País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U), SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)
GlaxoSmithKline LLC
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE 45 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
ADVAIR HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. ADVAIR HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2 -adrenergic agonist (LABA). Limitations of Use ADVAIR HFA is not indicated for the relief of acute bronchospasm. ADVAIR HFA is contraindicated in the following conditions: Risk Summary There are insufficient data on the use of ADVAIR HFA or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. There are clinical considerations with the use of ADVAIR HFA in pregnant women. (See Clinical Considerations.) In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits, was observed with subcutaneously administered maternal toxic doses of fluticasone propionat
ADVAIR HFA is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a purple plastic actuator with a light purple cap: Each inhaler is packaged with a Patient Information leaflet. The purple actuator supplied with ADVAIR HFA should not be used with any other product canisters, and actuators from other products should not be used with an ADVAIR HFA canister. Counter ADVAIR HFA has a counter attached to the canister. The counter starts at 124 or 064 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000. Contents under Pressure Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator. Storage Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.
New Drug Application
ADVAIR HFA- FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE AEROSOL, METERED GLAXOSMITHKLINE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ADVAIR HFA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADVAIR HFA. ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL INHALATION AEROSOL), FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE ADVAIR HFA is a combination of fluticasone propionate, an inhaled corticosteroid, and salmeterol, a long- acting beta ‑adrenergic agonist (LABA), indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. (1) Limitations of use: Not indicated for relief of acute bronchospasm. (1) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Inhalation aerosol: • • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • • • • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥3%) include: upper respiratory tract infection or inflammation, throat irritation, dysphonia, headache, dizziness, nausea and vomiting. (6.1) 2 For oral inhalation only. (2.1) Adult and adolescent patients aged 12 years and older: 2 inhalations of ADVAIR HFA 45 mcg/21 mcg, ADVAIR HFA 115 mcg/21 mcg, or ADVAIR HFA 230 mcg/21 mcg twice daily. (2.2) Starting dosage is based on asthma severity. (2.2) 45 mcg fluticasone propionate/21 mcg salmeterol per actuation (3) 115 mcg fluticasone propionate/21 mcg salmeterol per actuation (3) 230 mcg fluticasone propionate/21 mcg salmeterol per actuation (3) Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. (4) Hypersensitivity to any ingredient. (4) LABA monotherapy increases the risk of serious asthma-related events. (5.1) Do not initiate in acutely deteriorating asthma or to treat acute symptoms. (5.2) Do not use in combination with an additional medicine containing a LABA because of risk of overdose. (5.3) _Candida albic Leia o documento completo