"The European Medicines Agency (EMA) has approved mepolizumab (Nucala, GlaxoSmithKline) as an add-on treatment for severe refractory eosinophilic asthma in adults in the 31 European countries covered by the EMA, according to a company state"...
Aerobid, Aerobid M
AEROBID (flunisolide) Inhaler is indicated in the maintenance treatment of asthma as prophylactic therapy. AEROBID is also indicated for asthma patients who require systemic corticosteroid administration, where adding AEROBID may reduce or eliminate the need for the systemic corticosteroids.
AEROBID Inhaler is NOT indicated for the relief of acute bronchospasm.
DOSAGE AND ADMINISTRATION
The AEROBID (flunisolide) Inhaler System is for oral inhalation only.
Adults: The recommended starting dose is 2 inhalations twice daily, morning and evening, for a total daily dose of 1 mg. The maximum daily dose should not exceed 4 inhalations twice a day for a total daily dose of 2 mg. When the drug is used chronically at 2 mg/day, patients should be monitored periodically for effects on the hypothalamic-pituitary-adrenal (HPA) axis.
Pediatric< Patients: For children and adolescents 6-15 years of age, two inhalations may be administered twice daily for a total daily dose of 1 mg. Higher doses have not been studied. Insufficient information is available to warrant use in children under age 6. With chronic use, pediatric patients should be monitored for growth as well as for effects on the HPA axis.
Rinsing the mouth after inhalation is advised.
Different considerations must be given to the following groups of patients in order to obtain the full therapeutic benefit of AEROBID (flunisolide) Inhaler.
Patients Not Receiving Systemic Corticosteroids:
Patients who require maintenance therapy of their asthma may benefit from treatment with AEROBID at the doses recommended above. In patients who respond to AEROBID, improvement in pulmonary function is usually apparent within one to four weeks after the start of therapy. Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose.
Patients Maintained on Systemic Corticosteroids:
Clinical studies have shown that AEROBID may be effective in the management of asthmatics dependent or maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.
The patient's asthma should be reasonably stable before treatment with AEROBID is started. Initially, AEROBID should be used concurrently with the patient's usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal; e.g. joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly.
During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.
AEROBID (flunisolide) Inhaler Systems are available in canisters of 100 metered inhalations.
NDC 0456-0672-99 AEROBID
NDC 0456-0670-99 AEROBID-M
"Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's)."
WARNING: Contains trichloromonofluoromethane, dichlorodifluoromethane and dichlorotetrafluoroethane, substances which harm public health and environment by destroying ozone in the upper atmosphere. "A notice similar to the above WARNING has been placed in the information for the patient of this product pursuant to EPA regulations."
Revised 3/02. mfd for: FOREST PHARMACEUTICALS, INC., St. Louis, MO 63045. mfd by 3M Pharmaceuticals, St. Paul, MN. FDA rev date: 11/26/2003This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/8/2008
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