INDICATIONS
COMBIVIR is indicated for the treatment of HIV
infection.
See CLINICAL PHARMACOLOGY for information about bioequivalence.
See CLINICAL PHARMACOLOGY: CLINICAL STUDIES.
DOSAGE AND ADMINISTRATION
The recommended oral dose of COMBIVIR for adults
and adolescents (at least 12 years of age) is one tablet
(containing 150 mg of lamivudine and 300 mg of zidovudine)
twice daily.
Dose Adjustment
Because it is a fixed-dose combination, COMBIVIR
should not be prescribed for patients requiring dosage adjustment
such as those with reduced renal function (creatinine clearance
£50 mL/min), those with low body weight(<50 kg
or 110 lb), or those experiencing dose-limiting adverse
events.
A reduction in the daily dose of zidovudine may be necessary
in patients with mild to moderate impaired hepatic function
or liver cirrhosis. Because COMBIVIR is a fixed-dose combination
that cannot be adjusted for this patient population, COMBIVIR
is not recommended for patients with impaired hepatic function.
HOW SUPPLIED
COMBIVIR Tablets, containing 150 mg lamivudine
and 300 mg zidovudine, are white, film-coated, modified-capsule-shaped
tablets engraved with “GXFC3” on one side. They
are available as follows:
60 Tablets/Bottle (NDC 0173-0595-00)
Store between 2° and 30°C (36° and 86°F).
Unit Dose Pack of 120 (NDC 0173-0595-02)
Store between 2° and 30°C (36° and 86°F).
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