FLUTICASONE PROPIONATE AND SALMETEROL DISKUS- fluticasone propionate and salmeterol powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Fluticasone Propionate/Salmeterol DISKUS inhalation powder 100/50 mcg 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 66993-584-97). Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg 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 66993-585-97). Fluticasone Propionate/Salmeterol DISKUS inhalation powder 500/50 mcg 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 66993-586-97). 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. Fluticasone Propionate/Salmeterol DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard Fluticasone Propionate/Salmeterol 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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FLUTICASONE PROPIONATE AND SALMETEROL DISKUS- FLUTICASONE PROPIONATE
AND SALMETEROL POWDER
PRASCO LABORATORIES
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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:
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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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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 asthmaticus or