Apriso (mesalamine)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Mesalamine, the 5-amino derivative of salicylic acid, is a GI anti-inflammatory agent.
USES: This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates.
It works by decreasing swelling in the colon.
Generic name: mesalamine
Pronunciation: (me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Apriso
Indications
The following indications are listed for Apriso:
- Ulcerative Colitis
- Ulcerative Colitis Remission
Also known as: Colitis Ulcerativa, Colitis Ulcerativa In Remission, Ulcerative Colitis In Remission.
Dosing
No dosing information is available for this tab.
Mesalamine is administered orally as delayed-release tablets and as extended-release capsules. Mesalamine is administered rectally as a retention enema or suppositories.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
There is no enhanced messaging for this drug.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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No enhanced messaging available.
Reproduction studies in rats and rabbits using oral mesalamine dosages of up to 1000 mg/kg daily and up to 800 mg/kg daily, respectively, have not revealed evidence of teratogenic effects or harm to the fetus. In addition, reproduction studies in rats and rabbits using oral mesalamine daily doses up to 5 and 8 times the maximum recommended human rectal dose, respectively, have not revealed evidence of fetal malformation. Sulfasalazine (a prodrug of mesalamine) has been used for the treatment of inflammatory bowel disease, including Crohn's disease and ulcerative colitis, during pregnancy. Although fetal abnormalities have been reported in infants born to women with inflammatory bowel disease who received sulfasalazine alone or combined with corticosteroids during pregnancy, most evidence indicates that sulfasalazine is not associated with a substantial risk of teratogenicity. The effect of sulfasalazine on subsequent growth, development, and functional maturation in children whose mothers received sulfasalazine during pregnancy has not been determined. Although the relevance to mesalamine of the experience with sulfasalazine in pregnant women currently is not known, placental transfer of mesalamine, but not sulfasalazine or sulfapyridine, has been reported to be negligible in pregnant women receiving oral sulfasalazine. Mesalamine crosses the placental barrier. Because there are no adequate and controlled studies to date using mesalamine or sulfasalazine in pregnant women, and animal studies are not always predictive of human response, the drugs should be used during pregnancy only when clearly needed.
Following oral administration, low concentrations of mesalamine and higher concentrations of its N-acetyl metabolite have been detected in human breast milk. Although the clinical importance of this effect is not known, mesalamine should be used with caution and only if the benefits outweigh the risks in nursing women. The manufacturer of mesalamine extended-release capsules states that hypersensitivity reactions (e.g., diarrhea) in the infant of a breast-feeding woman receiving mesalamine cannot be excluded. The manufacturer of mesalamine rectal suspension recommends that the drug not be used in nursing women.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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