FLUTICASONE PROPIONATE AND SALMETEROL powder, metered

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:

Bryant Ranch Prepack

Indgivelsesvej:

RESPIRATORY (INHALATION)

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2 -adrenergic agonist (LABA). Limitations of Use : Fluticasone Propionate/Salmeterol MDPI is not indicated for the relief of acute bronchospasm. Fluticasone Propionate/Salmeterol MDPI is contraindicated in: - the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions  (5.2)] . - patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see Warnings and Precautions (5.10) and Description (11)]

Produkt oversigt:

How Supplied Fluticasone Propionate/Salmeterol MDPI inhalation powder: Each Fluticasone Propionate/Salmeterol MDPI has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter. Discard the inhaler when the counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see Patient Counseling Information (17)]. Storage and Handling Store at room temperature (between 15ºC and 25ºC; 59ºF and 77ºF) in a dry place; excursions permitted from 59º F to 86º F (15ºC to 30ºC). Avoid exposure to extreme heat, cold, or humidity. Store Fluticasone Propionate/Salmeterol MDPI inside the unopened moisture‑protective foil pouch until initial use. Discard the product 30 days after opening the foil pouch or when the counter reads 0, whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Autorisation status:

New Drug Application Authorized Generic

Produktets egenskaber

FLUTICASONE PROPIONATE AND SALMETEROL- FLUTICASONE PROPIONATE AND
SALMETEROL POWDER, METERED
BRYANT RANCH PREPACK
----------
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/Salmeterol Multi-Dose Dry Powder Inhaler (MDPI)
is a combination of fluticasone
propionate, a corticosteroid, and salmeterol, a long-acting beta
-adrenergic agonist (LABA), indicated for
treatment of asthma in adult and pediatric patients aged 12 years and
older. Fluticasone
Propionate/Salmeterol inhalation powder should be used for patients
not adequately controlled on a long
term asthma control medication such as an inhaled corticosteroid or
whose disease warrants initiation of
treatment with both an inhaled corticosteroid and long acting beta
-adrenergic agonist (LABA). (1)
Limitations of Use:
Not indicated for the relief of acute bronchospasm. (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
Starting dosage is based on prior asthma therapy and disease severity.
(2.2)
1 inhalation of Fluticasone Propionate/Salmeterol 55 mcg/14 mcg, 113
mcg/14 mcg, or 232 mcg/14
mcg twice daily. (2.2)
Do not use with a spacer or volume holding chamber. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg of
fluticasone
propionate/salmeterol in each actuation (3).
CONTRAINDICATIONS
Primary treatment of status asthmaticus or acute episodes of asthma
requiring intensive measures.
(4)
Severe hypersensitivity to milk proteins or any ingredients of
Fluticasone Propionate/Salmeterol MDPI.
(4)
WARNINGS AND PRECAUTIONS
LABA monotherapy increases the risk of serious asthma-related events.
(5.1)
Deterioration of asthma and acute epi