Generic name: FLUNISOLIDE 80ug
Dosage form: inhalation aerosol, metered
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AEROSPAN Inhalation Aerosol should be administered by the orally inhaled route in asthmatic patients aged 6 years and older. This product contains a built-in spacer. Do not use with any external spacer or holding chamber devices. Instruct patients to prepare the inhaler for use by pulling the built-in purple actuator out from the gray spacer and snapping into an "L" shape prior to use. Pediatric patients should administer this product under adult supervision.
The onset and degree of symptom relief with orally inhaled corticosteroids is usually apparent within 2-4 weeks after the start of treatment, and varies with individual patients. The time to improvement in asthma control was not evaluated in clinical studies with AEROSPAN Inhalation Aerosol. For patients who do not respond adequately to the starting dose after 3-4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of AEROSPAN Inhalation Aerosol when administered in excess of recommended doses have not been established.
The recommended starting dosage and the highest recommended dosage of AEROSPAN Inhalation Aerosol are listed in Table 1.
† For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Clinical studies with AEROSPAN Inhalation Aerosol did not evaluate patients on oral corticosteroids. However, clinical studies with therapeutic doses of flunisolide CFC inhalation aerosol did show efficacy in the management of asthmatics dependent or maintained on systemic corticosteroids. Reduce the dose of prednisone no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with AEROSPAN. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.4)].
Table 1. Recommended Doses of AEROSPAN Inhalation Aerosol
Note: In all patients it is desirable to titrate to the lowest effective dose once asthma stability is achieved.
|Age Group||Recommended Starting Dose||Highest Recommended Dose|
|Adults and Adolescents 12 years of age and older†||160 mcg twice daily||320 mcg twice daily*|
|Children 6 to 11 years†||80 mcg twice daily||160 mcg twice daily*|