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Duexis

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Duexis

INDICATIONS

Carefully consider the potential benefits and risks of DUEXIS and other treatment options before deciding to use DUEXIS. Use the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and Use In Specific Populations].

DUEXIS, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. [see Clinical Studies and Use In Specific Populations]

DOSAGE AND ADMINISTRATION

The recommended daily dose of DUEXIS (ibuprofen and famotidine) 800 mg/26.6 mg is a single tablet administered orally three times per day.

DUEXIS tablets should be swallowed whole, and should not be cut to supply a lower dose. Do not chew, divide, or crush tablets.

Patients should be instructed that if a dose is missed, it should be taken as soon possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

HOW SUPPLIED

Dosage Forms And Strengths

DUEXIS (ibuprofen and famotidine) tablets, 800 mg/26.6 mg, are light blue, oval, biconvex, film-coated tablets debossed with “HZT” on one side.

Storage And Handling

DUEXIS (ibuprofen and famotidine) tablets, 800 mg/26.6 mg, are light blue, oval, biconvex, film-coated tablets debossed with “HZT” on one side and supplied as:

NDC Number Size
75987-010-03 Bottle of 90 tablets

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

Distributed by: Horizon Pharma USA, Inc. 1033 Skokie Boulevard, Suite 355 Northbrook, IL 60062. Manufactured by: Pharmaceutics International, Inc. 10819 Gilroy Road Hunt Valley, MD 21031. Revised: April 2011

Last reviewed on RxList: 1/31/2013
This monograph has been modified to include the generic and brand name in many instances.

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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.


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