BALSALAZIDE DISODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use Safety and effectiveness of balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide disodium capsules is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [see Warnings and Precautions (5.3), Adverse Reactions (6.2), Description (11)]. Risk Summary Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in

Product summary:

NDC: 63629-8301-2: 90 Capsules in a BOTTLE NDC: 63629-8301-1: 30 Capsules in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
BRYANT RANCH PREPACK
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Dosage and Administration,
Important Administration Instructions (2.1) 10/2020
Warnings and Precautions,
Mesalamine-Induced Acute Intolerance Syndrome (5.2) 10/2020
Hypersensitivity Reactions (5.3) 10/2020
Hepatic Failure (5.4) 10/2020
Photosensitivity (5.6) 10/2020
Nephrolithiasis (5.7) 10/2020
Interference with Laboratory Tests (5.8) 10/2020
INDICATIONS AND USAGE
Balsalazide is a locally acting aminosalicylate indicated for the
treatment of mildly to moderately active
ulcerative colitis in patients 5 years of age and older. (1)
Limitations of Use: Safety and effectiveness of balsalazide beyond 8
weeks in children (ages 5 to 17
years) and 12 weeks in adults have not been established. (1)
DOSAGE AND ADMINISTRATION
Administration Instructions
Evaluate renal function before initiating therapy with balsalazide
disodium capsules. (2.1)
Swallow capsules whole. Do not cut, break, crush or chew. (2.1)
For patients who cannot swallow intact capsules, the capsules may be
opened and sprinkled on
applesauce, then chewed and swallowed immediately. (2)
Teeth and/or tongue staining may occur when administered sprinkled on
applesauce.
Drink an adequate amount of fluids. (2, 5.7)
Take balsalazide disodium capsules with or without food. (2.1)
Dosage
_Adults:_
The recommended dosage is 2.25 g (three 750 mg capsules) three times
daily for 8 weeks. Some adult
patients required treatment for up to 12 weeks in clinical trials.
(2.2)
_Pediatric Patients 5 Years to 17 Years of Age:_
The recommended dosage is either:
2.25 g (three 750 mg capsules) three times for up to 8 weeks.
OR:
750 mg (one capsule) three times daily for up to 8 weeks. (2.2