BUDESONIDE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 0.25 mg in 2 mL

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 : • Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm. 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 show

Product summary:

Budesonide inhalation suspension is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose ampules together with patient instructions for use. There are 30 ampules in a carton (6 envelopes x 5 single-dose ampules). Each single-dose ampule contains 2 mL of sterile liquid suspension. Budesonide inhalation suspension is available in three strengths, each containing 2 mL: NDC # Strength 0781-7515-87 0.25 mg/2 mL 0781-7516-87 0.5 mg/2 mL 0781-7517-87 1 mg/2 mL Budesonide inhalation suspension should be stored upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protected from light. When an envelope has been opened, the shelf life of the unused ampules is 2 weeks when protected. After opening the aluminum foil envelope, the unused ampules should be returned to the aluminum foil envelope 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE- BUDESONIDE SUSPENSION
SANDOZ 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:
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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/2mL, 0.5 mg/2mL, 1 mg/2mL (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 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
conside re d.
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)