BUDESONIDE suspension

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Budesonide (UNII: Q3OKS62Q6X) (Budesonide - UNII:Q3OKS62Q6X)

Saatavilla:

Apotex Corp.

INN (Kansainvälinen yleisnimi):

BUDESONIDE

Koostumus:

BUDESONIDE 0.25 mg in 2 mL

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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) ]. Teratogenic Effects: Pregnancy Category B 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%

Tuoteyhteenveto:

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. Each single-dose ampule contains 2 mL of sterile liquid suspension. Budesonide inhalation suspension is available in three strengths, each containing 2 mL: NDC 60505-0820-0                0.25 mg/2 mL NDC 60505-0821-0                0.5 mg/2 mL NDC 60505-6206-3 1 mg/2 mL Budesonide inhalation suspension should be stored upright at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP] 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

BUDESONIDE- BUDESONIDE SUSPENSION
APOTEX CORP.
----------
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 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: 0.5 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)
DOSAGE FORMS AND STRENGTHS
Inhalation suspension: 0.25 mg/2mL, 0.5 mg/2mL, 1 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 a