Manufacturer
Recipharm Pharmaservices Private Limited (INDIA)
Registraction Number
MAL20076070ACZ
Content:
Each tablet contains 100 mg of bedaquiline fumarate.
Indications:
Sirturo is indicated for:
• Treatment of multi-drug resistant tuberculosis (MDR-TB) in adults and children (5 years and older, weighing at least 15 kg) when an effective treatment regimen cannot be otherwise provided.
Instructions:
1. Dosage:
o Adults: 400 mg (4 tablets) once daily for 2 weeks, followed by 200 mg (2 tablets) three times per week for 22 weeks.
o Children: Dosage is based on body weight.
2. Administration: Take Sirturo with food.
3. Monitoring: Regular monitoring of heart function (ECG), liver function, and electrolytes is required.
4. Directly Observed Therapy (DOT): It is recommended that Sirturo is administered under DOT to ensure compliance.
Malaysia
