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DELZICOL
Colorectal disorders
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Drug Name:

DELZICOL Rx

Generic Name and Formulations:
Mesalamine 400mg; del-rel caps.

Company:
Allergan

Therapeutic Use:

Indications for DELZICOL:

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

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. Two Delzicol 400mg caps are not bioequivalent to 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).

Warnings/Precautions:

Monitor renal function before and during therapy. History of renal disease. Monitor for mesalamine-induced acute intolerance syndrome; discontinue if suspected. Sulfasalazine allergy. Pre-existing liver disease. Upper GI tract obstruction. Reevaluate periodically. Elderly (monitor CBCs). Pregnancy (Cat.B). Nursing mothers.

Interactions:

Increased risk of renal reactions with nephrotoxic agents (eg, NSAIDs). Increased risk of blood disorders with azathioprine or 6-mercaptopurine.

Pharmacological Class:

Salicylate.

Adverse Reactions:

Eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, rash, dyspepsia, flu syndrome; acute intolerance syndrome, hypersensitivity reactions (including myocarditis, pericarditis, pneumonitis, hematologic abnormalities, others). Pediatrics: also, nasopharyngitis, headache, sinusitis, cough, diarrhea, fatigue, pyrexia, increased lipase.

How Supplied:

Caps—180

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