AEROSPAN flunisolide aerosol metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Acton Pharmaceuticals, Inc.

INN (International Name):

FLUNISOLIDE

Composition:

FLUNISOLIDE 80 ug

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

AEROSPAN- FLUNISOLIDE AEROSOL, METERED
ACTON PHARMACEUTICALS, INC.
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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
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
AEROSPAN is an inhaled corticosteroid indicated for
Maintenance treatment of asthma as prophylactic therapy in adult and
pediatric patients 6 years of age and older (1)
Asthma patients requiring oral corticosteroid therapy, where adding
AEROSPAN inhalation aerosol may reduce or
eliminate the need for oral corticosteroids (1)
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. (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)
Children (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)
DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol, 60 or 120 metered 80 mcg-doses (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures are required (4)
WARNINGS AND PRECAUTIONS
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. (5.1)
Immunosuppression: Potential worsening of existing tuberculosis;
fungal, bacterial, viral, or parasitic infection; or ocular
herpes simplex. More serious or even fatal course of chickenpox or
measles in susceptible patients. Use caution in
patients with above because of the potential for worsening of these
infections. (5.3)
Transferring patients from systemic corticost