nedocromil (Inhalation route)

ne-DOK-ROE-mil

Commonly used brand name(s):

In the U.S.

• Tilade

Available Dosage Forms:

• Aerosol Powder

Therapeutic Class: Antiasthma

Pharmacologic Class: Mast Cell Stabilizer

Uses For nedocromil

Nedocromil 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) to prevent bronchospasm (wheezing or difficulty in breathing). nedocromil will not help an asthma attack or bronchospasm 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 steroids (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 bronchospasm.

nedocromil was available only with your doctor's prescription.

Inhalation products containing nedocromil were withdrawn from the U.S. market by King Pharmaceuticals on April 30, 2008.

Before Using nedocromil

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 nedocromil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nedocromil 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of nedocromil in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Although appropriate studies on the relationship of age to the effects of nedocromil have not been performed in the geriatric population, no geriatrics-specific problems have been documented to date.

Pregnancy

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 nedocromil. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack—Should not be used in patients with this condition.

Proper Use of nedocromil

Nedocromil is used to help prevent symptoms of asthma or bronchospasm (wheezing or difficulty in breathing). When nedocromil 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 nedocromil. If you do not understand the directions or if you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor 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 finger-widths) 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 buildup 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 (e.g., 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 nedocromil.

Dosing

The dose of nedocromil 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 nedocromil. 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 (inhalation aerosol):
  • For prevention of asthma:
    • Adults and children 6 years of age or older—2 puffs four times a day at regularly spaced times.
    • Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of nedocromil, 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 medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep nedocromil 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 nedocromil

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

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

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

nedocromil Side 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 immediately if any of the following side effects occur:

• Abdominal pain
• body aches or pain
• chills
• congestion
• cough
• dryness or soreness of throat
• ear congestion
• fever
• hoarseness
• increased wheezing, tightness in chest, or difficulty in breathing
• loss of voice
• nasal congestion
• noisy breathing
• runny nose
• shortness of breath
• sneezing
• stuffy nose
• tender, swollen glands in neck
• trouble in swallowing
• unusual tiredness or weakness
• voice changes

• Pain, stiffness, or swelling of joints

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:

• Headache
• nausea or vomiting
• sensation of warmth
• throat irritation
• tremor
• unpleasant taste

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.

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