver

y. O

ther

clin

ical f

indi

ngs h

ave

inclu

ded

resp

irato

ry d

istre

ss, c

yano

sis, a

pnea

, sei

zure

s, te

mpe

ratu

re in

stabi

lity,

feed

ing

diffi

culty

, vom

iting

, hyp

ogly

cem

ia, h

ypot

onia

, hyp

erto

nia,

hype

rreffe

xia,

trem

or, j

itter

ines

s, irr

itabi

lity,

and

cons

tant

cry

ing.


NOT FOR R

EPRINT




TAB

LE 5

Moo

d St

abil

izin

g an

d A

ntic

onvu

lsan

ts

DRUG

BRA

ND

NAM

E/GE

NER

IC N

AME

FDA

APPR

OVED

AGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS◊ A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION

MOO

D ST

ABIL

IZIN

G AN

D AN

TICO

NVU

LSAN

T M

EDIC

ATIO

NS

Tegr

etol

, Teg

reto

l X

R, C

arba

trol,

Epi

tol

carb

amaz

epin

e

Seiz

ures

: any

age

Und

er 6

: 10–

35 m

g/kg

/day

Age

6–1

2: 2

0–10

00 m

g da

ilyA

ge 1

3–15

: 400

–100

0 m

g da

ilyA

ge 1

6 an

d ol

der:

400–

1200

mg

daily

**Rec

omm

ende

d th

erap

eutic

seru

m le

vels:

4–

12 m

cg/m

L**

Blac

k Box

War

ning

: 1) S

teve

ns-J

ohns

on sy

ndro

me

(par

ticul

arly

am

ong

Asia

ns).

2) A

plas

tic a

nem

ia.

3) A

gran

uloc

ytos

is.W

arni

ngs a

nd pr

ecaut

ions:

1) M

ay ca

use n

eutro

peni

a and

hy

pona

trem

ia. 2

) Ind

uces

met

abol

ism o

f itse

lf an

d so

me o

ther

dru

gs. 3

) May

dec

reas

e effi

cacy

of o

ral

cont

race

ptive

s. 4)

Cau

ses t

erat

ogen

icity.

5) D

on’t u

se

with

in 1

4 da

ys o

f an

MAO

I. 6)

Teg

reto

l XR

does

not

ha

ve d

osin

g re

com

men

datio

ns fo

r pat

ients

unde

r 6.

Preg

nanc

y: M

ay c

ause

feta

l har

m w

hen

adm

inist

ered

to

preg

nant

wom

en. D

ata

sugg

est t

hat t

here

may

be

an

asso

ciatio

n wi

th c

onge

nita

l malf

orm

atio

ns (i

nclu

ding

sp

ina

bifid

a), c

onge

nita

l ano

mali

es, a

nd d

evelo

pmen

t di

sord

ers.

Lacta

tion:

Car

bam

azep

ine

and

its m

etab

olite

are

ex

cret

ed in

to h

uman

bre

ast m

ilk.

Equ

etro

ca

rbam

azep

ine

exten

ded

relea

se ca

psul

es

18 a

nd o

lder

N/A

Blac

k Box

War

ning

: 1) S

teve

ns-J

ohns

on sy

ndro

me

(par

ticul

arly

am

ong

Asia

ns).

2) A

plas

tic a

nem

ia.

3) A

gran

uloc

ytos

is.Pr

egna

ncy:

May

cau

se fe

tal h

arm

whe

n ad

min

ister

ed to

pr

egna

nt w

omen

. Dat

a su

gges

t tha

t the

re m

ay b

e an

as

socia

tion

with

con

geni

tal m

alfor

mat

ions

(inc

ludi

ng


NOT FOR R

EPRINT




spin

a bi

fida)

, con

geni

tal a

nom

alies

, and

dev

elopm

ent

diso

rder

s.La

ctatio

n: C

arba

maz

epin

e an

d its

met

abol

ite a

re

excr

eted

into

hum

an b

reas

t milk

.D

epak

ote,

Dep

akot

e ER

, D

epak

ote

Sprin

kles

diva

lpro

ex so

dium

— Dep

aken

e, St

avza

r va

lpro

ic ac

id

Seiz

ures

(mon

othe

rapy

an

d ad

junc

tive)

: 10

and

old

er

10–6

0 m

g/kg

/day

Rec

omm

ende

d th

erap

eutic

seru

m le

vels:

50

–100

mcg

/mL

Blac

k Box

War

ning

: 1) H

epat

oxici

ty. 2

) Ter

atog

enici

ty.

3) P

ancr

eatit

is.W

arni

ngs a

nd p

reca

ution

s: 1)

May

cau

se u

rea

cycle

di

sord

ers,

mul

ti-or

gan

hype

rsen

sitiv

ity re

actio

n,

thro

mbo

cyto

peni

a, wi

thdr

awal

seiz

ures

, sui

cidal

idea

tion,

and

pol

ycys

tic o

varie

s. 2)

Use

may

dec

reas

e th

e ef

ficac

y of

birt

h co

ntro

l pill

s, so

alte

rnat

ive

cont

race

ptio

n sh

ould

be

used

. 3) D

epak

ote

Sprin

kles

m

ay b

e sw

allow

ed w

hole

or th

e co

nten

ts of

the

caps

ule

may

be

sprin

kled

on

soft

food

. The

food

sh

ould

be

swall

owed

and

not

che

wed.

Preg

nanc

y: C

an c

ause

con

geni

tal m

alfor

mat

ions

in

cludi

ng n

eura

l tub

e de

fect

s and

dec

reas

ed IQ

.La

ctatio

n: E

xcre

ted

in h

uman

bre

ast m

ilk.

Neu

ront

inga

bape

ntin

Seiz

ures

(adj

unct

): 3

and

olde

rA

ges 3

–11:

10–

50 m

g/kg

/day

Age

s 12

and

olde

r: 90

0–24

00 m

g da

ily

(Dos

es o

f 360

0 m

g/da

y ha

ve a

lso b

een

adm

inist

ered

to a

small

num

ber o

f pa

tient

s for

shor

t dur

atio

n an

d ha

ve

been

well

toler

ated

)

War

ning

s and

pre

caut

ions:

Dos

age

adju

stmen

ts ne

cess

ary

for r

enal

impa

irmen

t or t

hose

und

ergo

ing

hem

odia

lysis

.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pr

egna

nt w

omen

. Bas

ed o

n an

imal

data

, may

cau

se

feta

l har

m.

Lacta

tion:

Gab

apen

tin is

exc

rete

d in

hum

an b

reas

t milk

.(C

ontin

ued)


NOT FOR R

EPRINT




Lam

ictal,

La

mict

al X

R

lam

otrig

ine

Epi

lepsy

(adj

unct

): 2

and

olde

rE

pilep

sy (m

onot

hera

py):

16 a

nd o

lder

Adju

nct d

osin

g:**F

or a

ll pa

tient

s con

veni

ent s

tarte

r pa

cks a

re a

vaila

ble

that

ens

ures

that

tit

ratio

n is

slow.

Thi

s will

help

avo

id

Stev

ens-

John

son.

**A

ge 2

–12:

0.1

5–15

mg/

kg/d

ay o

r m

axim

um 3

00 m

g da

ily (m

ax d

ose

is 40

0 m

g da

ily if

taki

ng c

onfli

ctin

g m

edica

tions

)12

and

old

er: 2

5 m

g ev

ery

othe

r da

y–37

5 m

g da

ily (m

ax d

ose

is 50

0 m

g da

ily if

taki

ng c

onfli

cted

med

icatio

ns)

**abo

ve d

oses

may

hav

e to

be

incr

ease

d or

dec

reas

ed fo

r tho

se p

atie

nts t

akin

g co

ncom

itant

valp

orat

e, ca

rbam

azep

ine,

phen

ytoi

n, p

heno

barb

ital,

or

prim

idon

e**

Mon

othe

rapy

dos

ing:

16 a

nd o

lder

: 200

–500

mg

daily

Blac

k Box

War

ning

: Ser

ious

, life

-thr

eate

ning

rash

es

inclu

ding

Ste

vens

-Joh

nson

synd

rom

e. T

he ra

te o

f se

rious

rash

is g

reat

er in

ped

iatri

c pa

tient

s tha

n in

ad

ults.

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

vom

iting

, in

fect

ion,

feve

r, ac

ciden

tal i

njur

y, di

arrh

ea, a

bdom

inal

pain

, and

trem

or. C

an a

lso c

ause

acu

te m

ulti-

orga

n fa

ilure

, with

draw

al se

izur

es, b

lood

dys

cras

ias,

hype

rsen

sitiv

ity, a

nd su

icida

l ide

atio

n. 2

) Has

be

en re

porte

d to

cau

se fa

lse p

ositi

ve re

adin

gs fo

r ph

ency

clidi

ne (P

CP)

in so

me

urin

e dr

ug sc

reen

s. 3)

Som

e es

troge

n-co

ntai

ning

con

trace

ptiv

es h

ave

been

show

n to

dec

reas

e se

rum

con

cent

ratio

ns o

f lam

otrig

ine,

so d

osag

e ad

justm

ents

may

be

nece

ssar

y. 4)

Saf

ety

and

effic

acy

for 1

0–17

-yea

r-ol

ds w

ith

bipo

lar d

isord

er o

r 1- t

o 2-

year

-old

s for

adj

unct

th

erap

y fo

r sei

zure

s was

not

esta

blish

ed.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in

preg

nant

wom

en. I

n an

imal

studi

es, l

amot

rigin

e wa

s dev

elopm

enta

lly to

xic

at d

oses

lowe

r tha

n th

ose

adm

inist

ered

clin

ically

.La

ctatio

n: L

amot

rigin

e is

excr

eted

in h

uman

bre

ast

milk

. Apn

ea, d

rows

ines

s, an

d po

or su

ckin

g ha

ve b

een

repo

rted

in m

ilk fe

d in

fant

s exp

osed

to la

mot

rigin

e.

TAB

LE 5

(Continued

)

Moo

d St

abil

izin

g an

d A

ntic

onvu

lsan

ts

DRUG

BRA

ND

NAM

E/GE

NER

IC N

AME

FDA

APPR

OVED

AGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

WHE

N A

PPLI

CABL

EBL

ACK

BOX

WAR

NIN

GS/W

ARN

INGS

AN

D

PREC

AUTI

ONS/

ADDI

TION

AL IN

FORM

ATIO

N


NOT FOR R

EPRINT




(Con

tinue

d)

Esk

alith

, Lith

obid

lithi

um ca

rbon

ate/

citra

te

Bipo

lar m

ania

: 12

and

olde

r30

0–2,

400

mg

daily

The

rape

utic

seru

m le

vels:

0.6

–1.2

mE

q/L

(toxi

c co

ncen

tratio

ns se

en a

t lev

els

grea

ter t

han

1.5

mE

q/L)

Blac

k Box

War

ning

: Tox

icity

abo

ve th

erap

eutic

seru

m

leve

ls.W

arni

ngs a

nd p

reca

ution

s: 1)

May

cau

se re

nal f

unct

ion

impa

irmen

t, po

lyur

ia, t

rem

or, d

iarrh

ea, n

ause

a, an

d hy

poth

yroi

d. 2

) Pat

ient

s with

sign

ifica

nt

rena

l or c

ardi

ovas

cular

dise

ase,

seve

re d

ebili

tatio

n,

dehy

drat

ion,

or s

odiu

m d

eplet

ion

are

at h

ighe

r risk

of

toxi

city.

Preg

nanc

y: Li

thiu

m m

ay c

ause

feta

l har

m w

hen

adm

inist

ered

to a

pre

gnan

t wom

an. D

ata

from

lit

hium

birt

h re

gistr

ies s

ugge

st an

incr

ease

in c

ardi

ac

and

othe

r abn

omali

es. I

f pos

sible,

lith

ium

shou

ld b

e wi

thdr

awn

for a

t lea

st th

e fir

st tri

mes

ter.

Lacta

tion:

Lith

ium

is e

xcre

ted

in h

uman

bre

ast m

ilk. I

t is

reco

mm

ende

d to

try

to a

void

bre

astfe

edin

g wh

ile

on li

thiu

m.

Trile

ptal

oxca

rbaz

epin

eSe

izur

es (m

onot

hera

py):

4 an

d ol

der

Seiz

ures

(adj

unct

):2

and

olde

r

Mon

othe

rapy

: 60

0–21

00 m

g da

ily (i

nitia

te a

t 8–

10 m

g/kg

/day

)A

djun

ct: 1

50–1

,800

mg

daily

(8–6

0 m

g/kg

/day

)**M

ax d

oses

are

dep

ende

nt o

n pa

tient

’s we

ight

**

War

ning

s and

pre

caut

ions:

1) M

ay c

ause

hyp

onat

rem

ia

and

suici

dal i

deat

ion.

2) M

ay d

ecre

ase

the

effe

ctiv

enes

s of h

orm

onal

cont

race

ptiv

es. 3

) Dos

e ad

justm

ents

nece

ssar

y in

thos

e wi

th a

cre

atin

ine

clear

ance

less

than

30

ml/m

in.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d cli

nica

l stu

dies

in p

regn

ant w

omen

. Clo

sely

relat

ed

struc

tura

lly to

car

bam

azep

ine,

which

is c

onsid

ered

to

be te

rato

geni

c in

hum

ans.

Ani

mal

studi

es sh

ow th

e po

tent

ial f

or h

arm

to th

e fe

tus a

s well

.La

ctatio

n: O

xcar

baze

pine

and

its a

ctiv

e m

etab

olite

are

ex

cret

ed in

hum

an b

reas

t milk

.


NOT FOR R

EPRINT




Topa

max

, To

pam

ax X

R

topi

ram

ate

Epi

lepsy

(mon

othe

rapy

an

d ad

junc

tive)

: 2

and

olde

rM

igra

ine:

12

and

old

er

Mon

othe

rapy

:10

and

old

er: 2

5–40

0 m

g da

ily (f

or th

ose

<10

, the

re a

re sp

ecifi

c we

ight

bas

ed

max

es)

Adju

nctiv

e:A

ge 2

–16:

25

mg

daily

–9 m

g/kg

/day

(R

ecom

men

ded

dose

: 5–9

mg/

kg/d

ay)

17 a

nd o

lder

: 25

–400

mg

daily

25–1

00 m

g da

ily (m

igra

ines

)

War

ning

s and

pre

caut

ions:

1) B

ecau

se o

f the

bitt

er

taste

, tab

lets s

houl

d no

t be

brok

en. 2

) Dec

reas

es th

e ef

ficac

y of

con

trace

ptiv

es a

nd c

an c

ause

incr

ease

d br

eakt

hrou

gh b

leedi

ng.

Preg

nanc

y: To

pira

mat

e ca

n ca

use

feta

l har

m w

hen

adm

inist

ered

to a

pre

gnan

t wom

an. I

nfan

ts ex

pose

d to

topi

ram

ate

have

an

incr

ease

d ris

k of

clef

t lip

and

/or

pala

te.

Lacta

tion:

Top

iram

ate

is ex

cret

ed in

hum

an b

reas

t milk

. T

he e

ffect

s of t

opira

mat

e ex

posu

re o

n br

eastf

ed

infa

nts a

re u

nkno

wn.

Trok

endi

XR

, Q

udex

y X

Rto

pira

mat

e

Epi

lepsy

(mon

othe

rapy

an

d ad

junc

tive

ther

apy)

: 6 a

nd o

lder

Mon

othe

rapy

:A

ges 6

–9: 2

5 m

g–40

0 m

g da

ilyA

ge 1

0 an

d ol

der:

50–4

00 m

g da

ilyAd

junc

tive:

25 m

g da

ily–9

mg/

kg/d

ay (R

ecom

men

ded

dose

: 5–9

mg/

kg/d

ay)

**Max

dos

es a

re d

epen

dent

on

the

child

’s we

ight

**

War

ning

s and

pre

caut

ions:

1) D

ecre

ases

the

effic

acy

of

cont

race

ptive

s and

can

cau

se in

crea

sed

brea

kthr

ough

bl

eedi

ng. 2

) Cap

sules

hav

e to

be

swall

owed

who

le an

d m

ay n

ot b

e sp

rinkl

ed o

n fo

od, c

rush

ed, o

r che

wed.

Preg

nanc

y: To

pira

mat

e ca

n ca

use

feta

l har

m w

hen

adm

inist

ered

to a

pre

gnan

t wom

an. I

nfan

ts ex

pose

d to

topi

ram

ate

have

an

incr

ease

d ris

k of

clef

t lip

and

/or

pala

te.

Lacta

tion:

Top

iram

ate

is ex

cret

ed in

hum

an b

reas

t milk

. T

he e

ffect

s of t

opira

mat

e ex

posu

re o

n br

eastf

ed

infa

nts a

re u

nkno

wn.

Not

e: ◊ T

he F

DA

has

a w

arni

ng o

n A

LL a

ntico

nvul

sant

s abo

ut th

e in

crea

sed

risk

of su

icida

l tho

ught

s and

beh

avio

r.

TAB

LE 5

(Continued

)

Moo

d St

abil

izin

g an

d A

ntic

onvu

lsan

ts

DRUG

BRA

ND

NAM

E/GE

NER

IC N

AME

FDA

APPR

OVED

AGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

WHE

N A

PPLI

CABL

EBL

ACK

BOX

WAR

NIN

GS/W

ARN

INGS

AN

D

PREC

AUTI

ONS/

ADDI

TION

AL IN

FORM

ATIO

N


NOT FOR R

EPRINT




TAB

LE 6

Anx

ioly

tics

DRUG

BRA

ND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM

LEVE

L W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION

Xan

ax

alpr

azola

m18

and

old

erN

/A

Busp

ar

busp

irone

Gen

erali

ze a

nxie

ty

diso

rder

: 6–1

7 ye

ars

7.5

mg–

60 m

g da

ilyLa

ctatio

n: T

he ex

tent

of e

xcre

tion

of b

uspi

rone

and

its m

etab

olite

s int

o hu

man

milk

is

not k

nown

. Bus

piro

ne a

nd it

s met

abol

ites a

re e

xcre

ted

in th

e m

ilk o

f lac

tatin

g ra

ts.Li

briu

m

chlor

diaz

epox

ide

Anx

iety

: 6 a

nd o

lder

10–3

0 m

g da

ily

Klo

nopi

n clo

naze

pam

18 a

nd o

lder

N/A

Tran

xene

clo

raze

pate

Parti

al se

izur

es: 9

–12

year

s15

–60

mg

daily

War

ning

s and

pre

caut

ions:

Rec

omm

ende

d to

mon

itor b

lood

coun

t and

live

r fun

ctio

n te

sts.

Valiu

m

diaz

epam

Anx

iety

: 6 m

onth

s an

d ol

der

1 m

g to

2.5

mg,

3 or

4

times

dai

ly

initi

ally;

incr

ease

gr

adua

lly a

s nee

ded

and

toler

ated

War

ning

s and

pre

caut

ions:

Acc

ordi

ng to

the

man

ufac

ture

r, or

al di

azep

am ta

blet

s ar

e co

ntra

indi

cate

d in

thos

e wi

th se

vere

hep

atic

dise

ase.

In g

ener

al, a

ll fo

rms o

f di

azep

am sh

ould

be

adm

inist

ered

cau

tious

ly to

pat

ient

s with

mild

to m

oder

ate

hepa

tic d

iseas

e, cir

rhos

is, h

epat

ic fib

rosis

, and

acu

te o

r chr

onic

hepa

titis,

bec

ause

its

elim

inat

ion

half-

life

can

be p

rolo

nged

, pos

sibly

resu

lting

in to

xicit

y.A

tivan

lor

azep

amA

nxie

ty: 1

2 an

d ol

der

2–10

mg

daily

Sera

x ox

azep

am18

and

old

erN

/A

Not

es: C

lassi

ficat

ion of

bus

piro

ne: a

nxio

lytic

psy

choa

ctiv

e dr

ug o

f the

aza

piro

nes c

hem

ical c

lass

War

ning

s/prec

autio

ns fo

r all b

enzo

diaz

epin

es: 1

) Avo

id ab

rupt

with

draw

al. T

hese

agen

ts sh

ould

be u

sed

for a

lim

ited

time p

erio

d, an

d di

scon

tinua

tion

of th

ese d

rugs

requ

ires t

aper

ing.

2)

Ben

zodi

azep

ines

shou

ld b

e adm

inist

ered

caut

ious

ly to

pat

ients

with

rena

l im

pairm

ent o

r ren

al fai

lure

, hep

atic

dise

ase,

or h

epat

ic en

ceph

alopa

thy.

3) L

iver a

nd re

nal f

uncti

on sh

ould

be m

onito

red

regu

larly

durin

g pr

olon

ged

ther

apy.

4) A

ssocia

ted

with

serio

us ad

verse

even

ts wh

en co

mbi

ned

with

opi

oids

, ben

zodi

azep

ines

, alco

hol, o

r oth

er d

rugs

that

dep

ress

the c

entra

l ner

vous

syste

m.

War

ning

s in

preg

nanc

y/la

ctatio

n for

benz

odia

zepi

nes:

1) H

ave

been

ass

ociat

ed w

ith n

egat

ive o

utco

mes

in p

regn

ant w

omen

, inc

ludi

ng te

rato

geni

city.

Use

of b

enzo

diaz

epin

es d

urin

g pr

egna

ncy,

parti

cular

ly in

the

first

trim

este

r, ge

nera

lly in

crea

ses t

he ri

sk o

f con

geni

tal m

alfor

mat

ions

and

dec

reas

es v

iabili

ty. 2

) Bec

ause

of t

he p

oten

tial f

or a

dver

se e

ffect

s in

nurs

ing

infa

nts—

such

as

seda

tion,

feed

ing

diffi

culti

es, b

reat

hing

diff

iculti

es, f

eedi

ng d

ifficu

lties

, and

weig

ht lo

ss—

it is

gene

rally

not

reco

mm

ende

d to

bre

astfe

ed d

urin

g us

e.


NOT FOR R

EPRINT




TAB

LE 7

AD

HD

Med

icat

ions

DRUG

BR

AND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION

AD

HD

Med

icat

ions

(Dru

gs b

elow

are s

timul

ants

, exc

ept a

tom

oxet

ine,

clon

idin

e, an

d gu

anfa

cine

)E

veke

o am

pheta

min

e sul

fate

AD

HD

: 3 a

nd o

lder

Nar

colep

sy:

6 an

d ol

der

Exo

geno

us o

besit

y: 1

2 an

d ol

der

2.5–

40 m

g da

ily (A

DH

D)

5–60

mg

daily

(Nar

colep

sy)

Up

to 3

0 m

g da

ily

(take

in d

ivid

ed d

oses

) 30

–60

min

utes

bef

ore

mea

ls (e

xoge

nous

obe

sity)

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant

wom

en. B

ased

on

anim

al da

ta, m

ay c

ause

feta

l har

m.

Lacta

tion:

Am

phet

amin

es a

re e

xcre

ted

in h

uman

bre

ast m

ilk.

Adz

enys

XR

amph

etam

ine

exten

ded

relea

se

AD

HD

: 6 a

nd o

lder

Age

s 6–1

2: 6

.3–1

8.8

mg

daily

Age

s 13

and

olde

r: 6.

3–12

.5 m

g da

ily

War

ning

s and

pre

caut

ions:

1) A

dzen

ys X

R is

the

first

amph

etam

ine

exte

nded

relea

se o

rally

disi

nteg

ratin

g ta

blet

. 2) D

o no

t su

bstit

ute

for o

ther

am

phet

amin

e pr

oduc

ts on

a m

g/m

g ba

sis.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant

wom

en. B

ased

on

anim

al da

ta, m

ay c

ause

feta

l har

m.

Lacta

tion:

Am

phet

amin

es a

re e

xcre

ted

in h

uman

bre

ast m

ilk.

Dya

nave

l XR

am

pheta

min

e ex

tende

d re

lease

AD

HD

: 6 a

nd o

lder

2.5–

20 m

g da

ilyW

arni

ngs a

nd p

reca

ution

s: 1)

Liq

uid

solu

tion

that

nee

ds to

be

shak

en p

rior t

o us

e. 2)

Do

not s

ubsti

tute

for o

ther

am

phet

amin

e pr

oduc

ts on

a m

g/m

g ba

sisPr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wo

men

. Bas

ed o

n an

imal

data

, may

cau

se fe

tal h

arm

.La

ctatio

n: A

mph

etam

ines

are

exc

rete

d in

hum

an b

reas

t milk

.


NOT FOR R

EPRINT




(Con

tinue

d)

Add

erall

M

ixed

am

pheta

min

e sa

lts

AD

HD

: 3 a

nd o

lder

N

arco

lepsy

: 6 a

nd

olde

r

2.5–

40 m

g da

ily (A

DH

D)

5–60

mg

daily

(N

arco

lepsy

)

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant

wom

en. B

ased

on

anim

al da

ta, m

ay c

ause

feta

l har

m.

Lacta

tion:

Am

phet

amin

es a

re e

xcre

ted

in h

uman

bre

ast m

ilk.

Add

erall

XR

M

ixed

am

pheta

min

e sa

lts ex

tende

d re

lease

AD

HD

: 6 a

nd o

lder

Age

s 6–1

2: 1

0–30

mg

daily

Age

s 13

and

olde

r:

10–2

0 m

g da

ily

War

ning

s and

pre

caut

ions:

Cap

sule

may

be

open

ed a

nd sp

rinkl

ed

on so

ft fo

ods.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant

wom

en. B

ased

on

anim

al da

ta, m

ay c

ause

feta

l har

m.

Lacta

tion:

Am

phet

amin

es a

re e

xcre

ted

in h

uman

bre

ast m

ilk.

Stra

ttera

at

omox

etine

AD

HD

: 6 a

nd o

lder

Up

to 7

0 kg

: 0.5

–1.4

mg/

kg

(less

er o

f 1.4

mg/

kg

or 1

00 m

g)O

ver 7

0 kg

: 40

–100

mg

daily

Blac

k Box

War

ning

: Inc

reas

ed ri

sk o

f sui

cidal

idea

tion

in c

hild

ren

or a

doles

cent

s.W

arni

ngs a

nd p

reca

ution

s: 1)

Do

not o

pen

caps

ule;

mus

t be

swall

owed

who

le. 2

) May

cau

se li

ver i

njur

y, ad

vers

e ps

ychi

atric

ev

ents,

incr

ease

blo

od p

ress

ure

and

hear

t rat

e, an

d se

rious

ca

rdio

vasc

ular

eve

nts,

inclu

ding

sudd

en d

eath

, par

ticul

arly

in

thos

e wi

th p

reex

istin

g str

uctu

ral c

ardi

ac a

bnor

mali

ties

or se

rious

hea

rt pr

oblem

s.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wo

men

.La

ctatio

n: It

is n

ot k

nown

if a

tom

oxet

ine

is ex

cret

ed in

hum

an

brea

st m

ilk. A

tom

oxet

ine

and/

or it

s met

abol

ites a

re e

xcre

ted

in th

e br

east

milk

of r

ats.

Kap

vay

cloni

dine

exten

ded

relea

se (E

R)

AD

HD

(mon

othe

rapy

or

adj

unct

to

stim

ulan

ts): 6

–17

0.1–

0.4

mg

daily

War

ning

s and

pre

caut

ions:

1) C

an lo

wer b

lood

pre

ssur

e an

d ca

use

seda

tion.

2) D

o no

t cru

sh, c

hew,

or b

reak

tabl

ets b

efor

e sw

allow

ing.

3) D

o no

t adm

inist

er w

ith h

igh-

fat m

eals

due

to

incr

ease

d ex

posu

re. 4

) May

not

see

effe

cts u

ntil

4–6

week

s. 5)

To

avoi

d re

boun

d hy

perte

nsio

n, d

o no

t abr

uptly

disc

ontin

ue.


NOT FOR R

EPRINT




6) Im

med

iate

-rele

ase

form

s of c

loni

dine

(Cat

apre

s) ar

e no

t FD

A a

ppro

ved

for u

se in

chi

ldre

n.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wo

men

.La

ctatio

n: C

loni

dine

is e

xcre

ted

in h

uman

bre

ast m

ilk.

Foca

lin

dexm

ethylp

heni

date

AD

HD

: 6–1

75–

20 m

g da

ilyPr

egna

ncy:

Lim

ited

hum

an d

ata.

Base

d on

ani

mal

data

, may

cau

se

feta

l har

m.

Lacta

tion:

It is

not

kno

wn w

heth

er d

exm

ethy

lphe

nida

te is

ex

cret

ed in

hum

an b

reas

t milk

.Fo

calin

XR

de

xmeth

ylphe

nida

te ex

tende

d re

lease

AD

HD

: 6 a

nd o

lder

5–30

mg

daily

War

ning

s and

pre

caut

ions:

1) C

apsu

le co

nten

ts ca

n be

sprin

kled

on

app

lesau

ce a

nd sw

allow

ed w

hole.

2) C

apsu

le sh

ould

not

be

crus

hed,

che

wed,

or d

ivid

ed.

Preg

nanc

y: Li

mite

d hu

man

dat

a. Ba

sed

on a

nim

al da

ta, m

ay c

ause

fe

tal h

arm

.La

ctatio

n: It

is n

ot k

nown

whe

ther

dex

met

hylp

heni

date

is

excr

eted

in h

uman

bre

ast m

ilk.

Dex

edrin

e, Pr

oCen

tra

Ora

l Sol

utio

n,

Zen

zedi

, D

extro

Stat

de

xtro

amph

etam

ine

AD

HD

: 3 a

nd o

lder

N

arco

lepsy

: 6

and

olde

r

2.5–

40 m

g da

ily (A

DH

D)

5–60

mg

daily

(nar

colep

sy)

War

ning

s and

pre

caut

ions:

Ext

ende

d re

lease

span

ules

can

be

used

on

ce a

day

whe

n ap

prop

riate

, tab

lets n

eed

to b

e gi

ven

mul

tiple

times

per

day

at i

nter

vals

of 4

–6 h

ours

.Pr

egna

ncy:

No

adeq

uate

or w

ell c

ontro

lled

studi

es in

pre

gnan

t wo

men

. Bas

ed o

n an

imal

data

, may

cau

se fe

tal h

arm

.La

ctatio

n: A

mph

etam

ines

are

exc

rete

d in

hum

an b

reas

t milk

.

TAB

LE 7

(Continued

)

AD

HD

Med

icat

ions

DRUG

BR

AND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




Intu

niv

guan

facin

e ext

ende

d re

lease

AD

HD

(mon

othe

rapy

an

d ad

junc

t to

stim

ulan

ts):

6 an

d ol

der

Age

s 6–1

2: 1

–4 m

g da

ily

(less

er o

f 0.1

2 m

g/kg

or

4 m

g da

ily)

Age

s 13–

17: 1

–7 m

g da

ily**m

ax d

ose

depe

nds o

n we

ight

of c

hild

**

War

ning

s and

pre

caut

ions:

1) S

edat

ion,

som

nolen

ce, a

nd fa

tigue

ar

e co

mm

on a

nd te

nd to

dec

line

over

tim

e. 2)

Do

not c

rush

, ch

ew, o

r bre

ak ta

blet

s. 3)

Do

not a

dmin

ister

with

hig

h fa

t m

eal.

4) D

o no

t disc

ontin

ue a

brup

tly. 5

) Dos

age

adju

stmen

ts ne

cess

ary

if us

ed w

ith st

rong

3A

4 in

hibi

tors

or i

nduc

ers.

6) Im

med

iate

relea

se g

uanf

acin

e/Te

nex

is ap

prov

ed fo

r hy

perte

nsio

n on

ly in

pat

ient

s 12

and

olde

r.Pr

egna

ncy:

No

adeq

uate

or w

ell-c

ontro

lled

studi

es in

pre

gnan

t wo

men

.La

ctatio

n: It

is n

ot k

nown

whe

ther

gua

nfac

ine

is ex

cret

ed in

hu

man

bre

ast m

ilk; h

owev

er, i

t is e

xcre

ted

in ra

t milk

.Vy

vans

e lis

dexa

mfet

amin

e di

mesy

late

AD

HD

: 6–1

730

–70

mg

daily

Add

ition

al In

form

atio

n: 1

) Dos

age

adju

stmen

ts ne

eded

for

rena

l im

pairm

ent.

2) C

apsu

les c

an b

e op

ened

and

mix

ed in

yo

gurt,

wat

er, o

r ora

nge

juice

. The

con

tent

s sho

uld

be m

ixed

un

til c

ompl

etel

y di

sper

sed,

and

the

entir

e m

ixtu

re sh

ould

be

cons

umed

imm

edia

tely.

Preg

nanc

y: Li

mite

d av

ailab

le da

ta fr

om p

ublis

hed

liter

atur

e an

d po

st-m

arke

ting

repo

rts a

re n

ot su

fficie

nt to

info

rm a

dru

g-as

socia

ted

risk

for b

irth

defe

cts a

nd m

iscar

riage

.La

ctatio

n: A

mph

etam

ines

are

pre

sent

in h

uman

bre

ast m

ilk.

Des

oxyn

m

etham

pheta

min

eA

DH

D: 6

and

old

erO

besit

y (sh

ort t

erm

): 12

an

d ol

der

5–25

mg

daily

5 m

g th

irty

min

utes

bef

ore

each

mea

l; tre

atm

ent

shou

ld n

ot e

xcee

d a

few

week

s.

Preg

nanc

y: N

o ad

equa

te o

r well

-con

trolle

d stu

dies

in p

regn

ant

wom

en. B

ased

on

anim

al da

ta, m

ay c

ause

feta

l har

m.

Lacta

tion:

Am

phet

amin

es a

re e

xcre

ted

in h

uman

bre

ast m

ilk.

(Con

tinue

d)


NOT FOR R

EPRINT




Rita

lin, M

ethy

lin

meth

ylphe

nida

teA

DH

D: 6

and

old

er10

–60

mg

daily

War

ning

s and

pre

caut

ions:

Met

hylin

is a

che

wabl

e ta

blet

. It s

houl

d be

take

n wi

th a

t lea

st 8

ounc

es o

f wat

er o

r oth

er fl

uid

to

prev

ent c

hoki

ng.

Preg

nanc

y: T

here

are

lim

ited

publ

ished

stud

ies a

nd sm

all c

ase

serie

s tha

t rep

ort o

n th

e us

e of

met

hylp

heni

date

in p

regn

ant

wom

en; h

owev

er, t

he d

ata

are

insu

fficie

nt to

info

rm a

ny d

rug

asso

ciate

d ris

ks.

Lacta

tion:

Lim

ited

publ

ished

lite

ratu

re re

ports

that

m

ethy

lphe

nida

te is

pre

sent

in h

uman

bre

ast m

ilk.

Met

hylin

ER

, M

etad

ate

ER,

Rita

lin S

R,

Apt

ensio

XR

meth

ylphe

nida

te ex

tende

d re

lease

AD

HD

: 6 a

nd o

lder

10–6

0 m

g da

ilyW

arni

ngs a

nd p

reca

ution

s: 1)

Apt

ensio

XR

cap

sules

can

be

open

ed a

nd th

e co

nten

ts ca

n be

sprin

kled

ove

r a sp

oonf

ul o

f ap

ples

auce

. Thi

s mix

ture

shou

ld b

e co

nsum

ed in

its e

ntire

ty. 2

) R

italin

SR

tabl

ets m

ust b

e sw

allow

ed w

hole

and

neve

r cru

shed

or

che

wed.

Preg

nanc

y: T

here

are

lim

ited

publ

ished

stud

ies a

nd sm

all c

ase

serie

s tha

t rep

ort o

n th

e us

e of

met

hylp

heni

date

in p

regn

ant

wom

en; h

owev

er, t

he d

ata

are

insu

fficie

nt to

info

rm a

ny d

rug

asso

ciate

d ris

ks.

Lacta

tion:

Lim

ited

publ

ished

lite

ratu

re re

ports

that

m

ethy

lphe

nida

te is

pre

sent

in h

uman

bre

ast m

ilk.

TAB

LE 7

(Continued

)

AD

HD

Med

icat

ions

DRUG

BR

AND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




Rita

lin L

A,

Met

adat

e C

D,

Qui

lliC

hew

ER,

Qui

lliva

nt X

Rm

ethylp

heni

date

exten

ded

relea

se

AD

HD

: 6 a

nd o

lder

20–6

0 m

g da

ilyW

arni

ngs a

nd p

reca

ution

s: 1)

Rita

lin L

A a

nd M

etad

ate

CD

ca

psul

es c

an b

e op

ened

and

the

cont

ents

can

be sp

rinkl

ed

over

a sp

oonf

ul o

f app

lesau

ce. T

his m

ixtu

re sh

ould

be

cons

umed

in it

s ent

irety.

2) Q

uilli

Che

w ER

is th

e fir

st on

ce-

daily

long

-lasti

ng m

ethy

lphe

nida

te c

hewa

ble

tabl

et. I

t can

be

bro

ken

in h

alf. 3

) Qui

lliva

nt X

R is

the

first

once

-dai

ly

long

-lasti

ng m

ethy

lphe

nida

te li

quid

. It n

eeds

to b

e sh

aken

vi

goro

usly

for a

t lea

st 10

seco

nds b

efor

e us

e.Pr

egna

ncy:

The

re a

re li

mite

d pu

blish

ed st

udie

s and

small

cas

e se

ries t

hat r

epor

t on

the

use

of m

ethy

lphe

nida

te in

pre

gnan

t wo

men

; how

ever

, the

dat

a ar

e in

suffi

cient

to in

form

any

dru

g as

socia

ted

risks

.La

ctatio

n: L

imite

d pu

blish

ed li

tera

ture

repo

rts th

at

met

hylp

heni

date

is p

rese

nt in

hum

an b

reas

t milk

.C

once

rta

meth

ylphe

nida

te lon

g acti

ng

AD

HD

: 6 a

nd o

lder

Age

s 6–1

2: 1

8–54

mg

daily

Age

s 13–

17: 1

8–72

mg

daily

(not

to e

xcee

d 2

mg/

kg/d

ay)

War

ning

s and

pre

caut

ions:

Shou

ld b

e sw

allow

ed w

hole

and

not

chew

ed o

r cru

shed

.Pr

egna

ncy:

The

re a

re li

mite

d pu

blish

ed st

udie

s and

small

cas

e se

ries t

hat r

epor

t on

the

use

of m

ethy

lphe

nida

te in

pre

gnan

t wo

men

; how

ever

, the

dat

a ar

e in

suffi

cient

to in

form

any

dru

g as

socia

ted

risks

.La

ctatio

n: L

imite

d pu

blish

ed li

tera

ture

repo

rts th

at

met

hylp

heni

date

is p

rese

nt in

hum

an b

reas

t milk

.D

aytra

nam

ethylp

heni

date

patch

AD

HD

: 6–1

710

–30

mg

daily

War

ning

s and

pre

caut

ions:

Shou

ld b

e ap

plie

d to

the

hip

area

two

hour

s bef

ore

an e

ffect

is n

eede

d an

d re

mov

ed n

ine

hour

s afte

r ap

plica

tion

(alte

rnat

e hi

ps).

Preg

nanc

y: T

here

are

lim

ited

publ

ished

stud

ies a

nd sm

all c

ase

serie

s tha

t rep

ort o

n th

e us

e of

met

hylp

heni

date

in p

regn

ant

(Con

tinue

d)


NOT FOR R

EPRINT




wom

en; h

owev

er, t

he d

ata

are

insu

fficie

nt to

info

rm a

ny d

rug

asso

ciate

d ris

ks.

Lacta

tion:

Lim

ited

publ

ished

lite

ratu

re re

ports

that

m

ethy

lphe

nida

te is

pre

sent

in h

uman

bre

ast m

ilk.

Not

es: C

lassi

ficat

ion of

non

stim

ulan

t dru

gs: (

1) a

tom

oxet

ine

is a

selec

tive

nore

pine

phrin

e re

upta

ke in

hibi

tor,

or N

RI; (

2) c

loni

dine

and

(3) g

uanf

acin

e ar

e cla

ssifi

ed a

s alp

ha-2

rece

ptor

ag

onist

s.Bl

ack B

ox W

arni

ng fo

r all

stim

ulan

ts: A

buse

pot

entia

l. R

isk o

f sud

den

deat

h an

d se

rious

car

diov

ascu

lar e

vent

s.W

arni

ngs/p

reca

ution

s for

all

stim

ulan

ts: M

ay c

ause

sudd

en d

eath

in th

ose

with

pre

exist

ing

struc

tura

l car

diac

abn

orm

alitie

s or s

erio

us h

eart

prob

lems.

May

cau

se h

yper

tens

ion,

psy

chia

tric

adve

rse

even

ts, a

nd p

ossib

le gr

owth

supp

ress

ion.

War

ning

s for

all

amph

etam

ines:

Infa

nts b

orn

to m

othe

rs d

epen

dent

on

amph

etam

ines

hav

e an

incr

ease

d ris

k of

pre

mat

ure

deliv

ery

and

low

birth

wei

ght.

The

se in

fant

s may

exp

erie

nce

sym

ptom

s of w

ithdr

awal

as d

emon

strat

ed b

y dy

spho

ria, a

gita

tion,

and

sign

ifica

nt fa

tigue

.So

urce

s: (1

) Men

tal H

ealth

Med

icatio

ns. N

atio

nal I

nstit

utes

of M

enta

l Hea

lth U

S D

epar

tmen

t of H

ealth

and

Hum

an S

ervic

es N

atio

nal I

nstit

utes

of H

ealth

. [ht

tp://

www.

nim

h.ni

h.go

v/he

alth/

publ

icatio

ns/m

enta

l-hea

lth-m

edica

tions

/inde

x.sht

ml]

Dec

embe

r 12,

2012

. (2)

Viti

ello

B. P

rincip

les in

usin

g ps

ycho

tropi

c med

icatio

n in

child

ren

and

adol

esce

nts.

In R

ey JM

(ed)

, IA

CA

PAP

e-Te

xtbo

ok o

f Chi

ld an

d A

doles

cent

Men

tal H

ealth

. Gen

eva:

Inte

rnat

iona

l Ass

ociat

ion

for C

hild

and

Ado

lesce

nt P

sych

iatry

and

Alli

ed P

rofe

ssio

ns 2

012.

(3) S

chat

zber

g A

F, C

ole J

O, D

eBat

tista

C. (

2010

) Man

ual o

f Clin

ical P

sych

opha

rmac

olog

y. (7

th ed

.). A

rling

ton

VA: A

mer

ican

Psyc

hiat

ric P

ublis

hing

, Inc

.

TAB

LE 7

(Continued

)

AD

HD

Med

icat

ions

DRUG

BR

AND

NAM

E/

GEN

ERIC

NAM

EFD

A AP

PROV

EDAGE/INDICATION

PEDI

ATRI

C DO

SAGE

/SER

UM L

EVEL

W

HEN

APP

LICA

BLE

BLAC

K BO

X W

ARN

INGS

/WAR

NIN

GS A

ND

PR

ECAU

TION

S/AD

DITI

ONAL

INFO

RMAT

ION


NOT FOR R

EPRINT




CLAS

S OF

DRU

GSTY

PICA

L SI

DE E

FFEC

TSPO

SSIB

LE T

ERAT

OGEN

IC R

ISK

Ant

ipsy

chot

ic

Med

icat

ions

Aka

thisi

a an

d dy

stoni

c re

actio

ns a

re se

en in

chi

ldre

n tre

ated

with

SG

As,

but r

isk o

f tar

dive

dys

kine

sia is

small

com

pare

d to

FG

As.

Wei

ght g

ain

is a

signi

fican

t pro

blem

with

SG

As.

Oth

er si

de e

ffect

s: co

nstip

atio

n, d

ry m

outh

, diz

zine

ss.

Seda

tion/

cogn

itive

blu

ntin

g m

ay o

ccur

with

FG

As a

nd S

GA

s.A

doles

cent

male

s at m

uch

grea

ter r

isk fo

r dys

toni

c rea

ctio

ns th

an ad

ults.

Sign

ifica

nt d

rop

in n

eutro

phils

and

incr

ease

d ris

k of

seiz

ures

with

clo

zapi

ne (s

houl

d be

use

d as

trea

tmen

t of l

ast r

esor

t).

FGA

s: R

are

anom

alies

, fet

al jau

ndice

, fet

al an

ticho

liner

gic

effe

cts a

t birt

h.SG

As:

Ges

tatio

nal d

iabe

tes,

large

birt

hwei

ght.

Ant

idep

ress

ant

Med

icat

ions

TC

As:

May

cau

se si

gnifi

cant

slow

ing

of c

ardi

ac c

ondu

ctio

n (P

R in

terv

al ov

er 0

.20

mse

c, Q

RS in

terv

al ov

er 0

.12

mse

c) m

ay re

quire

lowe

ring

dose

. Car

diac

long

QT

synd

rom

e m

ay b

e m

echa

nism

resp

onsib

le fo

r 4

case

s of r

epor

ted

sudd

en d

eath

in c

hild

ren.

Oth

er e

ffect

s: dr

y m

outh

, ur

inar

y re

tent

ion,

seda

tion,

con

stipa

tion,

wei

ght g

ain

and

hypo

tens

ion.

TC

As:

Feta

l tac

hyca

rdia

, fet

al wi

thdr

awal,

feta

l an

ticho

liner

gic

effe

cts,

urin

ary

rete

ntio

n, b

owel

obstr

uctio

n.

In a

dditi

on to

stric

t die

tary

restr

ictio

ns w

ith M

AO

Is: D

aytim

e sle

epin

ess,

dizz

ines

s, lig

hthe

aded

ness

, low

blo

od p

ress

ure,

diffi

culty

urin

atin

g, dr

y m

outh

, alte

red

sens

e of

taste

, ner

vous

ness

, mus

cle a

ches

, ins

omni

a an

d we

ight

gai

n.

MA

OIs

: Rar

e fe

tal m

alfor

mat

ions

: rar

ely

used

in

preg

nanc

y du

e to

hyp

erte

nsio

n.

Safe

ty/s

ide

effe

ct p

rofil

es o

f SSR

Is a

re su

perio

r to

thos

e of

TC

As.

Oth

er

SSRI

side

effe

cts:

inso

mni

a, se

datio

n, a

ppet

ite c

hang

es (u

p or

dow

n),

naus

ea, d

ry m

outh

, hea

dach

e, se

xual

dysfu

nctio

n, T

reat

men

t-em

erge

nt

akat

hisia

from

SSR

Is m

ay b

e m

ore

evid

ent i

n pe

diat

ric d

epre

ssio

n as

socia

ted

with

bip

olar

diso

rder

and

gre

ater

suici

de ri

sk.

SSRI

s: Pe

rinat

al an

d ca

rdio

vasc

ular

com

plica

tions

, sp

onta

neou

s abo

rtion

s. Po

tent

ial p

rem

atur

e de

liver

y an

d ne

onat

al pe

rsist

ent p

ulm

onar

y hy

perte

nsio

n (P

PHN

).

TAB

LE 8

Psyc

hotr

opic

Dru

gs: S

ide

Effe

cts a

nd T

erat

ogen

ic R

isks

(Con

tinue

d)


NOT FOR R

EPRINT




CLAS

S OF

DRU

GSTY

PICA

L SI

DE E

FFEC

TSPO

SSIB

LE T

ERAT

OGEN

IC R

ISK

Side

effe

cts a

nd o

ther

con

cern

s with

SN

RIs:

naus

ea, i

nsom

nia,

seda

tion,

se

xual

dysfu

nctio

n, sw

eatin

g, hy

perte

nsio

n, a

nd d

iscon

tinua

tion

synd

rom

e.

SNRI

s: Po

tent

ial p

rem

atur

e de

liver

y. C

linica

l ou

tcom

e da

ta sp

arse

com

pare

d to

SSR

Is o

r T

CA

s.Bu

prop

ion

(am

inok

eton

e cla

ss) c

omm

on si

de e

ffect

s: he

adac

he, a

gita

tion,

re

stles

s ins

omni

a, we

ight

loss

, ano

rexi

a, sw

eatin

g, tre

mor

, and

hy

perte

nsio

n.

Bupr

opio

n: R

isks u

nkno

wn, b

ut n

ot

reco

mm

ende

d ov

er S

SRIs

in p

regn

ancy

.

Moo

d St

abili

zing

and

Ant

icon

vulsa

nt

Med

icat

ions

Lith

ium

com

mon

reac

tions

: tre

mor

, pol

yuria

, pol

ydip

sia, w

eigh

t gai

n,

diar

rhea

, vom

iting

, dro

wsin

ess,

cogn

itive

impa

irmen

t, m

uscle

wea

knes

s, im

paire

d co

ordi

natio

n, a

nore

xia,

naus

ea, b

lurre

d vi

sion,

xer

osto

mia

, fa

tigue

, alo

pecia

, rev

ersib

le leu

kocy

tosis

, acn

e, an

d ed

ema.

Lith

ium

: Ass

ocia

ted

with

incr

ease

in b

irth

defe

cts

inclu

ding

car

diac

ano

mali

es (e

sp. E

bste

in’s

anom

aly)

and

beh

avio

ral e

ffect

s.

Valp

roat

e: C

hild

ren

youn

ger t

han

2 yr

s. ar

e at

gre

ates

t risk

for

hepa

toto

xicit

y. C

omm

on re

actio

ns: h

eada

che,

naus

ea/v

omiti

ng, l

oss o

f m

uscle

stre

ngth

, som

nolen

ce, t

hrom

bocy

tope

nia,

dysp

epsia

, diz

zine

ss,

diar

rhea

, abd

omin

al pa

in, t

rem

or.

Valp

roat

e: N

eura

l tub

e de

fect

s (i.e

., ra

te 6

–20%

); hi

gh ra

tes o

f men

tal r

etar

datio

n an

d lo

wer I

Q

mea

sure

s.

Car

bam

azep

ine:

May

cau

se d

izzi

ness

, dro

wsin

ess,

unste

adin

ess,

impa

ired

coor

dina

tion,

nau

sea/

vom

iting

, blu

rred

visio

n, n

ysta

gmus

, ras

h,

conf

usio

n.

Car

bam

azep

ine:

Neu

ral t

ube

defe

cts,

min

or

anom

alies

.

Oxc

arba

zepi

ne: M

ay c

ause

diz

zine

ss, s

omno

lence

, dip

lopi

a, vi

sual

chan

ges,

fatig

ue, h

eada

che,

naus

ea, v

omiti

ng, a

nd a

taxi

a.O

xcar

baze

pine

: Unk

nown

.

Lam

otrig

ine:

Chi

ldre

n ar

e at

gre

ater

risk

for r

ash

than

adu

lts. M

ay c

ause

na

usea

, vom

iting

, diz

zine

ss, v

ertig

o, vi

sual

distu

rban

ce, s

omno

lence

, at

axy,

prur

itus/

rash

, hea

dach

e, ph

aryn

gitis

, rhi

nitis

, dia

rrhea

, fev

er, l

oss

of m

uscle

stre

ngth

.

Lam

otrig

ine:

Unk

nown

but

ther

e ap

pear

s to

be a

hi

gh ra

te o

f clef

t lip

and

pala

te

(i.e.,

4–9

/1,0

00).

Gab

apen

tin: M

ay c

ause

diz

zine

ss, s

omno

lence

, ata

xia,

fatig

ue, p

erip

hera

l ed

ema,

nysta

gmus

, nau

sea,

vom

iting

, and

vira

l inf

ectio

n.G

abap

entin

/pre

gaba

lin: U

nkno

wn.

TAB

LE 8

(Continued

)

Psyc

hotr

opic

Dru

gs: S

ide

Effe

cts a

nd T

erat

ogen

ic R

isks


NOT FOR R

EPRINT




Preg

abali

n: M

ay c

ause

diz

zine

ss, s

omno

lence

, xer

osto

mia

, per

iphe

ral

edem

a, bl

urre

d vi

sion,

wei

ght g

ain,

abn

orm

al th

inki

ng, c

onsti

patio

n,

impa

ired

coor

dina

tion,

pai

n, d

ecre

ased

plat

elets.

Ant

ianx

iety

M

edic

atio

nsBe

nzod

iaze

pine

s (BZ

Ds):

If u

sed

for d

aytim

e an

xiet

y, ca

n in

crea

se

activ

ity a

nd p

rodu

ce o

r agg

rava

te b

ehav

ior d

isord

ers (

parti

cular

ly in

A

DH

D).

Dru

gs c

ause

toler

ance

and

phy

sical/

psyc

holo

gica

l dep

ende

nce.

May

cau

se so

mna

mbu

lism

and

am

nesia

. Oth

er si

de e

ffect

s inc

lude

ps

ycho

mot

or re

tard

atio

n, m

emor

y im

pairm

ent,

para

doxi

cal d

isinh

ibiti

on

(i.e.,

incr

ease

d ex

citem

ent,

irrita

bilit

y, ag

gres

sion,

hos

tility

and

im

pulsi

vity

), de

pres

sion

and

emot

iona

l blu

ntin

g.Se

dativ

e an

tihist

amin

es m

ay h

ave

som

e an

tianx

iety

or h

ypno

tic a

bilit

y. Pr

olon

ged

used

of t

hese

age

nts m

ay le

ad to

ant

ichol

iner

gic

side

effe

cts

and

cogn

itive

impa

irmen

t.Bu

spiro

ne c

an c

ause

dro

wsin

ess,

dizz

ines

s, im

paire

d co

ncen

tratio

n, n

ause

a, an

d he

adac

he. D

epre

ssio

n, h

ostil

ity a

nd a

kath

isia,

dysto

nia,

tard

ive

dysk

ines

ia, a

nd E

PS c

an o

ccur

.

BZD

s: “F

lopp

y ba

by,”

with

draw

al, in

crea

sed

risk

of c

left l

ip o

r pala

te.

Hyp

notic

BZ

Ds:

Dec

reas

ed in

traut

erin

e gr

owth

.Bu

spiro

ne: U

nkno

wn.

*Not

e: R

isk C

ateg

orie

s: A

: Con

trolle

d stu

dies

show

no

risk

to h

uman

s. B:

No

evid

ence

of r

isk in

hum

ans,

but a

dequ

ate

hum

an st

udie

s may

not

hav

e be

en p

erfo

rmed

. C: R

isk c

anno

t be

ruled

out

. D: P

ositi

ve e

vide

nce

or ri

sk to

hum

ans;

risk

may

be

outw

eigh

ed b

y po

tent

ial b

enef

it. X

: Con

train

dica

ted

in p

regn

ancy

.So

urce

s: (1

) Sch

atzb

erg

AF,

Col

e JO

, DeB

attis

ta C

. (20

10) M

anua

l of C

linica

l Psy

chop

harm

acol

ogy.

(7th

ed.).

Arli

ngto

n VA

: Am

erica

n Ps

ychi

atric

Pub

lishi

ng, I

nc. (

2) H

ilt R

J. M

onito

ring

Psyc

hiat

ric M

edica

tions

in C

hild

ren.

Ped

iatric

Ann

als. A

pril

2012

, Vol

ume 4

1, Is

sue 4

:157

–163

. (3)

Sol

chan

y J.

Psyc

hotro

pic M

edica

tion

and

Chi

ldre

n in

Fos

ter C

are:

Tip

s fo

r Adv

ocat

es an

d Ju

dges

. Pra

ctice

and

Polic

y Br

ief, A

mer

ican

Bar A

ssoc

iatio

n C

ente

r on

Chi

ldre

n an

d th

e Law

. Oct

ober

201

1. (4

) FD

A A

lerts

[7/2

006]

: Inc

reas

ed R

isk o

f Neo

nata

l Pe

rsiste

nt P

ulm

onar

y Hyp

erte

nsio

n. In

form

atio

n fo

r Hea

lthca

re P

rofe

ssion

als: P

arox

etin

e (M

arke

ted

as P

axil)

. Acc

esse

d we

bsite

on

Febr

uary

20,

2013

http

://ww

w.fd

a.gov

/Dru

gs/D

rugS

afet

y/Po

stmar

ketD

rugS

afet

yInf

orm

atio

nfor

Patie

ntsa

ndPr

ovid

ers/D

rugS

afet

yInf

orm

atio

nfor

Hea

thca

rePr

ofes

siona

ls/uc

m08

4319

.htm

(5) Y

onke

rs KA

, Wisn

er K

L, S

tewa

rt D

E, O

berla

nder

TF,

Dell

D

L, S

totla

nd N

, Ram

ine S

, Cha

udro

n L,

Loc

kwoo

d C

. The

Man

agem

ent o

f Dep

ressi

on D

urin

g Pr

egna

ncy:

A R

epor

t fro

m th

e Am

erica

n Ps

ychi

atric

Asso

ciatio

n an

d th

e Am

erica

n C

olleg

e of

Obs

tetri

cians

and

Gyn

ecol

ogist

s. Fo

cus,

Win

ter 2

012,

Vol. X

, No.

1.


NOT FOR R

EPRINT




re

co

mm

end

ed c

lIn

Ica

l m

on

Ito

rIn

g o

f c

hIl

dr

en a

nd

ad

ole

scen

ts

for

Psy

ch

ot

ro

PIc

dr

ug

s (a

ll c

lass

es) (

ta

bles

9-1

5)TA

BLE

9

Atyp

ical

Ant

ipsy

chot

ics

CLAS

S OF

DRU

GSM

ONIT

ORIN

G RE

COM

MEN

DATI

ONFR

EQUE

NCY

SUG

GEST

ION

Aty

pica

l A

ntip

sych

otic

M

edic

atio

ns

1. H

eigh

t and

wei

ght,

BMI.

2. L

abs:

fasti

ng b

lood

suga

r, A

1C, f

astin

g tri

glyc

erid

e/ch

oles

tero

l. 3

. Scr

een

for d

yski

nesia

mov

emen

ts. 4

. Lab

s: C

BC w

ith d

iffer

entia

l valu

es (d

iff).

5. B

lood

Pre

ssur

e/pu

lse.

6. C

ardi

ac h

istor

y. 7

. Det

erm

ine

if tre

atm

ent i

s res

pons

ive.

8. P

regn

ancy

testi

ng 9

. Con

sider

get

ting

prol

actin

leve

ls wh

en u

sing

rispe

ridon

e.10

. For

Clo

zapi

ne, L

ower

AN

C th

resh

old

for

initi

atio

n, T

est f

or m

yoca

rditi

s, C

onsid

er E

CG

fo

r for

car

diom

yopa

thy.

1. A

t bas

eline

and

at e

ach

follo

w-up

visi

t (at

leas

t eve

ry

6 m

onth

s).2.

At l

east

ever

y 6

mon

ths.

3. A

t lea

st ev

ery

6 m

onth

s.4.

Onc

e ev

ery

2–3

mon

ths a

fter s

tart

of d

rug.

5. A

t lea

st on

ce a

fter s

tart

of d

rug.

6. A

t bas

eline

and

obt

ain

EC

G if

in d

oubt

abo

ut ri

sk

from

a m

ild Q

T in

crea

se.

7. R

epea

t diso

rder

-spe

cific

ratin

g sc

ales(s

) unt

il re

miss

ion

is ac

hiev

ed. I

ncre

ase

at 4

–6 w

eek

inte

rvals

if

insu

fficie

nt d

rug

bene

fit.

8. Te

st m

yoca

rditi

s for

st six

wee

ks, E

CG

ann

ually

.

Sour

ces:

(1) H

ilt R

J. M

onito

ring

Psyc

hiat

ric M

edica

tions

in C

hild

ren.

Ped

iatri

c A

nnals

. Apr

il 20

12, V

olum

e 41

, Iss

ue 4

: 157

–163

. (2)

Tex

as D

epar

tmen

t of F

amily

and

Pro

tect

ive

Serv

ices a

nd th

e U

nive

rsity

of T

exas

at A

ustin

Col

lege

of P

harm

acy.

Psyc

hotro

pic

Med

icatio

n U

tiliz

atio

n Pa

ram

eter

s for

Fos

ter C

hild

ren.

Dec

embe

r 201

0. (3

) Sch

atzb

erg

AF,

Col

e JO

, D

eBat

tista

C. (

2010

) Man

ual o

f Clin

ical P

sych

opha

rmac

olog

y. (7

th e

d). A

rling

ton

VA: A

mer

ican

Psyc

hiat

ric P

ublis

hing

, Inc

. (4)

McC

lellan

J, K

owat

ch, F

indl

ing

RL, a

nd th

e W

ork

Gro

up o

n Q

ualit

y Is

sues

. Pra

ctice

Par

amet

er fo

r the

Ass

essm

ent a

nd T

reat

men

t of C

hild

ren

and

Ado

lesce

nts w

ith B

ipol

ar D

isord

er. J

Am

Aca

d C

hild

Ado

lesc

Psyc

hiat

ry 4

6:1,

Janu

ary

2007

. (5)

Epo

crat

es O

nlin

e [h

ttps:

//on

line.e

pocr

ates

.com

/u/1

000/

Dru

gs?lC

lD=

sear

ch-d

rugs

] (6)

Aut

oind

uctio

n an

d ste

ady-

state

pha

rmac

okin

etics

of c

arba

maz

epin

e an

d its

majo

r m

etab

olite

s. Br

J Clin

Pha

rmac

(199

2), 3

3, 61

1–61

5.


NOT FOR R

EPRINT




TAB

LE 1

0

Ant

idep

ress

ants

(SSR

Is)

CLAS

S OF

DRU

GSM

ONIT

ORIN

G RE

COM

MEN

DATI

ONFR

EQUE

NCY

SUG

GEST

ION

Ant

idep

ress

ant

(SSR

I)

Med

icat

ions

1. Bl

ood

pres

sure

mon

itorin

g.2.

Ass

ess f

or su

icida

l thi

nkin

g/be

havi

ors,

clini

cal

wors

enin

g or

oth

er c

hang

es in

beh

avio

rs.

3. In

quire

abo

ut a

ctiv

atio

n sy

mpt

oms.

4. In

quire

abo

ut b

leedi

ng/b

ruisi

ng.

5. M

easu

re h

eigh

t and

wei

ght.

6. D

eter

min

e tre

atm

ent r

espo

nse.

7. Pr

egna

ncy

testi

ng.

1. Pr

ior t

o tre

atm

ent a

nd w

ith d

ose

titra

tion.

2. Ba

selin

e an

d as

clin

ically

indi

cate

d.3.

Ong

oing

—us

ually

aro

und

week

2, w

eeks

4–6

, and

ot

her v

isits.

4. Sc

reen

for n

ew ir

ritab

ility

or a

gita

tion

arou

nd w

eek

2 an

d we

eks 4

–6.

5. A

t lea

st on

ce a

fter t

reat

men

t beg

ins.

6. A

t bas

eline

and

each

F/U

visi

t, at

leas

t eve

ry 6

mon

ths.

7. R

epea

t diso

rder

-spe

cific

ratin

g sc

ales(s

) unt

il re

miss

ion

is ac

hiev

ed. I

ncre

ase

at 4

–6 w

eek

inte

rvals

if

insu

fficie

nt d

rug

bene

fit.

8. A

s clin

ically

indi

cate

d.So

urce

s: (1

) Hilt

RJ.

Mon

itorin

g Ps

ychi

atric

Med

icatio

ns in

Chi

ldre

n. P

edia

tric

Ann

als. A

pril

2012

, Vol

ume

41, I

ssue

4: 1

57–1

63. (

2) T

exas

Dep

artm

ent o

f Fam

ily a

nd P

rote

ctiv

e Se

rvice

s and

the

Uni

vers

ity o

f Tex

as a

t Aus

tin C

olleg

e of

Pha

rmac

y. Ps

ycho

tropi

c M

edica

tion

Util

izat

ion

Para

met

ers f

or F

oste

r Chi

ldre

n. D

ecem

ber 2

010.

(3) S

chat

zber

g A

F, C

ole

JO,

DeB

attis

ta C

. (20

10) M

anua

l of C

linica

l Psy

chop

harm

acol

ogy.

(7th

ed)

. Arli

ngto

n VA

: Am

erica

n Ps

ychi

atric

Pub

lishi

ng, I

nc. (

4) M

cClel

lan J,

Kow

atch

, Fin

dlin

g RL

, and

the

Wor

k G

roup

on

Qua

lity

Issu

es. P

ract

ice P

aram

eter

for t

he A

sses

smen

t and

Tre

atm

ent o

f Chi

ldre

n an

d A

doles

cent

s with

Bip

olar

Diso

rder

. J A

m A

cad

Chi

ld A

doles

c Ps

ychi

atry

46:

1, Ja

nuar

y 20

07. (

5) E

pocr

ates

Onl

ine

[http

s: //

onlin

e.epo

crat

es.co

m/u

/100

0/D

rugs

?lClD

=se

arch

-dru

gs] (

6) A

utoi

nduc

tion

and

stead

y-sta

te p

harm

acok

inet

ics o

f car

bam

azep

ine

and

its m

ajor

met

abol

ites.

BrJ C

lin P

harm

ac (1

992)

, 33,

611–

615.


NOT FOR R

EPRINT




TABLE 12

Tricyclic Antidepressants

CLASS OF DRUGS MONITORING RECOMMENDATION FREQUENCY SUGGESTIONTricyclic

Antidepressant Medications

1. Height and weight.2. Blood pressure and

pulse.3. Electrocardiograms

(ECGs).4. Obtain outside

consultation.5. Lower dosage with

significant slowing of cardiac conduction.

6. Monitor for emergence of suicidal ideation or behavior.

1. Prior to staring TCA therapy, when dose exceeds 3 mg/kg and then every 2 weeks if dose is being increased.

2. When prescribing doses >5 mg/kg.

3. In cases with ECG findings: PR interval over 0.20 msec, QRS interval over 0.12 msec.

4. Ongoing—usually around week 2, weeks 4–6, and other visits.

Sources: (1) Hilt RJ. Monitoring Psychiatric Medications in Children. Pediatric Annals. April 2012, Volume 41, Issue 4:157–163. (2) Texas Department of Family and Protective Services and the University of Texas at Austin College of Pharmacy. Psychotropic Medication Utilization Parameters for Foster Children. December 2010. (3) Schatzberg AF, Cole JO, DeBattista C. (2010) Manual of Clinical Psychopharmacology. (7th ed). Arlington VA: American Psychiatric Publishing, Inc. (4) McClellan J, Kowatch, Findling RL, and the Work Group on Quality Issues. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Bipolar Disorder. J Am Acad Child Adolesc Psychiatry 46:1, January 2007. (5) Epocrates Online [https://online.epocrates.com/u/1000/Drugs?lClD=search-drugs] (6) Autoinduction and steady-state pharmacokinetics of carbamazepine and its major metabolites. BrJ Clin Pharmac (1992), 33, 611–615.

TABLE 11

Antidepressants (SNRIs)

CLASS OF DRUGS MONITORING RECOMMENDATION FREQUENCY SUGGESTIONAntidepressant

(SNRI) Medications

1. Blood pressure.2. Monitor for emergence

of suicidal ideation or behaviour.

3. Pregnancy testing.

1. Prior to initiating treatment, during dosage titration and as clinically indicated.

2. At baseline and as clinically indicated.

3. Ongoing—usually around week 2, weeks 4–6, and other visits.

4. As clinically indicated.Sources: (1) Hilt RJ. Monitoring Psychiatric Medications in Children. Pediatric Annals. April 2012, Volume 41, Issue 4: 157–163. (2) Texas Department of Family and Protective Services and the University of Texas at Austin College of Pharmacy. Psychotropic Medication Utilization Parameters for Foster Children. December 2010. (3) Schatzberg AF, Cole JO, DeBattista C. (2010) Manual of Clinical Psychopharmacology. (7th ed). Arlington VA: American Psychiatric Publishing, Inc. (4) McClellan J, Kowatch, Findling RL, and the Work Group on Quality Issues. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Bipolar Disorder. J Am Acad Child Adolesc Psychiatry 46:1, January 2007. (5) Epocrates Online [https: //online.epocrates.com/u/1000/Drugs?lClD=search-drugs] (6) Autoinduction and steady-state pharmacokinetics of carbamazepine and its major metabolites. BrJ Clin Pharmac (1992), 33, 611–615.


NOT FOR R

EPRINT




TAB

LE 1

3

Stim

ulan

ts

CLAS

S OF

DRU

GSM

ONIT

ORIN

G RE

COM

MEN

DATI

ONFR

EQUE

NCY

SUG

GEST

ION

Stim

ulan

t M

edic

atio

ns1.

Hei

ght a

nd w

eigh

t.2.

Bloo

d pr

essu

re a

nd p

ulse

.3.

Car

diac

hist

ory.

4. R

efill

mon

itorin

g.5.

CBC

with

diff

.6.

Det

erm

ine

if tre

atm

ent r

espo

nse.

1. A

t bas

eline

and

eac

h F/

U v

isit,

at le

ast e

very

6 m

onth

s.2.

At b

aseli

ne a

nd a

t lea

st on

ce o

n a

give

n do

se o

f m

edica

tion.

3. A

t bas

eline

to d

eter

min

e if

any

risks

from

adr

ener

gic

stim

ulat

ion.

4. Tr

ack

date

of e

ach

refil

l to

iden

tify

signs

of d

rug

dive

rsio

n.5.

For m

ethy

lphe

nida

te o

nly,

at le

ast o

nce e

very

6 m

onth

s.6.

Rep

eat A

DH

D-s

pecif

ic ra

ting

scale

(s) u

ntil

rem

issio

n is

achi

eved

. Inc

reas

e at

2 to

4 w

eeks

if in

suffi

cient

re

spon

se.

Sour

ces:

(1) H

ilt R

J. M

onito

ring

Psyc

hiat

ric M

edica

tions

in C

hild

ren.

Ped

iatri

c A

nnals

. Apr

il 20

12, V

olum

e 41

, Iss

ue 4

: 157

–163

. (2)

Tex

as D

epar

tmen

t of F

amily

and

Pro

tect

ive

Serv

ices a

nd th

e U

nive

rsity

of T

exas

at A

ustin

Col

lege

of P

harm

acy.

Psyc

hotro

pic

Med

icatio

n U

tiliz

atio

n Pa

ram

eter

s for

Fos

ter C

hild

ren.

Dec

embe

r 201

0. (3

) Sch

atzb

erg

AF,

Col

e JO

, D

eBat

tista

C. (

2010

) Man

ual o

f Clin

ical P

sych

opha

rmac

olog

y. (7

th e

d). A

rling

ton

VA: A

mer

ican

Psyc

hiat

ric P

ublis

hing

, Inc

. (4)

McC

lellan

J, K

owat

ch, F

indl

ing

RL, a

nd th

e W

ork

Gro

up o

n Q

ualit

y Is

sues

. Pra

ctice

Par

amet

er fo

r the

Ass

essm

ent a

nd T

reat

men

t of C

hild

ren

and

Ado

lesce

nts w

ith B

ipol

ar D

isord

er. J

Am

Aca

d C

hild

Ado

lesc

Psyc

hiat

ry 4

6:1,

Janu

ary

2007

. (5)

Epo

crat

es O

nlin

e [h

ttps:

//on

line.e

pocr

ates

.com

/u/1

000/

Dru

gs?lC

lD=

sear

ch-d

rugs

] (6)

Aut

oind

uctio

n an

d ste

ady-

state

pha

rmac

okin

etics

of c

arba

maz

epin

e an

d its

majo

r m

etab

olite

s. Br

J Clin

Pha

rmac

(199

2), 3

3, 61

1–61

5.


NOT FOR R

EPRINT




TAB

LE 1

4

Moo

d St

abil

izin

g an

d A

ntic

onvu

lsan

ts

CLAS

S OF

DRU

GSM

ONIT

ORIN

G RE

COM

MEN

DATI

ONFR

EQUE

NCY

SUG

GEST

ION

Moo

d St

abili

zing

and

Ant

icon

vulsa

nt

Med

icat

ions

1. Li

thiu

m: (

a) C

hem

istry

Pan

el, C

BC w

ith p

latele

ts,

seru

m c

reat

inin

e, th

yroi

d fu

nctio

n te

sts, p

regn

ancy

te

st, E

CG

. (b)

Onc

e do

se is

stab

le—lit

hium

leve

ls,

rena

l and

thyr

oid

func

tion

and

urin

alys

is.2.

Div

alpro

ex so

dium

: (a

) Che

mist

ry P

anel,

C

BC w

ith p

latele

ts, li

ver f

unct

ion

tests

, pr

egna

ncy

test.

(b) S

erum

dru

g le

vels,

hep

atic

and

hem

atol

ogica

l ind

ices.

(c) H

LA-B

*150

2 ge

netic

testi

ng fo

r all

Asia

n in

divi

duals

.3.

Car

bam

azep

ine

: (a

) CBC

, elec

troly

tes a

nd

liver

func

tion

tests

. (b)

The

rape

utic

drug

leve

ls.

(c) P

regn

ancy

.

1. Ba

selin

e m

onito

ring

(b) e

very

3–6

mon

ths.

2. Ba

selin

e m

onito

ring

(b) e

very

3–6

mon

ths.

3. Ba

selin

e m

onito

ring

(b) R

outin

e m

onito

ring

to

chec

k fo

r aut

oind

uctio

n of

car

bam

azep

ine—

usua

lly

occu

rrin

g af

ter o

ne w

eek

and/

or d

osag

e ch

ange

s.

Sour

ces:

(1) H

ilt R

J. M

onito

ring

Psyc

hiat

ric M

edica

tions

in C

hild

ren.

Ped

iatri

c A

nnals

. Apr

il 20

12, V

olum

e 41

, Iss

ue 4

: 157

–163

. (2)

Tex

as D

epar

tmen

t of F

amily

and

Pro

tect

ive

Serv

ices a

nd th

e U

nive

rsity

of T

exas

at A

ustin

Col

lege

of P

harm

acy.

Psyc

hotro

pic

Med

icatio

n U

tiliz

atio

n Pa

ram

eter

s for

Fos

ter C

hild

ren.

Dec

embe

r 201

0. (3

) Sch

atzb

erg

AF,

Col

e JO

, D

eBat

tista

C. (

2010

) Man

ual o

f Clin

ical P

sych

opha

rmac

olog

y. (7

th e

d). A

rling

ton

VA: A

mer

ican

Psyc

hiat

ric P

ublis

hing

, Inc

. (4)

McC

lellan

J, K

owat

ch, F

indl

ing

RL, a

nd th

e W

ork

Gro

up o

n Q

ualit

y Is

sues

. Pra

ctice

Par

amet

er fo

r the

Ass

essm

ent a

nd T

reat

men

t of C

hild

ren

and

Ado

lesce

nts w

ith B

ipol

ar D

isord

er. J

Am

Aca

d C

hild

Ado

lesc

Psyc

hiat

ry 4

6:1,

Janu

ary

2007

. (5)

Epo

crat

es O

nlin

e [h

ttps:

//on

line.e

pocr

ates

.com

/u/1

000/

Dru

gs?lC

lD=

sear

ch-d

rugs

] (6)

Aut

oind

uctio

n an

d ste

ady-

state

pha

rmac

okin

etics

of c

arba

maz

epin

e an

d its

majo

r m

etab

olite

s. Br

J Clin

Pha

rmac

(199

2), 3

3, 61

1–61

5.


NOT FOR R

EPRINT




TAB

LE 1

5

Slee

p A

gent

s

GEN

ERIC

NAM

EBR

AND

NAM

ESFD

A AP

PROV

AL

AGE/

INDI

CATI

ONOT

HER

COM

MON

US

ES IN

CHI

LDRE

NPO

TEN

TIAL

SID

E EF

FECT

SM

ONIT

ORIN

GD

iphe

nhyd

ram

ine

Bena

dryl

App

rove

d fo

r ch

ildre

n 12

an

d ol

der

for t

he

treat

men

t of

inso

mni

a

Non

e•

Dro

wsin

ess

•D

izzi

ness

•D

rym

outh

•N

ause

a•

Ner

vous

ness

•Bl

urre

dvi

sion

•D

ecre

ased

men

tala

lertn

ess

•Pa

rado

xica

lexc

itatio

n•

May

lowe

rsei

zure

thre

shol

d

•C

autio

n—as

sess

com

plia

nce

with

avo

idin

g op

erat

ion

of m

achi

nery

or p

ower

eq

uipm

ent u

ntil

med

icatio

n ef

fect

s with

use

of t

his

med

icatio

n ar

e de

term

ined

•D

aytim

ese

datio

n/ha

ngov

er

Traz

odon

e*D

esyr

el18

and

old

erN

one

•Su

icida

ltho

ught

sorb

ehav

iors

•A

bnor

mal

gene

raliz

edb

leedi

ngri

sk•

Hyp

onat

rem

ia•

Stom

ach

disc

omfo

rt•

Flu-

likes

ympt

omsi

fsto

pped

too

quick

ly•

Orth

ostat

ichy

poten

sion/

sync

opy

•C

ogni

tive/

mot

orim

pairm

ent

•Pr

iapi

sm-m

ales

•Q

Tp

rolo

ngat

ion

and

risk

ofsu

dden

ca

rdiac

dea

th

•Su

icida

ltho

ught

sor

beha

vior

s•

Seiz

ure

risk

with

oth

er

med

icatio

ns•

Wei

ght

•Bl

ood

pres

sure

bas

eline

and

pe

riodi

cally

•EK

Gb

aseli

nea

nd

perio

dica

lly

Esz

oplic

lone

*Lu

nesta

18 a

nd o

lder

Non

e•

Abn

orm

alth

inki

nga

ndb

ehav

iora

lch

ange

s•

With

draw

alef

fect

s•

Dru

gab

use

and

depe

nden

ce•

Toler

ance

•C

autio

n—do

not

ope

rate

m

achi

nery

or p

ower

eq

uipm

ent u

ntil

med

icatio

n ef

fect

s with

use

of t

his

med

icatio

n•

Day

time

seda

tion/

hang

over

(Con

tinue

d)


NOT FOR R

EPRINT




Mela

toni

nD

osin

g: 0

.05–

0.15

mg/

kg/d

ay

up to

tota

l dos

e of

5 m

g/da

y in

ch

ildre

n an

d ad

oles

cent

s

Not

FD

A

regu

lated

Reg

ulat

ed b

y FD

A a

s a

diet

ary

supp

lemen

t an

d no

t as a

m

edica

tion

•Se

datio

n•

May

adv

erse

lya

ffect

repr

oduc

tive

orga

nde

velo

pmen

t•

Giv

edi

rect

lyb

efor

esle

epo

nset

des

ired

due

to sh

ort h

alf-li

fe

•C

autio

n—do

not

ope

rate

m

achi

nery

or p

ower

eq

uipm

ent u

ntil

med

icatio

n ef

fect

s with

use

of t

his

med

icatio

n•

Day

time

seda

tion/

hang

over

Ram

elteo

n*R

ozer

em18

and

old

erN

one

•A

bnor

mal

thin

king

and

beh

avio

ral

chan

ges

•C

NS

depr

essio

n•

Dec

reas

edte

stoste

rone

•H

yper

prol

actin

emia

•C

autio

n—do

not

ope

rate

m

achi

nery

or p

ower

eq

uipm

ent u

ntil

med

icatio

n ef

fect

s with

use

of t

his

med

icatio

n•

Day

time

seda

tion/

hang

over

Hyd

roxy

zine

Vist

aril,

Ata

rax

All

ages

for

anxi

ety—

and

all a

ges f

or

Prur

itis/

for t

he

treat

men

t of

Itch

y sk

in-

App

rove

d fo

r an

xiet

y an

d te

nsio

n;

appr

oved

as

pre

-pr

oced

ural

seda

tion

and

follo

wing

ge

nera

l an

esth

esia

•D

rows

ines

s•

Diz

zine

ss•

Dry

mou

th•

Nau

sea

•N

ervo

usne

ss•

Blur

red

visio

n•

Dec

reas

edm

enta

laler

tnes

s•

Para

doxi

cale

xcita

tion

asso

ciate

dwi

th

small

risk

of Q

T p

rolo

ngat

ion

and

Tors

ades

•C

autio

n—do

not

ope

rate

m

achi

nery

or p

ower

eq

uipm

ent u

ntil

med

icatio

n ef

fect

s with

use

of t

his

med

icatio

n

•D

aytim

ese

datio

n/ha

ngov

er

Zol

pide

m*

Am

bien

Am

bien

CR

NO

T F

DA

R

egul

ated

Non

e•

Hall

ucin

atio

nsin

chi

ldre

n6–

17h

ave

been

repo

rted

•Sh

ould

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aPPendIx

Checklist Before Prescribing Medication

1. Complete diagnostic work-up2. Proper informed consent3. Choice of target symptoms4. Appropriate outcome measures5. Monitor side effects6. Monitor compliance

EKG Parameters

PR <= 200 msQRS duration <= 120 msQTc <= 460 msEKG = electrocardiograph.

Serotonin Discontinuation Syndrome

1. Emerges 1–3 days after discontinuation of medication2. More common in SSRIs with short half-lives3. Gl symptoms4. Flu-like symptoms5. Dizziness6. Sleep disturbance7. Anxiety8. Tearfulness9. Irritability and agitationSSRIs = selective serotonin reuptake inhibitors;GI = gastrointestinal.

Signs of NMS

1. Fever2. Rigidity3. Altered consciousness4. Autonomic instability5. Elevated CPKNMS = neuroleptic malignant syndrome;CPK = creatine phosphokinase.


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Signs Of Toxic [Central] Serotonin Syndrome

1. Gl symptoms2. Sweating3. Fever4. Tachycardia5. Hypertension6. Myoclonus7. Increased motor activity8. IrritabilityGI = gastrointestinal.

Internet Resources

• CytochromeP450Drug InteractionTablewww.drug-interactions.com

• HeightandWeightCharts—girlshttp://www.cdc.gov/nchs/about/major/nhanes/growthcharts/set1clinical/CJ41C022.pdf

• HeightandWeightCharts—boyshttp://www.cdc.gov/nchs/about/major/nhanes/growthcharts/set1clinical/CJ41C021.pdf

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dosing and monitoring: children and adolescents buspar: 20–60 carbamazepine: ... hydroxyzine...

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