MESALAMINE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals (USA) Inc.

INN (International Name):

MESALAMINE

Composition:

MESALAMINE 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Safety and effectiveness of Mesalamine delayed-release tablets beyond 6 weeks have not been established. Mesalamine delayed-release tablets are contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Mesalamine delayed-release tablets [see Warnings and Precautions (5.3), Adverse Reactions (6.2), and Description (11)]. Pregnancy Category C Risk summary There are no adequate well controlled studies of Mesalamine delayed-release tablets use in pregnant women. Limited published human data on mesalamine show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. Furthermore, all pregnancies, regardless of drug exposure, have a background rate

Product summary:

Mesalamine delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with "WC 800" in black. NDC 68382-484-28    Bottle of 180 tablets 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]

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MESALAMINE- MESALAMINE TABLET, DELAYED RELEASE
ZYDUS PHARMACEUTICALS (USA) INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MESALAMINE DELAYED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MESALAMINE DELAYED-RELEASE
TABLETS.
MESALAMINE DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
MESALAMINE DELAYED-RELEASE TABLETS is an aminosalicylate indicated for
the treatment of moderately active ulcerative
colitis in adults. (1)
Limitation of Use: Safety and effectiveness of Mesalamine
delayed-release tablets 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 Mesalamine delayed-release 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
Mesalamine delayed-release tablets (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 Mesalamine
delayed-release 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