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DELZICOL 400mg(Mesalamine)
2017-03-31 09:12:39 来源: 作者: 【 】 浏览:480次 评论:0

DELZICOL 400mg(Mesalamine)
Generic Name and Formulations:
Mesalamine 400mg; del-rel caps.
Company:
Allergan

Select therapeutic use: Colorectal disorders
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. Conditions predisposing to myocarditis, pericarditis. Sulfasalazine allergy. Pre-existing liver disease. Upper GI tract obstruction. Reeva luate 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:
Abdominal pain, eructation, pain, headache, back pain, diarrhea, rash, dyspepsia, rhinitis, flu syndrome, asthenia, flatulence, vomiting, fever, arthralgia, constipation, GI bleeding; acute intolerance syndrome (discontinue if occurs), cardiac hypersensitivity reactions. Pediatrics: also, nasopharyngitis, sinusitis.

How Supplied:
Caps—180 

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