• Basic Info
• Top Questions
• Clinical Info
• Interactions

Uses

Asthma

Long-term prevention of bronchospasm in patients with asthma.

In corticosteroid-dependent patients, may permit a substantial reduction in the daily maintenance dosage of the systemic corticosteroid or gradual discontinuance of systemic corticosteroid maintenance dosages.

Oral inhalation should not be used for the treatment of nonasthmatic bronchitis or for rapid relief of bronchospasm.

Dosage and Administration

General

• Adjust dosage carefully according to individual requirements and response.
• After a satisfactory response is obtained, decrease dosage gradually to the lowest possible dosage that maintains an adequate clinical response. Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Pediatric Use under Cautions.)

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• When switching from systemic corticosteroids to orally inhaled flunisolide, asthma should be reasonably stable before initiating treatment with the oral inhalation.
• Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid. After about 1 week, gradually withdraw the systemic corticosteroid.
• Decrements usually should not exceed 2.5 mg of prednisone (or its equivalent) every 1–2 weeks in patients receiving the oral inhalation.
• During withdrawal of oral therapy, symptoms of systemic corticosteroid withdrawal may occur despite maintenance or even improvement in pulmonary function; continue oral inhalation therapy but monitor for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, increase systemic corticosteroid dosage temporarily and continue withdrawal more slowly.
• Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly. (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)
• If exacerbations of asthma occur after transfer to oral inhalation therapy, administer short courses of systemic corticosteroids, then taper dosage as symptoms subside. Supplemental systemic corticosteroid therapy may also be required during periods of stress.

Administration

Oral Inhalation

Administer by oral inhalation using an oral aerosol inhaler.

Administer twice daily in the morning and evening.

Shake well immediately prior to use and hold inhaler upright prior to actuation. Exhale out as completely as possible and place the mouthpiece of the inhaler well into the mouth with lips closed firmly around it. Inhale slowly through the mouth while pressing the metal canister down with the forefinger. After holding the breath for as long as possible, remove the mouthpiece and exhale slowly. If additional inhalations are required, wait 1 minute between inhalations, shake the inhaler again, and repeat the procedure.

Following each treatment, rinse mouth thoroughly with water or mouthwash to remove drug deposited in the oropharyngeal area.

Clean inhaler every few days by removing canister from the inhaler and rinsing plastic cap and inhaler in warm water; allow to dry thoroughly.

Dosage

Available as flunisolide hemihydrate; dosage expressed in terms of flunisolide.

Oral inhalation aerosol delivers 250 mcg of flunisolide from the actuator (mouthpiece) per metered spray. The inhaler system delivers at least 100 metered sprays.

Pediatric Patients

Asthma

Oral

Children 6–15 years of age: 500 mcg (2 inhalations) twice daily.

Adults

Asthma

Oral

Initially, 500 mcg (2 inhalations) twice daily. If required, dosage may be increased to 1 mg (4 inhalations) twice daily. Higher dosages have been recommended by some clinicians for patients with severe persistent asthma.

Prescribing Limits

Pediatric Patients

Oral

Dosages >500 mcg (2 inhalations) twice daily not evaluated.

Adults

Oral

Manufacturer recommends maximum 1 mg (4 inhalations) twice daily (2 mg total daily dosage).

Special Populations

No special population dosage recommendations at this time.