BALSALAZIDE DISODIUM capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Hikma Pharmaceuticals USA Inc.

INN (Mezinárodní Name):

BALSALAZIDE DISODIUM

Složení:

BALSALAZIDE DISODIUM 750 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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, 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 wit

Přehled produktů:

Balsalazide Disodium Capsules, USP The 750 mg capsule is supplied as a light orange opaque capsule with “54 795” printed in black ink on cap and body, containing a yellow-orange powder . NDC 0054-0079-28: Bottle of 280 capsules Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
HIKMA PHARMACEUTICALS USA INC.
----------
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
•
INDICATIONS AND USAGE
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
Dosage:
•
•
•
•
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 AND PRECAUTIONS
•
•
•
•
•
Warnings and Precautions,
Renal Impairment (5.1) 11/2022
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 beyond 8
weeks in children (ages 5 to 17
years) and 12 weeks in adults have not been established. (1)
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)
_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.