Drug reference
Multiple-drug resistant pulmonary tuberculosis, in combination with other drugs ▶BY MOUTH ▶Adult: Initially 400 mg once daily for 2 weeks, then 200 mg 3 times a week for 22 weeks, intervals of at least 48 hours between each dose, continue appropriate combination therapy after bedaquiline
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QTc interval more than 500 milliseconds (derived using Fridericia’s formula). ventricular arrhythmia
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Hypothyroidism. QTc interval (derived using Fridericia’s formula) 450–500 milliseconds. risk factors for QT interval prolongation (e.g. electrolyte disturbances, heart failure, history of symptomatic arrhythmias, bradycardia, congenital long QT syndrome)
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→Appendix 1: bedaquiline
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▶Common or very common Arthralgia. diarrhoea. dizziness. headache. hepatic function abnormal. myalgia. nausea. QT interval prolongation. vomiting SIDE-EFFECTS, FURTHER INFORMATION If syncope occurs, obtain ECG.
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Manufacturer advises avoid unless potential benefit outweighs risk.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises caution in moderate impairment; avoid in severe impairment—no information available.
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Manufacturer advises caution if eGFR less than 30 mL/minute/1.73 m2.
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▶Determine serum potassium, calcium, and magnesium before starting treatment (correct if abnormal)— remeasure if QT prolongation occurs during treatment. ▶Obtain ECG before starting treatment, and then at least monthly during treatment or more frequently if concomitant use with other drugs known to prolong the QT interval. ▶Monitor liver function before starting treatment and then at least monthly during treatment—discontinue treatment if severe abnormalities in liver function tests.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 4, 8, 21 ▶Sirturo (Janssen-Cilag Ltd) A Bedaquiline (as Bedaquiline fumarate) 100 mg Sirturo 100mg tablets | 24 tablet P £2,387.28
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Missed doses If a dose is missed during the first two weeks of treatment, the missed dose should not be taken and the next dose should be taken at the usual time; if a dose is missed during weeks 3–24 of treatment, the missed dose should be taken as soon as possible and then the usual regimen resumed. Driving and skilled tasks Dizziness may affect performance of skilled tasks (e.g. driving)
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Initially 400 mg once daily for 2 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
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