Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
BALSALAZIDE DISODIUM (UNII: 1XL6BJI034) (BALSALAZIDE - UNII:P80AL8J7ZP)
Physicians Total Care, Inc.
BALSALAZIDE DISODIUM
BALSALAZIDE DISODIUM 750 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
BALSALAZIDE DISODIUM - BALSALAZIDE DISODIUM CAPSULE PHYSICIANS TOTAL CARE, INC. ---------- 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 Přečtěte si celý dokument