Drug: Aerobid, Aerobid M

Flunisolide, the active component of AEROBID Inhaler System, is an anti-inflammatory steroid having the chemical name 6α-fluoro-11/3, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic-16, 17-acetal with acetone. It has the following structure: Flunisolide is a white to creamy white crystalline powder with a molecular weight of 434.49. It is soluble in acetone, sparingly soluble in chloroform, slightly soluble in methanol, and practically insoluble in water. It has a melting point of about 245°C. AEROBID Inhaler is delivered in a metered-dose aerosol system containing a microcrystalline suspension of flunisolide as the hemihydrate in propellants (trichloromonofluoromethane, dichlorodifluoromethane and dichlorotetrafluoroethane) with sorbitan trioleate as a dispersing agent. AEROBID-M also contains menthol as a flavoring agent. Each activation delivers approximately 250 mcg of flunisolide to the patient. One AEROBID Inhaler System is designed to deliver at least 100 metered inhalations.

Source: http://www.rxlist.com

Adverse events reported in controlled clinical trials and long-term open studies in 514 patients treated with AEROBID (flunisolide) are described below. Of those patients, 463 were treated for 3 months or longer, 407 for 6 months or longer, 287 for 1 year or longer and 122 for 2 years or longer. Musculoskeletal reactions were reported in 35% of steroid-dependent patients in whom the dose of oral steroid was being tapered. This is a well-known effect of steroid withdrawal. Incidence 10% or greater: Gastrointestinal: diarrhea (10%), nausea and/or vomiting (25%), upset stomach (10%)
General: flu (10%)
Mouth and Throat: sore throat (20%)
Nervous System: headache (25%)
Respiratory: cold symptoms (15%), nasal congestion (15%), upper respiratory infection (25%)
Special Senses: unpleasant taste (10%) Incidence 3-9% Cardiovascular: palpitations
Gastrointestinal: abdominal pain, heartburn
General: chest pain, decreased appetite, edema, fever
Mouth and Throat: Candida infection
Nervous System: dizziness, irritability, nervousness, shakiness
Reproductive: menstrual disturbances
Respiratory: chest congestion, cough* hoarseness, rhinitis, runny nose, sinus congestion sinus drainage, sinus infection, sinusitis, sneezing, sputum, wheezing*
Skin: eczema, itching (pruritus), rash
Special Senses: ear infection, loss of smell or taste Incidence 1-3% General: chills, increased appetite and weight gain, malaise, peripheral edema, sweating, weakness
Cardiovascular: hypertension, tachycardia
Gastrointestinal: constipation, dyspepsia, gas
Hemic/Lymph: capillary fragility, enlarged lymph nodes
Mouth and Throat: dry throat, glossitis, mouth irritation, pharyngitis, phlegm, throat irritation
Nervous System: anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity insomnia, moodiness, numbness, vertigo
Respiratory: bronchitis, chest tightness* dyspnea, epistaxis, head stuffiness, laryngitis, nasal irritation, pleurisy, pneumonia, sinus discomfort
Skin: acne, hives or urticaria
Special Senses: blurred vision, earache, eye discomfort, eye infection Incidence less than 1%, judged by investigators as possibly or probably drug related: abdominal fullness, shortness of breath. *The incidences as shown of cough, wheezing, and chest tightness were judged by investigators to be possibly or probably drug related. In placebo-controlled trials, the overall incidences of these adverse events (regardless of investigators'judgement of drug relationship) were similar for drug and placebo-treated groups. They may be related to the vehicle or delivery system. Read the Aerobid, Aerobid M (flunisolide inhaler) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

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.

Source: http://www.rxlist.com

No information provided Read the Aerobid, Aerobid M Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

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.

Source: http://www.rxlist.com

AEROBID (flunisolide) Inhaler is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients of this preparation contraindicates its use.Last reviewed on RxList: 5/8/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided

Source: http://www.rxlist.com

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: 11/26/2003  Last reviewed on RxList: 5/8/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General: Because of the relatively high molar dose of flunisolide per activation in this preparation, and because of the evidence suggesting higher levels of systemic absorption with flunisolide than with other comparable inhaled corticosteroids (see CLINICAL PHARMACOLOGY section), patients treated with AEROBID (flunisolide) should be observed carefully for any evidence of systemic corticosteroid effect, including suppression of bone growth in children. Particular care should be taken in observing patients post-operatively or during periods of stress for evidence of a decrease in adrenal function. During withdrawal from oral steroids, some patients may experience symptoms of systemically active steroid withdrawal, e.g. joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement of respiratory function. (See DOSAGE AND ADMINISTRATION for details.) In responsive patients, flunisolide may permit control of asthmatic symptoms without suppression of HPA function. Since flunisolide is absorbed into the circulation and can be systemically active, the beneficial effects of AEROBID Inhaler in minimizing or preventing HPA dysfunction may be expected only when recommended dosages are not exceeded. The long-term local and systemic effects of AEROBID (flunisolide) in human subjects are still not fully known. In particular, the effects resulting from chronic use of AEROBID on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex. Pulmonary infiltrates with eosinophilia may occur in patients on AEROBID Inhaler therapy. Although it is possible that in some patients this state may become manifest because of systemic steroid withdrawal when inhalational steroids are administered, a causative role for the drug and/or its vehicle cannot be ruled out. Information for Patients: Since the relief from AEROBID Inhaler depends on its regular use and on proper inhalation technique, patients must be instructed to take inhalations at regular intervals. They should also be instructed in the correct method of use. (See Patient Instruction Leaflet.) Patients whose systemic corticosteroids have been reduced or withdrawn should be instructed to carry a warning card indicating they may need supplemental systemic steroids during periods of stress or a severe asthmatic attack that is not responsive to bronchodilators. Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. An illustrated leaflet of patient instructions for proper use accompanies each AEROBID Inhaler System. CONTENTS UNDER PRESSURE Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F (49°C) may cause container to explode. Never throw container into fire or incinerator. Keep out of reach of children. Carcinogenesis: Long-term studies were conducted in mice and rats using oral administration to evaluate the carcinogenic potential of the drug. There was an increase in the incidence of pulmonary adenomas in mice, but not in rats. Female rats receiving the highest oral dose had an increased incidence of mammary adenocarcinoma compared to control rats. An increased incidence of this tumor type has been reported for other corticosteroids. Impairment of Fertility: Female rats receiving high doses of flunisolide (200 mcg/kg/ day) showed some evidence of impaired fertility. Reproductive performance in the low- (8 mcg/kg/day) and mid-dose (40 mcg/kg/day) groups was comparable to controls. Pregnancy: Pregnancy Category C. As with other corticosteroids, flunisolide has been shown to be teratogenic in rabbits and rats at doses of 40 and 200 mcg/kg/day respectively. It was also fetotoxic in these animal reproductive studies. There are no adequate and well-controlled studies in pregnant women. Flunisolide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when flunisolide is administered to nursing women. Pediatric Use: Safety and effectiveness have not been established in children below the age of 6. Oral corticoids have been shown to cause growth suppression in children and adolescents, particularly with higher doses over extended periods. If a child or adolescent on any corticoid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of steroids should be considered. Last reviewed on RxList: 5/8/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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