Aerobid, Aerobid M

DRUG DESCRIPTION

Flunisolide, the active component of AEROBID Inhaler System, is an anti-inflammatory steroid having the chemical name 6?-fluoro-11/3, 16?, 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 245C. 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,...

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


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.

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


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)?
  • What are the possible side effects of flunisolide inhalation (Aerobid, Aerobid M)?
  • What is the most important information I should know about flunisolide inhalation (Aerobid, Aerobid M)?
  • What should I discuss with my healthcare provider before using flunisolide inhalation (Aerobid, Aerobid M)?
  • How should I use flunisolide inhalation (Aerobid, Aerobid M)?
  • What happens if I miss a dose (Aerobid, Aerobid M)?
  • What happens if I overdose (Aerobid, Aerobid M)?
  • What should I avoid while using flunisolide inhalation (Aerobid, Aerobid M)?
  • What other drugs will affect flunisolide inhalation (Aerobid, Aerobid M)?
  • Where can I get more information?

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.

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

Do not use flunisolide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

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.

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