Lialda

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

    • Lialda Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Mesalamine 1.2g; del-rel tabs.

    Pharmacological Class

    Aminosalicylate.

    How Supplied

    Tabs—120

    Manufacturer

    Takeda Pharmaceutical Company

    Generic Availability

    YES

    Mechanism of Action

    The mechanism of action of mesalamine is not fully understood, but it shows to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, 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.

    Lialda Indications

    Indications

    For induction and maintenance of remission in adults with mildly to moderately active ulcerative colitis. To treat mildly to moderately active ulcerative colitis in pediatric patients weighing ≥24kg.

    Lialda Dosage and Administration

    Adult

    Swallow whole with food. Induction: 2.4–4.8g once daily. Maintenance: 2.4g once daily.

    Children

    <24kg: not established. Swallow whole with food. Take once daily. 24–35kg (Weeks 0 to 8): 2.4g; (after Week 8): 1.2g. >35–50kg (Weeks 0 to 8): 3.6g; (after Week 8): 2.4g. >50kg (Weeks 0 to 8): 4.8g; (after Week 8): 2.4g.

    Lialda Contraindications

    Not Applicable

    Lialda Boxed Warnings

    Not Applicable

    Lialda Warnings/Precautions

    Warnings/Precautions

    Sulfasalazine allergy. Upper GI tract obstruction (eg, pyloric stenosis) may delay onset of action. 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. 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.

    Lialda Pharmacokinetics

    Absorption

    After a single-dose (1.2g, 2.4g, or 4.8g) administered in the fasted state, plasma concentrations were detectable after 2 hours and reached a maximum by 9–12 hours on average.

    When taken with food, plasma concentrations were detectable after 4 hours and were maximal by 8 hours after a single dose (2.4g or 4.8g). Steady state was achieved generally by 2 days after dosing.

    Distribution

    Plasma protein bound: ~43% (at the concentration of 2.5 mcg/mL).

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: 7–9 hours (after 2.4g dose); 8–12 hours (after 4.8g dose).

    Lialda Interactions

    Interactions

    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.

    Lialda Adverse Reactions

    Adverse Reactions

    Headache, flatulence, abnormal LFTs, abdominal pain, diarrhea; children also: upper RTI, vomiting, anemia, viral infection; acute intolerance syndrome (cramping, bloody diarrhea, fever, headache, rash), renal impairment, hypersensitivity reactions, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP); rare: pancreatitis.

    Lialda Clinical Trials

    See Literature

    Lialda Note

    Not Applicable

    Lialda Patient Counseling

    See Literature

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