Tapentadol
تاپنتادول
🧠 Nervous SystemOpioid agonist and norepinephrine reuptake inhibitor
Market / country: 🇺🇸 USA
Nucynta (US)
🧮 Dose calculator
Severe pain requiring an opioid · Regimen source: FDA Nucynta · 2.3
- • Day 1: the second dose may be given 1 h after the first. Over 700 mg on day 1 and 600 mg thereafter not studied. The calculator shows 6-hourly. FDA Nucynta · 2.3
- • Moderate hepatic impairment: 50 mg no more often than every 8 h; severe: not recommended. FDA Nucynta · 2.5
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Significant respiratory depression; acute or severe asthma without monitoring; GI obstruction or paralytic ileus; hypersensitivity; MAOIs now or within 14 days. FDA Nucynta · 4
Warnings
- • Boxed warning: addiction and misuse, life-threatening respiratory depression, accidental ingestion in children, neonatal opioid withdrawal, interactions with benzodiazepines and CYP3A4 inhibitors. Keep naloxone available. FDA Nucynta · Boxed WarningFDA Nucynta · 2.2
- • Serotonin syndrome with serotonergic drugs; seizures. FDA Nucynta · 5
Formulations
- 50 mg tablet — tablet 🇺🇸 USA FDA Nucynta · 3
- 75 mg tablet — tablet 🇺🇸 USA FDA Nucynta · 3
- 100 mg tablet — tablet 🇺🇸 USA FDA Nucynta · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Nucynta · Boxed Warning
“( 5.2 ) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Nucynta · 8.2
“Risk Summary There are no data on the presence of tapentadol in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
Label: only ≥6 years weighing at least 40 kg. Accidental ingestion by a child can be fatal. FDA Nucynta · 8.4
“The safety and effectiveness of NUCYNTA (tapentadol) tablets in pediatric patients ages 6 years and older who weigh at least 40 kg have been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Nucynta · 8.5
“In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Nucynta · 8.3
“Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential.”
🔗 Reference links
- FDA (approval record)NDA022304
- DailyMed (FDA label)FDA Nucynta
- MedlinePlus (NIH)Tapentadol
- WHO ATC/DDDN02AX06
- Darooyab (Iran)Tapentadol
🇮🇷 Not found in Iran list Darooyab · G-5336/Tapentadol
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 Nucynta · 3FDA Nucynta · 2.3FDA Nucynta · 2.5FDA Nucynta · 4FDA Nucynta · Boxed WarningFDA Nucynta · 2.2FDA Nucynta · 5FDA Nucynta · 8.2FDA Nucynta · 8.4FDA Nucynta · 8.5FDA Nucynta · 8.3FDA Nucynta · SPL approval / marketing category
- 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-5336/Tapentadol
- Clinical review⚠ Unverified