BUDESONIDE- budesonide suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, 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. Important Limitations of Use: The use of budesonide inhalation suspension is contraindicated in the following conditions: 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 to 1997 (ie, Swedish Medical Birth Registry; Registry of Congenital Malformations; Child Cardiology Registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. Congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual period), th

Product summary:

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 68788-0012-1). 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 68788-0013-1). 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE- BUDESONIDE SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
----------
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:_
2.
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:
6.
7.
8.
9.
10.
DOSAGE FORMS AND STRENGTHS
Inhalation suspension: 0.25 mg/2 mL, 0.5 mg/2 mL (3)
CONTRAINDICATIONS
3.
4.
WARNINGS AND PRECAUTIONS
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
ADVERSE REACTIONS
Adverse reactions at an incidence of ≥3%:
Maintenance treatment of asthma and as prophylactic therapy in
children 12 months to 8 years of age (1.1)
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)
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)
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 be