Carefully consider the potential benefits and risks of PREVACID NapraPAC and other treatment options before deciding to use PREVACID NapraPAC. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

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

Carefully consider the potential benefits and risks of PREVACID NapraPAC and other treatment options before deciding to use PREVACID NapraPAC. Use the lowest effective NAPROSYN dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

The recommended PREVACID NapraPAC doses for the risk reduction of NSAID-associated gastric ulcers ¾ in adult patients with a history of a documented gastric ulcer who require the use of an NSAID ¾ for the treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and/or ankylosing spondylitis are the following:

1) PREVACID NapraPAC 250: One 15 mg PREVACID capsule once daily and one 250 mg NAPROSYN tablet BID (500 mg of NAPROSYN daily);
2) PREVACID NapraPAC 375: One 15 mg PREVACID capsule once daily and one 375 mg NAPROSYN tablet BID (750 mg of NAPROSYN daily); or
3) PREVACID NapraPAC 500: One 15 mg PREVACID capsule once daily and one 500 mg NAPROSYN tablet BID (1000 mg of NAPROSYN daily).

In the morning before eating, take the PREVACID capsule and one NAPROSYN tablet with a glass of water. In the evening, take the second NAPROSYN tablet with a glass of water. PREVACID Delayed-Release Capsules should be swallowed whole; they should not be chewed or crushed.

After observing the response to initial therapy with PREVACID NapraPAC, the NAPROSYN dose and frequency should be adjusted to suit an individual patient's needs. Controlled studies of PREVACID NapraPAC did not extend beyond 12 weeks.

Renal insufficiency patients and geriatric patients do not require adjustment of the 15 mg PREVACID component of PREVACID NapraPAC. However, dose adjustment for the NAPROSYN component of PREVACID NapraPAC should be considered for geriatric patients and patients with liver disease. NAPROSYN-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance < 30 mL/minute).(See WARNINGS, Renal Effects; PRECAUTIONS, Hepatic Effects; and PRECAUTIONS, Geriatric Use).

PREVACID NapraPAC 250 is supplied as a weekly blister card packaged as a monthly (28 days) course of therapy. Each weekly blister card contains:

PREVACID

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

NAPROSYN

- Fourteen round, yellow, biconvex tablets, engraved with NPR LE 250 on one side and scored on the other.

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

PREVACID

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

NAPROSYN

- Fourteen pink, biconvex oval tablets, engraved with NPR LE 375 on one side.

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

PREVACID

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

NAPROSYN

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

NDC 0300-1548-07 Weekly Blister Card, 250 mg
NDC 0300-1545-07 Weekly Blister Card, 375 mg
NDC 0300-1546-07 Weekly Blister Card, 500 mg
NDC 0300-1548-30 One Month Administration Pack, 250 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.

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