8.5 Tuberculosis drug formulations

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    Only quality-assured drugs should be used. Several internationally recognized mechanisms ensure the quality of TB drugs a Citation a. Quality assurance:
    • WHO Prequalification Scheme: http://apps.who.int/prequal/
    • Stringent Regulatory Authorities (SRA): https://www.who.int/initiatives/who-listed-authority-reg-authorities/SRAs
    , b Citation b. Supply:
    Global Drug Facility: https://www.stoptb.org/facilitate-access-to-tb-drugs-diagnostics/global-drug-facility-gdf
    .

    8.5.1 Fixed-dose combinations

    FDC formulations combine several TB drugs (2, 3 or 4) in the same tablet. FDCs are only available for first-line TB drugs.

    FDCs improve adherence (decreased pill burden, decreased risk of omission of one or more drugs).

     

    Table 8.6 – Quality-assured FDC formulations

     

    FDCs

    Available formulations

    Children

    HZR

    H50 mg/Z150 mg/R75 mg

    HR

    H50 mg/R75 mg

    Adults

    EHZR

    E275 mg/H75 mg/Z400 mg/R150 mg

    EHR

    E275 mg/H75 mg/R150 mg

    HR

    H75 mg/R150 mg

     

    Note: when needed in children, ethambutol is given as a single formulation, in addition to the paediatric FDCs.

    8.5.2 Individual drugs

    Quality-assured single drug formulations are available for all first-line TB drugs. It may be necessary to use them when FDCs cannot be used due to adverse effects or drug interactions.

    There are no quality-assured FDCs for second-line TB drugs. The treatment of DR-TB is based on a combination of individual drugs.

    8.5.3 Paediatric formulations

    Paediatric formulations should be used whenever possible.

     

    However, they are not available for all TB drugs. When the only option is to manipulate the adult formulations:

    • Preferably use scored tablets.
    • Ensure that tablets/capsules can be split, crushed or opened (e.g. active ingredients may be protected from gastric acidity by an enteric coating).
    • If tablets must be crushed (or capsules opened), a fraction of the powder corresponding to the required dose is mixed with food or liquids. Such manipulations should be done immediately before administering the drug. Any remaining powder should be discarded.
    • The preparation of extemporaneous formulations using adult formulations is an alternative, however, this can only be considered if there are qualified personnel to ensure preparation in compliance with the appropriate compounding procedures.

     

    Footnotes