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:

GlaxoSmithKline LLC

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 an ICS 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, as monotherapy (without ICS) 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 an ICS 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 an ICS. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low- or medium-dose ICS. Pediatric and Adolescent Patients Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent pati

Produkt oppsummering:

SEREVENT DISKUS is supplied as a disposable teal green plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00). Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. SEREVENT DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard SEREVENT DISKUS 6 weeks after opening the foil pouch or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

GlaxoSmithKline LLC
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MEDICATION GUIDE
SEREVENT DISKUS (SER uh vent DISK us)
(salmeterol xinafoate inhalation powder)
for oral inhalation use
What is the most important information I should know about SEREVENT
DISKUS?
SEREVENT DISKUS can cause serious side effects, including:
•
People with asthma who take long-acting beta2-adrenergic agonist
(LABA) medicines, such as
salmeterol (the medicine in SEREVENT DISKUS), have an increased risk
of death from asthma
problems if they use SEREVENT DISKUS without also using a medicine
called an inhaled
corticosteroid (ICS).
•
Call your healthcare provider if breathing problems worsen over time
while using SEREVENT
DISKUS. You may need different treatment.
•
Get emergency medical care if:
•
your breathing problems worsen quickly.
•
you use your rescue inhaler, but it does not relieve your breathing
problems.
•
Do not use SEREVENT DISKUS as your only asthma medicine. SEREVENT
DISKUS must only
be used with an ICS.
•
SEREVENT DISKUS should be used only if your healthcare provider
decides that your asthma is
not well controlled with an ICS.
•
Children and adolescents who take LABA medicines as their only asthma
medicine may have an
increased risk of being hospitalized for asthma problems.
What is SEREVENT DISKUS?
•
SEREVENT DISKUS is a prescription inhaled LABA medicine. LABA
medicines such as
salmeterol help the muscles around the airways in your lungs stay
relaxed to prevent symptoms,
such as wheezing, cough, chest tightness, and shortness of breath.
These symptoms can happen
when the muscles around the airways tighten. This makes it hard to
breathe.
•
SEREVENT DISKUS is not used to relieve sudden breathing problems and
will not replace a
rescue inhaler.
•
It is not known if SEREVENT DISKUS is safe and effective in children
younger than 4 years.
•
SEREVENT DISKUS is used for asthma, exercise-induced bronchospasm
(EIB), and chronic
obstructive pulmonary disease (COPD) as follows:
Asthma:
•
SEREVENT DISKUS is a prescription medicine used to contro

Preparatomtale

SEREVENT DISKUS- SALMETEROL XINAFOATE POWDER, METERED
GLAXOSMITHKLINE LLC
----------
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 USE
INITIAL U.S. APPROVAL: 1994
WARNING: ASTHMA-RELATED DEATH
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
SEREVENT DISKUS is a LABA indicated for:
•
•
•
Important limitation of use: Not indicated for relief of acute
bronchospasm. (1.1, 1.3)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Inhalation powder: Inhaler containing salmeterol (50 mcg) as a powder
formulation for oral inhalation. (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
LONG-ACTING BETA -ADRENERGIC AGONISTS (LABA), SUCH AS SALMETEROL, THE
ACTIVE
INGREDIENT IN SEREVENT DISKUS, AS MONOTHERAPY (WITHOUT INHALED
CORTICOSTEROIDS
[ICS]) INCREASE THE RISK OF ASTHMA-RELATED DEATH. A U.S. TRIAL SHOWED
AN INCREASE IN
ASTHMA-RELATED DEATHS IN SUBJECTS RECEIVING SALMETEROL (13 DEATHS OUT
OF 13,176
SUBJECTS TREATED FOR 28 WEEKS ON SALMETEROL VERSUS 3 OUT OF 13,179
SUBJECTS ON
PLACEBO). WHEN LABA ARE USED IN FIXED-DOSE COMBINATION WITH ICS, DATA
FROM LARGE
CLINICAL TRIALS DO NOT SHOW A SIGNIFICANT INCREASE IN THE RISK OF
SERIOUS ASTHMA-
RELATED EVENTS (HOSPITALIZATIONS, INTUBATIONS, DEATH) COMPARED WITH
ICS ALONE.
(5.1)
2
PRESCRIBE SEREVENT DISKUS ONLY AS ADDITIONAL THERAPY FOR PATIENTS WITH
ASTHMA
WHO ARE CURRENTLY TAKING BUT ARE INADEQUATELY CONTROLLED ON AN ICS. DO
NOT USE
SEREVENT DISKUS FOR PATIENTS WHOSE ASTHMA IS ADEQUATELY CONTROLLED ON
LOW- OR
MEDIUM-DOSE ICS. (1.1, 5.1)
AVAILABLE DATA FROM CONTROLLED CLINICAL TRIALS SUGGEST THAT LABA AS
MONOTHERAPY
INCREASE THE RISK OF ASTHMA-RELATED HOSPITALIZATION IN PEDIATRIC AND
ADOLESCENT
PATIENTS. (5.1)
Treatment of asthma in patients aged 4 years and older with an