Mannitol

What it is and how it works

Mechanism of Action The precise mechanisms through which inhaled mannitol causes bronchoconstriction are not known.

Indications

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. ARIDOL is a sugar alcohol 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.

Dosage and administration (summary)

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 FEV 1 from baseline or a 10% incremental reduction in FEV 1 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 Bronchial Challenge Test Kit Ove…

Contraindications

is contraindicated in: Patients with known hypersensitivity to mannitol or to the gelatin used to make the capsules Patients 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 [ see Warnings and Precautions ].

Warnings and precautions

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.

Pregnancy

Pregnancy Risk Summary 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.

Storage and supply

How Supplied ARIDOL is a bronchial challenge test kit. Each kit contains one single patient use, dry powder inhaler device and 3 consecutively numbered foil blister packs containing a total of 19 capsules of dry powder mannitol for oral inhalation as described below: Blister pack "1" : Marked 1 - 1 x empty clear capsule printed with two white bands…

Source: Mannitol (Aridol Bronchial Challenge Test Kit) — US FDA prescribing information, 2026-04-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.