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Lopinavir/ritonavir

لوپیناویر/ریتوناویر

⚠ Unverified

🦠 Antiinfectives For Systemic UseRitonavir-boosted protease inhibitor

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution ⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA021251 ATC J05AR10

Market / country: 🇺🇸 USA

Kaletra (US)

🧮 Dose calculator

Disease / regimen

HIV-1 infection (treatment) · Regimen source: FDA Kaletra · 2.3, Table 2

• Not once daily: with ≥3 resistance substitutions, carbamazepine/phenobarbital/phenytoin, or pregnancy. Pregnancy: 400/100 twice daily. Swallow tablets whole; solution with food. Children: per weight/BSA tables. FDA Kaletra · 2.3 FDA Kaletra · 2.5 FDA Kaletra · 2.1 FDA Kaletra · 2.4

Formulation

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🛡️ Safety & information

Contraindications

⛔ Prior serious hypersensitivity (TEN, SJS, angioedema) to any ingredient; CYP3A-dependent narrow-index drugs and potent CYP3A inducers (per label table). FDA Kaletra · 4

Warnings

• Serious drug interactions; toxicity in preterm neonates (solution: ethanol and propylene glycol); pancreatitis; hepatotoxicity; QT and PR prolongation; diabetes; lipid elevations. FDA Kaletra · 5

Formulations

200 mg lopinavir / 50 mg ritonavir tablet — tablet 🇺🇸 USA FDA Kaletra · 3
80 mg lopinavir / 20 mg ritonavir per mL oral solution — solution 🇺🇸 USA FDA Kaletra · 3

👥 Special populations

🤰 PregnancyUse with caution
Label: registry data show no difference from the background rate; in pregnancy use tablets 400/100 mg twice daily; avoid the oral solution (ethanol). FDA Kaletra · 8.1
“Available data from the Antiretroviral Pregnancy Registry show no difference in the risk of overall major birth defects 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 Kaletra · 8.2
“Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Kaletra · 8.4
“The safety, efficacy, and pharmacokinetic profiles of KALETRA in pediatric patients below the age of 14 days have not been established.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Kaletra · 8.5
“In general, appropriate caution should be exercised in the administration and monitoring of KALETRA in elderly patients 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 Kaletra · 8.3
“Contraception Use of KALETRA may reduce the efficacy of combined hormonal contraceptives.”

🔗 Reference links

FDA (approval record)NDA021251
DailyMed (FDA label)FDA Kaletra
MedlinePlus (NIH)❌ None
WHO ATC/DDDJ05AR10
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

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)✅ Present
FDA Kaletra · 3 FDA Kaletra · 2.3, Table 2 FDA Kaletra · 2.3 FDA Kaletra · 2.5 FDA Kaletra · 2.1 FDA Kaletra · 2.4 FDA Kaletra · 4 FDA Kaletra · 5 FDA Kaletra · SPL approval / marketing category FDA Kaletra · 8.1 FDA Kaletra · 8.2 FDA Kaletra · 8.4 FDA Kaletra · 8.5 FDA Kaletra · 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)✅ Present
Darooyab · search
Clinical review⚠ Unverified

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