BUDESONIDE suspension

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)

Предлага се от:

Sun Pharmaceutical Industries, Inc.

Начин на приложение:

RESPIRATORY (INHALATION)

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: - Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm. The use of budesonide inhalation suspension is contraindicated in the following conditions: - Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - Hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see Warnings and Precautions (5.3), Description (11), Adverse Reactions (6.2)]. Risk Summary There are no adequate well-controlled studies of budesonide in pregnant women. However, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women. In animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and redu

Каталог на резюме:

Budesonide inhalation suspension is supplied in sealed aluminum foil pouch containing one plastic strip of five single-dose ampules together with patient instructions for use. There are 30 ampules in a carton. Each single-dose ampule contains 2 mL of sterile off-white colored liquid suspension. Budesonide inhalation suspension is available in three strengths, each containing 2 mL: 0.25 mg/2 mL: carton of 30 single-dose ampules (NDC 47335-631-49) 0.5 mg/2 mL: carton of 30 single-dose ampules (NDC 47335-632-49) 1 mg/2 mL: carton of 30 single-dose ampules (NDC 47335-633-49) Budesonide inhalation suspension should be stored upright 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], and protected from light. When a pouch has been opened, the shelf life of the unused ampules is 2 weeks when protected. After opening the aluminum foil pouch, the unused ampules should be returned to the aluminum foil pouch to protect them from light. Any opened ampule must be used promptly. Gently shake the ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

BUDESONIDE - BUDESONIDE SUSPENSION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE INHALATION
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR BUDESONIDE
INHALATION SUSPENSION.
BUDESONIDE INHALATION SUSPENSION INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Budesonide is an inhaled corticosteroid indicated for:
Maintenance treatment of asthma and as prophylactic therapy in
children 12 months to 8 years of age
(1)
Limitations of Use:
Not indicated for the relief of acute bronchospasm (1)
DOSAGE AND ADMINISTRATION
Recommended dosing based on previous therapy(2). Start with the lowest
recommended dose:
Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily
Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up
to 0.5 mg twice daily
Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily
In symptomatic children not responding to non-steroidal therapy, a
starting dose of 0.25 mg once daily
may be considered
If once-daily treatment does not provide adequate control, the total
daily dose should be increased
and/or administered as a divided dose. Once asthma stability is
achieved, titrate the dose downwards
For inhalation use via compressed air driven jet nebulizers only (not
for use with ultrasonic devices). Not
for injection. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation suspension: 0.25 mg/2 mL, 0.5 mg/2 mL, 1 mg/2 mL (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures
are required (4)
Hypersensitivity to any of the ingredients in budesonide inhalation
suspension (4)
WARNINGS AND PRECAUTIONS
Localized Infections:_Candida albicans_ infection of the mouth and
throat may occur. Monitor patients
periodically for signs of adverse effects on the oral cavity. Advise
patients to rinse the mouth following
inhalation (5.1)
Deterioration of Disease and Acute Asthma Episodes: Do not use for the
relief