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Methadone
متادون
🧠 Nervous SystemOpioid agonist (OUD maintenance)
🤰 Pregnancy:Use with caution🤱 Breastfeeding:Use with caution👶 Children:Safety not established👴 Older adults:Use with caution⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Registered in Iran⛔ 1 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA075082ATC N07BC02
Market / country: 🇺🇸 USA
Diskets (US)
🧮 Dose calculator
Opioid use disorder · Regimen source: FDA Methadone 40 mg · 2.5FDA Methadone 40 mg · 2.1FDA Methadone 40 mg · 2.4
⛔ Only in certified opioid treatment programmes. First dose 20–30 mg supervised, when the patient shows withdrawal and is not sedated; the first dose must not exceed 30 mg. If withdrawal persists after 2–4 h, give 5–10 mg more. Further titration per label. Disperse in water or juice; never inject. FDA Methadone 40 mg · 2.5FDA Methadone 40 mg · 2.1FDA Methadone 40 mg · 2.4
🛡️ Safety & information
Contraindications
- ⛔ Significant respiratory depression; acute or severe asthma without monitoring; GI obstruction or ileus; hypersensitivity. FDA Methadone 40 mg · 4
Warnings
- • Boxed warning: life-threatening respiratory depression (peak later and longer than the analgesic effect), QT prolongation, accidental pediatric ingestion and benzodiazepine interactions. FDA Methadone 40 mg · Boxed WarningFDA Methadone 40 mg · 2.2
Formulations
- 40 mg dispersible tablet (quadrisected; disperse in ~120 mL liquid) — tablet 🇺🇸 USA FDA Methadone 40 mg · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Methadone 40 mg · 8.1
“Risk Summary The majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Methadone 40 mg · 8.2
“Risk Summary Based on two small clinical studies, methadone was present in low levels in human milk, but the exposed infants in these studies did not show adverse reactions.”
- 👶 ChildrenSafety not established
Label: not established under 18. Accidental ingestion by a child is fatal. FDA Methadone 40 mg · 8.4
“The safety, effectiveness, and pharmacokinetics of methadone in pediatric patients below the age of 18 years 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 Methadone 40 mg · 8.5
“Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Methadone 40 mg · 8.3
“Infertility The effect of methadone hydrochloride tablets for oral suspension on fertility is unknown.”
🔗 Reference links
- FDA (approval record)ANDA075082
- DailyMed (FDA label)FDA Methadone 40 mg
- MedlinePlus (NIH)MethadoneMethadone Injection
- WHO ATC/DDDN07BC02
- Darooyab (Iran)Methadone
🇮🇷 Registered in Iran Darooyab · G-127/Methadone
Dosage forms with Iranian generic codes, per Darooyab.
- 01586 · METHADONE 10MG/ML AMP · آمپول متادون ۱۰ میلی‌گرم / میلی‌لیتر
- 10456 · METHADONE 25MG/5ML 120ML ORAL SOLUTION · محلول خوراکی متادون ۲۵ میلی‌گرم / ۵ میلی‌لیتر ۱۲۰ میلی‌لیتر
- 02444 · METHADONE 25MG/5ML 250ML ORAL SOLUTION · محلول خوراکی متادون ۲۵ میلی‌گرم / ۵ میلی‌لیتر ۲۵۰ میلی‌لیتر
- 00818 · METHADONE 5MG TAB · قرص متادون ۵ میلی‌گرم
- 00819 · METHADONE 5MG/1ML AMP · آمپول متادون ۵ میلی‌گرم / ۱ میلی‌لیتر
- 14076 · METHADONE 5MG/5ML 120ML SYRUP · شربت متادون ۵ میلی‌گرم / ۵ میلی‌لیتر ۱۲۰ میلی‌لیتر
- 06394 · METHADONE 5MG/5ML 250ML SYRUP · شربت متادون ۵ میلی‌گرم / ۵ میلی‌لیتر ۲۵۰ میلی‌لیتر
- 13770 · METHADONE HCL 20MG DISPERSIBLE TAB · قرص پراکنده‌شونده متادون هیدروکلراید ۲۰ میلی‌گرم
- 02705 · METHADONE HCL 20MG TAB · قرص متادون هیدروکلراید ۲۰ میلی‌گرم
- 13771 · METHADONE HCL 40MG DISPERSIBLE TAB · قرص پراکنده‌شونده متادون هیدروکلراید ۴۰ میلی‌گرم
- 02706 · METHADONE HCL 40MG TAB · قرص متادون هیدروکلراید ۴۰ میلی‌گرم
- 01362 · METHADONE POWDER · پودر متادون
- 51978 · METHADONE HYDROCHLORIDE SOLUTION ORAL 5 mg/5 mL 240 mL · محلول خوراکی متادون هیدروکلراید ۵ میلی‌گرم / ۵ میلی‌لیتر ۲۴۰ میلی‌لیتر
- 51871 · METHADONE HYDROCHLORIDE TABLET, FOR SUSPENSION ORAL 40 mg · سوسپانسیون خوراکی متادون هیدروکلراید ۴۰ میلی‌گرم
- 51870 · METHADONE HYDROCHLORIDE TABLET, FOR SUSPENSION ORAL 20 mg · سوسپانسیون خوراکی متادون هیدروکلراید ۲۰ میلی‌گرم
- 52833 · METHADONE HYDROCHLORIDE SOLUTION ORAL 25 mg/5 mL 15 mL · محلول خوراکی متادون هیدروکلراید ۲۵ میلی‌گرم / ۵ میلی‌لیتر ۱۵ میلی‌لیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Methadone 40 mg · 3FDA Methadone 40 mg · 2.5FDA Methadone 40 mg · 2.1FDA Methadone 40 mg · 2.4FDA Methadone 40 mg · 4FDA Methadone 40 mg · Boxed WarningFDA Methadone 40 mg · 2.2FDA Methadone 40 mg · SPL approval / marketing categoryFDA Methadone 40 mg · 8.1FDA Methadone 40 mg · 8.2FDA Methadone 40 mg · 8.4FDA Methadone 40 mg · 8.5FDA Methadone 40 mg · 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 · G-127/Methadone
- Clinical review⚠ Unverified