Bedaquiline is an innovative diarylquinoline anti-mycobacterial drug. It was first approved for marketing in the United States in 2012, offering a new treatment option for drug-resistant tuberculosis.
What Are the Indications for Bedaquiline?
Indications
Bedaquiline is indicated as part of a combination therapy regimen for the treatment of pulmonary tuberculosis that is resistant to at least rifampicin and isoniazid.
The eligible population includes adult patients and pediatric patients aged 2 years and older with a body weight of at least 8 kilograms (approximately 17.6 pounds).
This drug is specifically intended for active, sputum smear-positive pulmonary infections caused by drug-resistant Mycobacterium tuberculosis.
Limitations of Use
Latent Mycobacterium tuberculosis infection (i.e., asymptomatic infection).
Drug-susceptible pulmonary tuberculosis.
Extrapulmonary tuberculosis (e.g., tuberculous meningitis, skeletal tuberculosis, etc.).
Infections caused by non-tuberculous mycobacteria.
Dosage Forms and Characteristics of Bedaquiline
Drug Specifications
20 mg tablets: White to off-white, oval, uncoated tablets with functional score lines. The tablets have score lines on both sides; one side is imprinted with "2" and "0", while the other side is blank.
100 mg tablets: White to off-white, round, biconvex, uncoated tablets. One side is imprinted with "T" over "207", and the other side is imprinted with "100".
Characteristic Features
Functional score lines (20 mg tablets): Tablets of this specification can be split equally into two halves along the central score line, with each half containing 10 mg of bedaquiline. This facilitates accurate dosing for patients requiring smaller doses (such as low-weight children).
Flexible administration methods (20 mg tablets): For patients unable to swallow the whole tablet, the 20 mg tablets can be administered in multiple ways, including dispersion in water for oral intake, dispersion and mixing with beverages or soft food, crushing and mixing with soft food, or administration via a feeding tube.
Storage Methods for Bedaquiline
Storage Conditions
Tablets of both specifications should be stored at room temperature, with a specific range of 15°C to 30°C (59°F to 86°F). Short-term temperature fluctuations are allowed in accordance with the controlled room temperature standards specified in the United States Pharmacopeia.
The drug should be protected from light and moisture, and the container should be kept tightly closed.
Specific Storage Methods
20 mg tablets: Must be stored in the original packaging bottle. The bottle contains a desiccant to absorb moisture—do not discard the desiccant. Always keep the bottle tightly closed and store it in a light-proof, dry place.
100 mg tablets: It is recommended to dispense and store the tablets in the original container. If the tablets need to be removed from the original bottle and stored in another container, a light-proof, airtight container should be used, and the expiration date labeled on the container shall not exceed 3 months after removal.
