Apriso

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Bausch Health Companies Inc.

    Generic Availability

    YES

    Mechanism of Action

    The mechanism of action of mesalamine is not fully understood, but appears to be a local anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways (eg, prostanoids), and through the lipoxygenase pathways (eg, leukotrienes and hydroxyeicosatetraenoic acids), is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

    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

    Absorption

    Steady state was reached on Day 6 of once daily dosing. Peak plasma concentrations: at ~4 hours post-dose.

    Distribution

    Plasma protein bound: 43 ± 6%.

    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

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