Prevacid Naprapac (Lansoprazole / Naproxen) - Indications and Dosage

INDICATIONS AND USAGE

PREVACID^® NapraPAC™ (375 or 500) is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of documented gastric ulcer who require the use of an NSAID for treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Controlled studies did not extend beyond 12 weeks.

DOSAGE AND ADMINISTRATION

Risk Reduction of NSAID-Associated Gastric Ulcers in the Treatment of Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis

Each convenience package of PREVACID^® NapraPAC™ (375 or 500) contains sufficient product for seven days of treatment. Each daily dose consists of one PREVACID 15 mg capsule and two NAPROSYN tablets, either 375 mg or 500 mg. Take the PREVACID capsule and one NAPROSYN tablet in the morning before eating with a glass of water. Take the second NAPROSYN tablet in the evening with a glass of water.

The maximum daily naproxen dose of PREVACID^® NapraPAC™ (375 or 500) is 1000 mg. Controlled studies for PREVACID^® NapraPAC™ did not extend beyond 12 weeks.

For PREVACID^® NapraPAC™ (375 or 500), no adjustment of the 15 mg PREVACID component is necessary in patients with renal insufficiency or for the elderly. Dosage adjustment for the NAPROSYN component should be considered for patients with renal insufficiency, liver disease or the elderly (see PRECAUTIONS - Renal Effects and Hepatic Function).

PREVACID Delayed-Release Capsules should be swallowed whole. The capsule should not be chewed or crushed.

HOW SUPPLIED

PREVACID^® NapraPAC™ 375 is supplied as a weekly blister card packaged as a monthly (28 days) course of therapy. Each weekly blister card contains:

   NAPROSYN

• fourteen pink, biconvex oval tablets, engraved with NPR LE 375 on one side.

   PREVACID

• seven opaque, hard gelatin, pink and green PREVACID 15 mg capsules, with the TAP logo and "PREVACID 15" imprinted on the capsules.

PREVACID^® NapraPAC™ 500 is supplied as a weekly blister card packaged as a monthly (28 days) course of therapy. Each weekly blister card contains:

   NAPROSYN

• fourteen yellow, capsule-shaped tablets, engraved with NPR LE 500 on one side and scored on the other.

   PREVACID

• seven opaque, hard gelatin, pink and green PREVACID 15 mg capsules, with the TAP logo and "PREVACID 15" imprinted on the capsules.

NDC 0300-1545-07 Weekly Blister Card, 375 mg

NDC 0300-1546-07 Weekly Blister Card, 500 mg

NDC 0300-1545-30 One Month Administration Pack,     375 mg

NDC 0300-1546-30 One Month Administration Pack,     500 mg

Storage: Protect from light and moisture.

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

Store and dispense in original container.

Rx only

U.S. Patent No. 6,047,829

Distributed by TAP Pharmaceuticals Inc.

Lake Forest, Illinois 60045, U.S.A.

ALEVE^® is a registered trademark of Bayer-Roche L.L.C.

ANAPROX^® /ANAPROX DS^® , EC-NAPROSYN^® , NAPROSYN^® , and NAPROSYN^® SUSPENSION are registered trademarks of and NapraPAC™ is a trademark of Syntex Pharmaceuticals International Ltd., A Bermuda Corporation

PREVACID^® is a registered trademark of TAP Pharmaceuticals Inc.

3646-R3, Rev. November, 2003

© 2003 TAP Pharmaceutical Products Inc.