Flunisolide Oral Inhalation (patient information)

IMPORTANT WARNING

If you are switching (or have recently switched) from an oral corticosteroid such as betamethasone, dexamethasone, methylprednisolone, prednisolone, or prednisone to flunisolide inhalation and have an injury, infection, or severe asthma attack, use a full dose (even if you have been gradually decreasing your dose) of the oral corticosteroid and call your doctor for additional instructions.

Carry an identification card that indicates that you may need to take supplementary doses (write down the full dose you took before gradually decreasing it) of the corticosteroid during periods of stress (injuries, infections, and severe asthma attacks). Ask your pharmacist or doctor how to obtain this card. List your name, medical problems, drugs and dosages, and doctor's name and telephone number on the card.

Why this medication is prescribed

Flunisolide, a corticosteroid, is used to prevent wheezing, shortness of breath, and troubled breathing caused by severe asthma and other lung diseases.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How this medication should be used

Flunisolide comes as an aerosol to inhale by mouth. It usually is inhaled three or four times a day at evenly spaced intervals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use flunisolide exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not stop using flunisolide without talking to your doctor.

Before you use flunisolide the first time, read the written instructions that come with it. Ask your doctor, pharmacist, or respiratory therapist to demonstrate the proper technique. Practice using the inhaler while in his or her presence.

To use the inhaler, follow these steps:

1. Shake the inhaler well.
2. Remove the protective cap.
3. Exhale (breathe out) as completely as possible through your nose while keeping your mouth shut.
4. Open Mouth Technique: Open your mouth wide, and place the open end of the mouthpiece about 1-2 inches from your mouth.Closed Mouth Technique: Place the open end of the mouthpiece well into your mouth, past your front teeth. Close your lips tightly around the mouthpiece.
5. Take a slow, deep breath through the mouthpiece and, at the same time, press down on the container to spray the medication into your mouth. Be sure that the mist goes into your throat and is not blocked by your teeth or tongue. Adults giving the treatment to young children may hold the child's nose closed to be sure that the medication goes into the child's throat.
6. Hold your breath for 5-10 seconds, remove the inhaler, and exhale slowly through your nose or mouth. If you take 2 puffs, wait 2 minutes and shake the inhaler well before taking the second puff.
7. Replace the protective cap on the inhaler.After each treatment, rinse your mouth with water or mouthwash.

If you have difficulty getting the medication into your lungs, a spacer (a special device that attaches to the inhaler) may help; ask your doctor, pharmacist, or respiratory therapist.

Special precautions

Before using flunisolide:

• tell your doctor and pharmacist if you are allergic to flunisolide or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are using, especially arthritis medications, aspirin, digoxin (Lanoxin), diuretics ('water pills'), estrogen (Premarin), ketoconazole (Nizoral), oral contraceptives, phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), theophylline (Theo-Dur), and vitamins.
• if you have a fungal infection (other than on your skin), do not use flunisolide without talking to your doctor.
• tell your doctor if you have or have ever had liver, kidney, intestinal, or heart disease; diabetes; an underactive thyroid gland; high blood pressure; mental illness; myasthenia gravis; osteoporosis; herpes eye infection; seizures; or ulcers.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using flunisolide, call your doctor.
• if you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit your consumption of alcoholic beverages while using this drug. Flunisolide makes your stomach and intestines more susceptible to the irritating effects of alcohol, aspirin, and certain arthritis medications. This effect increases your risk of ulcers.

Special dietary instructions

Your doctor may instruct you to follow a low-sodium, low-salt, potassium-rich, or high-protein diet. Follow these directions.

What to do if you forget a dose

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Side effects

Minor side effects

Flunisolide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry or irritated throat and mouth
• cough
• difficult or painful speech

Severe side effects

If you experience any of the following symptoms, call your doctor immediately:

• skin rash
• increased difficulty breathing
• white spots or sores in your mouth
• swollen face, lower legs, or ankles
• vision problems
• cold or infection that lasts a long time
• muscle weakness

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. Avoid puncturing the aerosol container, and do not discard it in an incinerator or fire.

Other information

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to flunisolide.

Flunisolide is not used for rapid relief of breathing problems. If you do not have another inhaler for prompt relief of breathing difficulty, ask your doctor to prescribe one.

If your doctor has prescribed a bronchodilator (a drug to be inhaled for rapid relief of difficult breathing), use it several minutes before you use your flunisolide inhaler so that flunisolide can reach deep into your lungs.

Avoid exposure to chicken pox and measles. This drug makes you more susceptible to these illnesses. If you are exposed to them while using flunisolide, call your doctor. Do not have a vaccination or other immunization unless your doctor tells you that you may.

Report any injuries or signs of infection (fever, sore throat, pain during urination, and muscle aches) that occur during treatment.

If your sputum (the matter you cough up during an asthma attack) thickens or changes color from clear white to yellow, green, or gray, call your doctor; these changes may be signs of an infection.

Inhalation devices require regular cleaning. Once a week, remove the drug container from the plastic mouthpiece, wash the mouthpiece with warm tap water, and dry it thoroughly.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• AeroBid® Inhaler System
• AeroBid-M® Inhaler System