Forest Pharmaceuticals, Inc.
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Forest Pharmaceuticals, Inc. Drugs
AEROSPAN Inhalation Aerosol should be administered by the orally inhaled route in asthmatic patients aged 6 years and older. 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.
Note: In all patients it is desirable to titrate to the lowest effective dose once asthma stability is achieved.
Adults (age 12 and older): The recommended starting dose is 160 mcg twice daily. The maximum dose should not exceed 320 mcg twice daily. Higher doses have not been studied.
Children (age 6 to 11): The recommended starting dose is 80 mcg twice daily. The maximum dose should not exceed 160 mcg twice daily. Higher doses have not been studied.
Pediatric patients should administer this product under adult supervision.
The recommended dosage of AEROSPAN Inhalation Aerosol relative to flunisolide CFC inhalation aerosol is lower due to differences in delivery characteristics between the products. Recognizing that a definitive comparative therapeutic ratio between AEROSPAN Inhalation Aerosol and flunisolide CFC inhalation aerosol has not been demonstrated, any patient who is switched from flunisolide CFC inhalation aerosol to AEROSPAN Inhalation Aerosol should be dosed appropriately, taking into account the dosing recommendations above, and should be monitored to ensure that the dose of AEROSPAN Inhalation Aerosol selected is safe and efficacious. As with any inhaled corticosteroid, physicians are advised to select the dose of AEROSPAN Inhalation Aerosol that would be appropriate based upon the patient's disease severity and titrate the dose of AEROSPAN Inhalation Aerosol downward over time to the lowest level that maintains proper asthma control.
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.
If a patient is already on a systemic corticosteroid for asthma control, AEROSPAN Inhalation Aerosol should be used concurrently with the patient's usual maintenance dose of oral corticosteroid before an attempt is made to withdraw systemic corticosteroid. The patient's asthma should be reasonably stable before withdrawal of oral corticosteroid is initiated. After approximately one week, gradual withdrawal of the systemic corticosteroid may be started by reducing the daily or alternate daily dose. The next reduction may be made after an interval of one or two weeks, depending on the response of the patients. In general, these decrements should not exceed 2.5 mg of prednisone or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency (see WARNINGS). During their withdrawal from a systemic corticosteroid, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or musculoskeletal pain, lassitude and depression, despite maintenance or even improvements in pulmonary function. Such patients should be encouraged to continue with AEROSPAN Inhalation Aerosol and 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, patients being transferred may require supplementary treatment with a systemic corticosteroid.
FOR PROPHYLAXIS IN ADULTS AND CHILDREN: Adults: The recommended adult dose of Flumadine is 100 mg twice a day. In patients with severe hepatic dysfunction, renal failure (CrCI ≤10 mL/min.) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. There are currently no data available regarding the safety of rimantadine during multiple dosing in subjects with renal or hepatic impairment. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with any degree of renal insufficiency should be monitored for adverse effects, with dosage adjustments being made as necessary.
Children: In children less than 10 years of age, Flumadine should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg. For children 10 years of age or older, use the adult dose.
FOR TREATMENT IN ADULTS: The recommended adult dose of Flumadine is 100 mg twice a day. In patients with severe hepatic dysfunction, renal failure (CrCI ≤10 mL/min) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. There are currently no data available regarding the safety of rimantadine during multiple dosing in subjects with renal or hepatic impairment. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with any degree of renal insufficiency should be monitored for adverse effects, with dosage adjustments being made as necessary. Flumadine therapy should be initiated as soon as possible, preferably within 48 hours after onset of signs and symptoms of influenza A infection. Therapy should be continued for approximately seven days from the initial onset of symptoms.
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