Vioxx (Rofecoxib) - Indications and Dosage

INDICATIONS AND USAGE

VIOXX is indicated:

For relief of the signs and symptoms of osteoarthritis.

For relief of the signs and symptoms of rheumatoid arthritis in adults.

For the management of acute pain in adults.

For the treatment of primary dysmenorrhea.

For the acute treatment of migraine attacks with or without aura in adults.

The safety and effectiveness of VIOXX have not been established for cluster headache, which is present in an older, predominantly male, population.

DOSAGE AND ADMINISTRATION

VIOXX is administered orally. The lowest dose of VIOXX should be sought for each patient.

OSTEOARTHRITIS

The recommended starting dose of VIOXX is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. The maximum recommended daily dose is 25 mg.

RHEUMATOID ARTHRITIS

The recommended dose is 25 mg once daily. The maximum recommended daily dose is 25 mg.

MANAGEMENT OF ACUTE PAIN AND TREATMENT OF PRIMARY DYSMENORRHEA

The recommended dose of VIOXX is 50 mg once daily. The maximum recommended daily dose is 50 mg. Use of VIOXX for more than 5 days in management of pain has not been studied. Chronic use of VIOXX 50 mg daily is not recommended. (See ADVERSE REACTIONS, Clinical Studies in OA and RA with VIOXX 50 mg).

ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA

The recommended starting dose of VIOXX is 25 mg once daily. Some patients may receive additional benefit with 50 mg as compared to 25 mg. The maximum recommended daily dose is 50 mg. The safety of treating more than 5 migraine attacks in any given month has not been established. Chronic daily use of VIOXX for the acute treatment of migraine is not recommended.

HEPATIC INSUFFICIENCY

Because of significant increases in both AUC and C_max in patients with moderate hepatic impairment (Child-Pugh score: 7-9), the maximum recommended chronic daily dose is 12.5 mg. (See CLINICAL PHARMACOLOGY, Special Populations). The efficacy of 12.5 mg in rheumatoid arthritis patients with moderate hepatic insufficiency has not been studied.

VIOXX Tablets may be taken with or without food.

ORAL SUSPENSION

VIOXX Oral Suspension 12.5 mg/5 mL or 25 mg/5 mL may be substituted for VIOXX Tablets 12.5 or 25 mg, respectively, in any of the above indications. Shake before using.

HOW SUPPLIED

No. 3810 -- Tablets VIOXX, 12.5 mg, are cream/off-white, round, shallow cup tablets engraved MRK 74 on one side and VIOXX on the other. They are supplied as follows:

NDC 0006-0074-31 unit of use bottles of 30

NDC 0006-0074-28 unit dose packages of 100

NDC 0006-0074-68 bottles of 100

NDC 0006-0074-82 bottles of 1000

NDC 0006-0074-80 bottles of 8000.

No. 3834 -- Tablets VIOXX, 25 mg, are yellow, round tablets engraved MRK 110 on one side and VIOXX on the other. They are supplied as follows:

NDC 0006-0110-31 unit of use bottles of 30

NDC 0006-0110-28 unit dose packages of 100

NDC 0006-0110-68 bottles of 100

NDC 0006-0110-82 bottles of 1000

NDC 0006-0110-80 bottles of 8000.

No. 3835 -- Tablets VIOXX, 50 mg, are orange, round tablets engraved MRK 114 on one side and VIOXX on the other. They are supplied as follows:

NDC 0006-0114-31 unit of use bottles of 30

NDC 0006-0114-28 unit dose packages of 100

NDC 0006-0114-68 bottles of 100

NDC 0006-0114-74 bottles of 500

NDC 0006-0114-81 bottles of 4000.

No. 3784 -- Oral Suspension VIOXX, 12.5 mg/5 mL, is an opaque, white to faint yellow suspension with a strawberry flavor that is easily resuspended upon shaking.

NDC 0006-3784-64 unit of use bottles containing 150 mL (12.5 mg/5 mL).

No. 3785 -- Oral Suspension VIOXX, 25 mg/5 mL, is an opaque, white to faint yellow suspension with a strawberry flavor that is easily resuspended upon shaking.

NDC 0006-3785-64 unit of use bottles containing 150 mL (25 mg/5 mL).

STORAGE

VIOXX TABLETS:

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

VIOXX ORAL SUSPENSION:

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

Rx only

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

9556416 Issued March 2004