Composition
ODIVIR-250 Kit
Each kit contains
(A) One Efavirenz tablet 600 mg
Each film-coated tablet contains Efavirenz 600 mg Colours: Yellow oxide of
iron & Titanium Dioxide

(B) One Lamivudine tablet 300 mg
Each film-coated tablet contains Lamivudine 300 mg, Colour: Titanium
Dioxide

(C) One Didanosine Delayed-release capsule 250 mg
Each capsule contains Didanosine 250 mg (as enteric-coated beadlets)

ODIVIR-400 Kit
Each kit contains

(A) One Efavirenz tablet 600 mg
Each film-coated tablet contains Efavirenz 600 mg, Colours: Yellow oxide
of iron & Titanium Dioxide

(B) One Lamivudine tablet 300 mg
Each film-coated tablet contains Lamivudine 300 mg, Colour : Titanium
Dioxide

(C) One Didanosine Delayed-release capsule 400 mg
Each capsule contains Didanosine 400 mg (as enteric-coated beadlets)

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

Dosage and Administration
For patients weighing <60 kg, one Odivir-250 Kit (all 3 drugs) to be taken in
the evening.
For patients weighing ³60 kg, one Odivir-400 Kit (all 3 drugs to be taken in
the evening.
It is important to take all 3 drugs before meals on an empty stomach, or at
least 2 hours after a meal. Since the green/white (or blue/white) capsule of
didanosine contains the drug as enteric-coated beadlets, it should be
swallowed intact and not be opened, chewed or enshed.
Dosage Adjustment
Patients with reduced renal function (creatinine clearance £ 50 ml/min) or
those with low body weight (< 50 kg or 110 lb) require the dose of lamivudine
to be adjusted. Patients with renal impairment may also be at risk of toxicity
from didanosine. Hence, Odivir Kit is not suitable for these patients.

Contraindications
Odivir Kit is contraindicated in patients with clinically significant
hypersensitivity to any of the components of the kit. It is also contraindicated
in patients with reduced renal function (< 50 ml/min) or low body weight
(<50 kg or 110 lb).

WARNING
DIDANOSINE IS A COMPONENT OF THIS KIT. FATAL AND NON-FATAL PANCREATITIS
HAVE OCCURRED DURING THERAPY WITH DIDANOSINE USED ALONE OR IN
COMBINATION REGIMENS IN BOTH TREATMENT-NAÏVE AND TREATMENT-EXPERIENCED
PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. DIDANOSINE
SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND
DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS (SEE WARNINGS AND
PRECAUTIONS).

LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL
CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE
OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS. FATAL
LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE
COMBINATION OF DIDANOSINE AND STAVUDINE WITH OTHER ANTIRETROVIRAL AGENTS.

PREGNANCY SHOULD BE AVOIDED IN WOMEN RECEIVING ODIVIR KIT BECAUSE OF
POSSIBLE TERATOGENIC EFFECTS WITH EFAVIRENZ, WHICH IS A COMPONENT OF
THIS KIT.