ADVAIR DISKUS fluticasone propionate and salmeterol powder

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)

זמין מ:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (שם בינלאומי):

SALMETEROL XINAFOATE

הרכב:

SALMETEROL 50 ug

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
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 INH