BALSALAZIDE DISODIUM capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

BALSALAZIDE DISODIUM (UNII: 1XL6BJI034) (BALSALAZIDE - UNII:P80AL8J7ZP)

Tilgjengelig fra:

Oceanside Pharmaceuticals

INN (International Name):

BALSALAZIDE DISODIUM

Sammensetning:

BALSALAZIDE DISODIUM 750 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Balsalazide Disodium Capsule is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of Balsalazide Disodium Capsules beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established. Patients with hypersensitivity to salicylates or to any of the components of Balsalazide Disodium capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this

Produkt oppsummering:

Balsalazide Disodium Capsules are available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black. NDC 68682-750-02 Bottles of 280 capsules. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
OCEANSIDE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BALSALAZIDE DISODIUM CAPSULES SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BALSALAZIDE
DISODIUM CAPSULES.
BALSALAZIDE DISODIUM CAPSULE FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
1.
OR:
2.
•
DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg (3)
CONTRAINDICATIONS
Patients with hypersensitivity to salicylates or to any of the
components of Balsalazide Disodium capsules or balsalazide
metabolites. Hypersensitivity reactions may include, but are not
limited to the following: anaphylaxis, bronchospasm, and
skin reaction. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence >3%) are headache, abdominal
pain, diarrhea, nausea, vomiting, respiratory
infection, and arthralgia. Adverse reactions in children were similar.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VALEANT PHARMACEUTICALS
NORTH AMERICA LLC AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
In an _in vitro _study using human liver microsomes, balsalazide and
its metabolites were not shown to inhibit the major CYP
enzymes evaluated (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5). (7)
USE IN SPECIFIC POPULATIONS
Renal impairment: Use Balsalazide Disodium capsules with caution in
patients with a history of renal disease. (5.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2016
Balsalazide Disodium capsule is a locally acting aminosalicylate
indicated for the treatment of mildly to moderately
active ulcerative colitis in patients 5 years of age and older. (1)
Safety and effectiveness of Balsalazide Disodium capsule beyond 8
weeks in children (ages 5-17 years) and 12 weeks
in adults have not been established. (1)
Adult dose is three 750 mg Balsalazide Disodium capsules 3 times a day
(6.75 g/day) with or witho