Aerobid

AeroBid is a prescription medication used to treat chronic asthma.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

This section provides information on the proper use of a number of products that contain flunisolide. It may not be specific to Aerobid. Please read with care.

This medicine is used with a special inhaler and comes with patient information leaflet. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

When you use the inhaler for the first time, or if you have not used it for more than 2 weeks, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine two times into the air away from the face.

How to use this medicine:

• The inhaler contains a built-in spacer. Do not separate the purple actuator from the gray spacer. Do not use this medicine with other spacer or holding chamber devices.
• Open and position the inhaler by pulling the built-in purple actuator out from the gray spacer and snap into an "L" shape before using it.
• The first time you use the inhaler, or if you have not used the inhaler for 2 weeks or longer, prime the inhaler before use by shaking it well and then releasing a test spray away from your eyes and face. Press down on the metal canister two times for one second each in order to release 2 test sprays into the air.
• To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright. Do not block the mouthpiece with your teeth or tongue.
• While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• After 10 seconds, breathe out and breathe normally.
• If your doctor has prescribed 2 or more sprays at each use, wait for 20 seconds, and follow exactly the same steps you used for the first puff.
• Snap the purple actuator back to the straight position and gently push it back into the gray spacer.
• Gargle and rinse your mouth with water after each dose. You may also want to brush your teeth.

Each inhaler comes with a Check-Off chart to track the number of puffs you have used. Mark off or check through each of your doses. Before you reach the last number of sprays, call your doctor to find out if you need a refill. You must discard the inhaler, actuator, and spacer after 60 sprays even if the canister is not empty. Do not place the canister under water to find out the amount of medicine still left in the canister.

If you are also taking oral corticosteroids (e.g., prednisone) together with this medicine, you doctor may want to adjust your dose of prednisone. Ask your doctor first before changing your dose.

Dosing

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

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

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

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine 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:

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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

For oral inhalation only

Rxonly

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, wheezing1   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. 1 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.

Applies to flunisolide: compounding powder, inhalation aerosol, inhalation aerosol with adapter

General

The most commonly reported adverse reactions include pharyngitis, rhinitis, headache, sinusitis, and increased cough.[Ref]

Respiratory

Very common (10% or more): Pharyngitis (up to 17.5%), rhinitis (up to 15.7%)
Common (1% to 10%): Increased cough, sinusitis, epistaxis, bronchitis, laryngitis, voice alteration, cold symptoms, nasal congestion, sinus drainage, sinus infection, sneezing, sputum, wheezing, bronchospasm, dyspnea, head stuffiness, nasal irritation, sinus discomfort, sore throat, dry throat[Ref]

Gastrointestinal

Common (1% to 10%): Vomiting, dyspepsia, abdominal pain, diarrhea, gastroenteritis, nausea, oral moniliasis, upset stomach, heartburn, constipation, gas, abdominal fullness, glossitis, mouth irritation, phlegm[Ref]

Nervous system

Very common (10% or more): Headache (up to 13.8%)
Common (1% to 10%): Migraine, taste perversion, weakness, numbness, hyperactivity[Ref]

Musculoskeletal

Common (1% to 10%): Neck pain, myalgia
Frequency not reported: Decreased bone mineral density; reduction in growth velocity[Ref]

Ocular

Common (1% to 10%): Blurred vision, eye discomfort, eye infection
Frequency not reported: Glaucoma, increased intraocular pressure, cataracts[Ref]

Dermatologic

Common (1% to 10%): Erythema multiforme, sweating, eczema, pruritus, acne, urticaria

Cardiovascular

Common (1% to 10%): Chest pain, edema, palpitations, tachycardia, hypertension[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, dysmenorrhea, vaginitis[Ref]

Hematologic

Common (1% to 10%): Enlarged lymph nodes, capillary fragility[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Decreased appetite, increased appetite, weight gain[Ref]

Other

Common (1% to 10%): Ear pain, chills, malaise, vertigo, fatigue, loss of smell, ear infection[Ref]

Psychiatric

Common (1% to 10%): Insomnia, irritability, shakiness, anxiety, depression, moodiness, hypoactivity[Ref]

Some side effects of Aerobid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.