BALSALAZIDE DISODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

BALSALAZIDE DISODIUM

Composition:

BALSALAZIDE DISODIUM 750 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
MYLAN PHARMACEUTICALS INC.
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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 CAPSULES, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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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
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ADVERSE REACTIONS
Most common adverse reactions in adults (incidence ≥ 3%) are
headache, abdominal pain, diarrhea, nausea, vomiting,
respiratory infection, and arthralgia. Adverse reactions in children
were similar. (6.1)
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2014
Drug Interactions (7) 2/2007
Post-Marketing Experience (6.2) 5/2008
Balsalazide disodium capsules are a locally acting aminosalicylate
indicated for the treatment of mildly to moderately
active ulcerative colitis in adults. (1)
Safety and effectiveness of balsalazide disodium beyond 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 without food for 8 weeks.
Some adult patients required treatment for up to 12 weeks. (2.1)
Capsules may be swallowed whole or may be opened and sprinkled on
applesauce, then chewed or swallowed
immediately. (2.3, 12.3)
Exacerbation of the symptoms of ulcerative colitis was reported in
adult patients. Observe patients closely for
worsening of these symptoms while on treatment. (5.1)
Prolonged gastric retention of balsalazide may occur in patients with