PULMICORT RESPULES- budesonide suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 0.25 mg in 2 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PULMICORT RESPULES 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: • PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm. The use of PULMICORT RESPULES 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 PULMICORT RESPULES [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% of the pregnancies from 1995-1997 (ie, Swedish Medic

Product summary:

PULMICORT RESPULES is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose RESPULES ampules together with patient instructions for use. There are 30 RESPULES ampules in a carton. Each single-dose RESPULES ampule contains 2 mL of sterile liquid suspension. PULMICORT RESPULES is available in three strengths, each containing 2 mL: NDC 54868-5774-0              0.25 mg/2 mL NDC 54868-5621-0              0.5 mg/2 mL PULMICORT RESPULES should be stored upright at controlled room temperature 20-25°C (68-77°F) [see USP], and protected from light. When an envelope has been opened, the shelf life of the unused RESPULES ampules is 2 weeks when protected. After opening the aluminum foil envelope, the unused RESPULES ampules should be returned to the aluminum foil envelope to protect them from light. Any opened RESPULES ampule must be used promptly. Gently shake the RESPULES ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

PULMICORT RESPULES - BUDESONIDE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
_THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PULMICORT RESPULES SAFELY AND EFFECTIVELY. SEE FULL_
_PRESCRIBING INFORMATION FOR PULMICORT RESPULES ._
PULMICORT RESPULES (BUDESONIDE INHALATION SUSPENSION)
INITIAL U.S. APPROVAL 2000
INDICATIONS AND USAGE
_PULMICORT RESPULES® is an inhaled corticosteroid indicated for: _(1)
• Maintenance treatment of asthma and as prophylactic therapy in
children 12 months to 8 years of age (1.1) (1)
Important Limitations of Use: (1)
Not indicated for the relief of acute bronchospasm (1.1) (1)
DOSAGE AND ADMINISTRATION
Recommended dosing based on previous therapy (2). Start with the
lowest recommended dose: (2)
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 (2)
Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily (2)
In symptomatic children not responding to non-steroidal therapy, a
starting dose of 0.25 mg once daily may be
considered. (2)
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. (2)
For inhalation use via compressed air driven jet nebulizers only (not
for use with ultrasonic devices). Not for injection.
(2.2) (2)
DOSAGE FORMS AND STRENGTHS
Inhalation suspension: 0.25 mg/2mL, 0.5 mg/2mL, 1 mg/2mL (3) (3)
CONTRAINDICATIONS
• Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures are required. (4.1)
(4)
• Hypersensitivity to any of the ingredients in PULMICORT RESPULES
(4.2) (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.