Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
BALSALAZIDE DISODIUM (UNII: 1XL6BJI034) (BALSALAZIDE - UNII:P80AL8J7ZP)
Par Pharmaceutical Inc.
BALSALAZIDE DISODIUM
BALSALAZIDE DISODIUM 1.1 g
PRESCRIPTION DRUG
Abbreviated New Drug Application
BALSALAZIDE DISODIUM - BALSALAZIDE DISODIUM TABLET PAR PHARMACEUTICAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BALSALAZIDE DISODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BALSALAZIDE DISODIUM TABLETS. BALSALAZIDE DISODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE Balsalazide Disodium Tablets is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. (1) (1) Limitations of Use (1) Effectiveness in female patients was not demonstrated in clinical trials. (1) Safety and effectiveness of Balsalazide Disodium Tablets beyond 8 weeks have not been established. (1) DOSAGE AND ADMINISTRATION Three 1.1 g Balsalazide Disodium Tablets 2 times a day (6.6 g/day) with or without food for up to 8 weeks. (2) (2) DOSAGE FORMS AND STRENGTHS Tablets: 1.1 g (3) (3) CONTRAINDICATIONS Patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium tablets or balsalazide metabolites (4) (4) WARNINGS AND PRECAUTIONS Exacerbation of the symptoms of ulcerative colitis was reported. Observe patients closely for worsening of these symptoms while on treatment. (5.1) Renal impairment may occur. Assess renal function at the beginning of treatment and periodically during treatment. (5.2) Use with caution with pre-existing liver disease. (5.3) ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) in male UC patients are anemia, diarrhea, pharyngolaryngeal pain, and urinary tract infection. (6.1) (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PAR PHARMACEUTICAL INC. AT 1-800-828-9393 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH (6) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 2/2016 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS & USAGE 2 DOSAGE & ADMINISTRATION 3 DOSAGE FORMS & STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Exacerba Přečtěte si celý dokument