BUDESONIDE INHALATION suspension

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Actavis Pharma, Inc.

INN (שם בינלאומי):

BUDESONIDE

הרכב:

BUDESONIDE 0.25 mg in 2 mL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BUDESONIDE INHALATION- BUDESONIDE SUSPENSION
ACTAVIS PHARMA, 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 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 (1.1)
Important Limitations of Use:
Not indicated for the relief of acute bronchospasm (1.1)
DOSAGE AND ADMINISTRATION
Recommended dosing based on previous therapy (2). Start with the
lowest recommended dose:
Bronchodilators alone: 0.25 mg twice daily
Inhaled corticosteroids: 0.25 mg twice daily up to 0.5 mg twice daily
Oral corticosteroids: 0.5 mg twice daily
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/2mL and 0.5 mg/2mL (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures are required.
(4.1)
Hypersensitivity to any of the ingredients in budesonide inhalation
suspension (4.2)
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 of acute bronchospasm. (5.2)
Hypersensitivity reactions: anaphylaxis, rash, contact dermatitis,
urticaria, angioedema, and bronchospasm have been
reported with use of budesonide inhalation suspension. Discontinue
budesonide inhalation suspension if such reactions
occur (5.3)
Immunosuppress