Finished product reference
Atazanavir / Ritonavir
Tablet · Oral · 300 mg/100 mg
- List code
- 51946
- Pharmacologic class
- Antiretroviral; HIV protease inhibitor with pharmacokinetic booster
What it is and how it works
Atazanavir is an azapeptide inhibitor of HIV-1 protease that prevents cleavage of viral Gag-Pol polyproteins, resulting in immature, non-infectious virions. Low-dose ritonavir inhibits CYP3A4, increasing atazanavir plasma concentrations and allowing once-daily dosing.
Indications
Treatment of HIV-1 infection in adults and adolescents in combination with other antiretroviral agents.
Dosage and administration (summary)
Atazanavir 300 mg with ritonavir 100 mg orally once daily with food, as part of combination antiretroviral therapy.
Contraindications
Severe hepatic impairment; co-administration with drugs highly dependent on CYP3A4 for clearance or strong inducers (e.g. rifampicin, St John's wort, simvastatin, lovastatin, midazolam oral, ergot derivatives, certain antiarrhythmics).
Warnings and precautions
Unconjugated hyperbilirubinaemia and jaundice are common and usually benign. PR-interval prolongation, nephrolithiasis, cholelithiasis and hepatotoxicity (especially with hepatitis B or C co-infection) may occur. Numerous clinically important drug interactions; absorption is reduced by acid-reducing agents.
Pregnancy
May be used in pregnancy when indicated, with monitoring; neonatal hyperbilirubinaemia should be considered.
Storage and supply
Store below 30 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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