ABRIDGED PRESCRIBING INFORMATION: ATAZOR-R Tablet

Composition:

Each film-coated tablet contains Atazanavir Sulphate equivalent to Atazanavir 300 mg and Ritonavir 100 mg.


Indication:

Treatment of HIV-1 infection in combination with other antiretroviral agents.


Dosage:

Antiretroviral naive/ patients - the recommended dose is atazanavir 300 mg / ritonavir 100 mg once daily with food. When coadministered with tenofovir, it is recommended that atazanavir 300 mg / ritonavir 100 mg should be given along with tenofovir 300 mg (all as a single daily dose with food). Not recommended with efavirenz containing regimen. H2 antagonist dose should not exceed equivalent to 40 mg famotidine and should be given simultaneously or atazanavir 300 mg / ritonavir 100 mg be taken at least 10 hours after H2 antagonist. The proton-pump inhibitor dose should not exceed a dose comparable to omeprazole 20 mg and must be taken approximately 12 hours prior to the atazanavir 300 mg / ritonavir 100 mg dose in treatment-naive patients. Treatment-experienced patients - Atazanavir 300 mg / ritonavir 100 mg once daily with food at least simultaneously or at least 10 hours after the H2-receptor antagonist. Proton-pump inhibitors should not be used in treatment-experienced patients receiving atazanavir. Not recommended with efavirenz containing regimen. Atazanavir/ritonavir tablets are not recommended in patients taking both tenofovir and an H2-receptor antagonist.


Contraindications:

Patients with previously demonstrated hypersensitivity to any component of the product. Co-administration of atazanavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.


Warnings and Precautions:

Transient jaundice may develop in patients on atazanavir. Atazanavir/ritonavir has not been studied in subjects with hepatic impairment and is not recommended. Liver functions need to be monitored in patients co-infected with Hepatitis B and Hepatitis C. Few cases of erythema multiforme and Steven Johnson’s syndrome have been reported with use of atazanavir. Redistribution of body fat with peripheral wasting and central obesity may be seen. Immune Reconstitution Syndrome has been seen in patients receiving combination antiretroviral therapy including Atazanavir. Patients receiving atazanavir may develop new onset or exacerbations of diabetes mellitus/hyperglycemia. PR interval may be prolonged in patients on Atazanavir. Atazanavir/ritonavir should not be administered to treatment-experienced patients with end stage renal disease managed with hemodialysis.


Drug Interactions:

Atazanavir is an inhibitor of CYP3A, CYP2C8, and UGT1A1. Co-administration of atazanavir and drugs primarily metabolized by CYP3A, CYP2C8, or UGT1A1 may result in increased plasma concentrations of the other drug that could increase or prolong both its therapeutic and adverse effects. The potential for drug interactions with atazanavir changes when atazanavir is co-administered with the potent CYP3A inhibitor ritonavir.


Pregnancy:

Category B. This drug should be used during pregnancy only if clearly needed.


Nursing mothers:

Atazanavir is secreted in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving atazanavir.


Adverse reactions:

Headache, nausea, vomiting, abdominal pain, diarrhea, jaundice, scleral icterus, dizziness, insomnia, depression, peripheral neuropathic symptoms, rash, fever, depression, myalgia, cardiac conduction abnormalities, rash, nephrolithiasis.


Storage:

Store in a cool, dry and dark place.


Presentation:

HDPE bottle containing 30 tablets. For further information, please consult the full prescribing information.