Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT), FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Rebel Distributors Corp
SALMETEROL XINAFOATE
SALMETEROL XINAFOATE 50 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
ADVAIR DISKUS is indicated for the treatment of asthma in patients aged 4 years and older. Long-acting beta2 -adrenergic agonists (LABAs), such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions (5.1)] . Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, s
ADVAIR DISKUS 100/50 is supplied as a disposable purple device containing 60 blisters. The DISKUS inhalation device is packaged within a plastic-coated, moisture-protective foil pouch (NDC 21695-361-60). 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 Rebel Distributors Corp ---------- MEDICATION GUIDE ADVAIR [ad′ vair] DISKUS® 100/50 (fluticasone propionate 100 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 can cause serious side effects, including: 1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with salmeterol. • Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment. • Get emergency medical care if: • breathing problems worsen quickly and • you use your rescue inhaler medicine, but it does not relieve your breathing problems. 2. ADVAIR DISKUS should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as inhaled corticosteroids. 3. When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR DISKUS. Your healthcare provider will decide if you can stop ADVAIR DISKUS without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid. 4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems. What is ADVAIR DISKUS? • ADVAIR DISKUS combines an inhaled corticosteroid medicine, fluticasone propionate (the same medicine foun Izlasiet visu dokumentu
ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER REBEL DISTRIBUTORS CORP ---------- 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: ASTHMA-RELATED DEATH _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ LONG-ACTING BETA -ADRENERGIC AGONISTS (LABAS), SUCH AS SALMETEROL, ONE OF THE ACTIVE INGREDIENTS IN ADVAIR DISKUS, 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). CURRENTLY AVAILABLE DATA ARE INADEQUATE TO DETERMINE WHETHER CONCURRENT USE OF INHALED CORTICOSTEROIDS OR OTHER LONG-TERM ASTHMA CONTROL DRUGS MITIGATES THE INCREASED RISK OF ASTHMA-RELATED DEATH FROM LABAS. AVAILABLE DATA FROM CONTROLLED CLINICAL TRIALS SUGGEST THAT LABAS INCREASE THE RISK OF ASTHMA-RELATED HOSPITALIZATION IN PEDIATRIC AND ADOLESCENT PATIENTS. (5.1) WHEN TREATING PATIENTS WITH ASTHMA, ONLY PRESCRIBE ADVAIR DISKUS FOR PATIENTS NOT ADEQUATELY CONTROLLED ON A LONG-TERM ASTHMA CONTROL MEDICATION, SUCH AS AN INHALED CORTICOSTEROID, OR WHOSE DISEASE SEVERITY CLEARLY WARRANTS INITIATION OF TREATMENT WITH BOTH AN INHALED CORTICOSTEROID AND A LABA. ONCE ASTHMA CONTROL IS ACHIEVED AND MAINTAINED, ASSESS THE PATIENT AT REGULAR INTERVALS AND STEP DOWN THERAPY (E.G., DISCONTINUE ADVAIR DISKUS) IF POSSIBLE WITHOUT LOSS OF ASTHMA CONTROL AND MAINTAIN THE PATIENT ON A LONG-TERM ASTHMA CONTROL MEDICATION, SUCH AS AN INHALED CORTICOSTEROID. DO NOT USE ADVAIR DIS Izlasiet visu dokumentu