Apriso label

Apriso

Apriso Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

APRISO capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.

History

There is currently no drug history available for this drug.

Other Information

Each APRISO capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an anti-inflammatory drug.  The structural formula of mesalamine is:

Chemical Structure

Molecular Weight: 153.14

Molecular Formula: C7H7NO3

Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above.

The inactive ingredients of APRISO capsules are colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, simethicone emulsion, ethylacrylate/methylmethacrylate copolymer nonoxynol 100 dispersion, hypromellose, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, aspartame, anhydrous citric acid, povidone, vanilla flavor, and edible black ink.

Apriso Manufacturers

  • Physicians Total Care, Inc.
    Apriso | Physicians Total Care, Inc.
    No Recall

    Apriso | Physicians Total Care, Inc.

    Apriso | Physicians Total Care, Inc.

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

  • Salix Pharmaceuticals, Inc.
    Apriso | Salix Pharmaceuticals, Inc.
    No Recall

    Apriso | Salix Pharmaceuticals, Inc.

    Apriso | Salix Pharmaceuticals, Inc.

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