Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
BALSALAZIDE DISODIUM (UNII: 1XL6BJI034) (BALSALAZIDE - UNII:P80AL8J7ZP)
Mylan Pharmaceuticals Inc.
BALSALAZIDE DISODIUM
BALSALAZIDE DISODIUM 750 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE MYLAN PHARMACEUTICALS INC. ---------- 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 • • DOSAGE AND ADMINISTRATION • • 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 • • 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 Citiți documentul complet