Aerobid, Aerobid M (Flunisolide Inhaler)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Aerobid, Aerobid M (Flunisolide Inhaler)

AEROBID® AEROBID-M
(flunisolide) Inhaler System

For oral inhalation only

DRUG DESCRIPTION

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:

AEROBID (flunisolide)  structural formula illustration

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.

What are the possible side effects of flunisolide inhalation (AeroBid, AeroBid-M)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • fast or pounding heartbeats, pain or fluttering in your chest;
  • wheezing or breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • changes in the shape or...

Read All Potential Side Effects and See Pictures of Aerobid, Aerobid M »

What are the precautions when taking flunisolide inhaler (Aerobid, Aerobid M)?

Before using flunisolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as menthol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by...

Read All Potential Precautions of Aerobid, Aerobid M »

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

INDICATIONS

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.

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."

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.

SIDE EFFECTS

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 effects »

DRUG INTERACTIONS

No information provided

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

WARNINGS

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.

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.

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.

OVERDOSE

No information provided

CONTRAINDICATIONS

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.

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

PATIENT INFORMATION

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.

Directions for Use - illustration

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

>

PATIENT INFORMATION

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.

Directions for Use - illustration

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

Disclaimer

Aerobid, Aerobid M Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FLUNISOLIDE - ORAL INHALATION

(floo-NIS-oh-lide)

COMMON BRAND NAME(S): Aerobid

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 USES: 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.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, consult your doctor, pharmacist, or respiratory therapist.

Shake the canister well before each use. Inhale this medication by mouth, usually 2 times a day or as directed by your doctor. Dosage is based on your medical condition and response to treatment.

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

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.

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

Keep track of the number of inhalations used. Discard the canister after using the labeled number of inhalations on the package, even if it feels as though there is medication left in the canister. Follow the instructions for cleaning the mouthpiece. Do not wash the metal canister or put any part of it in water.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens. Ask your doctor what to do if you have worsening cough or shortness of breath, wheezing, increased sputum, or worsening peak flow meter readings. Learn when you can self-medicate and when you should get medical help right away.

If you are regularly using a different corticosteroid taken by mouth (such as prednisone), you should not stop using it unless directed by your doctor. You may have withdrawal symptoms if the drug is suddenly stopped. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication after you are using flunisolide. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. See also Precautions section.

Keep track of how often you need to use your quick-relief inhaler and inform your doctor. If your quick-relief inhaler does not seem to work as well or if you need to use more of your quick-relief inhaler than usual for 2 or more days in a row, seek immediate medical attention.

You may begin to feel this medication working within a week, but it may take 4 weeks before the full benefit of this drug takes effect. Tell your doctor if your condition persists or worsens.

Disclaimer

Aerobid, Aerobid M Consumer (continued)

SIDE EFFECTS: See also Precautions section.

Dry/sore throat, hoarseness, a bad taste in the mouth, headache, or voice changes 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.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as ear pain, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush (yeast infection). Contact your doctor if you notice white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Aerobid, Aerobid M (flunisolide inhaler) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using flunisolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as menthol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Flunisolide may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is not known if flunisolide passes into breast milk and the effect on a nursing infant is unknown. Discuss the risk and benefits with your doctor before breast-feeding

Disclaimer

Aerobid, Aerobid M Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: aldesleukin, other drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy, natalizumab), large doses of aspirin and aspirin-like drugs (salicylates), nonsteroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ibuprofen), mifepristone, quinolone antibiotics (such as ciprofloxacin, levofloxacin), drugs that can cause bleeding/bruising (including "blood thinners" such as warfarin, antiplatelet drugs such as clopidogrel).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This product may interfere with certain lab tests (such as skin 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 poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

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).

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). 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 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised February 2011. Copyright(c) 2011 First Databank, Inc.

Aerobid, Aerobid M Patient Information Including Side Effects

Brand Names: AeroBid, AeroBid-M

Generic Name: flunisolide inhalation (Pronunciation: flew NISS oh lide)

What is flunisolide inhalation (Aerobid, Aerobid M)?

Flunisolide is a steroid. It prevents the release of substances in the body that cause inflammation.

Flunisolide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Flunisolide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of flunisolide inhalation (Aerobid, Aerobid M)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • fast or pounding heartbeats, pain or fluttering in your chest;
  • wheezing or breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
  • worsening asthma symptoms.

Less serious side effects may include:

  • nausea, diarrhea, upset stomach;
  • headache, dizziness;
  • dryness in your mouth, nose, or throat;
  • white patches or sores inside your mouth or on your lips;
  • stuffy nose, sinus pain, sore throat, cough; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Aerobid, Aerobid M (flunisolide inhaler) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about flunisolide inhalation (Aerobid, Aerobid M)?

Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

Side Effects Centers

Aerobid, Aerobid M Patient Information including How Should I Take

What should I discuss with my healthcare provider before using flunisolide inhalation (Aerobid, Aerobid M)?

Before using this medication, tell your doctor if you have been sick or had an infection of any kind (especially tuberculosis). You may not be able to use flunisolide inhalation until you are well.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether flunisolide passes into breast milk or if it could harm a nursing baby. Do not use flunisolide inhalation without telling your doctor if you are breast-feeding a baby.

Flunisolide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child younger than 5 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

How should I use flunisolide inhalation (Aerobid, Aerobid M)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Flunisolide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using flunisolide inhalation. Do not swallow.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

It is important to use flunisolide inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

Store flunisolide inhalation at room temperature away from moisture and heat. Keep the medicine canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot.

Side Effects Centers

Aerobid, Aerobid M Patient Information including If I Miss a Dose

What happens if I miss a dose (Aerobid, Aerobid M)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Aerobid, Aerobid M)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of flunisolide inhalation is not expected to produce life-threatening symptoms.

What should I avoid while using flunisolide inhalation (Aerobid, Aerobid M)?

Steroid medication can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Contact your doctor if you have been exposed to someone with measles or chicken pox.

What other drugs will affect flunisolide inhalation (Aerobid, Aerobid M)?

There may be other drugs that can interact with flunisolide inhalation. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about flunisolide inhalation.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.06. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com