WARNINGS AND PRECAUTIONS

• Greater care should be taken in people with underlying liver problems.
• The safety and efficacy of atazanavir 300mg has not been established in patients with significant underlying liver disorders.
• Those patients who carried chronic hepatitis B or hepatitis C and are treated with the combination of antiretroviral therapy are more likely at the increased risk for severe and potentially fatal hepatic adverse reactions.
• There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses in the patients with type A and B haemophiliac, treated with protease inhibitors.
• Chronic disease (like kidney disease) in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
• Patients are advised to ask for medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
• Rashes are usually mild -to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir.
• Patients should be advised of the signs and symptoms and monitored closely for skin reactions and Atazanavir should be discontinued if severe rash develops.
• Alcohol should be avoided for the initial few weeks (first 4) of therapy and should be used with caution thereafter.
• Atazanavir and ritonavir should be administered simultaneously with, or at least 10 hours after, the H2-receptor antagonist.