Drug Catalog - Product Detail
APRISO EXTENDED RELEASE CAPS 0.375GM 120CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65649-0103-02 | BAUSCH HEALTH US | 120 | 0.375GM | CAPSULE |
PACKAGE FILES
Generic Name
MESALAMINE
Substance Name
MESALAMINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA022301
Description
11 DESCRIPTION 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 aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 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: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING APRISO ® extended-release capsules are available as light blue opaque hard gelatin capsules containing 0.375 g mesalamine in a light blue opaque gelatin capsule with the letters “G” and “M” imprinted on either side of a black band and are available in bottles of 120 capsules (NDC 65649-103-02). 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].
Indications & Usage
1 INDICATIONS AND USAGE APRISO ® is indicated for the maintenance of remission of ulcerative colitis in adults. APRISO is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Dosage The recommended dosage in adults is 1.5 g (four 0.375 g capsules) orally once daily in the morning. Administration Instructions Evaluate renal function before initiating therapy with APRISO [see Warnings and Precautions ( 5.1 )]. Swallow APRISO capsules whole. Do not cut, break, crush or chew the capsules. Avoid co-administration of APRISO with antacids [see Drug Interactions ( 7.1 )]. Drink an adequate amount of fluids [see Warnings and Precautions ( 5.7 )]. Take APRISO without regard to meals [see Clinical Pharmacology ( 12.3 )]. Dosage The recommended dosage is 1.5 g (four 0.375 g capsules) once daily in the morning. ( 2 ) Administration Instructions Evaluate renal function before initiating therapy with APRISO. ( 2 ) Swallow the capsules whole. Do not cut, break, crush or chew the capsules. ( 2 ) Avoid co-administration with antacids. ( 2 , 7.1 ) Drink an adequate amount of fluids. ( 2 , 5.7 ) Take APRISO without regard to meals. ( 2 )