Aridol

What is Aridol?

• Aridol (mannitol) is a sugar alcohol used for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma.

Mannitol structure

Mannitol-3D-balls

What are the uses of this medicine?

• ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma.

Limitations of Use:

• ARIDOL is not a standalone 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.

How does this medicine work?

• The precise mechanisms through which inhaled mannitol causes bronchoconstriction are not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to mannitol or to the gelatin used to make the capsules
• with conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. Some examples include: aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident.

What drug interactions can this medicine cause?

• No studies of interactions of ARIDOL(mannitol) with other drugs have been conducted.

Is this medicine FDA approved?

• Initial U.S. Approval: 1964

How should this medicine be used?

Recommended dosage:

• For Oral Inhalation Use Only
• 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.

Administration:

• 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.
• ARIDOL is a bronchial challenge test kit containing the required capsules of dry powder mannitol for oral inhalation in graduated doses with the supplied single patient use inhaler necessary to perform one bronchial challenge test.
• Do not swallow ARIDOL capsules.
• The airway response to bronchial challenge testing with ARIDOL is measured using forced expiratory volume in one second (FEV1).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation powder: 0mg, 5mg, 10mg, 20mg, and 40mg of mannitol dry powder per capsule in a bronchial challenge test kit

This medicine is available in fallowing brand namesː

• ARIDOL BRONCHIAL CHALLENGE TEST KIT

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• pharyngolaryngeal pain
• throat irritation
• nausea
• cough
• rhinorrhea
• dyspnea
• chest discomfort
• wheezing
• retching
• dizziness

What special precautions should I follow?

• 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.
• Bronchial challenge testing with ARIDOL should be performed 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• bronchospasm

Management of overdosage:

• If such bronchospasm occurs, immediately administer a short-acting inhaled beta-agonist and other medical treatments such as oxygen, as necessary.

Can this medicine be used in pregnancy?

• There are no available human data regarding inhaled mannitol to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of ARIDOL for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma have been established.
• Safety and effectiveness of ARIDOL have not been established in pediatric patients less than 6 years old.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• MANNITOL

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured by: Pharmaxis Ltd 20 Rodborough Rd Frenchs Forest NSW AUSTRALIA

Manufactured for: Methapharm, Inc. West Sample Road, Suite 101 Coral Springs, FL, USA

What should I know about storage and disposal of this medication?

• Store below 77°F (25°C) with excursions permitted between 59°F-86°F (15°C-30°C).
• Do not freeze
• Do not refrigerate.

• Dailymed label info on Aridol
• FDA Aridol

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