Delzicol

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders

Delzicol Generic Name & Formulations

General Description

Mesalamine 400mg; del-rel caps; contains iron 2.7mg/tab.

Pharmacological Class

Salicylate.

How Supplied

Caps—180

Manufacturer

Generic Availability

YES

Mechanism of Action

The mechanism of action of mesalamine is not fully understood, but appears to be a topical 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.

Delzicol Indications

Indications

Mildly to moderately active ulcerative colitis (UC) in patients ≥5 years of age. Maintenance of remission of UC in adults.

Delzicol Dosage and Administration

Adult

Swallow caps whole; if unable to swallow, may open and swallow contents (four 100mg tabs). Treatment: 800mg 3 times daily for 6 weeks. Maintenance: 1.6g/day in 2–4 divided doses. Do not substitute two Delzicol 400mg caps with one mesalamine 800mg del-rel tab.

Children

<5yrs: not established. Give twice daily dosing for 6 weeks. ≥5yrs (17–32kg): 36–71mg/kg/day, up to max 1.2g/day (800mg in the AM + 400mg in the afternoon); (33–53kg): 37–61mg/kg/day, up to max 2g/day (1200mg in the AM + 800mg in the afternoon); (54–90kg): 27–44mg/kg/day, up to max 2.4g/day (1200mg in the AM + 1200mg in the afternoon).

Delzicol Contraindications

Not Applicable

Delzicol Boxed Warnings

Not Applicable

Delzicol 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. Consider iron content of Delzicol in those taking iron supplementation or at risk of iron overload. 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.

Delzicol Pharmacokinetics

Absorption

Approximately 28% of mesalamine in mesalamine delayed-release formulation is absorbed after oral ingestion.

Metabolism

Hepatic.

Elimination

Renal, fecal (minor). Half-life: ~25 hours (range: 1.5–296 hours).

Delzicol 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; consider other alternative assay.

Delzicol Adverse Reactions

Adverse Reactions

Eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, rash, dyspepsia, flu syndrome; acute intolerance syndrome, hypersensitivity reactions, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP). Pediatrics: also, nasopharyngitis, headache, sinusitis, cough, diarrhea, fatigue, pyrexia, increased lipase.

Delzicol Clinical Trials

See Literature

Delzicol Note

Not Applicable

Delzicol Patient Counseling

See Literature