Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Budesonide (UNII: Q3OKS62Q6X) (Budesonide - UNII:Q3OKS62Q6X)
Cardinal Health
Budesonide
Budesonide 0.5 mg in 2 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
BUDESONIDE- BUDESONIDE SUSPENSION CARDINAL HEALTH ---------- 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 (1.1) 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: 0.25 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) DOSAGE FORMS AND STRENGTHS Inhalation suspension: 0.25 mg/2mL, 0.5 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 episodes: Do not use for the relief of acute bronchospasm. (5.2) Hypersensitivity reactions: anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur (5.3) Immunosuppression: Potential worsen Прочетете целия документ