BALSALAZIDE DISODIUM capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

AvKARE

INN (الاسم الدولي):

BALSALAZIDE DISODIUM

تركيب:

BALSALAZIDE DISODIUM 750 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. Patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. Pregnancy Category B. Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response,

ملخص المنتج:

Balsalazide Disodium Capsules, USP are available as white, opaque capsules imprinted “APO B750” in red ink. Balsalazide Disodium Capsules, USP are supplied as follows: Bottles of 280 (NDC 42291-157-28).  Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º and 30ºC (59º and 86ºF). See USP Controlled Room Temperature.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
BALSALAZIDE DISODIUM
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 ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Balsalazide is a locally acting aminosalicylate indicated for the
treatment of mildly to moderately active
ulcerative colitis in patients 5 years of age and older. ( 1)
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)
DOSAGE AND ADMINISTRATION
Adult dose is three 750 mg balsalazide disodium 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)
Pediatric dose is EITHER: ( 2.2, 8.4)
1. Three 750 mg balsalazide disodium capsules 3 times a day (6.75
g/day) with or without food for 8
weeks.
OR:
2. One 750 mg balsalazide disodium capsule 3 times a day (2.25 g/day)
with or without food for up to 8
weeks.
Capsules may be swallowed whole or may be opened and sprinkled on
applesauce, then chewed or
swallowed immediately. ( 2.3, 12.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg ( 3)
CONTRAINDICATIONS
Patients with hypersensitivity to salicylates or to any of the
components of balsalazide disodium capsules
or balsalazide metabolites. Hypersensitivity reactions may include,
but are not limited to the following:
anaphylaxis, bronchospasm, and skin reaction. ( 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)
Prolonged gastric retention of balsalazide may occur in patients with
pyloric stenosis. ( 5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥3%) are headache,