Aridol Mannitol Capsules for oral inhalation

Aridol®(mannitol inhalation powder) Bronchial Challenge Test Kit 

Welcome to the U.S. Homepage for Aridol®(mannitol inhalation powder) Bronchial Challenge Test Kit

ARIDOL®was approved by the U.S. Food and Drug Administration on October 5, 2010 and is now commercially available.

ARIDOL® is used for the assessment of bronchial hyperresponsivesness in patients six years of age or older who do not have clinically apparent asthma.  ARIDOL® is not a stand alone test or a screening test for asthma.  Bronchial challenge testing with ARIDOL® should be used only as part of a physician’s overall assessment of asthma. 

ARIDOL® is a single-use, indirect test that is easy-to-administer, accurate and reproducible and requires minimal preparation and administration time.

The ARIDOL® test requires patients to inhale increasing doses of dry powder mannitol from a hand-held device, which causes airways to narrow and contract when airway inflammation is present.  The doses are contained in capsules that are administered at one-minute intervals until a positive response is achieve or until all the capsules have been inhaled, indicating a negative result.  A positive response is indicated when there is a 15% reduction in FEV1 from baseline or a 10% incremental reduction in FEV1 between doses.   

ARIDOL® is manufactured by Pharmaxis Ltd (Frenchs Forest, Sydney Australia) and marketed by Pharmaxis, Inc. (Exton, PA).  ARIDOL® is approved for use in 19 countries, including Australia, major European countries and Korea, and has been used by more than 96,000 patients worldwide.  

ARIDOL® is included in official international guidelines for the clinical assessment of asthma including the International Olympic Committee Medical Commission’s Independent Panel on Asthma, the US Asthma Management Guidelines, the Global Initiative for Asthma (GINA) Report on Global Strategy for Asthma Management and Prevention and the Australian Asthma Management Handbook. 

For more detailed product information please refer to the Product Information and United States (PI & Test Kit Instructions) pages.

ABOUT ARIDOL®

Indication

Mannitol, the active ingredient in ARIDOL®, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma. 

 

ARIDOL® is not a stand alone test or a screening test for asthma.  Bronchial challenge testing with ARIDOL® should be used only as part of a physician’s overall assessment of asthma.


ARIDOL® is contraindicated in patients with known hypersensitivity to mannitol, the active ingredient in ARIDOL, or to the gelatin used to make the capsules.  The product is also contraindicated for patients with medical conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers.

Bronchial challenge testing with ARIDOL® should not be performed in children less than 6 years of age due to their inability to provide reliable spirometric measurements.

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 low  er respiratory tract infection that may worsen with use of a bronchial irritant.

The most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness.  No formal drug-drug interaction studies have been conducted with ARIDOL®.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. 

Visit www.FDA.gov/medwatch or call 1-800-FDA-1088

For more information about Aridol™ please contact:

Pharmaxis Inc
One East Uwchlan Avenue

Suite 405

Exton, PA 19341
Telephone: 1-888-416-1828
Fax:  610-363-5926
Email: usa.info@pharmaxis.com

US-A-11-10-060

 

For information about ARIDOL®, please call one of our Regional Customer Specialists at:  1-888-416-1828

To report SUSPECTED ADVERSE REACTIONS, contact Pharmaxis, Inc. at 1-888-659-6396 or email at adverse.events@pharmaxis.com.au

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

WARNING: RISK OF SEVERE BRONCHOSPASM
See full prescribing information for complete boxed warning.  Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Only trained professionals under the supervision of a physician who are familiar with the management of acute bronchospasm should perform bronchial challenge testing with ARIDOL. Medications (such as short acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. Because of the potential for severe bronchoconstriction, bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV1<1-1.5 liters or <70% of the predicted values) (5.1)

Manufactured for:           Pharmaxis Inc.
One East Uwchlan Avenue, Suite 405
Exton, PA 19341
610-363-5120

Customer Service: 888-416-1828

Manufactured by Pharmaxis Ltd
2/10 Rodborough Road
Frenchs Forest NSW 2086
www.pharmaxis.com.au

Aridol is a registered trademark of Pharmaxis Ltd.

Phamaxis