Prevacid NapraPAC

Prevacid NapraPAC

INDICATIONS

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

PREVACID NapraPAC (lansoprazole) 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.

DOSAGE AND ADMINISTRATION

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

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

PREVACID NapraPAC (lansoprazole) 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 (lansoprazole) , the NAPROSYN dose and frequency should be adjusted to suit an individual patient's needs. Controlled studies of PREVACID NapraPAC (lansoprazole) 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 (lansoprazole) , however dose adjustment should be considered for patients with severe liver disease.

Dose adjustment for the NAPROSYN component of PREVACID NapraPAC (lansoprazole) 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 less than 30 mL per minute) (see WARNINGS, Renal Effects; PRECAUTIONS, Hepatic Effects; and PRECAUTIONS, Geriatric Use).

HOW SUPPLIED

PREVACID NapraPAC (lansoprazole) 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 "TAP" 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 64764-546-07 Weekly Blister Card, 500 mg
NDC 64764-546-30 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.

Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. July 2008. FDA Rev date: 10/20/2008

Last reviewed on RxList: 12/19/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

Prevacid NapraPAC - User Reviews

Prevacid NapraPAC User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Prevacid NapraPAC sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Arthritis

Get the latest treatment options

Related Drugs
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations