Apriso

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders

Apriso Generic Name & Formulations

General Description

Mesalamine 0.375g; ext-rel caps; contains phenylalanine 0.56mg/cap.

Pharmacological Class

Aminosalicylate.

How Supplied

Caps—120

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

Metabolism

Hepatic.

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