ASACOL HD- mesalamine tablet, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Allergan, Inc.

INN (International Name):

MESALAMINE

Sammensetning:

MESALAMINE 800 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Asacol HD is indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use : Safety and effectiveness of Asacol HD beyond 6 weeks have not been established. Asacol HD is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Asacol HD [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) , and Description (11) ]. Risk Summary Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. No fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2

Produkt oppsummering:

Asacol®   HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black. N DC     0023-5901-18             Bottle of 180 tablets Protect from moisture. Tablets can be dispensed without desiccant for up to 6 weeks. Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]

Autorisasjon status:

New Drug Application

Preparatomtale

ASACOL HD- MESALAMINE TABLET, DELAYED RELEASE
ALLERGAN, INC.
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions
Renal Impairment (5.1) 11/2022
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
Important Administration Instructions:
Do not substitute one Asacol HD 800 tablet for two mesalamine
delayed-release 400 mg oral
products. (2.1)
Evaluate renal function prior to initiation of Asacol HD. (2.1, 5.1)
Take on an empty stomach, at least 1 hour before and 2 hours after a
meal. (2.1)
Swallow whole; do not cut, break or chew the tablets. (2.1)
Drink an adequate amount of fluids. (2.1, 5.7)
Treatment of Moderately Active Ulcerative Colitis:
Recommended dosage is 1600 mg (two 800 mg tablets) three times daily
for 6 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets: 800 mg (3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicylates or aminosalicylates
or to any of the ingredients of
Asacol HD tablets. (4, 5.3)
WARNINGS AND PRECAUTIONS
Renal Impairment: Assess renal function at the beginning of treatment
and periodically during
treatment. Evaluate the risks and benefits in patients with known
renal impairment or taking
nephrotoxic drugs; monitor renal function. Discontinue Asacol HD if
renal function deteriorates. (5.1,
7.1, 8.6)
Mesalamine-induced Acute Intolerance Syndrome: Symptoms may be
difficult to distinguish from an
ulcerative colitis exacerbation; monitor for worsening symptoms;
discontinue if acute intolerance
syndrome suspected. (5.2)
Hypersensitivity Reactions, including Myocarditis and Pericar