BUDESONIDE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: The use of budesonide inhalation suspension is contraindicated in the following conditions: 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, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (MRHDID), but these effects were not seen in rats that received inhaled doses approximately 2 times the MRHDID (see Data ). Studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnan

Product summary:

Illustrated Patient's Instructions for Use accompany each package of budesonide inhalation suspension. Budesonide inhalation suspension, 0.5 mg/2 mL is supplied in a single-dose vial. Each single-dose vial contains 2 mL of sterile liquid suspension, supplied : Overbagged with 5 x 2 mL Individually wrapped unit-dose vials, NDC 55154-4849-5 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE- BUDESONIDE SUSPENSION
CARDINAL HEALTH 107, LLC
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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 FOR INHALATION USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
_Budesonide inhalation suspension is an inhaled corticosteroid
indicated for:_
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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:
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DOSAGE FORMS AND STRENGTHS
Inhalation suspension: 0.25 mg/2 mL, 0.5 mg/2 mL (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Maintenance treatment of asthma and as prophylactic therapy in
children 12 months to 8 years of
age (1)
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)
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)
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)
Deteriora