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Codes ATC: J04AM02
EMLc
Indication
Tuberculosis Code ICD11: 1B4Z
INN
Isoniazid + rifampicin
Type de médicament
Chemical agent
Type de liste
Liste de base (EML)
(EMLc)
Additional notes
WHO recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations, including modified dosage forms, non-refrigerated products and paediatric dosage forms of assured pharmaceutical quality.
Formulations
Oral > Solid: 50 mg + 75 mg tablet (dispersible) (EMLc) ; 75 mg + 150 mg tablet (EML) ; 150 mg + 300 mg tablet (EML)
Historique des statuts LME
Ajouté pour la première fois en 1989 (TRS 796)
Modifié en 1995 (TRS 867)
Modifié en 1997 (TRS 882)
Modifié en 1999 (TRS 895)
Modifié en 2007 (TRS 950)
Modifié en 2009 (TRS 958)
Modifié en 2017 (TRS 1006)
Modifié en 2019 (TRS 1021)
Sexe
Tous
Âge
Aussi recommandé pour les enfants
Équivalence thérapeutique
La recommandation concerne ce médicament spécifique
Renseignements sur le brevet
Patents have expired in most jurisdictions
Lire la suite sur les brevets.
Résumé des preuves et recommandation du comité d'experts
The Expert Committee recommended the deletion of the 60 mg + 60 mg and 150 mg + 150 mg formulations of isoniazid + rifampicin for intermittent use three times weekly from the core list of the EML, noting the advice of the WHO Global TB Programme that their use is no longer recommended in current WHO guidelines based on evidence that patients who received three times weekly dosing had a higher risk of treatment failure, disease relapse and acquired drug resistance compared with patients who received daily dosing (1). References: 1. Guidelines for treatment of drug-susceptible tuberculosis and patient care, 2017 update. Geneva: World Health Organization; 2017.