Nedocromil oral inhalation (patient information)

Why is this medication prescribed

Nedocromil is used to prevent the wheezing, shortness of breath, and troubled breathing caused by asthma. It works by preventing the release of substances that cause inflammation (swelling) in the air passages of the lungs.

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

How should this medicine be used

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

It may take up to 4 weeks for nedocromil to work. You should take it regularly for it to be effective. If your symptoms have not improved after 4 weeks, tell your doctor.

Nedocromil is used with a special inhaler. Before you use nedocromil inhalation for the first time, read the instructions for your device. Ask your doctor, pharmacist, or respiratory therapist to demonstrate the proper technique. Practice using the inhalation device while in his or her presence.

To use the inhaler, follow these steps:

• Shake the inhaler well.
• Remove the protective cap.
• Exhale (breathe out) as completely as possible through your nose while keeping your mouth shut.
• 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.
• 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.
• 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.
• Replace the protective cap on the inhaler.

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.

What special precautions should I follow

Before using nedocromil

• tell your doctor and pharmacist if you are allergic to nedocromil or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are using, including vitamins.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using nedocromil, call your doctor.

What should I do if I 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

Mild side effects

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

• sore throat
• bad taste in the mouth
• stomach pain
• cough
• stuffy nose
• itching or burning nasal passages
• sneezing
• headache

Severe side effects

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

• wheezing
• increased difficulty breathing

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].

What storage conditions are needed for this medicine

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.

What other information should I know

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

Do not use nedocromil to relieve an asthma attack that has already started; continue to use the medication prescribed for your acute attacks.

To relieve dry mouth or throat irritation caused by nedocromil inhalation, rinse your mouth with water, chew gum, or suck sugarless hard candy after each treatment.

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. Follow the written instructions for care of other inhalation devices.

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

Brand names

• Tilade® Inhaler