ABRIDGED PRESCRIBING INFORMATION: VIRO-4 KIT:

Combikit of Lamivudine and Tenofovir Disoproxil Fumarate IP and Atazanavir Sulphate and Ritonavir Tablets.

Composition: Part A:

Each film coated tablet contains: Lamivudine IP 300 mg and Tenofovir Disoproxil fumarate IP 300 mg eq. to Tenofovir Disoproxil 245 mg Part B: Each film coated tablet contains: Atazanavir Sulphate IP eq. to Atazanavir 300 mg; Ritonavir IP 100 mg.


Indication:

VIRO-4 KIT is indicated for the treatment of HIV-1 infection in adults.


Dosage and administration:

Contents of one kit should be consumed once daily with food.


Contraindications:

Patients with previously demonstrated 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:

Tenofovir and Lamivudine: Lactic acidosis/severe hepatomegaly with steatosis; new-onset or worsening renal impairment, patients with HIV-1 and HBV co-infection, emergence of lamivudine-resistant HBV, Use with interferon- and ribavirin-based regimens, decrease in bone marrow density.
Atazanavir: Prolongation of PR interval, maculopapular skin eruptions, hyperbilirubinemia, caution in patients with hepatic impairment, nephrolithiasis, new onset diabetes mellitus or exacerbation of existing hyperglycemia, increased bleeding. fat redistribution, immune reconstitution syndrome.


Adverse drug reactions (common):

Tenofovir: mild to moderate gastrointestinal events and dizziness.
Lamivudine: Stomatitis, hyperglycemia, anemia, lymphadenopathy, splenomegaly, hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B, anaphylaxis, urticaria, muscle weakness, CPK elevation, rhabdomyolysis, paresthesia, peripheral neuropathy, abnormal breath sounds/wheezing, alopecia, rash, pruritus.
Atazanavir/r: Cardiac conduction abnormalities, rash, hyperbilirubinaemia, nephrolithiasis.


Use in special population::


Pregnancy:

Category C. Use only if benefits justify the risk.


Lactation:

Mothers should be instructed not to breastfeed if they are receiving VIRO-4 kit.


Renal impairment:

Should not be used in patients with creatinine clearance <50 ml/min.


Hepatic impairment:

Not recommended.


Pediatric use:

Not indicated.


Geriatric use:

Dose selection should be done cautiously.


Storage:

Store protected from moisture, at a temperature not exceeding 30°C.


Presentation:

A strip of 6 Combikits. For further information, please consult full prescribing information.


Prepared by Dr. Aditi Apte on 25-10-2011

Edited PB 24.11.11