Efavir

Description:

Efavir
Efavirenz 200 mg Capsules/Efavirenz 600 mg Tablets

COMPOSITION

EFAVIR-200 Capsules
Each hard gelatin capsule contains:
Efavirenz ……… 200 mg


INDICATIONS

EFAVIR (efavirenz) Capsules and Tablets , in combination with other antiretroviral agents, are indicated for HIV-1 infection. This indication is based on two clinical trials of at least a year`s duration, which demonstrated prolonged suppression of HIV RNA.

DOSAGE AND ADMINISTRATION

Adults
The recommended dose of EFAVIR Capsules and Tablets is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside reverse transcriptase inhibitors (NRTIs).

It is recommended that EFAVIR Capsules and Tablets be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of EFAVIR Capsules and Tablets with food might lead to an increase in the frequency of adverse events (see PHARMACOLOGY, Pharmacokinetics, Effect of Food on Oral Absorption ). Dosing at bedtime may improve the tolerability of nervous system symptoms (see WARNINGS AND PRECAUTIONS, Nervous System Symptoms and UNDESIRABLE EFFECTS ).

Concomitant Antiretroviral Therapy
EFAVIR Capsules and Tablets must be given in combination with other antiretroviral medications (see WARNINGS AND PRECAUTIONS, Drug Interactions and INDICATIONS ).

Dosage Adjustment
If EFAVIR Capsules and Tablets are co-administered with voriconazole, the voriconazole maintenance dose should be increased to 400 mg every 12 hours and the efavirenz dose should be decreased to 300 mg once daily, using the EFAVIR Capsules formulation (three 100 mg capsules or one 200 mg and one 100 mg capsule).

CONTRAINDICATIONS

Hypersensitivity
EFAVIR Capsules and Tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.
PACKAGING INFORMATION

EFAVIR-200 Capsules………………… Container of 30 tabletsOther Information