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Bedaquiline

بداکیلین

⚠ Unverified

🦠 Antiinfectives For Systemic UseDiarylquinoline (antimycobacterial)

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Dangerous / avoid 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Registered in Iran 🇺🇸 FDA approved (NDA) NDA204384 ATC J04AK05

Market / country: 🇺🇸 USA

Sirturo (US)

🧮 Dose calculator

Disease / regimen

Tuberculosis · Regimen source: FDA Sirturo · 2.3, Table 1 FDA Sirturo · 2.4, Table 2 FDA Sirturo · 2.6

⛔ With at least 3 other active drugs, with food, under directly observed therapy. Three-times-weekly doses at least 48 h apart. Children ≥2 y and ≥8 kg per label Table 2 by weight. Baseline and periodic ECG. FDA Sirturo · 2.3, Table 1 FDA Sirturo · 2.4, Table 2 FDA Sirturo · 2.6

🛡️ Safety & information

Warnings

• Boxed warning: QTc prolongation — monitor ECGs; stop for significant ventricular arrhythmia or QTc >500 ms. FDA Sirturo · Boxed Warning

Formulations

100 mg tablet — tablet 🇺🇸 USA FDA Sirturo · 3
20 mg tablet (functionally scored) — tablet 🇺🇸 USA FDA Sirturo · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Sirturo · 8.1
“Risk Summary Available data from published literature of SIRTURO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Sirturo · 8.2
“Because of the potential for serious adverse reactions in a breastfed infant, including hepatotoxicity, advise patients that breastfeeding is not recommended during treatment with SIRTURO and for 27.5 months (5 times the half-life) after the last dose unless infant formula is not available.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Sirturo · 8.4
“The safety and effectiveness of SIRTURO have been established in pediatric patients 2 years and older weighing at least 8 kg.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Sirturo · 8.5
“Clinical studies of SIRTURO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients [see Clinical Pharmacology (12.3) ] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA204384
DailyMed (FDA label)FDA Sirturo
MedlinePlus (NIH)Bedaquiline
WHO ATC/DDDJ04AK05
Darooyab (Iran)Bedaquiline

🇮🇷 Registered in Iran Darooyab · G-5465/Bedaquiline

Dosage forms with Iranian generic codes, per Darooyab.

51945 · BEDAQUILINE TABLET ORAL 100 mg · قرص بداکویلین ۱۰۰ میلی‌گرم

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Sirturo · 3 FDA Sirturo · 2.3, Table 1 FDA Sirturo · 2.4, Table 2 FDA Sirturo · 2.6 FDA Sirturo · Boxed Warning FDA Sirturo · SPL approval / marketing category FDA Sirturo · 8.1 FDA Sirturo · 8.2 FDA Sirturo · 8.4 FDA Sirturo · 8.5
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-5465/Bedaquiline
Clinical review⚠ Unverified

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