Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U), SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)
Bryant Ranch Prepack
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2 -adrenergic agonist (LABA). Limitations of Use : Fluticasone Propionate/Salmeterol MDPI is not indicated for the relief of acute bronchospasm. Fluticasone Propionate/Salmeterol MDPI is contraindicated in: - the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions (5.2)] . - patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see Warnings and Precautions (5.10) and Description (11)]
How Supplied Fluticasone Propionate/Salmeterol MDPI inhalation powder: Each Fluticasone Propionate/Salmeterol MDPI has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter. Discard the inhaler when the counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see Patient Counseling Information (17)]. Storage and Handling Store at room temperature (between 15ºC and 25ºC; 59ºF and 77ºF) in a dry place; excursions permitted from 59º F to 86º F (15ºC to 30ºC). Avoid exposure to extreme heat, cold, or humidity. Store Fluticasone Propionate/Salmeterol MDPI inside the unopened moisture‑protective foil pouch until initial use. Discard the product 30 days after opening the foil pouch or when the counter reads 0, whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
New Drug Application Authorized Generic
FLUTICASONE PROPIONATE AND SALMETEROL- FLUTICASONE PROPIONATE AND SALMETEROL POWDER, METERED BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER, FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE Fluticasone Propionate/Salmeterol Multi-Dose Dry Powder Inhaler (MDPI) is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta -adrenergic agonist (LABA), indicated for treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol inhalation powder should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta -adrenergic agonist (LABA). (1) Limitations of Use: Not indicated for the relief of acute bronchospasm. (1) DOSAGE AND ADMINISTRATION For oral inhalation only. (2.1) Starting dosage is based on prior asthma therapy and disease severity. (2.2) 1 inhalation of Fluticasone Propionate/Salmeterol 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg twice daily. (2.2) Do not use with a spacer or volume holding chamber. (2.2) DOSAGE FORMS AND STRENGTHS Inhalation powder: 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg of fluticasone propionate/salmeterol in each actuation (3). CONTRAINDICATIONS Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. (4) Severe hypersensitivity to milk proteins or any ingredients of Fluticasone Propionate/Salmeterol MDPI. (4) WARNINGS AND PRECAUTIONS LABA monotherapy increases the risk of serious asthma-related events. (5.1) Deterioration of asthma and acute epi Læs hele dokumentet