SEREVENT DISKUS- salmeterol xinafoate powder, metered

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Dispensing Solutions, Inc.

INN (International Name):

SALMETEROL XINAFOATE

Sammensetning:

SALMETEROL 50 ug

Administreringsrute:

RESPIRATORY (INHALATION)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

SEREVENT DISKUS is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma. LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS, increase the risk of asthma-related death [see Warnings and Precautions (5.1)] . Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated [see Contraindications (4)] . Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue SERE

Produkt oppsummering:

SEREVENT DISKUS is supplied as a disposable teal green device containing 60 blisters. The DISKUS inhalation device is packaged within a plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00). SEREVENT DISKUS is also supplied in an institutional pack of 1 disposable teal green unit containing 28 blisters. The drug product is packaged within a plastic-coated, moisture-protective foil pouch (NDC 0173-0520-00). Store at controlled room temperature (see USP), 20º to 25ºC (68º to 77ºF) 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 6 weeks after removal from the moisture-protective foil pouch or after all blisters have been used (when the dose indicator reads “0”), whichever comes first. Do not attempt to take the DISKUS apart.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

SEREVENT DISKUS- SALMETEROL XINAFOATE POWDER, METERED
Dispensing Solutions, Inc.
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MEDICATION GUIDE
SEREVENT® [ser′ uh-vent] DISKUS®
(salmeterol xinafoate inhalation powder)
Read the Medication Guide that comes with SEREVENT 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 SEREVENT
DISKUS?
SEREVENT DISKUS can cause serious side effects, including:
1.
People with asthma who take long-acting beta2-adrenergic agonist
(LABA) medicines such as
salmeterol (SEREVENT DISKUS), have an increased risk of death from
asthma problems.
•
Call your healthcare provider if breathing problems worsen over time
while using
SEREVENT DISKUS. You may need a 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.
Do not use SEREVENT DISKUS as your only asthma medicine. SEREVENT
DISKUS must only
be used with a long-term asthma-control medicine, such as an inhaled
corticosteroid.
3.
When your asthma is well controlled, your healthcare provider may tell
you to stop taking
SEREVENT DISKUS. Your healthcare provider will decide if you can stop
SEREVENT
DISKUS without loss of asthma control. You will continue taking your
long-term asthma-control
medicine, 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 SEREVENT DISKUS?
•
SEREVENT DISKUS is a LABA medicine. 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 ca

Preparatomtale

SEREVENT DISKUS- SALMETEROL XINAFOATE POWDER, METERED
DISPENSING SOLUTIONS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEREVENT DISKUS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR SEREVENT DISKUS.
SEREVENT DISKUS
(SALMETEROL XINAFOATE INHALATION POWDER)
FOR ORAL INHALATION
INITIAL U.S. APPROVAL: 1994
WARNING:ASTHMA-RELATED DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
LONG-ACTING BETA -ADRENERGIC AGONISTS (LABA), SUCH AS SALMETEROL, THE
ACTIVE INGREDIENT IN SEREVENT
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 LABA.
(5.1)
PRESCRIBE SEREVENT DISKUS ONLY AS ADDITIONAL THERAPY FOR PATIENTS WITH
ASTHMA WHO ARE CURRENTLY
TAKING BUT ARE INADEQUATELY CONTROLLED ON A LONG-TERM ASTHMA CONTROL
MEDICATION, SUCH AS AN INHALED
CORTICOSTEROID. ONCE ASTHMA CONTROL IS ACHIEVED AND MAINTAINED, ASSESS
THE PATIENT AT REGULAR INTERVALS
AND STEP DOWN THERAPY (E.G., DISCONTINUE SEREVENT 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 SEREVENT DISKUS FOR PATIENTS WHOSE ASTHMA
IS ADEQUATELY CONTROLLED ON
LOW- OR MEDIUM-DOSE INHALED CORTICOSTEROIDS. (1.1, 5.1)
AVAILABLE DATA FROM CONTROLLED CLINICAL TRIALS SUGGEST THAT LABA
INCREASE THE RISK OF ASTHMA-RELATED
HOSPITALIZATION IN PEDIATRIC AND ADOLESCENT PATIENTS. (5.1)
RECENT MAJOR CHANGES
Boxed Warning
December 2010
Indications and Usage (1.1, 1.2)
December 2010
Dosage and Administration (2.1, 2.2)
December 2010
Warnings and Precautions, Asthma-Related Death (