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:
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:
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.
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 this medicine. 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 this medicine. Gargling and rinsing the mouth after each dose may help prevent these effects.
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 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:
To use the inhaler:
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:
To clean the inhaler:
For patients using nedocromil regularly (e.g., every day):
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.
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.
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 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.
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
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.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
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). This medicine 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.
This medicine 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.