BALSALAZIDE DISODIUM capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

American Health Packaging

INN (Nama Antarabangsa):

BALSALAZIDE DISODIUM

Komposisi:

BALSALAZIDE DISODIUM 750 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BALSALAZIDE DISODIUM CAPSULES, USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BALSALAZIDE.
BALSALAZIDE DISODIUM CAPSULES, USP FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Drug Interactions ( 7) 2/2007
Postmarketing Experience ( 6.2) 5/2008
INDICATIONS AND USAGE
Balsalazide is a locally acting aminosalicylate indicated for the
treatment of mildly to moderately active ulcerative colitis
in adults ( 1)
Safety and effectiveness of balsalazide beyond 12 weeks in adults have
not been established ( 1)
DOSAGE AND ADMINISTRATION
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. ( 2.2, 12.3)
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
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)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX AT
1-800-706-5575 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
DRUG IN