COLAZAL- balsalazide disodium capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Salix Pharmaceuticals, Inc

INN (Alþjóðlegt nafn):

BALSALAZIDE DISODIUM

Samsetning:

BALSALAZIDE DISODIUM 750 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

COLAZAL ® is 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 COLAZAL beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. COLAZAL is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of COLAZAL 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 COLAZAL, 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 pregnancy (see Clinica

Vörulýsing:

COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black. NDC 65649-101-02 750 mg Bottles of 280 capsules Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Leyfisstaða:

New Drug Application

Vara einkenni

COLAZAL- BALSALAZIDE DISODIUM CAPSULE
SALIX PHARMACEUTICALS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLAZAL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COLAZAL.
COLAZAL® (BALSALAZIDE DISODIUM) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions,
Renal Impairment ( 5.1) 11/2022
INDICATIONS AND USAGE
COLAZAL is an 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 COLAZAL beyond 8 weeks
in children (ages 5-17 years)
and 12 weeks in adults have not been established. ( 1)
DOSAGE AND ADMINISTRATION
Administration Instructions
Evaluate renal function before initiating therapy with COLAZAL. ( 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. ( 2.1)
Teeth and/or tongue staining may occur when administered sprinkled on
applesauce. ( 2.1)
Drink an adequate amount of fluids. ( 2.1, 5.8)
Take COLAZAL 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)
DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg ( 3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicylates, aminosalicylates,
or any of the components of
COLAZAL capsules or balsalazide metabolites. ( 4, 5.3)
WARNINGS AND PRECAUTIONS
Renal Impairment: Assess renal function at the beginning of treatment
and periodically during
treatment. Evaluate the risks and b