GIAZO- balsalazide disodium tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Salix Pharmaceuticals, Inc

INN (Международно Name):

BALSALAZIDE DISODIUM

Композиция:

BALSALAZIDE DISODIUM 1.1 g

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. Limitations of Use: GIAZO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of GIAZO tablets [see Description (11)]. Risk Summary Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of GIAZO, 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 Clinical Considerations) . In animal reproduction studies, there were no adverse developmental effects observed after oral administration of balsalazide disodium in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended

Каталог на резюме:

GIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with “BZT” debossed on one side of the tablet. Bottles of 180 tablets NDC 65649-102-02 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].

Статус Оторизация:

New Drug Application

Данни за продукта

GIAZO- BALSALAZIDE DISODIUM TABLET, FILM COATED
SALIX PHARMACEUTICALS, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GIAZO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GIAZO.
GIAZO (BALSALAZIDE DISODIUM) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
GIAZO is a locally acting aminosalicylate indicated for the treatment
of mildly to moderately active ulcerative colitis in male
patients 18 years of age and older. (1)
Limitations of Use
•
•
DOSAGE AND ADMINISTRATION
Three 1.1 g GIAZO tablets 2 times a day (6.6 g/day) with or without
food for up to 8 weeks. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 1.1 g balsalazide disodium (3)
CONTRAINDICATIONS
Patients with hypersensitivity to salicylates or to any of the
components of GIAZO tablets or balsalazide metabolites (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥2%) in male UC patients
are anemia, diarrhea, pharyngolaryngeal pain, and
urinary tract infection. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SALIX PHARMACEUTICALS,
INC. AT 1-800-321-4576 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Exacerbations of Ulcerative Colitis
5.2 Renal Impairment
5.3 Use in Hepatic Impairment
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
®
Effectiveness in female patients was not demonstrated in clinical
trials. (1)
Safety and effectiveness of GIAZO beyond 8 weeks have not been
established. (1)
Exacerbation of the symptoms of ulcerative colitis was reported.
Observe patients closely for worsening of these
symptoms while on treatment. (5.1)
Renal impairment may occur. Assess renal function at the beginning of
treatment and p