COLAZAL 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:

Cardinal Health

INN (International Name):

BALSALAZIDE DISODIUM

Composition:

BALSALAZIDE DISODIUM 750 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

COLAZAL- BALSALAZIDE DISODIUM CAPSULE
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLAZAL® SEE FULL PRESCRIBING INFORMATION
FOR COLAZAL®
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Indications and Usage (1) 12/2006
Dosage and Administration,
Pediatric Dose (2.2) 12/2006
Dosage and Adminstration,
Administration Alternatives (2.3) 9/2006
Warnings and Precautions,
Exacerbations of
Ulcerative Colitis (5.1) 12/2006
INDICATIONS AND USAGE
• COLAZAL is indicated for the treatment of mildly to moderately
active ulcerative colitis in patients 5 years of age and
older. (1) (1)
• Safety and effectiveness of COLAZAL beyond 8 weeks in children
(ages 5-17 years) and 12 weeks in adults have not
been established. (1) (1)
DOSAGE AND ADMINISTRATION
• Adult dose is three 750 mg COLAZAL 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) (2)
• Pediatric dose is EITHER: (2.2, 8.4) 1. Three 750 mg COLAZAL
capsules 3 times a day (6.75 g/day) with or without food
for 8 weeks. (2)
OR: (2)
2. One 750 mg COLAZAL capsule 3 times a day (2.25 g/day) with or
without food for up to 8 weeks. (2)
• Capsules may be swallowed whole or may be opened and sprinkled on
applesauce, then chewed or swallowed
immediately. (2.3, 12.3) (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg (3)
CONTRAINDICATIONS
Patients with hypersensitivity to salicylates or to any of the
components of COLAZAL capsules or balsalazide metabolites.
Hypersensitivity reactions may include, but are not limited to the
following: anaphylaxis, bronchospasm, and skin reaction.
(4) (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) (5)
• Prolonged gastric retention of COLAZAL may occur in patients with
pyloric stenosis. (5.2) (5)
ADVERSE REAC