ABRIDGED PRESCRIBING INFORMATION: REATIX KIT
Combikit of Tenofovir & Emtricitabine Tablets IP and Atazanavir & Ritonavir Tablets.
Part A: Each film coated tablet contains: Emtricitabine IP 200 mg and Tenofovir Disoproxil Fumarate IP 300 mg equivalent to Tenofovir Disoproxil 245 mg Part B: Each film coated tablet contains: Atazanavir Sulphate IP equivalent Atazanavir 300 mg Ritonavir IP 100 mg.
for the treatment of HIV infection in adults.
Contents of one kit should be consumed once daily with food.
Hypersensitivity, not recommended to be administered with efavirenz containing regimen; contraindicated with drugs that are highly dependent on CYP3A or UGT1A1 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Warnings and precautions:
Redistribution of body fat, lactic acidosis and severe hepatomegaly, immune reconstitution syndrome, careful monitoring of renal and hepatic function, decrease in bone density, skin reactions, increase in PR interval on ECG, nephrolithiasis, exacerbation of existing diabetes or new onset diabetes mellitus.
Adverse effects (common):
Tenofovir: rash, diarrhea, headache, pain, depression, asthenia, and nausea.
Emtricitabine: headache, nausea, diarrhea, and skin rash. Atazanavir/r: Cardiac conduction abnormalities, rash, hyperbilirubinaemia, nephrolithiasis.
Use in special population:
Pregnancy: category C. Use only if the potential benefit justifies the potential risk. Lactation: Not recommended. Renal impairment: Should not be administered to patients with creatinine clearance < 50 ml/min.
Not recommended. Pediatric use: Not indicated. Geriatric use: Dose selection should be done cautiously.
Store protected from moisture, at temperature not exceeding from 30°C.
A strip of 6 Combikits. For further information please consult the full prescribing information.
Prepared by Dr. Aditi Apte on 09-09-2011
Revised PB 21-11-11