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.

Last updated on RxList: 5/8/2008

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.

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: 11/26/2003 

Last updated on RxList: 5/8/2008

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.

No information provided

Last updated on RxList: 5/8/2008

Particular care is needed in patients who are transferred from systemically active corticosteroids to AEROBID Inhaler because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery or infections, particularly gastroenteritis. Although AEROBID Inhaler may provide control of asthmatic symptoms during these episodes, it does NOT provide the systemic steroid that is necessary for coping with these emergencies. During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume systemic steroids (in large doses) immediately and to contact their physician for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack. To assess the risk of adrenal insufficiency in emergency situations, routine tests of adrenal cortical function, including measurement of early morning resting cortisol levels, should be performed periodically in all patients. An early morning resting cortisol level may be accepted as normal if it falls at or near the normal mean level.

Localized infections with Candida albicans or Aspergillus niger have occurred in the mouth and pharynx and occasionally in the larynx. Positive cultures for oral Candida may be present in up to 34% of patients. Although the frequency of clinically apparent infection is considerably lower, these infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with AEROBID Inhaler.

AEROBID Inhaler is not to be regarded as a bronchodilator and is not indicated for relief of bronchospasm.

Patients should be instructed to contact their physician immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment. During such episodes, patients may require therapy with systemic corticosteroids. Theoretically, the use of inhaled corticosteroids with alternate day prednisone systemic treatment should be accompanied by more HPA suppression than a therapeutically equivalent regimen of either alone.

Transfer of patients from systemic steroid therapy to AEROBID Inhaler may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g. rhinitis, conjunctivitis, and eczema.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered.

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 updated on RxList: 5/8/2008

No information provided

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 updated on RxList: 5/8/2008

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 6/3-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.

Last updated on RxList: 5/8/2008

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 inhala- tions, 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 thor- oughly. 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 chil- dren should always be supervised by an adult.

Last updated on RxList: 5/8/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FLUNISOLIDE - INHALATION

(flew-NISS-oh-lide)

COMMON BRAND NAME(S): Aerobid

USES: Flunisolide is used to help prevent asthma symptoms such as wheezing and shortness of breath. For those who must take corticosteroids by mouth to control their asthma, flunisolide can be used to help decrease the dose of the medication that must be taken by mouth. This medication belongs to a class of drugs known as corticosteroids. It works to make breathing easier by reducing the swelling of the airways in the lungs, and decreasing phlegm and other asthma symptoms.

This medication must be taken regularly to be effective. It does not work immediately and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (e.g., albuterol) as prescribed.

HOW TO USE: First read the manufacturers instruction leaflet provided by your pharmacist before you start using flunisolide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is inhaled into the lungs using a special inhaler device. To use the inhaler, shake the canister for about 10 seconds. Take a drink of water to moisten the throat. Place the inhaler mouthpiece into your mouth over the tongue. Close your lips tightly around the mouthpiece. Tilt your head back slightly, and press the inhaler while taking a slow deep breath for 5 seconds. Hold your breath for 10 seconds so that the drug can be absorbed into the lungs. Slowly breathe out.

Use this medication twice daily or as directed by your doctor. The dosage is based on your medical condition and response to therapy.

It is recommended that you use a spacer device with this medication. Ask your doctor or pharmacist for more information.

If 2 or more inhalations/puffs for each dose are prescribed, wait at least 1 minute between them.

If you are using other inhalers at the same time, use them first. Wait several minutes between the use of those inhalers and flunisolide.

To prevent dry mouth, hoarseness, and fungal infection of the mouth, rinse your mouth with water after each use. Do not swallow the rinse water.

Take this medication exactly as prescribed. Follow the dosing schedule carefully. If you have any questions, ask your doctor or pharmacist.

If you have been taking high doses of this medication for a long time, do not suddenly stop taking it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased to reduce symptoms such as extreme tiredness, weakness, weight loss, or nausea. Tell your doctor immediately if any of these symptoms occur after stopping the medication.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Stomach upset, nausea, vomiting, headache, sore throat, stuffy nose, or unpleasant taste in the mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, lightheadedness, shakiness, nervousness, white/sore patches in the mouth or throat, heartburn, loss of appetite, increased appetite, constipation, gas, menstrual period changes (e.g., delayed/irregular/absent periods), stomach/abdominal pain, fast/pounding/irregular heartbeat, unusual weight gain, swelling of the ankles/feet, mental/mood changes (e.g., depression, mood swings, agitation), fever, persistent sore throat, frequent/painful urination, eye pain/discharge, earache, cough, vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using flunisolide inhalation, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to other corticosteroids (e.g., beclomethasone, triamcinolone, prednisone, dexamethasone); or if you have any other allergies.

Though unlikely, it is possible this medication will be absorbed into your bloodstream, especially at higher doses. This may result in worsening of certain conditions. Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated active fungal infections, certain eye diseases (cataracts, glaucoma, herpes of the eye), certain heart problems (e.g., congestive heart failure), high blood pressure, severe liver disease (cirrhosis), kidney disease, underactive thyroid (hypothyroidism), diabetes, stomach/intestinal problems (e.g., diverticulitis, ulcer, ulcerative colitis), brittle bones (osteoporosis), certain muscle/nerve problems (e.g., myasthenia gravis), current infections (e.g., tuberculosis, positive tuberculosis test), other herpes infections (e.g., mouth/genital), HIV, inactive infections (e.g., Ameba, Toxoplasma, Cryptococcus), bleeding problems, history of blood clots, certain mental/mood conditions (e.g., psychosis, anxiety, depression), low salts in the blood (e.g., low potassium or calcium).

If you have switched from an oral corticosteroid (e.g., prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery or injury. Deaths due to low corticosteroid levels have sometimes occurred during such stresses. Tell your doctor immediately if any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) any type of corticosteroid. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress. Consult your doctor or pharmacist now for specific advice about stress situations. You may need to carry a supply of corticosteroid tablets as a precaution.

This drug may rarely make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication or have taken it within the last 12 months.

Do not have immunizations, vaccinations, or skin tests unless specifically directed by your doctor. Avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Avoid exposure to chickenpox or measles infection while taking this medication unless you have previously had these infections (e.g., in childhood). If you are exposed to either of these infections and you have not previously had them, seek immediate medical attention.

If you have diabetes, this drug may rarely make it harder to control your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in children because there is a slight risk that it may temporarily slow down a child's growth rate, but this will probably not affect final adult height. Though this effect is rare with inhaled steroids such as flunisolide, monitor your child's height regularly.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to the unborn baby when the mother was taking other corticosteroids. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using high doses of flunisolide for an extended time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: natalizumab.

If you are currently using this medication, tell your doctor or pharmacist before starting flunisolide.

Though unlikely, it is possible this medication will be absorbed into your bloodstream, especially at higher doses. This may result in certain drug interactions. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aldesleukin, large doses of aspirin and aspirin-like drugs (salicylates), nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen), birth control pills, estrogen hormone replacement, blood thinners (e.g., warfarin), bupropion, drugs for diabetes (e.g., glyburide, insulin, metformin), herbal products (e.g., licorice), drugs for myasthenia gravis (e.g., neostigmine, pyridostigmine), isoniazid, mifepristone, drugs that may cause potassium loss (e.g., amphotericin B, water pills/diuretics such as hydrochlorothiazide or furosemide).

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen) that may increase the risk of stomach bleeding. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This product may interfere with certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood glucose/salt levels, blood counts, height/weight measurements, blood pressure, eye examinations, X-rays, bone density tests) may be performed regularly to monitor your progress or check for side effects if this medication is used for prolonged periods. Consult your doctor for more details.

Lifestyle changes that may help reduce the risk of bone loss (osteoporosis) during long-term therapy include weight-bearing exercise, increasing calcium and vitamin D, stopping smoking and limiting alcohol. Talk with your doctor about lifestyle changes that might benefit you.

If you take this medication for a long time, wear or carry identification stating that you are using it.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Do not store or use near heat or open flame. Avoid storage at temperatures above 120 degrees F (49 degrees C) because this may cause the container to explode. 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 enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised August 2008 Copyright(c) 2008 First DataBank, Inc.