ADVAIR DISKUS- fluticasone propionate and salmeterol powder

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

GlaxoSmithKline LLC

DCI (Denominação Comum Internacional):

SALMETEROL XINAFOATE

Composição:

SALMETEROL 50 ug

Via de administração:

RESPIRATORY (INHALATION)

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

ADVAIR DISKUS 100/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0695-00). ADVAIR DISKUS 100/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0695-04). ADVAIR DISKUS 250/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0696-00). ADVAIR DISKUS 250/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0696-04). ADVAIR DISKUS 500/50 is supplied as a disposable purple plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0697-00). ADVAIR DISKUS 500/50 is also supplied in an institutional pack containing 14 blisters (NDC 0173-0697-04). 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. ADVAIR DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard ADVAIR DISKUS 1 month 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.

Status de autorização:

New Drug Application

Características técnicas

ADVAIR DISKUS- FLUTICASONE PROPIONATE AND SALMETEROL POWDER
GLAXOSMITHKLINE LLC
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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:
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Important limitation of use: Not indicated for relief of acute
bronchospasm. (1.1, 1.2)
DOSAGE AND ADMINISTRATION
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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
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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 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 not us