Flunisolide (Inhalation)

Flunisolide is used to help manage asthma symptoms and improve how your lungs work. This medicine will not stop an asthma attack that is already happening.

Flunisolide is part of a group of medicines called corticosteroids (cortisone-like medicines). It works by stopping inflammation (swelling) in the lungs that leads to an asthma attack.

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

It is very important for your doctor to check how you or your child are doing at regular visits. This helps ensure that this medicine is working well and to look out for any unwanted effects it may cause.

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

You or your child should not use this medicine if an asthma attack has already started or if there is already a severe asthma attack. Your doctor may prescribe a different medicine (e.g., a short-acting inhaler) to use during an acute asthma attack. Call your doctor right away for instructions.

This medicine may cause a fungus infection in the mouth or throat (thrush). Tell your doctor immediately 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 around someone with chickenpox or measles.

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

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

Using too much of this medicine or using it for a long time may increase your risk of having problems with your adrenal glands. Talk to your doctor if you or your child have more than one of these symptoms while 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 lower bone mineral density when used for a long time. Low bone mineral density can lead to weak bones or osteoporosis. If you have questions about this, ask your doctor.

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

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

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

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a choice you and your doctor will make together. For this medicine, the following should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems in children that would limit the usefulness of inhaled flunisolide. However, safety and effectiveness have not been established in children younger than 4 years old, and this medication is not recommended for children younger than 6 years old.

Geriatric

While studies on the effects of inhaled flunisolide in older adults have not been conducted, no specific problems for this age group have been reported so far. However, elderly patients are more likely to have age-related liver, kidney, or heart issues, which may require caution when using inhaled flunisolide.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this medicine, it is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change some of the other medicines you are taking.

• Desmopressin

Using this medicine with any of the following medicines is usually not advised, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

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

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medications may be the best option for you. If both are prescribed together, your doctor may change the dose or frequency for one or both medicines.

• Auranofin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Acute asthma attack
• Acute bronchospasm (difficulty breathing) — This medicine should not be used in patients with these conditions.

• Bone problems (e.g., osteoporosis) or
• Cataracts, or a history of or
• Glaucoma, or a history of — Use with caution. This medicine may worsen these conditions.

• Chickenpox (including recent exposure) or
• Herpes simplex (eye infection) or
• Untreated infections (virus, bacteria, fungus, parasite) or
• Measles or
• Untreated active tuberculosis or a history of — Use with caution. This medicine can lower the body's ability to fight off these infections.

• Infection or
• Stress or
• Surgery or
• Trauma — Oral corticosteroids may be necessary during these times. Check with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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.

In the U.S.

• Aerobid
• Aerobid-M
• Aerospan

Available Dosage Forms:

• Aerosol Powder

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

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.