国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
FLUNISOLIDE (UNII: QK4DYS664X) (FLUNISOLIDE ANHYDROUS - UNII:78M02AA8KF)
Meda Pharmaceuticals
FLUNISOLIDE
FLUNISOLIDE 80 ug
PRESCRIPTION DRUG
New Drug Application
AEROSPAN- FLUNISOLIDE AEROSOL, METERED MEDA PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AEROSPAN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AEROSPAN . AEROSPAN (FLUNISOLIDE) INHALATION AEROSOL, FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 1981 RECENT MAJOR CHANGES Indications and Usage (1) 6/2017 Dosage and Administration (2.1, 2.2) 6/2017 INDICATIONS AND USAGE AEROSPAN is an inhaled corticosteroid indicated for • Limitations of Use: Aerospan is NOT indicated for the relief of acute bronchospasm or in children less than 6 years of age. (1) DOSAGE AND ADMINISTRATION For oral inhalation only. Inhaler includes a built-in spacer. Do not use with external spacers or holding chambers. Shake well prior to each inhalation. (2.1) • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • • ADVERSE REACTIONS The most common adverse reactions are pharyngitis, rhinitis, headache, sinusitis, and increased cough. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDA PHARMACEUTICALS INC. AT 855-653-6325 OR FDA AT ® ® ® Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older (1) Starting dosage is based on prior asthma therapy and disease severity. (2.2) Adults and adolescents 12 years of age and older: The recommended starting dose is 160 mcg twice daily. Do not exceed 320 mcg twice daily. (2.2) Pediatric Patients 6 to 11 years: The recommended starting dose is 80 mcg twice daily. Do not exceed 160 mcg twice daily. Administer under adult supervision. (2.2) Inhalation aerosol: 60 or 120 metered 80 mcg-doses (3) Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required (4) Fungal infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse mouth following inhalation. (5 阅读完整的文件