drug and therapy bulletin - hpspc.inhpspc.in/pdf/dtb_issue5.pdf · drug information center himachal...

H.P. STATE

COUNCIL

DRUG AND THERAPYBULLETIN

Toll Free 18001210443

DRUG INFORMATION CENTERHIMACHAL PRADESH STATE

PHARMACY COUNCIL

Contents | Editorial | Drug Updates | Medical News

Local News | Importance of blood donation |

Which kind of queries can be asked from Drug Information Center?

Issue: 5 ● Volume: 2 ● Feb 2018

LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,

Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]

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DRUG AND THERAPY BULLETIN

Content

EDITORIAL

Patron

Mr. Gopal Krishan Sharma and Dr. Ran Singh

Editor-in-chief

Dr. Kamlesh Naik and Dr. M.S. Ashawat

Co-Editors

Dr. Vinay Pandit and Mr. Ankush Sharma

Advisory Board

Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma, Dr. Poonam

Sandhu, Dr. Rajender Guleria, Mr. Arvind Kumar, Mr. Bihari Lal Gupta, Mr, Hemant Sharma, Mr. Rakesh

Chandel, Mr. Praveen Upadhya, Mr. Kamashwar Chauhan, Mr. Lokesh Kumar, Mr. Vishal Kumar,

Mr. Y.S.Chandel, Mr. Birbal Sharma, Mr. Manoj Kumar, Mr. Yogesh Verma, Mr. Surender Nadda, Dr. Parshuram

Drug Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Medical News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Local News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Importance of blood donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Which kind of queries can be asked from Drug Information Center? . . . . . . . . . . . . . . . . . . . . . . 8

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DRUG UPDATES



Makena sub-Q Auto injector

On February 14, 2018, the US FDA approved

Makena(R) (hydroxyprogesterone caproate) as a

subcutaneous auto-injector, making it the second route

of administration for this product. Makena, already

marketed as an IM injection, is approved to reduce the

risk of preterm birth in women pregnant with a singleton

and who spontaneously delivered 1 preterm baby in the

past.

Pr e s c r i b i n g i n f o rma t i on can be f ound a t :

https://www.accessdata.fda.gov/drugsatfda_docs/label/

2018/021945s012lbl.pdf.

Erleada for NM-CRPC


Erleada(TM) (apalutamide) oral tablets to treat patients

with non-metastatic castration-resistant prostate cancer

(NM-CRPC). In the SPARTAN clinical trial, Erleada, a

next-generation androgen receptor inhibitor, showed a

risk reduction of distant metastasis or death as well as an

increase of 2 or more years in median metastasis-free

survival.

Prescribing information can be found at: https://

www.accessdata.fda.gov/drugsatfda_docs/label/2018/

210951s000lbl.pdf.

Symdeko for CF


Symdeko(TM) (tezacaftor/ivacaftor and ivacaftor) oral kit

to treat the underlying cause of cystic fibrosis (CF) in

patients 12 years of age or older who have 2 copies of the

F508del mutation in the cystic fibrosis transmembrane

conductance regulator (CFTR) gene or who have at least

1 mutation that is responsive to tezacaftor/ivacaftor.

Some CF mutations result in CFTR protein that does not

reach the cell surface due to it not being processed or

folded normally within the cell. Tezacaftor works in

addressing the processing CFTR protein defect which

allows it to reach the cell surface. Then, ivacaftor can

increase the amount of time the protein stays open.

Prescribing information can be found at: https://

www.accessdata.fda.gov/drugsatfda_docs/label/2018/

210491lbl.pdf.

Feraheme for all IDA

On Feb 5, 2018, the US FDA approved an expanded

indication for Feraheme(R) (ferumoxytol) IV injection to

include all eligible adult patients with iron deficiency

anemia (IDA) who have intolerance to oral iron or have

had inadequate response to oral iron. Feraheme was

previously approved only for IDA in adult patients with

chronic kidney disease. The boxed warning now states

that Feraheme should be administered as an IV infusion

over at least 15 minutes.

Pr e s c r i b i n g i n f o rma t i on can be f ound a t :

http://www.feraheme.com/pdfs/Feraheme-Prescribing-

Information.pdf.

Avicaz for HABP/VABP

On February 1, 2018, the US FDA approved a new

indication for Avycaz(R) (ceftazidime/avibactam) IV

injection to include the treatment of adult patients with

hospital-acquired bacterial pneumonia and ventilator-

associated bacterial pneumonia (HABP/VABP) caused

by the fo l lowing suscept ib le Gram-negat ive

microorganisms: Klebsiella pneumoniae, Enterobacter

cloacae, Escherichia coli, Serratia marcescens, Proteus

mirabilis, Pseudomonas aeruginosa, and Haemophilus

influenzae in patients. In a clinical trial, Avycaz was

shown to be non-inferior to meropenem for 28-day all-

cause mortality.



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Pre s c r i b i n g i n f o rma t i on can be f ound a t :

http://www.allergan.com/assets/pdf/avycaz_pi

Zomacton for adult GHD

On January 31, 2018, the US FDA approved a new

indication for Zomacton(R) (somatropin, e-coli derived)

5-mg and 10-mg subQ injection to replace growth

hormone in adult patients with growth hormone

deficiency (GHD). Zomacton is also approved to treat

pediatric patients who have growth failure due to an

inadequate secretion of endogenous growth hormone.

Prescribing information can be found at: www.

ferringusa.com/pi/zomacton

Frivanq for CDAD colitis

On January 29, 2018, the US FDA approved

Firvanq(TM) (vancomycin hydrochloride) powder for oral

solution to treat clostridium difficile associated diarrhea

(CDAD) and enterocolitis cause by Staphylococcus

aureus, including methicillin-resistant strains. Firvanq

could provide improved patient access and ease

pharmacists' workload as they will no longer have to

compound vancomycin oral liquid formulations.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2089

10s000lbl.pdf.

Trisenox with Tretinoin for APL


indication for Trisenox(R) (arsenic trioxide) IV injection

for the first-line treatment of adult patients with newly-

diagnosed low-risk acute promyelocytic leukemia (APL)

in combination with tretinoin. Trisenox, which is already

approved for relapsed or refractory APL, carries a boxed

warning for differentiation syndrome and cardiac

conduction abnormalities.

PI can be found at: www.trisenox.com/trisenox-

prescribing- information.pdf.

Lynparza now for breast cancer


indication for Lynparza(R) (olaparib) oral tablets for use

in patients with deleterious or suspected deleterious

gBRCAm, HER2-negative metastatic breast cancer, who

have been treated with chemotherapy in the

neoadjuvant, adjuvant, or metastatic setting. The FDA

also approved a complementary diagnostic test for

olaparib to assess the presence of deleterious or

suspected deleterious gBRCA-mutations. Lynparza is the

first PARP inhibitor to gain approval for the treatment of

breast cancer.

PI can be found at: https://www.accessdata.fda.gov/

drugsatfda_docs/label/2018/208558s001lbl.pdf

Opioid Cough/cold Meds for adults only

On January 11, 2018, the US FDA issued a safety

communication to limit the use of prescription cough and

cold medications containing codeine or hydrocodone to

adult patients 18 years of age or older. Because the risks

of misuse, abuse, addiction, overdose, and death

outweigh the benefits, these products are no longer

indicated for use in pediatric patients younger than 18

years of age. The FDA is requiring safety labeling updates

for all prescription codeine- or hydrocodone-containing

cough and cold medications.

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USFDA: olanzapine may cause DRESS

The United States Food and Drug Administration recently

issued a safety communication about the possible, rare

but serious skin reaction linked with Olanzapine use.

According to the warning, Olanzapine-containing

formulations may cause Drug Reaction with Eosinophilia

and Systemic Symptoms (DRESS) that can affect all over

the body.

Balcoltra: latest in birth control

Balcoltra (levonorgestrel and ethinyl estradiol tablets,

USP, and ferrous bisglycinate tablets) provides an oral

contraceptive regimen consisting of 21 orange active

tablets and 7 blue inactive tablets. Balcoltra is indicated

for use by females of reproductive potential to prevent

pregnancy.

Maha FDA asks CDSCO to notify bodies, officers and labs to implement compliance of new Medical Device Rules

In order to implement the newly notified Medical Device

Rules 2017 which is effective from January 1, 2018 in a

proper manner, the Maharashtra Food and Drug

Administration (FDA) has asked the Central Drugs

Standard Control Organization (CDSCO) to notify the

bodies, officers and labs designated for the purpose of

overseeing the compliance of new Medical Device Rules,

2017.

CDSCO Approves Macitentan for The Tr e a t m e n t O f Pu l m o n a r y A r t e r i a l Hypertension (PAH)

On December 07, 2017, CDSCO approved Macitentan

Bulk/Tablets 10 mg, which is indicated for the treatment

of Pulmonary Arterial Hypertension (PAH, World Health

Organization (WHO) group I) to delay disease

progression1. The manufacture and marketing approval

for Macitentan Tablet was granted to MSN laboratories

Private Limited. The Subject Expert Committee (SEC) of

Cardiovascular & Renal, CDSCO, after detailed

deliberation has recommended grant of manufacturing

and marketing permission with local clinical trial (Phase

IV) waiver and submission of Bioequivalence (BE) study

data.

CDSCO issues draft Clinical Trials Rules, 2018

The Central Drugs Standard Control Organization

(CDSCO) has issued the draft Clinical Trials Rules, 2018.

It applies to all new drugs, investigational new drugs for

human use, clinical trial, bioequivalence study,

bioavailability study and Ethics Committee. It will come

in to force after its final publication in the Official Gazette.

This will be under Part XA and Schedule Y of the Drugs

and Cosmetics Rules, 1945, and section 12 and 33 of

the Drugs and Cosmetics Act, 1940. The new

regulations clearly defines features of an academic study,

role of central licensing authority, trial protocol,

biomedical and health research.

Dr Reddy’s recalls over 80,000 bottles of Atorvastatin from US

Dr Reddy’s Laboratories has initiated voluntary recall of

over 80,000 bottles of its drug Atorvastatin Calcium

Tablets 10mg, 20mg and 40mg from the US market due

to quality concerns. Atorvastatin is a drug that blocks the

production of cholesterol and reduces its level in the

blood. According to the USFDA, the reason for the recall

was, “Failed Impurities/Degradations specifications; out-

of-specification results observed for Total Degradation

Impurities during stability.” The product was

manufactured at the drug maker’s Srikakulam plant in

MEDICAL NEWS MEDICALnews



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Mukhya Mantri Kshaya Rog Niwaran Yojna

(MMKRNY)

Himachal Pradesh govt. has implemented MMKRNY to

eliminate tuberculosis from state by 2021. The major

objectives of the scheme will be to detect all cases of

tuberculosis and ensure an early action for the treatment

of tuberculosis through DETECT- TREAT- PREVENT-

BUILD mode.

INSPIRE at Laureate

5 days INSPIRE (Innovation in Science Persuit for

Inspired Research) internship program was organized at

laureate Institute of Pharmacy (Jwalamukhi), from 22nd

January to 26th January 2018. Different professors from

different national universities share the knowledge with

students of different schools of Himachal Pradesh and

introduce the students with the future scope of technical

education. MD of Institute Dr. Ran Singh and Principal

Dr. M.S. Ashawat were also present in the program.

National Conference at Laureate

Laureate Institute of Pharmacy (Jwalamukhi) organised

the ICMR and HPTU sponsored National Conference of

two days on topic 'Phytoconstituents: An Advances in

Noval Drug Delivery System' on 30th-31st Jan 2018.

Differnet scientists from different areas of India share

their knowledge as well as their research papers with

s tuden t s and in t r oduce the s tuden t s w i th

phytoconstituents based noval drug delivery systems.

National Seminar at HIPER

Himachal institute of Pharmaceutical education and

Research (HIPER) at Nadaun (Distt. Hamirpur,HP)

organizing ICMR and HPTU sponsored a national

seminar on topic “current status and future scope for

nanomaterials and nanotechnology in drug discovery

and drug development on 23-24 Feb. 2018, aims to

bring together academicians, industrialists, researchers,

and scholars from different regions on a common

plat form to discuss advances and emerging

opportunities in Pharmaceutical sciences.

LOCAL NEWS

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IMPORTANCE OF BLOOD DONATION

Blood donation is definitely a noble act. Many clinics

and hospitals constantly require blood for several

purposes. This makes the idea of blood donation a

noble gesture as it provides life-saving help to people

and patients. On an average, human body contains

approximately 4 to 5 liters blood that can be donated

after every third month for men and every 4 months

for women. Many people believe that blood donation is

harmful for their body, however, this is untrue.

A person can donate blood if

between age group of 18-65 years.

weight is 45 kg or more.

haemoglobin is 12.5 gm% minimum.

last blood donation was 3 months earlier.

healthy and have not suffered from malaria, typhoid

or other transmissible disease in the recent past.

A person cannot donate blood if

old / fever in the past 1 week.

under treatment with antibiotics or any other

medication.

cardiac problems, hypertension, epilepsy, diabetes

(on insulin therapy), history of cancer, chronic

kidney or liver disease, bleeding tendencies,

venereal disease etc.

major surgery in the last 6 months.

vaccination in the last 24 hours.

had a miscarriage in the last 6 months or have been

pregnant / lactating in the last one year.

had fainting attacks during last donation.

have regularly received treatment with blood

products.

been tested positive for antibodies to HIV.

Pregnancy and Menstrual Cycle

Females should not donate blood during pregnancy.

They can donate after 6 weeks following a normal

delivery and when they are not breast feeding.

Females should not donate blood if they are having

heavy menstrual flow or menstrual cramps.

Benefits of blood donation

Lower Iron Levels: High iron levels in your blood can

lead to an increased risk of cardiovascular disease and

damaged arteries. Every time you give blood it lowers

your body's iron levels, which lowers your risk of

developing heart disease.

Reduced Risk of Cancer: It is safe to donate blood

every three months for men and every four months for

women. Consistent donations will actually drop your

cancer risk levels each time you donate. Donating

blood has been associated with a lower risk of liver,

lung, colon, stomach, and throat cancers in regular

donors.

Reduced Risk of Heart Attack: Years of regular blood

donation can lower your risk of heart attack by 88%,

as well as reduce your risk of stroke and other

cardiovascular events by 33%.

Replenish Blood: Your body naturally restores and

replenishes blood supplies in the event of blood loss.

Such replenishment can help your body work more

efficiently and stay healthy.



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Which kind of queries can be asked from Drug

Information Center?

It is the matter of pride for all the population of Himachal

Pradesh that there is drug information center (DIC) in the

state which is giving the services to promote the rational

drug use. Maximum population of state knows that there is

DIC, but they are unaware about the services of the DIC.

They all are confused that which kind of queries they can ask.

There is no any restriction to take the drug query

information by any one. Any person (physician, pharmacist,

nurse, patient, people of community, old persons, students,

researchers etc.) can come in or call in the DIC office to take

drug information.

Following kinds of queries regarding drugs can be asked

from DIC:

Ÿ If patient is administering two medicines at the same

time then he/she before administering the medicine,

can confirm from DIC that this combination is safe or not

safe. If combination will be not safe then it may also be

life threatening.

Ÿ If patient is administering a medicine then he/she can

confirm which kinds of foods have to be avoided.

Ÿ Someone can confirm that use of any specific medicine

in particular condition (like as pregnancy/lactation) is

safe or not safe.

Ÿ General information about drug identification can also

be taken from the DIC, like as use and side/adverse

effects , t ime of administrat ion, durat ion of

administration, dose in different age groups etc. about

any drug.

Ÿ Information about substituted drugs with different

prices can also be provided by DIC.

Ÿ Any updation about medicines can be confirmed from

DIC.

DIC will provide the accurate information on request

without any fear and favor. In short, we can say that DIC can

provide any kind of information about any medicine to

anyone without any cost. Personnel can assess directly, can

call in the DIC office, sent the query by post, by E-mail

Toll Free 18001210443, Phone: 09218428042, 9459220253

Scan this Quick Response (QR)

code to know more

You may download any QR code scanner from

Play Store/iTunes

Personnel can assess directly, can call in the DIC office, sent the query by post, by E-mail on following address.

Note: If any want to publish his/her article in the monthly bulletin of Drug Information Center regarding Pharma updates, they can send their articles with their full address and professional status on the following reference before 25th of every month.

Toll Free 18001210443

DRUG INFORMATION CENTER

HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Jwala Ji, Distt. Kangra HP 177101

Website: www.hpspc.in | Mail ID: [email protected], [email protected]

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