ASACOL HD mesalamine tablet delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Allergan, Inc.

INN (Nome Internazionale):

MESALAMINE

Composizione:

MESALAMINE 800 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

ASACOL HD- MESALAMINE TABLET, DELAYED RELEASE
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASACOL HD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ASACOL HD.
ASACOL
HD (MESALAMINE) DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Asacol HD is an aminosalicylate indicated for the treatment of
moderately active ulcerative colitis in adults. (1)
Limitation of Use: Safety and effectiveness of Asacol HD beyond 6
weeks have not been established (1)
DOSAGE AND ADMINISTRATION
Recommended dosage is two 800 mg tablets three times daily (4.8
grams/day) with or without food for 6 weeks (2.1)
Instruct patients to swallow tablets whole without cutting, breaking,
or chewing (2.2)
One Asacol HD 800 mg tablet cannot be substituted for two Asacol
(mesalamine) delayed-release 400 mg tablets (2.2)
Recommend that renal function be evaluated prior to initiation of
Asacol HD (2.3, 5.1)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets: 800 mg (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to salicylates or
aminosalicylates or
to any of the ingredients of Asacol HD tablets (4, 5.3)
WARNINGS AND PRECAUTIONS
_Development of Renal Impairment (for example, minimal change_
_nephropathy, acute and chronic interstitial nephritis renal failure):
_Assess
renal function at beginning of treatment and periodically during
therapy (5.1)
_Mesalamine-induced Acute Intolerance Syndrome: _Has been reported.
Observe patients closely for worsening of these symptoms while on
treatment (5.2)
_Hypersensitivity Reactions_: Use caution when treating patients who
are hypersensitive to sulfasalazine. Mesalamine-
induced cardiac hypersensitivity reactions (myocarditis and
pericarditis) have been reported (5.3)
_Hepatic Failure: _Has been reported in patients with pre-existing
liver
disease. Use caution when treating patients with liver disease (5.4)
_Prolonged Gastric Retention in Patients with Upper Gastrointestin