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  • Constituents of Monthly Patient-wise Boxes [PWB] for Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen

    Content

    The patient on shorter oral Bedaquiline-containing multi-drug resistant (MDR)/rifampicin resistant TB (RR-TB) regimen shall be put on Type A and Type B box when initiated on treatment on a monthly patient wise box (PWB). Bedaquiline (Bdq) needs to be issued separately and stopped after 6 months. The patient should be provided with only Type A boxes when started on continuation phase (CP).​

    Table 1: Constituents of monthly-type A and B PWB of shorter oral Bedaquiline-containing MDR/RR-TB regimen; Source : Guidelines for PMDT, India 2021, p.132-133

    TYPE A BOX

    (USE IN IP AS WELL AS CP)

    Drugs

    Strength

    16-29 kg

    30-45 kg

    46-70 kg

    >70 kg

    Tab. Levofloxacin#

    250/500 mg

    250 mg *30tab

    250 mg *30tab + 500 mg *30tab

    500 mg *60tab

    500 mg *60tab

    Tab. Clofazimine

    50/100 mg

    50 mg *30tab

    100 mg *30tab

    100mg *30tab

    100 mg *60tab

    Tab. Ethambutol

    400/800 mg

    400 mg *30tab

    800 mg *30tab

    400 mg *30tab + 800 mg *30tab

    800 mg *60tab

    Tab. Pyrazinamide

    500/750 mg

    750 mg *30tab

    500 mg *30tab + 750 mg *30tab

    500 mg *60tab + 750 mg *30tab

    500 mg *30tab + 750 mg *60tab

    Tab. Pyridoxine

    50/100 mg

    50 mg*30tab

    100 mg*30tab

    100 mg*30tab

    100 mg*30tab

    Type B Box

    (Use in IP)

    Drugs

    Strength

    16-29 kg

    30-45 kg

    46-70 kg

    >70 kg

    Tab. Isoniazid

    100/300 mg

    300 mg *30tab

    300 mg *60tab

    300 mg *90tab

    300 mg *90tab

    Tab. Ethionamide

    125/250 mg

    125 mg *30tab + 250 mg *30tab

    250 mg *60tab

    250 mg *90tab

    250 mg *120tab

    Bedaquiline bottle

    100 mg

    1 Jar (Jar of 188 tablets for full course)

    # When moxifloxacin prescribed under exceptional condition instead of levofloxacin, the modified box with moxifloxacin (normal dose) can be prepared from standard box at district drug store (DDS)

     

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  • Pharmacist: Longer Oral M/XDR-TB Regimen

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    • Longer Oral M/XDR-TB: Regimen and Duration

      Content

      Longer oral Multi (M)/ Extensive Drug-resistant (XDR) -TB treatment is specified with a definite regime and duration.

       

      Regimen: (18-20) Levofloxacin (Lfx), Bedaquiline (Bdq) (6 months or longer), Linezolid# (Lzd), Clofazimine (Cfz), Cycloserine (Cs)​​ (# dose of Lzd will be tapered to 300 mg after the initial 6–8 months of treatment)​

       

      • Duration: 18-20 months
      • No separate Intensive Phase (IP) and Continuation Phase (CP).
      • Bdq will be given for 6 months and extended beyond 6 months as an exception.
      • Pyridoxine should be given to all Drug-resistant TB (DR-TB) patients as per the weight bands.
      • For Extensively Drug-resistant TB (XDR-TB) patients, the duration of a longer oral XDR-TB regimen would be for 20 months.

       

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    • Treatment Extension in Longer Oral M/XDR-TB Regimen

      Content

      The total duration of a longer oral Multidrug/ Extensively drug-resistant TB (M/XDR-TB) regimen is 18–20 months. ​

       

      Process overview

      Figure: Protocol for Treatment Extension in Longer Oral M/XDR-TB Treatment Regimen

       

       

      Extension of Bedaquiline (Bdq) beyond 6 months is to be considered in patients in whom an effective regimen cannot otherwise be designed.

      • If any additional resistance to Group A, B or C drugs in use is detected, the patient needs to be reassessed at the Nodal/ District Drug-resistant Tuberculosis Centre (N/DDR-TBC) for modification of a longer oral M/XDR-TB regimen immediately on receiving the report.
      • A treatment duration of 15–17 months after culture conversion is suggested for most patients. The duration may be modified according to the patient’s response to treatment.

       

       

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    • Adverse Drug Reactions due to Longer oral M/XDR-TB Regimen

      Content

      The table below showcases the adverse drug events that may be caused by drugs used for longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen. In these situations, replacement drugs are used instead of these drugs.

       

      Table: Possible Adverse Drug Events in the Longer Oral M/XDR-TB Regimen

      ADVERSE DRUG EVENTS

      DRUGS

      QT prolongation

      		  Bedaquiline (Bdq), Fluoroquinolone (FQ), Clofazimine (Cfz)
      Rash, allergic reaction and anaphylaxis

      Any drug

      Gastrointestinal symptoms

      		 Ethionamide (Eto), P-Aminosalicylic Acid (PAS), Pyrazinamide (Z), Ethambutol (E), Bdq, Cfz, Linezolid (Lzd), FQs

      Diarrhoea and/or flatulence

      PAS, Eto

      Hepatitis

      Z, Eto, PAS, Bdq

      Giddiness

      Amikacin (Am), Eto, FQ and/or Z

      Haematological abnormalities

      Lzd

      Hypothyroidism

      Eto, PAS

      Arthralgia

      Z, FQ, Bdq

      Peripheral neuropathy

      Lzd, Cycloserine (Cs), Am, FQ, rarely Eto, E

      Headache

      Bdq, Cs

      Depression

      Cs, FQ, Eto

      Psychotic symptoms

      Cs, Isoniazid (H), FQ

      Suicidal ideation

      Cs, Eto

      Seizures

      Cs, H, FQ

      Tendonitis and tendon rupture

      FQ

      Nephrotoxicity (renal toxicity)

      Am

      Vestibular toxicity (tinnitus and dizziness

      Am, Cs, FQs, Eto, Lzd

      Hearing loss

      		 Am

      Optic neuritis

      E, Lzd, Eto, Cfz

      Metallic taste

      Eto, FQs

      Electrolyte disturbances (Hypokalaemia and Hypomagnesaemia

      Am

      Gynaecomastia

      Eto

      Alopecia

      Eto

      Superficial fungal infection and thrush

      FQ

      Lactic acidosis

      Lzd

      Dysglycaemia and Hyperglycaemia

      Eto

       

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    • Dosages of M/XDR-TB Drugs for Adult in Longer Oral M/XDR-TB Regimen​

      Content

      It is important to know the dosages of Multi (M)/ Extensively Drug-resistant TB (XDR-TB) drugs for adults on a longer oral M/XDR-TB regimen.​

       

       

      The table below shows the M/XDR-TB regimen drugs for adults weight band-wise, used in longer oral M/XDR-TB regimen customized for India by national experts.

       

       

      Table: Dosages of M/XDR-TB Drugs for Adults in Longer Oral M/XDR-TB Regimen

      Sr.No

      Drugs

      16-29 kg

      30-45 kg

      46-70 kg

      >70 kg

      1

      Levofloxacin (Lfx)

      250 mg

      750 mg

      1000 mg

      1000 mg

      2

      Moxifloxacin (Mfx)

      200 mg

      400 mg

      400 mg

      400 mg

      3

      High dose Mfx (Mfxh)

      400 mg

      600 mg

      600 mg

      600 mg

      4

      Bedaquiline (Bdq)

      Week 0–2: Bdq 400 mg daily 

      Week 3–24: Bdq 200 mg 3 times per week

      5

      Clofazimine (Cfz)

      50 mg

      100 mg

      100 mg

      200 mg

      6

      Cycloserine (Cs)3

      250 mg

      500 mg

      750 mg

      1000 mg

      7

      Linezolid (Lzd)

      300 mg

      600 mg

      600 mg

      600 mg

      8

      Delamanid (Dlm)

      50 mg twice daily (100 mg) for 24 weeks in 6-11 years of age

       100 mg twice daily (200 mg) for 24 weeks for ≥12 years of age

      9

      Amikacin (Am)1

      500 mg

      750 mg

      750 mg

      1000 mg

      10

      Pyrazinamide (Z)

      750 mg

      1250 mg

      1750 mg

      2000 mg

      11

      Ethionamide (Eto)3

      375 mg

      500 mg

      750 mg

      1000 mg

      12

      Na - PAS (60% weight/ vol)2,3 

      10 gm

      14 gm

      16 gm

      22 gm

      13

      Ethambutol (E)

      400 mg

      800 mg

      1200 mg

      1600 mg

      14

      Imipenem-Cilastatin (Imp-Cln)3

      2 vials (1g + 1g) bd (to be used with Clavulanic acid)

      15

      Meropenems (Mpm)3

      1000 mg three times daily (alternative dosing is 2000 mg twice daily) (to be used with Clavulanic acid)

      16

      Amoxicillin-Clavulanate (Amx-Clv) (to be given with Carbapenems only)

      875/125 mg bd

      875/125 mg bd

      875/125 mg bd

      875/125 mg bd

      17

      Pyridoxine (Pdx)

      50 mg

      100 mg

      100 mg

      100 mg

       

      1For adults more than 60 years of age, the dose of Second-line Injectable (SLI) should be reduced to 10 mg/kg (max up to 750 mg).

      2In patients of Para Amino Salicylic Acid (PAS) with 80% weight/ volume the dose will be changed to 7.5 gm (16-29 kg); 10 gm (30-45 Kg); 12 gm (46-70 kg) and 16 gm (>70 kg).

      3Drugs can be given in divided doses in a day in the event of intolerance.

       

       

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  • Constituents of Patient-wise Boxes [PWB] for Isoniazid [H] Mono/Poly DR-TB Regimen​

    Content

    Standard Patient-wise Boxes (PWBs) are constituted for TB patients initiated on Isoniazid (H) Mono/ Poly Drug-resistant TB (DR-TB) regimen. 

     

    This regimen has no segregation in terms of Intensive Phase (IP) or Continuation Phase (CP), hence drugs are provided in a single type of PWB. 

    Table: Constituents of standard PWB (6 months) of H mono/ poly DR-TB regimen; Source: Guidelines for PMDT, India 2021, p134

    STANDARD PWB

     

    		 CONTINUE FOR COMPLETE TREATMENT

    Drugs

    Strength

    16-29 kg

    30-45 kg

    46-70 kg

    >70 kg

    Tab. Levofloxacin

     250/ 500 mg

    250 mg *180 tab

    250 mg *180 tab + 500 mg *180 tab

    500 mg *360 tab

    500 mg *360 tab

    Tab. Rifampicin

     150/ 300/ 450 mg

     300 mg *180 tab

    450 mg *180 tab

    300 mg *360 tab

    300 mg *360 tab + 150 mg *180 tab

    Tab. Ethambutol

     400/ 800 mg

    400 mg *180 tab

    800 mg *180 tab

    400 mg *180 tab + 800 mg *180 tab

    800 mg *360 tab

    Tab. Pyrazinamide

     500/ 750 mg

    750 mg *180 tab

    750 mg *180 tab + 500 mg *180 tab

    750 mg *180 tab + 500  mg *360 tab

    750 mg *360 tab + 500 mg *180 tab

    Tab. Pyridoxine

    50/100 mg

    50 mg *30 tab

    100 mg *30 tab

    100 mg *30 tab

    100 mg *30 tab

    *No separate box for IP and CP.

     

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