Aridol

• Severe bronchospasm: Aridol may cause severe bronchospasm in susceptible patients. Administer by trained professionals under the supervision of a physician. Medications and equipment to treat severe bronchospasm must be present in the testing area.
• Subjects with co-morbid conditions: Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of Aridol such as: severe cough, ventilatory impairment, unstable angina, or active upper or lower respiratory tract infection that may worsen with use of a bronchial irritant.

Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness.

To report SUSPECTED ADVERSE REACTIONS, contact Methapharm, Inc. at 1-866-701-4636 or email at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Oral Inhalation Use Only

• One Aridol test kit contains dry powder mannitol capsules in graduated doses and a single patient use inhaler necessary to perform one bronchial challenge test.
• The mannitol capsules supplied in the Aridol kit are to be used with the single patient use inhaler device. Discard the inhaler after use.
• Capsule contents are to be inhaled in increasing dosage until either a positive response (15% reduction in FEV1 from baseline or a 10% incremental reduction in FEV1 between consecutive doses) is achieved or all capsules are inhaled (maximum total dose 635mg)
• Starting and maximum dose is the same for children (≥ 6 years old) and adults

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

• Known hypersensitivity to mannitol or to the gelatin used to make the capsules
• Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers

No formal drug-drug interaction studies have been conducted with Aridol

Pregnancy and Breastfeeding

It is not known if Aridol can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is also not known if Aridol passes into breast milk. Talk to your doctor if you are breastfeeding or plan to breastfeed.

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.