Naltrexone
نالترکسون
🧠 Nervous SystemOpioid antagonist
Market / country: 🇺🇸 USA
Revia (US)
🧮 Dose calculator
Alcohol dependence · Regimen source: FDA Naltrexone · Dosage and Administration — Alcoholism
- • Studied for up to 12 weeks; only part of a comprehensive programme. FDA Naltrexone · Dosage and Administration — Alcoholism
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Receiving opioid analgesics; current opioid dependence (including methadone or buprenorphine); acute opioid withdrawal; failed naloxone challenge or positive urine screen; hypersensitivity. FDA Naltrexone · Contraindications
Formulations
- 50 mg tablet (scored) — tablet 🇺🇸 USA FDA Naltrexone · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Naltrexone · Pregnancy
“Teratogenic Effects Category C Naltrexone has been shown to increase the incidence of early fetal loss when given to rats at doses ≥ 30 mg/kg/day (180 mg/m 2 /day; 5 times the recommended therapeutic dose, based on body surface area) and to rabbits at oral doses ≥ 60 mg/kg/day (720 mg/m 2 /day; 18 times the …”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Naltrexone · Nursing Mothers
“Because many drugs are excreted in human milk, caution should be exercised when naltrexone hydrochloride is administered to a nursing woman.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Naltrexone · Pediatric Use
“The safe use of naltrexone hydrochloride in pediatric patients younger than 18 years old has not been established.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA076264
- DailyMed (FDA label)FDA Naltrexone
- MedlinePlus (NIH)NaltrexoneNaltrexone Injection
- WHO ATC/DDDN07BB04
- Darooyab (Iran)Naltrexone
🇮🇷 Registered in Iran Darooyab · G-1970/Naltrexone
Dosage forms with Iranian generic codes, per Darooyab.
- 01718 · NALTREXONE HCL 25MG CAP · کپسول نالترکسون هیدروکلراید ۲۵ میلیگرم
- 01719 · NALTREXONE HCL 50MG CAP · کپسول نالترکسون هیدروکلراید ۵۰ میلیگرم
- 51777 · NALTREXONE INJECTION, POWDER, FOR SUSPENSION PARENTERAL 380 mg · پودر برای تهیه سوسپانسیون تزریقی نالترکسون ۳۸۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Naltrexone · How SuppliedFDA Naltrexone · Dosage and Administration — AlcoholismFDA Naltrexone · Dosage and Administration — Treatment of Opioid DependenceFDA Naltrexone · ContraindicationsFDA Naltrexone · SPL approval / marketing categoryFDA Naltrexone · PregnancyFDA Naltrexone · Nursing MothersFDA Naltrexone · Pediatric Use
- 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-1970/Naltrexone
- Clinical review⚠ Unverified