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:

Clinical Solutions Wholesale

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
CLINICAL SOLUTIONS WHOLESALE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BALSALAZIDE DISODIUM CAPSULES USP, 750 MG
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BALSALAZIDE DISODIUM CAPSULES USP. BALSALAZIDE
DISODIUM CAPSULES USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Drug Interactions (7) 2/2007
Postmarketing Experience (6.2) 3/2008
INDICATIONS AND USAGE
Balsalazide Disodium Capsules USP 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 Capsules USP beyond
12 weeks in adults have not been established.
(1)
DOSAGE AND ADMINISTRATION
Adult dose is three 750 mg balsalazide 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)
DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg (3) (3)
CONTRAINDICATIONS
Patients with hypersensitivity to salicylates or to any of the
components of Balsalazide Disodium Capsules USP or
balsalazide metabolites. Hypersensitivity reactions may include, but
are not limited to the following: anaphylaxis,
bronchospasm, and skin reaction. (4) (4)
WARNINGS AND PRECAUTIONS
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
pyloric stenosis. (5.2)
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) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROXANE LABORATORIES,