APRISO mesalamine
Refer to the “Also Known As” section to reference different products that include the same medication as APRISO.
Drug Basics
Brand Name: APRISO
Generic Name: MESALAMINE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: CAPSULE, EXTENDED RELEASE
Data Current As Of: 2018-10-07
indications & usage
APRISO capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.
warnings & precautions
renal impairment
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as APRISO that contain mesalamine or are converted to mesalamine.
It is recommended that patients have an evaluation of renal function prior to initiation of APRISO therapy and periodically while on therapy. Exercise caution when using APRISO in patients with known renal dysfunction or a history of renal disease.
In animal studies, the kidney was the principal organ for toxicity [see Nonclinical Toxicology (13.2)].
mesalamine-induced acute intolerance syndrome
Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, promptly discontinue treatment with APRISO.
hypersensitivity
Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to APRISO capsules or to other compounds that contain or are converted to mesalamine.
hepatic impairment
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering APRISO to patients with liver disease.
drug interactions
Based on in vitro studies, APRISO is not expected to inhibit the metabolism of drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.
antacids
Because the dissolution of the coating of the granules in APRISO capsules depends on pH, APRISO capsules should not be co-administered with antacids.
patient counseling information
patients with phenylketonuria
- Inform patients with phenylketonuria (PKU) or their caregivers that each APRISO capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day.
general counseling information
- Instruct patients not to take APRISO capsules with antacids, because it could affect the way APRISO dissolves.
- Instruct patients to contact a health care provider if they experience a worsening of ulcerative colitis symptoms, because it could be due to a reaction to APRISO.
Manufactured for:
Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
U.S. Patent Numbers: 6,551,620; 7,547,451; 8,337,886; 8,496,965; 8,865,688; 8,911,778; 8,940,328; and 8,956,647
Apriso is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.
©Valeant Pharmaceuticals North America LLC
Please see www.salix.com for patent information.
9510501
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- mesalamine (capsule, extended release)
- Mesalamine (enema)
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- Rowasa (suspension)
- sfRowasa Sulfite-Free Formulation (suspension)
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