Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)
Allergan, Inc.
MESALAMINE
MESALAMINE 400 mg
PRESCRIPTION DRUG
New Drug Application
ASACOL- MESALAMINE TABLET, DELAYED RELEASE ALLERGAN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ASACOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASACOL. ASACOL (MESALAMINE) DELAYED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Asacol is an aminosalicylate indicated for: Treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older (1.1) Maintenance of remission of mildly to moderately active UC adults (1.2) DOSAGE AND ADMINISTRATION Important Administration Instructions: Evaluate renal function prior to initiation of Asacol and periodically while on therapy (2.1, 5.1) Two Asacol 400 mg tablets are not interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet (2.1) Treatment of mildly to moderately active UC (2.2): Adults: 800 mg (two 400 mg tablets) three times daily for 6 weeks Pediatric Patients 5 years or older: Total daily dosage is weight-based up to a maximum of 2.4 grams/day divided into two daily doses (see Table 1) Maintenance of remission of mildly to moderately active UC (2.3) Adults: 1.6 grams (four 400 mg tablets) daily in two to four divided doses. DOSAGE FORMS AND STRENGTHS Delayed-release tablets: 400 mg (3) CONTRAINDICATIONS Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Asacol tablets (4, 5.3) WARNINGS AND PRECAUTIONS Renal Impairment: Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function (5.1, 7.1, 8.6, 13.2) Mesalamine-induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from a UC exacerbation; monitor for worsening symptoms; discontinue if acute intolerance syndrome suspected (5.2) Hypersensitivity Reactions, including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected (5.3) Hepatic Fai Soma hati kamili