Buprenorphine + naloxone (sublingual)
بوپرنورفین + نالوکسان (زیرزبانی)
🧠 Nervous SystemPartial opioid agonist for OUD
Market / country: 🇺🇸 USA
Suboxone (US)
🧮 Dose calculator
Opioid use disorder · Regimen source: FDA Buprenorphine-nalox. · 2.3
- • Shown as the buprenorphine component. After induction with sublingual buprenorphine; adjust in 2 or 4 mg steps; usual range 4–24 mg/day. Under the tongue until dissolved; do not chew or swallow. Start with supervised dosing. FDA Buprenorphine-nalox. · 2.3FDA Buprenorphine-nalox. · 2.1FDA Buprenorphine-nalox. · 2.4FDA Buprenorphine-nalox. · 2.5
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to buprenorphine or naloxone. FDA Buprenorphine-nalox. · 4
Warnings
- • Respiratory depression (especially with benzodiazepines or other CNS depressants); accidental pediatric exposure; keep naloxone available. FDA Buprenorphine-nalox. · 2.2FDA Buprenorphine-nalox. · 5
Formulations
- Buprenorphine 2 mg / naloxone 0.5 mg sublingual tablet — sublingual tablet 🇺🇸 USA FDA Buprenorphine-nalox. · 3
- Buprenorphine 8 mg / naloxone 2 mg sublingual tablet — sublingual tablet 🇺🇸 USA FDA Buprenorphine-nalox. · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Buprenorphine-nalox. · 8.1
“Risk Summary The data on use of buprenorphine, one of the active ingredients in Buprenorphine and Naloxone Sublingual Tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Buprenorphine-nalox. · 8.2
“Risk Summary Based on two studies in 13 lactating women maintained on buprenorphine treatment, buprenorphine and its metabolite norbuprenorphine were present in low levels in human milk and available data have not shown adverse reactions in breastfed infants.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Buprenorphine-nalox. · 8.4
“The safety and effectiveness of Buprenorphine and Naloxone Sublingual Tablets have not been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Buprenorphine-nalox. · 8.5
“… g therapy in geriatric patients, the decision to prescribe Buprenorphine and Naloxone Sublingual Tablets should be made cautiously in individuals 65 years of age or older and these patients should be monitored for signs and symptoms of toxicity or overdose.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Buprenorphine-nalox. · 8.3
“Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential.”
🔗 Reference links
- FDA (approval record)ANDA203326
- DailyMed (FDA label)FDA Buprenorphine-nalox.
- MedlinePlus (NIH)Buprenorphine Buccal (chronic pain)Buprenorphine Injection (opioid dependence)
- WHO ATC/DDDN07BC51
- Darooyab (Iran)Buprenorphine
🇮🇷 Registered in Iran Darooyab · G-34/Buprenorphine
Dosage forms with Iranian generic codes, per Darooyab.
- 01414 · BUPRENORPHINE 0.3MG/1ML AMP · آمپول بوپرنورفین ۰٫۳ میلیگرم / ۱ میلیلیتر
- 01983 · BUPRENORPHINE 0.4MG SL TAB · قرص بوپرنورفین ۰٫۴ میلیگرم SL
- 10102 · BUPRENORPHINE 15MG TAB · قرص بوپرنورفین ۱۵ میلیگرم
- 03799 · BUPRENORPHINE 2MG SL TAB · قرص بوپرنورفین ۲ میلیگرم SL
- 03800 · BUPRENORPHINE 8MG SL TAB · قرص بوپرنورفین ۸ میلیگرم SL
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Buprenorphine-nalox. · 3FDA Buprenorphine-nalox. · 2.3FDA Buprenorphine-nalox. · 2.1FDA Buprenorphine-nalox. · 2.4FDA Buprenorphine-nalox. · 2.5FDA Buprenorphine-nalox. · 4FDA Buprenorphine-nalox. · 2.2FDA Buprenorphine-nalox. · 5FDA Buprenorphine-nalox. · SPL approval / marketing categoryFDA Buprenorphine-nalox. · 8.1FDA Buprenorphine-nalox. · 8.2FDA Buprenorphine-nalox. · 8.4FDA Buprenorphine-nalox. · 8.5FDA Buprenorphine-nalox. · 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-34/Buprenorphine
- Clinical review⚠ Unverified