AEROSPAN flunisolide aerosol metered

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

FLUNISOLIDE (UNII: QK4DYS664X) (FLUNISOLIDE ANHYDROUS - UNII:78M02AA8KF)

Disponible depuis:

Meda Pharmaceuticals

DCI (Dénomination commune internationale):

FLUNISOLIDE

Composition:

FLUNISOLIDE 80 ug

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

AEROSPAN- FLUNISOLIDE AEROSOL, METERED
MEDA PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AEROSPAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AEROSPAN .
AEROSPAN (FLUNISOLIDE) INHALATION AEROSOL, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1981
RECENT MAJOR CHANGES
Indications and Usage (1) 6/2017
Dosage and Administration (2.1, 2.2) 6/2017
INDICATIONS AND USAGE
AEROSPAN is an inhaled corticosteroid indicated for
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Limitations of Use: Aerospan is NOT indicated for the relief of acute
bronchospasm or in children less than 6 years of age.
(1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. Inhaler includes a built-in spacer. Do not
use with external spacers or holding chambers. Shake well
prior to each inhalation. (2.1)
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions are pharyngitis, rhinitis, headache,
sinusitis, and increased cough. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDA PHARMACEUTICALS
INC. AT 855-653-6325 OR FDA AT
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Maintenance treatment of asthma as prophylactic therapy in adult and
pediatric patients 6 years of age and older (1)
Starting dosage is based on prior asthma therapy and disease severity.
(2.2)
Adults and adolescents 12 years of age and older: The recommended
starting dose is 160 mcg twice daily. Do not
exceed 320 mcg twice daily. (2.2)
Pediatric Patients 6 to 11 years: The recommended starting dose is 80
mcg twice daily. Do not exceed 160 mcg twice
daily. Administer under adult supervision. (2.2)
Inhalation aerosol: 60 or 120 metered 80 mcg-doses (3)
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures are required
(4)
Fungal infection of the mouth and pharynx. Monitor patients
periodically for signs of adverse effects on the oral
cavity. Advise patients to rinse mouth following inhalation. (5