RITONAVIR 100 mg Tablets

Pharmacokinetic Enhancer & Protease Inhibitor – HIV-1 Booster Agent

ATC Code: J05AE03 | Prescription Only | WHO Essential Antiretroviral

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Product Description:

Ritonavir is a protease inhibitor (PI) primarily used today as a pharmacokinetic enhancer (booster) in combination antiretroviral therapy (cART) for HIV-1 infection. At low doses, ritonavir inhibits cytochrome P450 3A4 (CYP3A4) enzymes, enhancing the plasma levels of co-administered PIs such as lopinavir, darunavir, or atazanavir. This boosting effect allows for lower dosing, once-daily administration, and improved antiviral efficacy of the partner PI.

Though ritonavir was originally developed as a full antiretroviral agent, its modern use is primarily as a booster, and it is a critical component of second-line or salvage regimens in WHO and national HIV treatment guidelines.

Available Presentation:

• Strength: 100 mg per tablet
• Formulation: Heat-stable, film-coated tablet (boosting dose)
• Packaging: Bottle of 30 or 60 tablets
• Route of Administration: Oral, with food
• Storage Conditions: Store below 25–30°C; protect from moisture

Uses:

• Used as a pharmacokinetic enhancer to increase the bioavailability of:
  • Lopinavir (e.g., in Kaletra® / LPV/r co-formulation)
  • Darunavir (DRV/r regimen)
  • Atazanavir (ATV/r regimen)
• May also be included in triple-PI salvage regimens for multidrug-resistant HIV
• Occasionally used in HCV combination regimens and studied in COVID-19 protocols (not standard)

Indications:

• HIV-1 infection:
  • For use as a booster of other protease inhibitors in adults and pediatric patients
  • Part of second-line ART regimens recommended by WHO, particularly in patients failing NNRTI-based first-line therapy
  • Used in patients with resistance requiring protease inhibitor–based rescue therapy
• Off-label uses include certain investigational protocols (e.g., HCV, SARS-CoV-2, with caution)

Regulatory and Safety Profile:

• ATC Code: J05AE03
• Pharmacologic Class: HIV Protease Inhibitor / CYP3A4 Inhibitor
• Pregnancy Category: B – May be used in pregnancy as per national HIV guidelines
• Common Adverse Effects: Diarrhea, nausea, lipid abnormalities, taste disturbances
• Serious Risks: Hepatotoxicity, pancreatitis, arrhythmias (with QT- or PR-prolonging drugs), significant drug-drug interactions
• Contraindications: Co-administration with drugs highly dependent on CYP3A for clearance (e.g., amiodarone, alfuzosin, simvastatin)
• Monitoring Parameters: Liver enzymes, triglycerides, co-medication interactions, adherence

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