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Apriso

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Apriso

Apriso

INDICATIONS

APRISO (mesalamine extended-release capsules) capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.

DOSAGE AND ADMINISTRATION

The recommended dose for maintenance of remission of ulcerative colitis in adult patients is 1.5 g (four APRISO (mesalamine extended-release capsules) capsules) orally once daily in the morning. APRISO (mesalamine extended-release capsules) may be taken without regard to meals. APRISO (mesalamine extended-release capsules) should not be co-administered with antacids. An evaluation of renal function is recommended before initiating therapy with APRISO (mesalamine extended-release capsules) .

HOW SUPPLIED

Dosage Forms And Strengths

Extended-release capsules containing 0.375 g mesalamine.

Storage And Handling

APRISO (mesalamine extended-release capsules) is available as light blue opaque hard gelatin capsules containing 0.375 g mesalamine and with the letters “G” and “M” on either side of a black band imprinted on the capsule.

NDC 65649-103-02 Bottles of 120 capsules

NDC 65649-103-01 Bottles of 4 capsules

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature.

Manufactured by : Catalent Pharma Solutions for Salix Pharmaceuticals, Inc., Morrisville, NC 27560.

Last reviewed on RxList: 9/14/2009
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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