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Apriso Generic Name & Formulations
Legal Class
Rx
General Description
Mesalamine 0.375g; ext-rel caps; contains phenylalanine 0.56mg/cap.
Pharmacological Class
Aminosalicylate.
How Supplied
Caps—120
Manufacturer
Generic Availability
YES
Apriso Indications
Indications
Maintenance of remission of ulcerative colitis (UC) in adults.
Apriso Dosage and Administration
Adult
Swallow whole. 1.5g once daily in the AM.
Children
Not established.
Apriso Contraindications
Not Applicable
Apriso Boxed Warnings
Not Applicable
Apriso Warnings/Precautions
Warnings/Precautions
Sulfasalazine allergy. Discontinue if acute intolerance syndrome is suspected. Discontinue at the 1st signs/symptoms of severe cutaneous adverse reactions. Conditions predisposing to myocarditis or pericarditis. Atopic dermatitis or eczema: may have more severe photosensitivity reactions. Nephrolithiasis. Ensure adequate hydration. Phenylketonuria. Renal or hepatic impairment. History of renal disease. Assess renal function prior to and periodically during therapy. Discontinue if renal function deteriorates while on therapy. Elderly (monitor CBCs, platelets). Pregnancy. Nursing mothers: monitor infants.
Apriso Pharmacokinetics
Elimination
Renal. Half-life: 9–10 hours.
Apriso Interactions
Interactions
Avoid concomitant antacids. Increased toxicity with nephrotoxic drugs (eg, NSAIDs). Increased risk for blood disorders, bone marrow failure, and associated complications with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity. May cause elevated test results when measuring urinary normetanephrine.
Apriso Adverse Reactions
Adverse Reactions
Headache, diarrhea, upper abdominal pain, nausea, nasopharyngitis; renal impairment, hypersensitivity reactions, mesalamine-induced acute intolerance syndrome (eg, cramping, abdominal pain, bloody diarrhea, fever, headache, rash), severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP).
Apriso Clinical Trials
See Literature
Apriso Note
Not Applicable
Apriso Patient Counseling
See Literature
