ADVAIR DISKUS- fluticasone propionate and salmeterol powder

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT), FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

متاح من:

Rebel Distributors Corp.

INN (الاسم الدولي):

SALMETEROL XINAFOATE

تركيب:

SALMETEROL XINAFOATE 50 ug

طريقة التعاطي:

RESPIRATORY (INHALATION)

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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, su

ملخص المنتج:

ADVAIR DISKUS 250/50 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 21695-196-01). ADVAIR DISKUS 500/50 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 21695-197-01). 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.

الوضع إذن:

New Drug Application

نشرة المعلومات

ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER
Rebel Distributors Corp.
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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 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 corticosteriod.
4.
Children and adolescents who take LABA medicines may have

خصائص المنتج

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 DI