ASACOL mesalamine tablet delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)

Tilgjengelig fra:

Warner Chilcott (US), LLC

INN (International Name):

MESALAMINE

Sammensetning:

MESALAMINE 400 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

ASACOL- MESALAMINE TABLET, DELAYED RELEASE
WARNER CHILCOTT (US), LLC
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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)