BUDESONIDE suspension

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Physicians Total Care, Inc.

INN (Isem Internazzjonali):

BUDESONIDE

Kompożizzjoni:

BUDESONIDE 0.25 mg in 2 mL

Rotta amministrattiva:

RESPIRATORY (INHALATION)

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Important 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) and Adverse Reactions, Post-marketing Experience (6.2) ]. Studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. The results from a large population-based prospective cohort epidemiological study reviewing data from three Swedish registries covering approximately 99% of the pregnancies from 1995-1997 (ie, Sw

Sommarju tal-prodott:

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 54868-3423-0]. 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 54868-3550-0]. 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BUDESONIDE - BUDESONIDE SUSPENSION
PHYSICIANS TOTAL CARE, 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, 0.5 mg/2mL (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 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)
Immunosuppression: Pot