Aerobid

Name: Aerobid

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.

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), mifepristone.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.

AeroBid Overview

AeroBid is a prescription medication used to treat chronic asthma. AeroBid belongs to a group of drugs called corticosteroids, which help decrease inflammation in the nose.

AeroBid is available as an inhaler and is usually used twice a day.

Common side effects of AeroBid include headache, nausea, and vomiting. 

Side Effects of AeroBid

Common side effects of AeroBid include:

  • headache
  • nausea
  • vomiting
  • upper respiratory infections
  • sore throat
  • cold symptoms
  • nasal congestion
  • diarrhea
  • upset stomach
  • flu
  • unpleasant taste

This is not a complete list of AeroBid side effects. Ask your doctor or pharmacist for more information.

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

Before Using Aerobid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled flunisolide in children. However, safety and efficacy have not been established in children younger than 4 years of age, and this medication is not indicated in children younger than 6 years of age.

Geriatric

Although appropriate studies on the relationship of age to the effects of inhaled flunisolide have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving inhaled flunisolide.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bemiparin
  • Bupropion
  • Nadroparin
  • Pixantrone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack, acute or
  • Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.
  • Bone problems (e.g., osteoporosis) or
  • Cataracts, or history of or
  • Glaucoma, or history of—Use with caution. May make these conditions worse.
  • Chickenpox (including recent exposure) or
  • Herpes simplex (virus) infection of the eye or
  • Infections (virus, bacteria, fungus, parasite), untreated or
  • Measles or
  • Tuberculosis, untreated active or history of—Use with caution. This medicine can reduce the body's ability to fight off these infections.
  • Infection or
  • Stress or
  • Surgery or
  • Trauma—Oral corticosteroids may be needed during these periods. Check with your doctor.

Description

Flunisolide, the active component of Aerobid Inhaler System, is an anti-inflammatory steroid having the chemical name 6α-fluoro-11β, 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.

Indications and usage

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.

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.

For the Consumer

Applies to flunisolide: inhalation aerosol liquid, inhalation aerosol powder

Along with its needed effects, flunisolide (the active ingredient contained in Aerobid) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking flunisolide:

More common
  • Body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • headache
  • hoarseness
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • trouble with swallowing
  • voice changes
Less common
  • Bladder pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody nose
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • chills
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • hives
  • itching
  • joint or muscle pain
  • lower back or side pain
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red, irritated eyes
  • skin rash
  • slow heartbeat
  • sore mouth or tongue
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • swelling
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known
  • Creamy white, curd-like patches in the mouth or throat
  • darkening of the skin
  • discouragement
  • fainting
  • feeling sad or empty
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • loss of strength or energy
  • muscle weakness
  • nausea
  • pain when eating or swallowing
  • trouble concentrating
  • trouble sleeping
  • vomiting

Some side effects of flunisolide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abdominal or stomach fullness
  • acid or sour stomach
  • appetite changes
  • bad, unusual, or unpleasant (after) taste
  • belching
  • blemishes on the skin
  • burning, dry, or itching eyes
  • change in taste
  • constipation
  • cramps
  • difficulty with moving
  • discharge or excessive tearing
  • dizziness or lightheadedness
  • ear pain
  • fear
  • feeling of constant movement of self or surroundings
  • gas
  • headache, severe and throbbing
  • heartburn
  • heavy bleeding
  • indigestion
  • irritability
  • itching of the vagina or genital area
  • loss of smell or taste
  • muscle aching or cramping
  • muscle stiffness
  • pain during sexual intercourse
  • pain in the neck
  • pimples
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • sensation of spinning
  • shakiness
  • skin rash, encrusted, scaly, and oozing
  • stomach discomfort, upset, or pain
  • swollen joints
  • thick, white vaginal discharge with no odor or with a mild odor
  • trouble sitting still
  • trouble sleeping
  • upset stomach

Administrative Information

LactMed Record Number

113

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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