Pretomanid
پرتومانید
🦠 Antiinfectives For Systemic UseNitroimidazooxazine (antimycobacterial)
Market / country: 🇺🇸 USA
Pretomanid (US)
🧮 Dose calculator
Tuberculosis · Regimen source: FDA Pretomanid · 2.2
- • Only with bedaquiline and linezolid, with food, under DOT. Liver tests, CBC, ECG and electrolytes before starting. If bedaquiline or pretomanid stops, stop the whole regimen. FDA Pretomanid · 2.1FDA Pretomanid · 2.3FDA Pretomanid · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Any contraindication to bedaquiline or linezolid. FDA Pretomanid · 4
Warnings
- • Hepatotoxicity; myelosuppression; peripheral and optic neuropathy; QT prolongation; lactic acidosis; male reproductive effects. FDA Pretomanid · 5
Formulations
- 200 mg tablet — tablet 🇺🇸 USA FDA Pretomanid · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Pretomanid · 8.1
“Risk Summary There are no studies or available data on pretomanid use in pregnant women to inform any drug-associated risks.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Pretomanid · 8.2
“Risk Summary There is no information regarding the presence of pretomanid in human milk, or its effects on milk production or the breastfed infant.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Pretomanid · 8.4
“Safety and effectiveness of Pretomanid Tablets in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Pretomanid · 8.5
“Clinical studies of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Pretomanid · 8.3
“Infertility Males Reduced fertility and/or testicular toxicity were observed in male rats and mice treated with oral pretomanid.”
🔗 Reference links
- FDA (approval record)NDA212862
- DailyMed (FDA label)FDA Pretomanid
- MedlinePlus (NIH)Pretomanid
- WHO ATC/DDDJ04AK08
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Pretomanid · 3FDA Pretomanid · 2.2FDA Pretomanid · 2.1FDA Pretomanid · 2.3FDA Pretomanid · 2.4FDA Pretomanid · 4FDA Pretomanid · 5FDA Pretomanid · SPL approval / marketing categoryFDA Pretomanid · 8.1FDA Pretomanid · 8.2FDA Pretomanid · 8.4FDA Pretomanid · 8.5FDA Pretomanid · 8.3
- 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)✅ PresentDarooyab · search
- Clinical review⚠ Unverified