FLUTICASONE PROPIONATE AND SALMETEROL DISKUS- fluticasone propionate and salmeterol powder

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

A-S Medication Solutions

Indgivelsesvej:

RESPIRATORY (INHALATION)

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluticasone Propionate/Salmeterol DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone Propionate/Salmeterol DISKUS should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2 -adrenergic agonist (LABA). Important Limitation of Use Fluticasone Propionate/Salmeterol DISKUS is NOT indicated for the relief of acute bronchospasm. Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Fluticasone Propionate/Salmeterol DISKUS inhalation po

Produkt oversigt:

Product: 50090-4214 NDC: 50090-4214-0 60 POWDER in a INHALER / 1 in a CARTON

Autorisation status:

New Drug Application Authorized Generic

Indlægsseddel

SALMETEROL POWDER
A-S Medication Solutions
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MEDICATION GUIDE
ADVAIR DISKUS ® [ ad′ vair disk′ us]
(fluticasone propionate and
salmeterol inhalation powder)
for oral inhalation
What is the most important information I should know about ADVAIR
DISKUS?
ADVAIR DISKUS can cause serious side effects, including:
•
People with asthma who take long-acting beta 2-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 LABA
medicines.
•
It is not known if LABA medicines such as salmeterol increase the risk
of death in people with
COPD.
•
Call your healthcare provider if breathing problems worsen over time
while using ADVAIR
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.
•
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 an
inhaled corticosteroid. 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.
•
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 the inhaled corticosteroid (ICS) medicine
fluticasone propionate and
the LABA medicine salmeterol.
•
ICS medicines such as fluticasone propionate help to decrease
inflammation in the lungs.
Inflammation in the lungs can lead to breathing problems.
•
LABA medicines such as sa

Produktets egenskaber

FLUTICASONE PROPIONATE AND SALMETEROL DISKUS- FLUTICASONE PROPIONATE
AND SALMETEROL POWDER
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUTICASONE
PROPIONATE/SALMETEROL DISKUS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
FLUTICASONE PROPIONATE/SALMETEROL DISKUS.
FLUTICASONE PROPIONATE/SALMETEROL DISKUS INHALATION POWDER, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Fluticasone Propionate/Salmeterol DISKUS is a combination product
containing a corticosteroid and a
long-acting beta -adrenergic agonist (LABA) indicated for:
•
•
Important limitation of use: Not indicated for relief of acute
bronchospasm. (1.1, 1.2)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Inhalation powder: Inhaler containing a combination of fluticasone
propionate (100, 250, or 500 mcg) and
salmeterol (50 mcg) as a powder formulation for oral inhalation. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
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2
Twice-daily treatment of asthma in patients aged 4 years and older.
(1.1)
Maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic
obstructive pulmonary disease (COPD). (1.2)
For oral inhalation only. (2)
Treatment of asthma in patients aged 12 years and older: 1 inhalation
of Fluticasone
Propionate/Salmeterol DISKUS inhalation powder 100/50 mcg, Fluticasone
Propionate/Salmeterol
DISKUS inhalation powder 250/50 mcg, and Fluticasone
Propionate/Salmeterol DISKUS inhalation
powder 500/50 mcg twice daily. Starting dosage is based on asthma
severity. (2.1)
Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of
Fluticasone
Propionate/Salmeterol DISKUS inhalation powder 100/50 mcg twice daily.
(2.1)
Maintenance treatment of COPD: 1 inhalation of Fluticasone
Propionate/Salmeterol DISKUS inhalation
powder 250/50 mcg twice daily. (2.2)
Primary treatment of status asthmatic