No clinical data on the use to treat extrapulmonary TB, infections due to mycobacterial species other than Mycobacterium tuberculosis
, latent infections w/ Mycobacterium tuberculosis
, as part of combination regimens used to treat drug-susceptible Mycobacterium tuberculosis
. Discontinue use if clinically significant ventricular arrhythmia & QTcF interval >500 ms confirmed by repeated ECG develops. Not recommended in patients w/ heart failure; QT interval as corrected by Fridericia method; history of congenital QT prolongation, Torsade de pointes; history of or ongoing hypothyroidism, bradyarrhythmia; hypokalemia; syncope; HIV-infected patients. Obtain ECG prior to & at least mthly after initiation; serum K, Ca & Mg at baseline. Follow-up monitoring of electrolytes if QT prolongation is detected. Monitor symptoms & laboratory tests (ALT, AST, alkaline phosphatase, bilirubin) at baseline. Not to be taken in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Avoid use w/ other hepatotoxic medicinal products & alcohol especially in patients w/ diminished hepatic reserve; moderate or strong CYP3A4 inducers & inhibitors. Concomitant use of medicinal products w/ known risk of QT prolongation; fluoroquinolones eg, gatifloxacin, moxifloxacin, sparfloxacin. Co-administration w/ clofazimine recommends clinical monitoring (frequent ECG assessment). May affect ability to drive & use machines. Not recommended in severe hepatic impairment. Moderate hepatic & severe renal impairment (CrCl <30 mL/min), end-stage renal disease requiring haemodialysis or peritoneal dialysis. Avoid use during pregnancy, lactation, in childn <18 yr & elderly ≥65 yr.