Nevirapine
نویراپین
🦠 Antiinfectives For Systemic UseNNRTI
Market / country: 🇺🇸 USA
Viramune (US)
🧮 Dose calculator
HIV-1 infection (treatment) · Regimen source: FDA Nevirapine · 2.1
- • The 14-day lead-in must be followed (fewer rashes). Do not escalate with rash during lead-in; do not extend beyond 28 days. Interruption >7 days: restart lead-in. With other antiretrovirals. FDA Nevirapine · 2.4FDA Nevirapine · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Moderate or severe hepatic impairment (Child-Pugh B/C); use in post-exposure prophylaxis (PEP). FDA Nevirapine · 4
Warnings
- • Boxed warning: fatal hepatotoxicity (especially first 18 weeks, women and higher CD4) and fatal skin reactions (SJS/TEN) — intensive monitoring for the first 18 weeks. FDA Nevirapine · Boxed Warning
Formulations
- 200 mg tablet (scored) — tablet 🇺🇸 USA FDA Nevirapine · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label: Antiretroviral Pregnancy Registry data show no difference from the background birth-defect rate. FDA Nevirapine · 8.1
“Available data from the APR show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Nevirapine · 8.2
“… 2) developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving nevirapine.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Nevirapine · 8.4
“The safety, pharmacokinetic profile, and virologic and immunologic responses of nevirapine have been evaluated in HIV-1 infected pediatric subjects aged 3 months to 18 years [see Adverse Reactions (6.1) and Clinical Studies (14.2) ].”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Nevirapine · 8.5
“In general, dose selection for an elderly patient should be cautious, 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 Nevirapine · 8.3
“Infertility Limited human data are insufficient to determine the risk of infertility in humans.”
🔗 Reference links
- FDA (approval record)ANDA077521
- DailyMed (FDA label)FDA Nevirapine
- MedlinePlus (NIH)Nevirapine
- WHO ATC/DDDJ05AG01
- Darooyab (Iran)Nevirapine
🇮🇷 Registered in Iran Darooyab · G-1191/Nevirapine
Dosage forms with Iranian generic codes, per Darooyab.
- 05516 · NEVIRAPIN 50MG/5ML ORAL SOLUTION · محلول خوراکی نویراپین ۵۰ میلیگرم / ۵ میلیلیتر
- 03375 · NEVIRAPINE 200MG TAB · قرص نویراپین ۲۰۰ میلیگرم
- 50473 · NEVIRAPINE SUSPENSION ORAL 50 mg/5mL 100 mL · سوسپانسیون خوراکی نویراپین ۵۰ میلیگرم / ۵ میلیلیتر ۱۰۰ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Nevirapine · 3FDA Nevirapine · 2.1FDA Nevirapine · 2.4FDA Nevirapine · 2.2FDA Nevirapine · 4FDA Nevirapine · Boxed WarningFDA Nevirapine · SPL approval / marketing categoryFDA Nevirapine · 8.1FDA Nevirapine · 8.2FDA Nevirapine · 8.4FDA Nevirapine · 8.5FDA Nevirapine · 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-1191/Nevirapine
- Clinical review⚠ Unverified