BALSALAZIDE DISODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical Inc.

INN (International Name):

BALSALAZIDE DISODIUM

Composition:

BALSALAZIDE DISODIUM 1.1 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BALSALAZIDE DISODIUM - BALSALAZIDE DISODIUM TABLET
PAR PHARMACEUTICAL INC.
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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