Darunavir
داروناویر
🦠 Antiinfectives For Systemic UseProtease inhibitor (boosted with ritonavir)
Market / country: 🇺🇸 USA
Prezista (US)
🧮 Dose calculator
HIV-1 infection (treatment) · Regimen source: FDA Prezista · 2.3
- • Always with other antiretrovirals (unless a complete regimen). FDA Prezista · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Drugs highly dependent on CYP3A with narrow therapeutic index (alfuzosin, ranolazine, dronedarone, colchicine in renal/hepatic impairment, lurasidone, pimozide, oral midazolam, triazolam, sildenafil for PAH, simvastatin, lovastatin, ergots…) and strong inducers (rifampin, St John’s wort). FDA Prezista · 4
Warnings
- • Hepatotoxicity; severe skin reactions; contains a sulfonamide moiety (caution in sulfa allergy). FDA Prezista · 5
Formulations
- 800 mg tablet — tablet 🇺🇸 USA FDA Prezista · 3
- 600 mg tablet — tablet 🇺🇸 USA FDA Prezista · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Prezista · 8.1
“Risk Summary Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects or miscarriage.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Prezista · 8.2
“Risk Summary The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Prezista · 8.4
“PREZISTA/ritonavir is not recommended in pediatric patients below 3 years of age because of toxicity and mortality observed in juvenile rats dosed with darunavir (from 20 mg/kg to 1000 mg/kg) up to days 23 to 26 of age [see Warnings and Precautions (5.10) , Use in Specific Populations (8.1) and Clinical Pharmacology …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Prezista · 8.5
“In general, caution should be exercised in the administration and monitoring of PREZISTA in elderly patients, reflecting the greater frequency of decreased hepatic function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Prezista · 8.3
“Contraception Use of PREZISTA may reduce the efficacy of combined hormonal contraceptives and the progestin only pill.”
🔗 Reference links
- FDA (approval record)NDA021976
- DailyMed (FDA label)FDA Prezista
- MedlinePlus (NIH)Darunavir
- WHO ATC/DDDJ05AE10
- Darooyab (Iran)Darunavir
🇮🇷 Registered in Iran Darooyab · G-4695/Darunavir
Dosage forms with Iranian generic codes, per Darooyab.
- 50333 · DARUNAVIR (AS ETHANOLATE) TABLET ORAL 150 mg · قرص داروناویر (معادل اتانولات) ۱۵۰ میلیگرم
- 22525 · DARUNAVIR (AS ETHANOLATE) TABLET ORAL 600 mg · قرص داروناویر (معادل اتانولات) ۶۰۰ میلیگرم
- 52875 · DARUNAVIR (AS ETHANOLATE) TABLET ORAL 800 mg · قرص داروناویر (معادل اتانولات) ۸۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Prezista · 3FDA Prezista · 2.3FDA Prezista · 2.4FDA Prezista · 4FDA Prezista · 5FDA Prezista · SPL approval / marketing categoryFDA Prezista · 8.1FDA Prezista · 8.2FDA Prezista · 8.4FDA Prezista · 8.5FDA Prezista · 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-4695/Darunavir
- Clinical review⚠ Unverified