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:

Clinical Solutions Wholesale, LLC

INN (International Name):

BALSALAZIDE DISODIUM

Composition:

BALSALAZIDE DISODIUM 750 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
CLINICAL SOLUTIONS WHOLESALE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BALSALAZIDE DISODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR BALSALAZIDE DISODIUM.
BALSALAZIDE DISODIUM CAPSULE FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Balsalazide Disodium 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)
Safety and effectiveness of Balsalazide Disodium beyond 8 weeks in
children (ages 5-17 years) and 12 weeks in adults
have not been established. ( 1)
DOSAGE AND ADMINISTRATION
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)
Pediatric dose is EITHER: ( 2.2, 8.4)
Three 750 mg Balsalazide Disodium capsules 3 times a day (6.75 g/day)
with or without food for 8 weeks.
OR:
One 750 mg Balsalazide Disodium capsule 3 times a day (2.25 g/day)
with or without food for up to 8 weeks.
Capsules may be swallowed whole or may be opened and sprinkled on
applesauce, then chewed or swallowed
immediately. ( 2.3, 12.3)
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
Exacerbation of the symptoms of ulcerative colitis was reported in
both adult and pediatric patients. Observe patients
closely for worsening of these symptoms while on treatment. ( 5.1)
Prolonged gastric retention of Balsalazide Disodium may occur in
patients with pyloric stenosis. ( 5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence >3%) are headache, abdominal