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AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN Inhalation Aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding AEROSPAN Inhalation Aerosol may reduce or eliminate the need for oral corticosteroids.
Important Limitations of Use
AEROSPAN Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
AEROSPAN Inhalation Aerosol is NOT indicated in children less than 6 years of age.
DOSAGE AND ADMINISTRATION
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.
Table 1: Recommended Doses of AEROSPAN Inhalation
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 mg twice daily*|
|Children 6 to 11 years†||80 mcg twice daily||160 mcg twice daily*|
|* Higher doses have not been studied.
† 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].
Dosage Forms And Strengths
AEROPSAN is an inhalation aerosol in a pressurized metered dose inhaler with a built in spacer that delivers 60 or 120 metered 80 mcg doses.
Storage And Handling
AEROSPAN Inhalation Aerosol is supplied as a pressurized lined aluminum canister in boxes of one. Each canister is supplied with a two-piece plastic purple actuator and gray spacer assembly, and tear-off patient's instructions, including a Patient Information and an illustrated. Instructions for Using Your AEROSPAN Inhalation Aerosol.
The following canister sizes are available: 8.9 g net weight, providing 120 metered actuations (trade size, NDC 75989-550-12); 5.1 g net weight providing 60 metered actuations (hospital size, NDC 75989-550-63); 5.1 g net weight providing 60 metered actuations (professional sample, NDC 75989-550-06).
Prime the inhaler by releasing two test sprays into the air away from the face before first use of AEROSPAN Inhalation Aerosol, and when the inhaler has not been used for more than 2 weeks.
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.
The appearance of a white ring on the orifice of the actuator and inside the spacer is normal. The performance of AEROSPAN Inhalation Aerosol is not affected by this residue. No cleaning is required.
When not in use, keep AEROSPAN Inhalation Aerosol out of reach of children. Pediatric patients should only administer AEROSPAN Inhalation Aerosol under adult supervision.
The plastic purple actuator and gray spacer assembly supplied as part of AEROSPAN Inhalation Aerosol should not be used with any other product canisters; and the actuator from other products should not be used with an AEROSPAN Inhalation Aerosol canister. Do not separate the purple actuator from the gray spacer. Do not use this product with any external spacer or holding chamber devices.
The labeled amount of medication in each actuation (80 mcg flunisolide) cannot be assured after 120 metered actuations (or 60 metered actuations in the hospital and sample size canisters), even though the canister is not completely empty and will continue to operate. The inhaler (canister plus actuator) should be discarded when the labeled number of actuations have been used.
Avoid spraying in eyes.
Contents under pressure: Do not puncture. Do not use or store near heat or open flame. Protect from freezing temperatures and prolonged exposure to sunlight. Exposure to temperatures above 120°F (49°C) may cause bursting. Never throw into fire or incinerator.
Store at 25 °C (77 °F); excursions permitted to 15 to 30 °C (59 to 86 °F) [see USP Controlled Room Temperature]. For best results, the canister should be at room temperature before use.
Manufactured By: 3M Drug Delivery Systems. Northridge, CA 91324. For: Acton Pharmaceuticals, Inc. Marlborough, MA 01752. Revised: Aug 2013.
Last reviewed on RxList: 9/11/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Aerospan HFA Information
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