CRIXIVAN in combination with antiretroviral agents is indicated for the treatment of HIV infection.

This indication is based on two clinical trials of approximately 1 year duration that demonstrated: 1) a reduction in the risk of AIDS-defining illnesses or death; 2) a prolonged suppression of HIV RNA.

The recommended dosage of CRIXIVAN is 800 mg (usually two 400-mg capsules) orally every 8 hours.

CRIXIVAN must be taken at intervals of 8 hours. For optimal absorption, CRIXIVAN should be administered without food but with water 1 hour before or 2 hours after a meal. Alternatively, CRIXIVAN may be administered with other liquids such as skim milk, juice, coffee, or tea, or with a light meal, e.g., dry toast with jelly, juice, and coffee with skim milk and sugar; or corn flakes, skim milk and sugar. (See CLINICAL PHARMACOLOGY, Effect of Food on Oral Absorption.)

To ensure adequate hydration, it is recommended that adults drink at least 1.5 liters (approximately 48 ounces) of liquids during the course of 24 hours.

Concomitant Therapy (See CLINICAL PHARMACOLOGY, Drug Interactions, and/or PRECAUTIONS: DRUG INTERACTIONS.)

Delavirdine

Dose reduction of CRIXIVAN to 600 mg every 8 hours should be considered when administering delavirdine 400 mg three times a day.

Didanosine

If indinavir and didanosine are administered concomitantly, they should be administered at least one hour apart on an empty stomach (consult the manufacturer's product circular for didanosine).

Itraconazole

Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended when administering itraconazole 200 mg twice daily concurrently.

Ketoconazole

Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended when administering ketoconazole concurrently.

Rifabutin

Dose reduction of rifabutin to half the standard dose (consult the manufacturer's product circular for rifabutin) and a dose increase of CRIXIVAN to 1000 mg (three 333-mg capsules) every 8 hours are recommended when rifabutin and CRIXIVAN are coadministered.

Hepatic Insufficiency

The dosage of CRIXIVAN should be reduced to 600 mg every 8 hours in patients with mild-to- moderate hepatic insufficiency due to cirrhosis.

Nephrolithiasis/Urolithiasis

In addition to adequate hydration, medical management in patients who experience nephrolithiasis/urolithiasis may include temporary interruption (e.g., 1 to 3 days) or discontinuation of therapy.

CRIXIVAN Capsules are supplied as follows:

No. 3755 — 100 mg capsules: semi-translucent white capsules coded "CRIXIVAN™ 100 mg" in green. Available as:

NDC 0006-0570-62 unit-of-use bottles of 180 (with desiccant).

No. 3756 — 200 mg capsules: semi-translucent white capsules coded "CRIXIVAN™ 200 mg" in blue. Available as:

NDC 0006-0571-43 unit-of-use bottles of 360 (with desiccant).

No. 3802 — 333 mg capsules: semi-translucent white capsules coded "CRIXIVAN™ 333 mg" in red and a radial red band on the body. Available as:

NDC 0006-0574-65 unit-of-use bottles of 135 (with desiccant).

No. 3758 — 400 mg capsules: semi-translucent white capsules coded "CRIXIVAN™ 400 mg" in green. Available as:

NDC 0006-0573-42 unit-dose packages of 42

NDC 0006-0573-40 unit-of-use bottles of 120 (with desiccant)

NDC 0006-0573-62 unit-of-use bottles of 180 (with desiccant)

NDC 0006-0573-54 unit-of-use bottles of 90 (with desiccant)

NDC 0006-0573-18 unit-of-use bottles of 18 (with desiccant). Storage

Bottles: Store in a tightly-closed container at room temperature, 15-30°C (59-86°F). Protect from moisture.

CRIXIVAN Capsules are sensitive to moisture. CRIXIVAN should be dispensed and stored in the original container. The desiccant should remain in the original bottle.

Unit-Dose Packages: Store at room temperature, 15-30°C (59-86°F). Protect from moisture.

MERCK & CO INC., Whitehouse Station, NJ 08889, USA. Issued November 2006. FDA Rev date: 7/18/2007

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