BUDESONIDE suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

BUDESONIDE

Sammensetning:

BUDESONIDE 0.25 mg in 2 mL

Administreringsrute:

RESPIRATORY (INHALATION)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 inhalation suspension 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, wa

Produkt oppsummering:

Illustrated Patient's Instructions for Use accompany each package of budesonide inhalation suspension. Budesonide inhalation suspension, 0.25 mg/2 mL is supplied in a sealed aluminum foil envelope containing one plastic strip of five single-dose vials. Each single-dose vial contains 2 mL of sterile liquid suspension, supplied in unit-dose cartons of 30 vials (6 pouches × 5 vials) (NDC 0093-6815-73). Budesonide inhalation suspension, 0.5 mg/2 mL is supplied in a sealed aluminum foil envelope containing one plastic strip of five single-dose vials. Each single-dose vial contains 2 mL of sterile liquid suspension, supplied in unit-dose cartons of 30 vials (6 pouches × 5 vials) (NDC 0093-6816-73). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store upright and protect from light. When an envelope has been opened, the shelf life of the unused vials is 2 weeks when protected. After opening the aluminum foil envelope, the unused vials should be returned to the aluminum foil envelope to protect them from light. Any opened vial must be used promptly. Gently shake the vial using a circular motion before use. Keep out of reach of children. Do not freeze.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BUDESONIDE- BUDESONIDE SUSPENSION
TEVA PHARMACEUTICALS USA, INC.
----------
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 FOR INHALATION USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
_Budesonide inhalation suspension 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
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 (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