Aridol

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:

• Before doing the bronchial challenge test, your doctor may ask you to perform a breathing or lung test (e.g., spirometry test).
• A nose clip will then be put on your nose so you will only able to breathe in and out of your mouth.
• Place 0 mg capsule into the inhaler. Press the side buttons of the inhaler once to puncture the capsule.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the inhaler just in front of your mouth.
• Open your mouth and breathe in slowly and deeply (like yawning).
• Hold your breath for about 5 seconds, then breathe out slowly before removal of the nose clip.
• You will be asked to repeat the above steps up to 8 times (total of 9 increasing doses of Aridol™). This is to measure the effect of Aridol™ in your lungs.
• Once you have finished the test, you will be given a short-acting inhaler to help you breathe (for patients who have a positive result).
• Throw away the inhaler after using.

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:

• Chest discomfort
• cough
• difficult or labored breathing
• dry heaves
• runny nose
• shortness of breath
• sore throat
• tightness in the chest
• troubled breathing
• vomiting
• wheezing

• Gagging

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

• Dizziness
• nausea
• sore throat

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.

Inhalation powder. One test kit contains dry powder mannitol capsules n graduated doses of 0mg, 5mg, 10mg, 20mg, and 40mg and one single patient use dry powder inhaler device

Severe Bronchospasm

Prior to administration patients should be informed of the potential for bronchial challenge testing with Aridol to cause severe bronchospasm and of the potential symptoms they may experience.

Subjects with Certain Co-morbid Conditions

Bronchial challenge testing with Aridol should be performed with caution in patients having severe cough, ventilatory impairment, spirometry-induced bronchoconstriction, hemoptysis of unknown origin, pneumothorax, recent abdominal or thoracic surgery, recent intraocular surgery, unstable angina, or active upper or lower respiratory tract infection or other conditions that may worsen with the use of a bronchial irritant.