1. Indications and Usage
\nMultidrug-Resistant Tuberculosis (MDR-TB):
\nIndicated as part of an all-oral combination treatment regimen for the treatment of pulmonary tuberculosis in adults (\u226518 years) with multidrug-resistant tuberculosis (MDR-TB) or rifampicin-resistant tuberculosis (RR-TB), when an effective treatment regimen cannot otherwise be provided.
\nNote: Safety and efficacy have not been established for treating latent tuberculosis infection or drug-susceptible active tuberculosis.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Oral Use ONLY. Must be taken with food to enhance bioavailability.
\nRecommended Dosage (24-Week Course):
\nLoading Phase (Weeks 1\u20132): 400 mg once daily for 2 weeks.
\nMaintenance Phase (Weeks 3\u201324): 200 mg three times per week (e.g., Monday, Wednesday, Friday) for 22 weeks. Each dose should be administered at least 48 hours apart.
\nMissed Dose:
\nIf a dose is missed during the first 2 weeks, do not make up for it. From Week 3 onward, patients should take the missed dose as soon as possible and then resume the normal schedule.
\n3. Mechanism of Action
\nATP Synthase Inhibition:
\nBedaquiline is a diarylquinoline antibiotic that specifically targets the mycobacterial adenosine triphosphate (ATP) synthase enzyme (a proton pump).
\nEnergy Deprivation:
\nBy inhibiting this enzyme, it blocks the synthesis of ATP, effectively cutting off the energy supply of the bacteria. This leads to bacterial death, including against non-replicating (dormant) organisms.
\n4. Safety and Warnings
\nQTc Interval Prolongation:
\nBedaquiline can prolong the QT interval. ECG monitoring is required at baseline, at least once every 2 weeks during treatment, and periodically until 24 weeks after treatment cessation. Concomitant use with other QT-prolonging drugs requires caution.
\nHepatotoxicity:
\nElevated liver enzymes and hepatotoxicity have been reported. Liver function tests (ALT, AST, Bilirubin) should be monitored regularly.
\nIncreased Mortality Risk:
\nClinical trials observed a higher mortality rate in the bedaquiline group compared to placebo (though this was likely confounded by baseline disease severity). It should only be used when effective alternatives are not available.
\n5. Adverse Reactions
\nMost Common:
\nGastrointestinal: Nausea, vomiting, abdominal pain.
\nMusculoskeletal: Arthralgia (joint pain), myalgia.
\nCardiac: QTc interval prolongation.
\nOthers: Headache, dizziness, increased serum amylase, rash.
\n6. Drug Interactions
\nMetabolic Pathway (CYP3A4):
\nBedaquiline is primarily metabolized by the cytochrome P450 enzyme CYP3A4.
\nContraindicated\/Avoided Combinations:
\nStrong CYP3A4 Inducers: Avoid concomitant use with Rifamycins (Rifampin, Rifabutin, Rifapentine) or Efavirenz, as they significantly reduce Bedaquiline exposure.
\nStrong CYP3A4 Inhibitors: Avoid concomitant use with strong inhibitors (e.g., Ketoconazole, Clarithromycin) for more than 14 days unless the benefit outweighs the risk, as they increase toxicity.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Bedaquiline Fumarate.
\nAppearance: White to off-white film-coated tablets.
\nStorage: Store at controlled room temperature (15\u00b0C\u201330\u00b0C) in the original package.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u65af\u8010\u745e\u00ae\uff08Sirturo\u00ae\uff09
\nGeneric Name: Bedaquiline Fumarate
\nStrength: 100mg per tablet\uff0c24 tablets per box
\nManufacturer: Janssen-Cilag SpA
\nMarketing Authorization Holder: Janssen Pharmaceuticals Limited
\nApproval Date in China: 2016
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 HJ20160033
\nStorage: Store sealed below 30\u2103, protect from moisture and light; keep away from children<\/p>\n
Price&Cost:Contact Us now for the best price of Bedaquiline Fumarate\uff08Sirturo\uff09<\/p>\n","protected":false},"featured_media":3728,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[27],"product_tag":[],"class_list":["post-3727","product","type-product","status-publish","has-post-thumbnail","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n