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Page 1: DESKTOP READY RECKONER - KHPTSputum smears for Microscopy (AFB & CBNAAT) TB Patients found positive on any follow-up sputum smear examination during treatment with irst line drugs,

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DESKTOP READY RECKONERDESKTOP READY RECKONER

Page 2: DESKTOP READY RECKONER - KHPTSputum smears for Microscopy (AFB & CBNAAT) TB Patients found positive on any follow-up sputum smear examination during treatment with irst line drugs,

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The THALI-TB training Desktop Ready Reckoner’ Guide was developed by St John’s Medical College, Bangalore, for the USAID Tuberculosis Health Action Learning Initiative (THALI) intervention implemented by the Karnataka Health Promotion Trust (KHPT).

Acknowledgements:

Content Specialists:Dr Uma Devaraj, Professor, Pulmonary Medicine, St John’s Medical College, BangaloreDr Priya Ramachandran, Professor, Pulmonary Medicine, St John’s Medical College, BangaloreDr Indumathi C K , Professor, Paediatrics, St John’s Medical College, BangaloreDr Mary Dias, Associate Professor, Microbiology, St John’s Medical College, BangaloreDr John Stephen S, Professor, Dermatology, St John’s Medical College, BangaloreMs Joyce Meshach , Training Coordinator, THALI, St John’s Medical College, Bangalore

Other resource persons who have significantly contributed to the development of this Desktop Ready Reckoner:Dr George D’souza, Professor, Department of Pulmonary Medicine, St John’s Medical College, BangaloreDr Sanjiv Lewin, Professor, Department of Paediatrics, St John’s Medical College, BangaloreDr Reynold Washington, Senior Technical Director/Advisor, KHPTDr Prakash Kudur, Project Director, THALI, KHPTDr K. Karthikeyan, Technical Specialist, THALI, KHPTDr Prarthana B S, Program Technical Coordinator, THALI, KHPTDr Aditi Krishnamurthy, Technical Consultant, KHPTDr Sushma J, State Technical Coordinator, THALI, KHPT

For all the support and encouragement, a special thank you to:Rev. Dr. Paul Parathazham, Director, St John’s National Academy of Health Sciences, Bangalore Dr Tony Raj, Dean, St John’s Research Institute, Bangalore

© St John’s -KHPT 2019All portions of this Desktop Ready Reckoner may be reproduced for use in TB Training, provided acknowledgement of the source and notification of such use is given to St John’s Medical College, Bangalore & Karnataka Health Promotion Trust (KHPT).

Page 3: DESKTOP READY RECKONER - KHPTSputum smears for Microscopy (AFB & CBNAAT) TB Patients found positive on any follow-up sputum smear examination during treatment with irst line drugs,

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Sequence of Care

If ANY one

1. Counsel 2. Collect sputum & examine

sputum for AFB OR 3. Refer to microscopy centre

for sputum examination

TB Diagnosis 1. Cough > 2 weeks* 2. Chronic fever 3. Weight loss 4. Evening rise of temperature 5. Suspicious nodes 6. Haemoptysis

Screen for TB

If NO to all 1. Explain treatment & follow

up care 2. Assess & support

adherence to ATT 3. Assess quality of DOTS by

DOTS provider

4. For HIV positive patient give posttest and ongoing support

Educa�on & Support

1. Do clinical review of signs and symptoms, medication use,

Assess

1. Assess pregnancy status 2. Screen contacts

Assess family

1. Provide the appropriate category of therapy

2. Manage common problems

3. Provide co -trimoxazoleprophylaxis if HIV positive

Provide TB therapy

1. Dispense and record medication

2. Schedule follow up; order tabs

3. Link with community services

4. Record on RNTCP treatment card

Arrange Patient continues with treatment support and DOTS 1. Family & friends

Refer to higher centre

Refer to higher centre Regular

screening at every

visit

If TB 1. Disease site

2. Type of TB 3. TB treatment Category

Determine

*Screen for TB in patients with ANY DURATION COUGH if:

� Contact of TB

� HIV Infected

side e�ects.

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Presume and Confirm DS-TB

Presume DR-TB

Presumptive TB

Persistent Cough> greater than 2 weeks, fever >2weeks,

significant weight loss, Chest X-ray abnormality

Confirm

Sputum smears for Microscopy (AFB & CBNAAT)

TB Patients found positive on any follow-up sputum smear examination during

treatment with first line drugs, Treatment failure cases, Contacts of DR-TB,

Previously treated TB patients, TB patients with HIV co-infection, Paediatric

TB non-responders, All notified new TB patients

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Molecular Diagnostic tests for TB

Rapid tests: Results available in 24-48 hrs

CBNAAT (GenXpert MTb rif)

Sensitive test – detects very few bacilli tooDetects MTb as well as Rif resistanceResults in 60 -90 minutesNot used for follow up testing

LPA – Line probe assay (Lab only test)

Diagnoses MDR-TB directly from smear +ve sputum samples (Needs more bacilli in sample)Used to detect FLD, SLD resistance Results in 48-72 hrs

FLD Resistance targets rpoB - Rif; kat G / inhA - INH

SLD Resistance targets gyrA, rrs, embB

Page 6: DESKTOP READY RECKONER - KHPTSputum smears for Microscopy (AFB & CBNAAT) TB Patients found positive on any follow-up sputum smear examination during treatment with irst line drugs,

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Culture & Drug Susceptibility Testing

Solid Culture

• Positive result: 2-8 weeks (detection) • DST - 8-12 weeks (2-3 months)

Liquid Culture

• Positive result: 4-21 days (7-14 days)• DST - 4-7 days (21-28 days) • Negative result: 42 days (sometimes 4 weeks)

Drug Susceptibility Test (DST) results

Lab Sr.No1st line drugs SLI FQ Other

R H (inhA

)

H (katG

)

S E Z Km

Cm

Am

Lfx

Mfx

(0.5

)

Mfx

(2)

Eto

PA

S

Lzd

Cfz

Clr

Azi

Date Result: ______________ Date Reported:_______________ Reported by:________________________ R: Resistant; S: Susceptible; C: Contaminated; -- Not done (Name and Signature)

Other tests for TB diagnosisTest (Please Specify): ______________________Result:__________________________________________________________________________________________________________________________________________________________________________Date reported:_______________ Reported by:_______________________ (Name and Signature)

Cartridge Based Nucleic Acid Amplification Test (CBNAAT)Sample A B

M. Tuberculosis Detected Not Detected N/A

Rif Resistance Detected Not Detected Indeterminate N/A

Test No Result Invalid Error – Error Code________ (Please arrange for fresh sample)

Date tested: ______________ Date Reported:_______________ Reported by:_______________________ (Name and Signature)

Culture ( LJ LC)Lab Sr. No Negative Positive NTM (write species) Contamination

Date Result: ______________ Date Reported:_______________ Reported by:_______________________ (Name and Signature)

Line Probe Assay (LPA) Direct Indirect Lab serial ___________

First line LPA

RpoB: ---- locus control: present absent

WT1: present absent WT2: present absent WT3: present absent WT4: present absent

WT5: present absent WT6: present absent WT7 : present absent WT8 : present absent

MUT1 (D516V): present absent MUT2A (H526Y): present absent MUT2B (H526D): present absent MUT3 (S531L): present absent

Kat G: ----- locus control: present absent

WT1 (315): present absent

MUT1 (S315T1): present absent

MUT2 (S315T2): present absent

Inh A:----- locus control: present absent

WT1 (-15, -16): present absent WT2 (-8): present absent

MUT1 (C15T): present absent MUT2 (A16G): present absent

MUT3A (T8C): present absent MUT3B (T8A): present absent

Second line LPA

gyrA:--

locus control: present absent

WT1 (85-90): present absent

WT2 (89-93): present absent

WT3 (92-97): present absent

MUT1 (A90V): present absent

MUT2 (S91P): present absent

MUT3A (D94A): present absent

MUT3B (D94N/Y): present absent

MUT3C (D94G): present absent

MUT3D (D94H): present absent

gyrB:----

locus control: present absent

WT1 (536-541): present absent

MUT1 (N538D): present absent

MUT2 (E540V): present absent

rrs:-----

locus control: present absent

WT1 (1401-02): present absent

WT2 (1484): present absent

MUT1 (A1401G): present absent

MUT2 (G1484T): present absent

eis:-----

locus control: present absent

WT1 (37): present absent

WT2 (14, 12, 10): present absent

WT3 (2): present absent

MUT1 (C-14T): present absent

Final LPA Interpretation: ---

MTB result MTB positive MTB NegativeRIF Sensitive Resistant Indeterminate INH Sensitive Resistant IndeterminateQuinolone Sensitive Resistant Indeterminate SLID Sensitive Resistant Indeterminate

Date Result: ______________ Date Reported:_______________ Reported by:________________________ (Name and Signature)

Solid Culture - LJ; Liquid culture - LC

Detects MTb, NTMDetects very few bacilli tooDetects all types of durg resistaneUsed for diagnosis, follow up tests

Durg Susceptibility Test results

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Classification of TB Based on DST

* Patients, who have any Rifampicin resistance, should be managed as in MDR TB.

Drug sensitive (DS-TB): No resistance demonstrated to any of the drugs

Mono-Resistance: Resistant to one first line Anti-TB drug only.

Poly-drug resistance: Resistant to more than one first line Anti-TB drug, other than both Rifampicin and INH.

Multidrug Resistance: Resistant both Rifampicin and INH, with or without resistance to other first line drugs.

Rifampicin Resistance: Resistance to Rifampicin with or without resistance to other Anti-TB drugs excluding INH.*

Extensive Drug Resistance (XDR): MDR TB + FQ & SLI res

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Diagnostic Algorithm for Pulmonary TB

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Diagnostic Algorithm for Paediatric Pulmonary TB

• Persistent Fever >2wk, without a known cause and/or • Unremitting Cough for >2w and/or • Wt loss of 5% in 3months or no wt gain in past 3 months

CBNAAT* (on sputum)

MTB detected

Microbiological con�rmed TB Case

MTB not detected OR Sputum not available

CXR highly suggestive CXR NS shadows TST ‐ve

CXR Normal TST +ve

CXR Normal TST -ve

Gastric Aspirate / Induced Sputum for CBNAAT

+ve ‐ve

No other likely alternative diagnosis Clinically diagnosed TB case

Persistent shadow and symptoms

Gastric Aspirate / Induced Sputum for CBNAAT

+ve ‐ve

Refer to expert for work up of persistent

pneumonia

Evaluate for EPTB Refer to expert

Look for alternate cause

Give course of Antibiotics

*If CBNAAT is not readily available, smear microscopy should be performed

X-Ray and TST

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*offer molecular testing for H mono/poly resistance to TB patients prioritized by risk as per the available lab capacity

** LC DST (Mfx 2.0, Km, Cm, Lzd) will be done only for patients with resistance on baseline SL-LPA. DST to Z, Cfz,

Bdq & Dlm would be considered for policy in future, whenever available, standardized & WHO endorsed.

States to advance I phased manner as per PMDT Scale up plan for universal DST based on lab capacity and policy on

use of diagnostics

Diagnostic Algorithm for DR-TB

Key/Vulnerablepopulations Paediatric age group People living with HIV EPTB sites Smear negative/NA with

X-ray suggestive of TB

Presumptive TB All diagnosed TB patients

Non responders to treatment

DR-TB contacts Previously treated TB TB-HIV co -infection New TB patients*

CBNAAT

RS TBRR TB for discordance on LPA for RR+TB-repeat CBNAAT at LPA lab

SL-LPA** FL-LPA**

FQ and SLI Sensitive FQ and /or SLI Resistance H Resistance H Resistance

*o�er molecular testing for H mono/poly resistance to TB patients prioritized by risk as per the available lab capacity** LC DST (Mfx 2.0, Km, Cm, Lzd) will be done only for patients with resistance on baseline SL-LPA. DST to Z, Cfz,Bdq & Dlm would be considered for policy in future, whenever available, standardized & WHO endorsed.� States to advance I phased manner as per PMDT Scale up plan for universal DST based on lab capacity and policy onuse of diagnostics

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Treatment Regimens for First Line Treatment

* have to be evaluated for DRTB

Treatment groups

Regimen

Intensive Phase (IP)Continuation Phase

(CP)

New/Previously Treated* 2HRZE 4HRE

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FDC Dosage for Pediatric TB

Weight category Number of tablets (FDCs)

Intensive phase

HRZ E

50/75/150 100

4-7kgs 1 1

8-11kgs 2 2

12-15kgs 3 3

16-24kgs 4 4

25-29kgs 3+1A 3

30-39kgs 2+2A 2

*A=Adult FDC (HRZE=75/150/400/275;HRE=75/150/275)

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FDC Dosage for Adult TB

Number of Tablets (FDCs)

Weight category Intensive phase Continuation phase

HRZE HRE

75/150/400/275 75/150/275

25-39kgs 2 2

40-54kgs 3 3

55-69kgs 4 4

>70kgs 5 5

Page 14: DESKTOP READY RECKONER - KHPTSputum smears for Microscopy (AFB & CBNAAT) TB Patients found positive on any follow-up sputum smear examination during treatment with irst line drugs,

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Side Effects and Management

Symptom-based approach to evaluation of possible side effects of anti-TB drugs

SymptomDrug

(abbreviation)Action to be taken by HW Action to be taken by MO

Gastrointestinal (vomiting or epigastric discomfort)

Any oral medication Reassure patient. Give drugs with less water and over a longerperiod of time (e.g. 20 minutes). Do not give drugs on an empty stomachIf the above fails, refer to MO

Maintain hydration•Considertreatmentwithanti-emetics (e.g. domperidone) and proton pump inhibitors (eg. Omeprazole)

Itching/Rash Isoniazid (and other drugs also)

Reassure patientIf severe, stop all drugs and refer patient to MO

Itching without rash or a mild rash

•Continuetreatmentandgiveantihistamines Itching with moderate to severe rash•Stopalldrugstillsymptomssubside•Treatwithantihistamines•Patientswithmucosalinvolvement,fever and hypotension will require treatment with corticosteroids•Whenthereactionsubsidesreintroduce drugs one by one in this order INH. Rifampicin Pyrazinamide Ethambutol•Re-introduceeachdruginasmalldose and gradually increase over 3 days before introducing the next drug

Tingling/burning /numbness extremities

Isoniazid Refer to MO Give pyridoxine 100 mg/day orally or parenterally until symptoms subside.•Patientsnotrespondingtopyridoxinewill require treatment with amitryptiline

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Joint pains Pyrazinamide Reassure that it is a self-limiting condition. Encourage patients to increase intake of liquids.If severe, refer patient to MO for evaluation

•GiveNSAIDslikeparacetamol,Aspirinor ibuprofen and in severe cases Indomethacin for a week to 10 days•Inseverecasesestimateserumuricacidlevels

� If uric acid levels are significantly raised treat with NSAIDs and colchicine. Allopurinol is not effective

� In severe cases with normal or slightly elevated uric acid consider eduction of the dose of Pyrazinamide.

Impaired vision Ethambutol STOP Ethambutol, refer patient for evaluation

•Refertoophthalmologistforevaluation•Impairedvisionusuallyreturnstonormal within a few weeks of stopping ethambutol.

Ringing in the ears, Loss of hearing, Dizziness and lossof balance

Aminoglycosides STOP Aminoglycosides, refer patient for evaluation

•Refertootorhinolaryngologistforopinion•Ashearinglossisusuallynotreversibledo not restart Streptomycin

Hepatitis: Anorexia / Nausea / vomiting / Jaundice

Isoniazid, Rifampicin or Pyrazinamide

STOP all anti TB drugs, Refer patient for evaluation

Rule out other causes of hepatitis•Donotrestarttreatmenttillsymptoms resolve and liver enzymes return to baseline levels•Ifliverenzymescannotbeperformedwait for 2 weeks after jaundice has disappeared to restart treatment•Restarttreatmentwithonedrugatatime starting with Rifampicin INH Pyrazinamide.•Inpatientswithseverediseaseinwhom treatment cannot be stopped use a non hepatotoxic regimen consisting of Streptomycin and Ethambutol

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Drug Interactions

Drug Drug interactions

Isoniazid

Inhibits the metabolism of certain drugs, which can increase their plasma level and cause toxicity.Carbamazepine, benzodiazepines, acetaminophen, valproate, serotonergic antidepressants, disulfaram, warfarin, theophyllin

Rifampicin

Induces hepatic enzymes and may increase the dosage requirements of drugs metabolised in the liver. Antibiotics, hormone therapy, warfarin, cyclosporine, steroids, anticonvulsants, digoxin, nifedipine, diltiazem, Propanolol, metoprolol, enalapril, losartan, theophylline, sulphonylurea, hypoglycaemics, hypolipidaemics, benzodiazapenes, haloperidol, nortryptiline, zolpidem.Nevirapine is never co-administered with Rifampicin. Alternate NNRTIs may be used.

Streptomycin

Other ototoxic or nephrotoxic should not be administered to patients receiving streptomycinAminoglycoside antibiotics, Amphotericin B, Cephalosporins, Cyclosporin, Cisplatin, Furosemide, Vancomycin

Pyrazinamide Alcohol increases hepatic toxicity of Pyrazinamide

Ethambutol Antacids reduce the absorption of Ethambutol

Page 17: DESKTOP READY RECKONER - KHPTSputum smears for Microscopy (AFB & CBNAAT) TB Patients found positive on any follow-up sputum smear examination during treatment with irst line drugs,

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Contact Screening & Chemoprophylaxis in DS-TB

Contact screening High priority

1. Children aged <6 years

2. Contacts with symptoms of tuberculosis

3. Contacts with immune-suppression (HIV)

4. Contacts of patients with MDR/XDR TB

Indications for chemo prophylaxis

(Only after ruling out active TB currently)

1. Child aged < 6 years

2. HIV infected patients

Chemoprophylaxis

• Isoniazid 10mg/kg/day X 6 months

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Sputum Collection

Sputum Samples

• Two sputum samples are the minimum required

� Spot sample (sample a) collected under supervision

� At least one an early morning sample (sample b) collected at home

Instruction to generate sputum

• The patient is asked to inhale deeply 2-3 times with mouth open, cough out deeply from the chest, open the labelled wide mouth container, spit out the sputum into it and close the container tightly

• Sputum should be collected in the open air or in a vacant room with open windows

• No one should be standing in front of the patient during this sputum collection

• The patient may need to try again if only saliva is brought out

• If the patient is unable to bring out sputum, sputum can be induced with 3% Saline nebulization

Collecting sputum for sputum microscopy

• Care provider needs to fill in the Sputum Lab Form completely

• Writing down the Lab serial number/ID number on the side of 2 sputum cups is mandatory.

• Given one of the sputum cups, the patient is instructed to collect sputum then and there at the health center. This collection should be always be attempted in a well-ventilated area (outdoors would be ideal). The sputum cup/ container should be closed tightly. This specimen is called a spot specimen.

• For the next day, the patient is given a second similarly marked sputum container to collect an early morning specimen on the next day or two that needs to be delivered to the laboratory. This specimen is called an early morning specimen.

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Special Situations

Special Scenario Special Issue

Pregnancy & Lactation All first line ATT drugs, except Streptomycin, can be used safely in pregnancy. Streptomycin causes fetal oto-toxicity hence deafness. All first line ATT drugs can be used safely during lactation. Breast feeding should be continued and mother should practice cough hygiene. Baby should be administered chemoprophylaxis as per guidelines.

Paediatric TB All children should be registered under RNTCP. Pediatric patient friendly dispersible tablets are available starting form 4kg onwards.

HIV TB is the commonest opportunistic infection and trigger for IRIS in HIV infected individuals. Due to drug interactions, Nevirapine should be avoided in patients receiving Rifampicin. TB in HIV infected persons is an indication for initiation fo ART within 2-8 weeks of starting Anti-TB Treatment. For more information, refer to the section on Management of TB-HIV in the annexure D.

Liver disease Patients with an underlying liver disease need to be started on first line ATT cautiously with frequent monitoring of liver function tests. Those patients who develop ATT induced hepatitis could be in liufe threatening danger and always need to be referred for management and modified ATT.

Renal failure Streptomycin should be avoided in patients with renal failure because of reduced excretion leads to toxic concentrations that lead to oto- and nephro-toxicity. No changes are required in Isoniazid and Rifampicin dosing as they are excreted through bile. Pyrazinamide and Ethambutol doses should be modified according to Creatinine clearance.

Diabetes mellitus The drug regimen is same as in non-diabetic patients. Strict control of blood glucose is required. Also, doses of oral hypoglycemic agents may have to be increased due to interaction with rifampicin.

Substance Abuse Smoking is associated with an increased risk of TB related mortality and morbidity. Alcohol may potentiate liver related toxicity of ATT drugs. Substance abuse may also interfere with adherence and cure. Patients especially on anti-TB treatment should refrain from smoking and alcohol.

Hospitalization The vast majority of patients can be treated on an ambulatory basis. Indications for hospitalization are complicated pulmonary (pneumothorax, frequent hemoptysis, massive pleural effusion, those requiring surgical intervention) and serious extra-pulmonary disease (Meningitis, Adrenal insufficiency, Arthritis, etc).

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Definitions - Outcome

Treatment outcomes for drug-susceptible TB patients

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Components of Pre-treatment evaluation for DR-TB

Ask - History

� Mental illness

� Seizure disorder

� Drug/alcohol abuse

� Other medication

Blood Test & lab Test

1. Complete Blood Count & lab Test (incl platelet count)

2. HIV I & II

3. Blood sugar (HbA1c if needed)

4. Liver function: AST, ALP, GGT, Bilirubin - total, direct, indirect, total protein, Albumin, Globulin, A:G Ratio, HBsAg

5. Kidney function : Blood Urea, Serum Creatinine

6. Thyroid function : TSH (T3, T4 if needed)

7. Serum electrolytes - potassium, magnesium, calcium (if Capreomycin needed)

8. Serum proteins, Lipase (if needed)

9. Routine & Microscopy (Urine Test)

10. Pregnancy test (for women in child bearing age gp)

11. ECG : Mfx/BDQ/DLM/, Cfz

Specialist evaluation

- Surgeon

- Mental health professional

- Ophthalmologist (newer drugs)

Check Weight, Height

Clinical Examination

Pulse BP, all systems

Chest X-ray

Hearing assessment

Audiometry

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Classes of anti TB Drugs for Treatment of TB

First Line Drugs (FLD)Rifampicin, Isoniazid, Ethambutol, Pyrazinamide

R / H / E / Z

A. Fluoroquinolones (FQ)Levofloxacin / Moxifloxacin / Gatifloxacin

Lfx / Mfx / Gfx

B. Second-line injectable agents (SLI)Amikacin / Capreomycin / Kanamycin (Streptomycin)

Am / Cm / Km

(S)

C. Other second-line agents

Ethionamide / prothionamide / Cycloserine / Terizidone Linezolid Clofazimine

Eto / Pto

Cs / Trd

Lzd

Cfz

D. Add - on agents

(not part of the core MDR-TB

regimen)

D1 Pyrazinamide Ethambutol High-dose Isoniazid

Z

E

Hh

D2 Bedaquiline Delamanid p-aminosalicylic acid Imipenem-cilastatin

Bdq

Dlm

PAS

Ipm/Cls

D3 Meropemen Amoxicillin-clavulanate (Thioacetazone)

Mpm

Amx-Clv

(T)

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Anti TB Drugs and their Dosages

S.No Drugs 16-29 kg 30-45 kg 46-70 kg >70 kg

1 Rifampicin (R1) 300 mg 450 mg 600 mg 600 mg

2 High dose H (Hh) 300 mg 600 mg 900 mg 900 mg

3 Ethambutol (E) 400 mg 800 mg 1200 mg 1600 mg

4 Pyrazinamide (Z) 750 mg 1250 mg 1750 mg 2000 mg

5 Kanamycin (Km)2 500 mg 750 mg 750 mg 1000 mg

6 Capreomycin (Cm) 500 mg 750 mg 750 mg 1000 mg

7 Amikacin (Am) 500 mg 750 mg 750 mg 1000 mg

8 Levofloxacin (Lfx)4 250 mg 750 mg 1000 mg 1000 mg

9 Moxifloxacin (Mfx)4 200 mg 400 mg 400 mg 400 mg

10 High dose Mfx (Mfxh)4 400 mg 600 mg 800 mg 800 mg

11 Ethionamide (Eto)4 375 mg 500 mg 750 mg 1000 mg

12 Cycloserine (Cs)4 250 mg 500 mg 750 mg 1000 mg

13 Na-Pas (60% weight/vol)3,4 10 gm 14 gm 16 gm 22 gm

14 Pyridoxine (Pdx) 50 mg 100 mg 100 mg 100 mg

15 Clofazimine (Cfz) 50 mg 100 mg 100 mg 200 mg

16 Linezolid (Lzd) 300 mg 600 mg 600 mg 600 mg

17Amoxyclav (Amx/Clv) (In child: WHO 80 mg/Kg in 2 divided doses)

875/125mg BD

875/125mg BD

875/125 mg (2 morning + 1

evening)

875/125(2 morning +1

evening)

18 Bedaquiline (Bdq)Week 0-2: Bdq 400 mg daily

Week 3-24: Bda 200 mg 3 times per week

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Resistance

patternRegimen class Intensive phase

Continuation

phase

Principle of

regimen design

Regimen for H mono/Play DR-TB

H Mono/Poly DR-TB (R Susceptible H resistant TB & DST of SEZ not known

H Mono-poly DR-TB regimen

(3-6) Lfx KmR E Z

(6) Lfx R E ZREZ + augmentwith 1 GpA + 1GpB drug

Shorter MDR-TB regimen

R resistant + Hsensitive / unknownor MDR - TB

Short MDR - TBregimen

(4-6) Mfxh

Km* Eto CfzZ Hh E

(5) Mfxh Cfz Z XAs per WHOrecommendation

Regimen for MDR / RR-TB

R resistant + Hsensitive / unknown or MDR-TB

ConventionalMDR-TBregimen

(6-9) Lfx KmEto Cs Z E

(18) Lfx Eto Cs E1 Gpa + 1GpB +2 GpC + Z + add on 1 Gpd1

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Resistance PatternDST guided ragimen

classIntensive phase Continuation phase Principle of regimen design

Regimen with new drugs for MDR-TB + FQ / SLI resistance

MDR/RR + resistance to FQ class / SLI1 class

MDR/RR + res to FQ Class(6-9) Km Eto CsZ Lzd3Cfz + (6) Bdq

(18) Eto CLzd3 CfzO GpA +1 GpB +2GpC + Z +add on 2GpC + 1 Gpd2

MDR/RR + res to SLI1 class(6-9) Lfx Cm1 Eto Cs Z Lzd3Cfz + (6) Bdq

(18) Lfx Eto CsLzd3

1 GpA + 1 GpB1 + 2GpC + Z + add on 2GpC + 1 GpD2

Regimen MDR-Tb + Fq / SLI resistance : (without new drugs)

MDR/RR + resistance /SLI1 class

MDR/RR +res to FQ class(6-9) Mfxh2 KmEto Cs Z Lzd3 Cfz

(18) Mfxh2 EtoCs Lzd3Cfz

1 Gpa2 + 1GpB +2GpC +Z add on 2 Gpc

MDR/RR +res to SLI1 class(6-9) Lfx Cm1 EtoCs Z Lzd3CFz

(18) Lfx Eto Cs Lzd3 1 GpA + 1 GpB1 + 2GpC + Z + add on 2 GpC

Regimen with new drugs for XDR-TB

XDR-TB (res to both FQ and SLI1 class

XDR-TB(6-12) Cm1Eto Cs Z Lzd3

Cfz E + (6) Bdq(18) Eto Cs Lzd3CFZ E

O GpA + 1 GpA1 + 2GpC + Z + add on 2GpC + 1 GpD1 +1 GpD2

Regimen for XDR -TB : (without new drugs)

XDR-TB (res to both FQ and SL1 class

XDR-TB(6-12)Mfxh2Cm1Eto Cs Z Lzd3Cfz E

(18) Mfxh2 EToCs Lzd3Cfz E

1 GpA2 + 1 GpB1 +2 GpC + Z + ass on2 GpC + 1GpD1

Regimen with new drugs for mixed pattern DR-TB:

Mixed pattern DR-TBMDR/RR-TB +res to FQ / SLI1 + Lzd3 or more

Modify the regimen with new drugs for XDR-TB as per the footnotes

Regimen for mixed pattern DR-TB : (without new drugs)

Mixed pattern DR-TB

H mono-poly + res to FQ/SLI1/ Lzd2

(3-6) R E ZCm1 Eto Lzd3 (6) R E Z Eto Lzd3 REZ + augment with 1 GpB1 + 2

GpC drug

MDR/RR-TB + FQ /SLI1 with Lzd3 or others

Modify the regimen for XDR-TB (without new drugs) as per the footnotes

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Notable adverse reactions to drugs used for

DR-TB Patients

Nausea/vomiting/stritis/Abdominal

Electrolyte Imbalance Depression

Pain Arthralgia Seizures

Diarrhoea Dizziness/vertigo Hypothyroidism

Anorexia Tinnitus Psychosis

Gastritis Sleep disturbances Suicidal ideation

Abdominal pain HeadacheHepatitis

(hepatotoxicity)

Allergic reaction Peripheral/neuropathyRenal failure

(nephrotoxicity)

Rash Visual disturbances QT prolongation

Refer

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Algorithmic Approach to Diagnosis of

DR-TB in Children

New Child TB patient

Con�rmed DR-TB

Con�rmed DS-TB

Contact with infectious TB patient ?

DRT/DST of source patient not known & Source is retreatment

TB patient &/or Child is failing 1st line treatment

Source is a

DR-TB patient

Source is a known

DS-TB patient or not known or no risk factor

Presumptive DRTB

Probable DR-TB

Probable DS-TB

Do DRT/DST of child or source�s specimen

Treat as DR-TB

If DRT/DST shows DR-TB, treat as

DR- TB

If DRT/DST shows DS-TBtreat as DS-TB

Treat as DS -TB

No

Yes or No

Do DRT/DST on an appropriate specimen from

child. Consult pediatrician to treat as DR TB according to

DST of child or source�s isolates, if child�s specimen

can�t be obtained

Yes

DRT/DST known

If poor response to treatment, consult

pediatrician to treat as Probable DR-TB

Yes

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Probable DR-TB in Children

• The term probable DR-TB would be applied to children

wherein bacteriologic confirmation is not available and

the decision regarding diagnosis and initiation of treatment

is taken by the experts on clinical grounds after ruling out

alternate diagnosis

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Disclaimer: This document is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of St John’s Medical College, Bangalore and KHPT and do not necessarily reflect the views of USAID or the United States Government.