BALSALAZIDE DISODIUM capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Zydus Lifesciences Limited

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 disodium capsules 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 are 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 disodium, 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 associa

Produkt oppsummering:

Balsalazide Disodium Capsules, USP 750 mg are yellow to orange granular powder filled in size "00" empty hard gelatin capsule having a yellow colored opaque cap imprinted with "1626" in black ink and a white colored opaque body. NDC 70771-1841-1 in bottles of 280 capsules with child resistant closure 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].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
ZYDUS LIFESCIENCES LIMITED
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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
Warnings and Precautions, Renal Impairment (5.1) 11/2022
INDICATIONS AND USAGE
Balsalazide disodium capsules are 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 balsalazide disodium
capsules beyond 8 weeks in
children (ages 5 years 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. (2.1)
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 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)
DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg (3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicylates, aminosalicylates,
or any of the components of
balsalazide disodium capsules or balsalazide metabolites. (4, 5.3)
WARNINGS