国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT), FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Dispensing Solutions Inc.
SALMETEROL XINAFOATE
SALMETEROL XINAFOATE 50 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
ADVAIR DISKUS is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients aged 4 years and older. Long-acting beta2 -adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death [see Warnings and Precautions (5.1)] . Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Important Limitations of Use: - ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. - ADVAIR DISKUS is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2 -agonists. ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in
ADVAIR DISKUS 100/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 100/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 250/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch (NDC 68258-3031-1). ADVAIR DISKUS 250/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 500/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. ADVAIR DISKUS 500/50 is also supplied in an institutional pack of 1 disposable purple device containing 14 blisters. The DISKUS inhalation device is packaged within a purple, plastic-coated, moisture-protective foil pouch. They are supplied by Dispensing Solutions Inc. as follows: This product was Manufactured By: GlaxoSmithKline Research Triangle Park, NC 27709 And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States Store at controlled room temperature (see USP), 20° to 25°C (68° to 77°F), in a dry place away from direct heat or sunlight. Keep out of reach of children. The DISKUS inhalation device is not reusable. The device should be discarded 1 month after removal from the moisture-protective foil overwrap pouch or after all blisters have been used (when the dose indicator reads “0”), whichever comes first. Do not attempt to take the device apart.
New Drug Application
ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER Dispensing Solutions Inc. ---------- MEDICATION GUIDE ADVAIR [ad′ vair] DISKUS® 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) ADVAIR DISKUS® 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) ADVAIR DISKUS® 500/50 (fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder) Read the Medication Guide that comes with ADVAIR DISKUS before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about ADVAIR DISKUS? • ADVAIR DISKUS contains 2 medicines: • fluticasone propionate (the same medicine found in FLOVENT®), an inhaled corticosteroid medicine. Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms. • salmeterol (the same medicine found in SEREVENT®), a long-acting beta2-agonist medicine or LABA. LABA medicines are used in patients with asthma and chronic obstructive pulmonary disease (COPD). LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and cause death if not treated right away. • In patients with asthma, LABA medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), may increase the chance of death from asthma problems. In a large asthma study, more patients who used salmeterol died from asthma problems compared with patients who did not use salmeterol. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, changes your chance of death from asthma problems seen with salmeterol. Talk with your healthcare provid 完全なドキュメントを読む
ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER DISPENSING SOLUTIONS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ADVAIR DISKUS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADVAIR DISKUS. ADVAIR DISKUS 100/50 (FLUTICASONE PROPIONATE 100 MCG AND SALMETEROL 50 MCG INHALATION POWDER) ADVAIR DISKUS 250/50 (FLUTICASONE PROPIONATE 250 MCG AND SALMETEROL 50 MCG INHALATION POWDER) ADVAIR DISKUS 500/50 (FLUTICASONE PROPIONATE 500 MCG AND SALMETEROL 50 MCG INHALATION POWDER) FOR ORAL INHALATION INITIAL U.S. APPROVAL: 2000 WARNING: RISK OF ASTHMA-RELATED DEATH _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ LONG-ACTING BETA -ADRENERGIC AGONISTS, SUCH AS SALMETEROL, ONE OF THE ACTIVE INGREDIENTS IN ADVAIR DISKUS, MAY INCREASE THE RISK OF ASTHMA-RELATED DEATH. A US STUDY SHOWED AN INCREASE IN ASTHMA- RELATED DEATHS IN PATIENTS RECEIVING SALMETEROL (13 DEATHS OUT OF 13,176 PATIENTS TREATED FOR 28 WEEKS ON SALMETEROL VERSUS 3 OUT OF 13,179 PATIENTS ON PLACEBO). (5.1) WHEN TREATING PATIENTS WITH ASTHMA, ONLY PRESCRIBE ADVAIR DISKUS FOR PATIENTS NOT ADEQUATELY CONTROLLED ON OTHER ASTHMA-CONTROLLER MEDICATIONS OR WHOSE DISEASE SEVERITY CLEARLY WARRANTS INITIATION OF TREATMENT WITH 2 MAINTENANCE THERAPIES. (1.1, 5.1) RECENT MAJOR CHANGES Warnings and Precautions, Reduction in Bone Mineral Density (5.13) March 2009 INDICATIONS AND USAGE ADVAIR DISKUS is a combination product containing a corticosteroid and a long-acting beta -adrenergic agonist indicated for: (1) Maintenance treatment of asthma in patients aged 4 years and older. (1.1) Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2) Important limitations: (1) Not indicated for patients whose asthma can be managed by inhaled corticosteroids with occasional use of inhaled short- acting beta -agonists. (1.1) Not indicated for the relief of acute bronchospasm. (1.1, 1.2) DOSAGE AN 完全なドキュメントを読む