Aerobid

Name: Aerobid

What is flunisolide nasal spray, and how does it work (mechanism of action)?

Flunisolide is a synthetic (man-made) corticosteroid. It is administered either as an oral metered-dose inhaler for the treatment of asthma (Aerobid) or as a nasal spray for treating allergic rhinitis. Corticosteroids are naturally- occurring hormones that prevent or suppress inflammation and immune responses. When given as an intranasal spray, flunisolide reduces watery nasal discharge (rhinorrhea), nasal congestion, postnasal drip, sneezing, and itching at the back of the throat that are common allergic symptoms. Eye symptoms such as itching and tearing that may be associated with allergy sometimes also are relieved. A beneficial response usually is noted within a few days but can take as long as 4 weeks. In asthmatic patients, the suppression of inflammation within the airways reduces the swelling caused by inflammation that narrows the airways. At the same time, mucus is reduced. Approximately 50% of flunisolide is absorbed into the blood. Flunisolide was FDA approved in September 1981.

What brand names are available for flunisolide nasal spray?

Aerospan

Uses

Flunisolide is used to prevent and control symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways.This medication must be used regularly to prevent breathing problems (attacks of wheezing/shortness of breath). It does not work immediately and should not be used to relieve an asthma attack. If an attack occurs, use your quick-relief inhaler as prescribed.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used to treat lung diseases such as bronchitis and emphysema.

Notes

Do not share this medication with others.Laboratory and/or medical tests (such as cortisol levels, eye exams, height/weight measurements, bone density tests) may be performed to monitor your progress and check for side effects.Avoid allergens (such as pollen, pet dander), irritants, smoking/secondhand smoke, and other factors that make asthma worse. Most people with asthma or ongoing lung disease should receive a flu shot annually. Discuss with your doctor.In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).Learn to use a peak flow meter and use it daily. Promptly tell your doctor if your condition persists or worsens (such as readings in the yellow/red range or increased use of quick-relief inhalers).

Storage

Store at room temperature. Because the canisters are under pressure, do not puncture or burn. Do not use or store near open flame or high heat (more than 120 degrees F/49 degrees C). Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

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Reviewed on 4/16/2014 References

Commonly used brand name(s)

In the U.S.

  • Aerobid
  • Aerobid-M
  • Aerospan

Available Dosage Forms:

  • Aerosol Powder
  • Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Clinical pharmacology

Flunisolide has demonstrated marked anti-inflammatory and anti-allergic activity in classical test systems. It is a corticosteroid that is several hundred times more potent in animal anti-inflammatory assays than the Cortisol standard. The molar dose of each activation of flunisolide in this preparation is approximately 2.5 to 7 times that of comparable inhaled corticosteroid products marketed for the same indication. The dose of flunisolide delivered per activation in this preparation is 10 times that per activation of Nasalide® (flunisolide) nasal solution. Clinical studies have shown therapeutic activity on bronchial mucosa with minimal evidence of systemic activity at recommended doses.

After oral inhalation of 1 mg flunisolide, total systemic availability was 40%. The flunisolide that is swallowed is rapidly and extensively converted to the 6β-OH metabolite and to water-soluble conjugates during the first pass through the liver. This offers a metabolic explanation for the low systemic activity of oral flunisolide itself since the metabolite has the low corticosteroid potency (on the order of the Cortisol standard). The inhaled flunisolide absorbed through the bronchial tree is converted to the same metabolites. Repeated inhalation of 2.0 mg of flunisolide per day (the maximum recommended dose) for 14 days did not show accumulation of the drug in plasma. The plasma half-life of flunisolide is approximately 1.8 hours.

The following observations relevant to systemic absorption were made in clinical studies. In one uncontrolled study a statistically significant decrease in responsiveness to metyrapone was noted in 15 adult steroid-independent patients treated with 2.0 mg of flunisolide per day (the maximum recommended dose) for 3 months. A small but statistically significant drop in eosinophils from 11.5% to 7.4% of total circulating leucocytes was noted in another study in children who were not taking oral corticosteroids simultaneously. A 5% incidence of menstrual disturbances was reported during open studies, in which there were no control groups for comparison.

Aerosol administration of flunisolide 2.0 mg twice daily for one week to 6 healthy male subjects revealed neither suppression of adrenal function as measured by early morning cortisol levels nor impairment of HPA axis function as determined by insulin hypoglycemia tests.

Controlled clinical studies have included over 500 patients with asthma, among them 150 children age 6 and over. More than 120 patients have been treated in open trials for two years or more. No significant adrenal suppression attributed to flunisolide was seen in these studies.

Significant decreases of systemic steroid dosages have been possible in flunisolide-treated patients. Recommended doses of flunisolide appear to be the therapeutic equivalent of an average of 10 mg/day of oral prednisone. Asthma patients have had further symptomatic improvement with flunisolide treatment even while reducing concomitant medication.

Precautions

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.

How supplied

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."

mfd for
FOREST PHARMACEUTICALS, INC.
St. Louis, MO 63045

mfd by
3M Pharmaceuticals
St. Paul, MN

Rev 3/02
624200

How to use your

Aerobid®Aerobid®-M

(flunisolide)

Inhaler System

DIRECTIONS FOR USE:

Before using your new Aerobid Inhaler System, it is important that you read over the following simple instructions and familiarize yourself with the inhaler and its metal cartridge.

As your doctor has probably told you, the Aerobid Inhaler System must be used for a few days before it begins working, and then should be used regularly to help reduce the frequency and severity of your asthma attacks. It is not a bronchodilator and will not provide relief during an actual asthmatic attack, but it can cut down the number of bad attacks if used regularly every day.

  1. Before the first use, place the Aerobid metal cartridge inside the plastic container as shown.
  2. Shake the inhaler system before each inhalation.
  3. Before each use, remove dustcap and inspect mouthpiece for foreign objects.
  4. Replace dustcap after each use.
  5. Breathe out as completely as possible.
  6. Hold the inhaler system upright and put plastic mouthpiece in your mouth as shown, being sure to close your lips tightly around the mouthpiece.
  7. Breathe in slowly through your mouth. At the same time firmly press down on the metal cartridge with your index finger.
  8. Hold your breath as long as you can.
  9. While holding your breath, stop pressing on the cartridge and remove mouthpiece from your mouth.
  10. If your doctor has prescribed two or more inhalations at each use, wait a minute to allow pressure to build up again in the metal canister, then repeat steps two through nine (2-9). Be sure to shake the inhaler system again before each inhalation.
  11. After the prescribed number of inhalations, rinse out your mouth thoroughly with water.
  12. Clean the inhaler system every few days. To do so, remove the metal cartridge, then rinse the plastic inhaler and cap with briskly running warm water. Dry thoroughly. Replace the cartridge and cap.

NOTE: If your mouth becomes sore or develops a rash, be sure to mention this to your doctor, but do not stop using your inhaler system unless he tells you.

WARNING: The contents of the metal cartridge are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperature above 120°F (49°C) may cause cartridge to explode. Never throw cartridge into fire or incinerator. Use by children should always be supervised by an adult.

mfd by

3M Pharmaceuticals, Inc. St. Paul, MN
For:

FOREST PHARMACEUTICALS, INC.
SUBSIDIARY OF FOREST LABORATORIES, INC.
ST. LOUIS, MISSOURI 63045

Aerobid 
flunisolide aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-0672
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
flunisolide (flunisolide) flunisolide 250 ug
Inactive Ingredients
Ingredient Name Strength
trichloromonofluoromethane  
dichlorodifluoromethane  
dichlorotetrafluoroethane  
sorbitan trioleate  
Packaging
# Item Code Package Description
1 NDC:0456-0672-99 100 AEROSOL, METERED (100 INHALATION) in 1 INHALER
Aerobid-M 
flunisolide aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-0670
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
flunisolide (flunisolide) flunisolide 250 ug
Inactive Ingredients
Ingredient Name Strength
trichloromonofluoromethane  
dichlorodifluoromethane  
dichlorotetrafluoroethane  
sorbitan trioleate  
menthol  
Packaging
# Item Code Package Description
1 NDC:0456-0670-99 100 AEROSOL, METERED (100 INHALATION) in 1 INHALER
Labeler - FOREST PHARMACEUTICALS, INC.
Revised: 12/2006   FOREST PHARMACEUTICALS, INC.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For inhalation dosage form (aerosol):
    • For preventing an asthma attack:
      • Adults and children 12 years of age and older—At first, 2 puffs two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 puffs two times a day. Each puff contains 80 micrograms (mcg) of flunisolide.
      • Children 6 to 11 years of age—At first, 1 puff two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 2 puffs two times a day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
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