1. Indications and Usage
\nTreatment of Multidrug-Resistant Tuberculosis (MDR-TB):
\nBedaquiline is indicated as part of an all-oral combination treatment regimen for adult patients with multidrug-resistant tuberculosis (MDR-TB), defined as resistance to isoniazid and rifampin.
\n2. Dosage and Administration
\nAdministration: Oral administration with food to enhance absorption. Swallow the tablet whole with water.
\nDosing (Adults):
\nWeeks 1-2: 400 mg once daily for 2 weeks (14 doses).
\nWeeks 3-24: 200 mg three times per week (e.g., Monday, Wednesday, Friday) for 22 weeks.
\nMissed Dose: If a dose is missed during Weeks 1-2, skip it and resume the normal schedule. If a dose is missed from Week 3 onwards, take it as soon as possible and resume the weekly schedule.
\nMonitoring: Obtain baseline ECG and serum electrolytes (potassium, magnesium, calcium) prior to initiation. Monitor ECG periodically during treatment.
\n3. Mechanism of Action
\nATP Synthase Inhibitor: Bedaquiline is a mycobacterial ATP synthase inhibitor.
\nPathway: It selectively binds to the subunit c of the mycobacterial membrane proton pump ATP synthase enzyme.
\nPhysiological Effect: By inhibiting this enzyme, it blocks the generation of energy (ATP) essential for the survival of the bacteria, leading to bacterial cell death.
\n4. Safety and Warnings
\nQTc Prolongation: Bedaquiline prolongs the QT interval. It is contraindicated in patients with known prolonged QTc interval (>500 ms) or uncorrected hypokalemia, hypomagnesemia, or hypocalcemia. Monitor ECG regularly.
\nHepatotoxicity: Hepatic enzyme elevations and severe liver injury can occur. Monitor liver function tests (ALT, AST) before and during treatment.
\nIncreased Mortality: An increase in mortality was observed in the treatment group compared to the placebo group in a clinical trial; the cause is unknown.
\nPregnancy and Lactation: Avoid use during pregnancy unless the potential benefit justifies the potential risk to the fetus.
\n5. Adverse Reactions
\nMost Common: Nausea, arthralgia (joint pain), headache, hemoptysis (coughing up blood), chest pain, and increased hepatic enzymes.
\n6. Drug Interactions
\nCYP3A4 Inhibitors: Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase bedaquiline plasma concentrations and the risk of QTc prolongation. Avoid concomitant use (except for short-course azole antifungals for mucocutaneous candidiasis).
\nCYP3A4 Inducers: Strong or moderate CYP3A4 inducers (e.g., rifampin, rifabutin, efavirenz) may decrease bedaquiline plasma concentrations and efficacy. Avoid concomitant use.
\nQTc-Prolonging Drugs: Concomitant use with other drugs known to prolong the QTc interval (e.g., clofazimine, fluoroquinolones, delamanid) is not recommended due to additive effects.
\n7. Pharmaceutical Information
\nChemical Name: (R)-N-(6-bromo-2-methoxy-1-oxo-1,2-dihydronaphthalen-2-yl)-6-(dimethylamino)-3,4-dihydro-1H-quinoline-2-carboxamide; (E)-butenedioate (1:1).
\nMolecular Formula: C32H31BrN2O2 \u2022 C4H4O4.
\nStorage: Store at 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F); excursions permitted to 15\u00b0C to 30\u00b0C (59\u00b0F to 86\u00b0F).<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u65af\u8010\u745e \u00ae(Sirturo\u00ae)
\nGeneric Name: Bedaquiline Fumarate
\nStrength: 0.1 g (100 mg) per tablet, 188 tablets per box
\nManufacturer: Recipharm Pharmaservices Private Limited
\nMarketing Authorization Holder: Janssen
\nApproval Date in China: November 23, 2016
\nRegistration Number:\u56fd\u836f\u51c6\u5b57 HJ20171366
\nStorage: Seal tightly, protect from light, store below 30\u2103; keep out of sight and reach of children<\/p>\n
Price&Cost:Contact Us now for the best price of Bedaquiline Fumarate\uff08Sirturo\uff09<\/p>\n","protected":false},"featured_media":3087,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[27],"product_tag":[],"class_list":["post-3085","product","type-product","status-publish","has-post-thumbnail","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n