Not to start or discontinue treatment if QTcF >500 ms is observed either before 1st dose or during treatment. Not to initiate treatment & should receive very frequent ECG monitoring throughout full treatment period in patients w/ known congenital prolongation of QTc-interval or any clinical condition known to prolong QTc interval; history of symptomatic cardiac arrhythmias or w/ clinically relevant bradycardia; any predisposing cardiac conditions for arrhythmia eg, severe HTN, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction; electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia. Continue planned combination therapy & initiate symptomatic therapy if necessary to suppress exaggerated immune reaction if paradoxical response is suspected. Extra pulmonary TB (eg, CNS, bone); infections due to Mycobacterial sp other than those of
M. tuberculosis complex; latent infection w/
M. tuberculosis. QT prolongation. Hypoalbuminaemia. Paradoxical drug reactions. Treatment for >24 consecutive wk. As part of combination regimens used to treat drug-susceptible
M. tuberculosis. Obtain ECG before initiation & mthly during full course treatment. Administer more frequent ECG monitoring if QTc interval duration exceeds 450/470 ms during treatment. Frequent monitoring of ECGs throughout full treatment period in patients who commence treatment w/ serum albumin <3.4 g/dL or experience fall in serum albumin into this range during treatment; if co-administration w/ any strong CYP3A4 inhibitor is necessary; if co-administration w/ fluoroquinolone is to be unavoidable. Obtain serum electrolytes eg, K at baseline & correct if abnormal. Concomitant treatment w/ medicinal products known to prolong QTc interval including (but not limited to) antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol); neuroleptics (eg, phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents; certain antimicrobial agents, including macrolides (eg, erythromycin, clarithromycin), moxifloxacin, sparfloxacin, bedaquiline, triazole antifungal agents, pentamidine, saquinavir; certain non-sedating antihistamines (eg, terfenadine, astemizole, mizolastine); certain antimalarials w/ QT-prolonging potential (eg, halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine); cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide. Not to be taken in patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Moderate influence on ability to drive & use machines. Not recommended in patients w/ severe renal impairment; moderate to severe hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Not to breastfeed during treatment. Childn weighing <30 kg.
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