Pronunciation:

floo-NIS-oh-lide

Brand Names:

• Aerobid
• Aerobid-M
• Aerospan

Dosage Forms:

• Aerosol Powder

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Flunisolide is used to help control symptoms of asthma and improve lung function. This medicine will not relieve an asthma attack that has already started.

Flunisolide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

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.

Other 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.

• Aspirin
• Bemiparin
• Bupropion
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin

Other interactions—

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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits, to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine.

If your symptoms do not improve within 2 to 4 weeks or if they become worse, call your doctor.

You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

Do not change your doses or stop using this medicine without asking first your doctor.

Your doctor may want you to carry a medical identification card stating that you or your child are using this medicine and that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think this is a problem.

Check with your doctor right away if you or your child have blurred vision, difficulty with reading, or any other change in vision while using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are have a cough, difficulty with breathing, shortness of breath, or wheezing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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.