In the U.S.—

In Canada—

• Anti-inflammatory, nonsteroidal (inhalation)
• antiallergic (inhalation)
• asthma prophylactic

Nedocromil (ne-DOK-roe-mil ) is used to prevent the symptoms of asthma. When it is used regularly, nedocromil lessens the number and severity of asthma attacks by reducing inflammation in the lungs. Nedocromil is also used just before exposure to conditions or substances (for example, allergens, chemicals, cold air, or air pollutants) that cause reactions, to prevent bronchospasm (wheezing or difficulty in breathing). In addition, nedocromil is used to prevent bronchospasm following exercise. This medicine will not help an asthma or bronchospasm attack that has already started.

Nedocromil may be used alone or with other asthma medicines, such as bronchodilators (medicines that open up narrowed breathing passages) and corticosteroids (cortisone-like medicines).

Nedocromil works by acting on certain inflammatory cells in the lungs to prevent them from releasing substances that cause asthma symptoms and/or bronchospasm.

This medicine is available only with your doctor's prescription, in the following dosage form:

Inhalation
• Inhalation aerosol (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nedocromil, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to nedocromil or to any other inhalation aerosol medicine.

Pregnancy—Nedocromil has not been studied in pregnant women. However, nedocromil has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether nedocromil passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Nedocromil has been tested in children 6 years of age and older. In effective doses, it is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way they do in younger adults. Although there is no specific information comparing use of nedocromil in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Nedocromil is used to help prevent symptoms of asthma or bronchospasm (wheezing or difficulty in breathing). When this medicine is used regularly, it decreases the number and severity of asthma attacks. Nedocromil will not relieve an asthma or bronchospasm attack that has already started.

Nedocromil inhalation aerosol usually comes with patient directions. Read them carefully before using this medicine. If you do not understand the directions or if you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

The nedocromil aerosol canister provides 104 inhalations for the inhaler that is available in the U.S. or 112 inhalations for the Canadian inhaler. You should keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike other aerosol canisters, cannot be floated in water to test its fullness.

When you use the inhaler for the first time, or if you have not used it for more than seven days, the inhaler may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it to make sure it provides the correct dose.

To prime the inhaler:

• Insert the metal canister firmly into the clean mouthpiece according to the manufacturer's instructions. Check to make sure the canister is placed properly into the mouthpiece.
• Take the cover off the mouthpiece and shake the inhaler well.
• Hold the canister well away from you against a light background, and press the top of the canister, spraying the medicine one time into the air. Repeat this two more times for a total of three sprays. If the inhaler is working properly, a fine mist will be sprayed from the mouthpiece.

To use the inhaler:

• Using your thumb and one or two fingers, hold the inhaler upright with the mouthpiece end down and pointing toward you.
• Take the cover off the mouthpiece. Check the mouthpiece for any foreign objects. Do not use the inhaler with any other mouthpieces.
• Gently shake the inhaler three or four times.
• Hold the mouthpiece away from your mouth and breathe out slowly and completely to the end of a normal breath.
• Use the inhalation method recommended by your doctor.
  • Open-mouth method: Place the mouthpiece about 1 to 2 inches (2 fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so the spray does not hit the roof of your mouth or your tongue. Close your eyes just before spraying to keep the spray out of your eyes.
  • Closed-mouth method: Place the mouthpiece in your mouth between your teeth and over your tongue with your lips closed tightly around it. Make sure your tongue or teeth are not blocking the opening.
• Tilt your head back a little. Start to breathe in slowly and deeply through your mouth and, at the same time, press the top of the canister once to get one puff of medicine. Continue to breathe in slowly for 3 to 4 seconds until you have taken a full breath. It is important to press down on the canister and breathe in slowly at the same time so the medicine is pulled into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
• Hold your breath as long as you can for up to 10 seconds (count slowly to 10). This gives the medicine time to get into your airways and lungs.
• Take the mouthpiece away from your mouth and breathe out slowly.
• If your doctor has told you to inhale more than one puff of medicine at each dose, wait 1 minute between puffs. Then, gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff. Breathe in only one puff at a time.
• If your doctor has told you to use an inhaled bronchodilator before using nedocromil, you should wait at least 2 minutes after using the bronchodilator before using nedocromil. This allows the nedocromil to get deeper into your lungs.
• When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.
• Keep track of the number of sprays you have used by noting each one on the chart provided with the inhaler. The inhaler should be discarded once 104 sprays have been used. Even though the inhaler may not be empty after 104 sprays, the dose may be inaccurate so you may not receive the correct amount of medicine.

Your doctor may want you to use a spacer device with the inhaler. A spacer makes the inhaler easier to use. It allows more of the medicine to reach your lungs and helps make sure that less of it stays in your mouth and throat.

To use a spacer device with the inhaler:

• Attach the spacer to the inhaler according to the manufacturer's directions. There are different types of spacers available, but the method of breathing remains the same with most spacers.
• Gently shake the inhaler and spacer three or four times.
• Hold the mouthpiece of the spacer away from your mouth and breathe out slowly to the end of a normal breath.
• Place the mouthpiece into your mouth between your teeth and over your tongue with your lips closed around it.
• Press down on the canister top once to release one puff of medicine into the spacer. Then, within one or two seconds, begin to breathe in slowly and deeply through your mouth for 5 to 10 seconds. Count the seconds while inhaling. Do not breathe in through your nose.
• Hold your breath as long as you can for up to 10 seconds (count slowly to ten).
• Breathe out slowly. Do not remove the mouthpiece from your mouth. Breathe in and out slowly two or three times to make sure the spacer device is emptied.
• If your doctor has told you to take more than one puff of medicine at each dose, wait a minute between puffs. Then, gently shake the inhaler and spacer again and take the second puff, following exactly the same steps you used for the first puff.
• When you have finished, remove the spacer device from the inhaler and replace the cover of the mouthpiece.

To clean the inhaler:

• Clean the inhaler often to prevent build-up of medicine and blocking of the mouthpiece. The mouthpiece can be washed every day and should be washed at least twice a week.
• Remove the metal canister from the inhaler and set it aside. Do not get the canister wet.
• Wash the mouthpiece in hot water.
• Shake off the excess water and let the mouthpiece air dry completely before replacing the metal canister and cover.

For patients using nedocromil regularly (for example, every day):

• In order for nedocromil to work properly, it must be inhaled every day in regularly spaced doses as ordered by your doctor .
• Usually about 2 to 4 weeks may pass before you begin to feel the full effects of this medicine.

Missed dose—

If you are using nedocromil regularly and you miss a dose of this medicine, take it as soon as possible. Then take any remaining doses for that day at regularly spaced times.

Dosing—

The dose of nedocromil will be different for different patients. Follow your doctor's orders or the directions on the label. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. The following information includes only the average doses of nedocromil. If your dose is different, do not change it unless your doctor tells you to do so:

• For inhalation dosage form (inhalation aerosol):
  • For prevention of asthma symptoms:
    • Adults and children 6 years of age or older—3.5 or 4 milligrams (mg) (2 puffs) two to four times a day at regularly spaced times.
    • Children up to 6 years of age—Use and dose must be determined by the doctor.
  • For prevention of bronchospasm caused by exercise or a substance:
    • Adults and children 12 years of age or older—4 mg (2 puffs) as a single dose up to thirty minutes before exercise or exposure to any condition or substance that may cause an attack.
    • Children up to 12 years of age—Use and dose must be determined by the doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct sunlight.
• Keep the medicine from freezing.
• Do not puncture, break, or burn the aerosol container, even if it is empty.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
• Always keep the dust cover on the mouthpiece when the inhaler is not in use.
• Store container at room temperature before use for best results.

If your symptoms do not improve within 2 to 4 weeks, check with your doctor. Also, check with your doctor if your condition becomes worse .

You may also be taking a corticosteroid or a bronchodilator for asthma along with this medicine. Do not stop taking the corticosteroid or bronchodilator even if your asthma seems better, unless you are told to do so by your doctor.

Throat irritation and/or an unpleasant taste may occur after you use this medicine. Gargling and rinsing the mouth after each dose may help prevent these effects.

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 as soon as possible if any of the following side effects occur:

• Less common
  • Abdominal pain;  increased wheezing, tightness in chest, or difficulty in breathing 
  
  

• Rare
  • Pain, stiffness, or swelling of joints;  signs of infection, such as fever, sore throat, body aches, or chills 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common or rare
  • Cough;  headache;  nausea or vomiting;  runny or stuffy nose;  sensation of warmth;  throat irritation ;  tremor 
  
  

After you use nedocromil inhalation aerosol, you may notice an unpleasant taste. This may be expected and will usually go away after a while.

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