Mannitol acts as a bronchoconstrictor and may cause severe bronchospasm. Mannitol bronchial challenge testing is for diagnostic purposes only and should be conducted only by trained professionals under a physician familiar with the test and management of acute bronchospasm (ie, testing area equipped with appropriate medications and equipment). Immediately administer a short-acting inhaled beta-agonist in the event of severe bronchospasm. Do not perform bronchial challenge testing with mannitol in a patient with asthma or very low baseline pulmonary function tests (eg, FEV1 less than 1 to 1.5 L or less than 70% of the predicted values) .
Mannitol inhalation is used in patients 6 years of age and older to help diagnose asthma. It is used in a procedure called bronchial challenge test to help your doctor measure the effect of this medicine on your lungs and check if you have difficulty with breathing.
This medicine is to be given only by or under the immediate supervision of your doctor.
In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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 pediatric-specific problems that would limit the usefulness of mannitol inhalation in children 6 years of age and older. However, mannitol inhalation should not be given to children younger than 6 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of mannitol inhalation in the geriatric population. Safety and efficacy have not been established.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Receiving this diagnostic test with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:
Inhaled mannitol is used with a special inhaler which will measure the effect of this medicine on your lungs. It is given by a doctor or other trained health professional who will be with you during the test. After you have completed the test, your doctor will know the result right away (positive or negative for asthma).
Aridol™ is a test kit containing one single patient use inhaler and 3 blister packs containing 19 capsules of mannitol for inhalation in marked doses to perform one bronchial challenge test.
Do not put the capsules in your mouth or swallow them.
To perform the test:
Your doctor will check you closely while doing the bronchial challenge test. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.
This medicine may cause severe bronchospasm. Tell your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after receiving this medicine. Your doctor will give you a short-acting inhaler right away to treat your symptoms.
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 or nurse 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.