ADVAIR DISKUS- fluticasone propionate and salmeterol powder

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

A-S Medication Solutions

ІПН (Міжнародна Ім'я):

SALMETEROL XINAFOATE

Склад:

SALMETEROL 50 ug

Адміністрація маршрут:

RESPIRATORY (INHALATION)

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

ADVAIR DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. ADVAIR 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 ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. ADVAIR DISKUS 250/50 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. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated. Important Limitatio

Огляд продуктів:

Product: 50090-0731 NDC: 50090-0731-0 60 POWDER in a INHALER / 1 in a CARTON

Статус Авторизація:

New Drug Application

інформаційний буклет

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 salmeterol help the

Характеристики продукта

ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER
A-S MEDICATION SOLUTIONS
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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 (FLUTICASONE PROPIONATE AND SALMETEROL INHALATION
POWDER), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
ADVAIR 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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•
•
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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 ADVAIR DISKUS 100/50,
ADVAIR DISKUS 250/50, or ADVAIR DISKUS 500/50 twice daily. Starting
dosage is based on asthma
severity. (2.1)
Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of
ADVAIR DISKUS 100/50 twice
daily. (2.1)
Maintenance treatment of COPD: 1 inhalation of ADVAIR DISKUS 250/50
twice daily. (2.2)
Primary treatment of status asthmaticus or acute episodes of asthma or
COPD requiring intensive
measures. (4)
Severe hypersensitivity to milk proteins or demonstrated
hypersensitivity to fluticasone propionate,
salmeterol, or any of the excipients. (4)
LABA monotherapy increases the risk of serious asthma-related events.
(5.1)
Do not initiate in acutely deteriorating asthma or COPD. Do n