Raltegravir
رالتگراویر
🦠 Antiinfectives For Systemic UseIntegrase inhibitor (INSTI)
Market / country: 🇺🇸 USA
Isentress (US)
🧮 Dose calculator
HIV-1 infection (treatment) · Regimen source: FDA Isentress · 2.2, Table 1
- • Always with other antiretrovirals (unless a complete regimen). FDA Isentress · 2.2
- • With rifampin: 800 mg twice daily. Chewable tablets and suspension are not interchangeable with film-coated tablets. FDA Isentress · 2.2, Table 1FDA Isentress · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Severe skin and hypersensitivity reactions (SJS, DRESS); rhabdomyolysis; immune reconstitution syndrome. FDA Isentress · 5
Formulations
- 400 mg film-coated tablet — tablet 🇺🇸 USA FDA Isentress · 3
- 600 mg HD tablet — tablet 🇺🇸 USA FDA Isentress · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label: Antiretroviral Pregnancy Registry data show no difference from the background birth-defect rate. FDA Isentress · 8.1
“Available data from the APR show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Isentress · 8.2
“Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Isentress · 8.4
“ISENTRESS HIV-1 Infected Children The safety, tolerability, pharmacokinetic profile, and efficacy of twice daily ISENTRESS were evaluated in HIV-1 infected infants, children and adolescents 4 weeks to 18 years of age in an open-label, multicenter clinical trial, IMPAACT P1066 [see Dosage and Administration (2.3) , …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Isentress · 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 potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA022145
- DailyMed (FDA label)FDA Isentress
- MedlinePlus (NIH)Raltegravir
- WHO ATC/DDDJ05AJ01
- Darooyab (Iran)Raltegravir
🇮🇷 Registered in Iran Darooyab · G-5318/Raltegravir
Dosage forms with Iranian generic codes, per Darooyab.
- 22527 · RALTEGRAVIR TABLET ORAL 400 mg · قرص رالتگراویر ۴۰۰ میلیگرم
- 24689 · RALTEGRAVIR TABLET, CHEWABLE ORAL 100 mg · قرص جویدنی رالتگراویر ۱۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Isentress · 3FDA Isentress · 2.2, Table 1FDA Isentress · 2.2FDA Isentress · 2.1FDA Isentress · 5FDA Isentress · SPL approval / marketing categoryFDA Isentress · 8.1FDA Isentress · 8.2FDA Isentress · 8.4FDA Isentress · 8.5
- 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-5318/Raltegravir
- Clinical review⚠ Unverified