FLUTICASONE PROPIONATE AND SALMETEROL powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone propionate and salmeterol inhalation powder 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 and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm. Fluticasone propionate and salmeterol inhalation powder 250 mcg/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 and salmeterol inhalation powder 250 mcg/50 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Flutica

Product summary:

Fluticasone Propionate and Salmeterol Inhalation Powder USP 250 mcg/50 mcg is supplied as a disposable gray plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 68788-8453-6). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place away from direct heat or sunlight. Keep out of reach of children. Fluticasone propionate and salmeterol inhalation powder should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard fluticasone propionate and salmeterol inhalation powder 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:

Abbreviated New Drug Application

Summary of Product characteristics

FLUTICASONE PROPIONATE AND SALMETEROL- FLUTICASONE PROPIONATE AND
SALMETEROL POWDER
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUTICASONE
PROPIONATE AND SALMETEROL INHALATION POWDER SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR FLUTICASONE PROPIONATE AND SALMETEROL
INHALATION
POWDER.
FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Fluticasone propionate and salmeterol inhalation powder 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 or 250 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 fluticasone propionate and
salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate
and salmeterol inhalation
powder 250 mcg/50 mcg, or fluticasone propionate and salmeterol
inhalation powder 500 mcg/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 and
salmeterol inhalation powder 100 mcg/50 mcg twice daily. (2.1)
Maintenance Treatment of COPD: 1 inhalation of fluticasone propionate
and salmeterol inhalation
powder 250 mcg/50 mcg twice daily. (2.2)
Primary treatment