BALSALAZIDE DISODIUM capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Physicians Total Care, Inc.

INN (الاسم الدولي):

BALSALAZIDE DISODIUM

تركيب:

BALSALAZIDE DISODIUM 750 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Balsalazide Disodium Capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in adults. Safety and effectiveness of Balsalazide Disodium Capsules beyond 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. Pregnancy Category B. 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 drug should be used during pregnancy only if clea

ملخص المنتج:

Balsalazide Disodium Capsules are supplied as light orange opaque capsules containing 750 mg balsalazide disodium and "54 795" printed in black ink on the cap and body, containing a yellow-orange powder. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Roxane Laboratories, Inc. Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK       74146

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

BALSALAZIDE DISODIUM - BALSALAZIDE DISODIUM CAPSULE
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BALSALAZIDE DISODIUM CAPSULES, 750 MG
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BALSALAZIDE DISODIUM CAPSULES. BALSALAZIDE
DISODIUM CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Drug Interactions (7) 2/2007
Postmarketing Experience (6.2) 5/2008
INDICATIONS AND USAGE
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 Capsules 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. (2.2, 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 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,
INC. AT 1-800-962-8364