Applies to the following strength(s): 100 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Tuberculosis - Resistant
Weeks 1 to 2: 400 mg orally once a day with food
Weeks 3 to 24: 200 mg orally 3 times a week with food (with at least 48 hours between doses) for a total dose of 600 mg per week
Duration of therapy: 24 weeks
-Reserve bedaquiline for use when an effective treatment regimen cannot otherwise be provided.
-Bedaquiline should be given by directly observed therapy.
-Bedaquiline should only be used in combination with at least 3 other drugs to which the patient's multi-drug resistant tuberculosis (MDR-TB) isolate has shown in vitro susceptibility.
-If in vitro testing results are not available, bedaquiline may be started in combination with at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible.
Approved indication: As part of combination therapy in adults with pulmonary MDR-TB
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Caution recommended.
Liver Dose Adjustments
Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Data not available; should be used with caution only when benefits outweigh risks.
Consult WARNINGS section for dosing related precautions.
End-stage renal disease requiring hemodialysis or peritoneal dialysis: Caution recommended.
-Take with food.
-Swallow tablets whole with water.
-Take as prescribed; compliance with the full course of therapy must be emphasized.
-Missed dose during Week 1 or 2: Patients should not make up the missed dose but should continue the usual dosing schedule.
-Missed dose during Week 3 to 24: Patients should take the missed dose as soon as possible, and then resume the 3 times/week regimen.
-General: Bedaquiline-related side effects; isolates for bedaquiline minimum inhibitory concentrations (if failure to convert or relapse after therapy).
-Hepatic: Symptoms and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin).
-Metabolic: Serum potassium, calcium, and magnesium.
-Avoid alcohol and other hepatotoxic agents during therapy.
-During treatment with and after the last dose of bedaquiline, continue companion drugs as directed.
More about bedaquiline
- Other brands: Sirturo