ODIVIR-250 Kit
Each kit contains:

(A) One Efavirenz tablet

Each film-coated tablet contains:
Efavirenz …….. 600 mg

(B) One Lamivudine tablet

Each film-coated tablet contains:
Lamivudine ……. 300 mg

(C) One Didanosine delayed-release capsule

Each capsule contains:
Didanosine ……… 250 mg (as enteric-coated beadlets)

ODIVIR-400 Kit
Each kit contains:

(A) One Efavirenz tablet

Each film-coated tablet contains:
Efavirenz ……. 600 mg

(B) One Lamivudine tablet

Each film-coated tablet contains:
Lamivudine …….. 300 mg

(C) One Didanosine delayed-release capsule

Each capsule contains:
Didanosine ……… 400 mg (as enteric-coated beadlets)

ODIVIR Kit is indicated for the treatment of HIV-1 infection, when therapy is warranted. Each kit contains once-daily doses of three commonly used antiretroviral drugs.

ODIVIR-250 Kit is intended for patients weighing <60 kg.
ODIVIR-400 Kit is intended for patients weighing >60 kg.

It is important to take all the three drugs on an empty stomach before dinner, or 2 hours after dinner. The capsule should be swallowed intact.

Dosage Adjustment

Renal Impairment

Lamivudine: Patients with impaired renal function, ie, creatinine clearance <50 mL/min require a dose adjustment.

Efavirenz: Not studied in patients with impaired renal function.

Didanosine: In adult patients with renal impairment, the dose of the didanosine enteric-coated formulation requires adjustment to compensate for the slower rate of elimination.

ODIVIR Kit is not suitable for the above categories of patients.

ODIVIR Kit is contraindicated in patients with clinically significant hypersensitivity (eg, anaphylaxis) to any of the components of the kit. It is also contraindicated in patients with reduced renal function (<50 m l /min).

Efavirenz must not be administered concurrently with astemizole, cisapride, midazolam, triazolam or ergot alkaloids because competition for the CYP450 3A4 enzyme by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life-threatening adverse events (eg, cardiac arrhythmias, prolonged sedation, or respiratory depression).

ODIVIR-250 Kit…………………. Carton of 10 kits
ODIVIR-400 Kit…………………. Carton of 10 kits