BUDESONIDE INHALATION SUSPENSION- budesonide inhalant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla USA Inc.

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 0.25 mg in 2 mL

Administration route:

ORAL

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: •  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),Adverse Reactions(6.2) ]. 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, w

Product summary:

Budesonide inhalation suspension is supplied in sealed aluminum foil envelope containing one plastic strip of either one single-dose ampule or 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 should be stored upright at controlled room temperature 20 to 25°C (68 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE INHALATION SUSPENSION- BUDESONIDE INHALANT
CIPLA USA 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)
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:
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 considered
If once-daily treatment does not provide adequate control, the total
dailydose 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 Acute Asthma Episod