البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Preferred Pharmaceuticals Inc.
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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: 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 to 1997 (i.e., 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
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 (6 pouches x 5 single-dose ampules). Each single-dose ampule contains 2 mL of sterile liquid suspension. Budesonide inhalation suspension is available in three strengths, each containing 2 mL: NDC # Strength 68788-7020-3 0.25 mg/2 mL Budesonide inhalation suspension should be stored upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] 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.
Abbreviated New Drug Application
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 ONLY 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: • • • • • • DOSAGE FORMS AND STRENGTHS Inhalation suspension: 0.25 mg/2mL, 0.5 mg/2mL, 1 mg/2mL (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • • • • • 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) Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. (4.1) Hypersensitivity to any of the ingredients in budesonide inhalation suspension.(4.2) Localized infections: _Candida albicans_infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavi اقرأ الوثيقة كاملة