Rx Item-Aridol KIT-Cool Store- by Metha Pharma USA , Clinical Information:
Generic Code And Description: 61391 Mannitol Inhalation Cap With Device 5-10-20-40
Strength: 0 Mg (1)-5 Mg (1)-10 Mg (1)-20 Mg (1)-40 Mg (15)
Dose Form: Capsule With Inhalation Device
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 36700000 Respiratory Function
Active Ingredients: 2272 Mannitol 69658
Inactive Ingredients: Drug Class: Drug Class: 36700000 Respiratory Function
, OMP Family: Waiting for Details, Temparature Zone: 20 Cool-Store Cont Temp, Unit Dose Indicator: NO, Item Size: , Brand Label Flag: BRANDBRAND , Storage Temperature Zone: 20 Cool-Store Cont Temp, Item Size Code: , Item Strength Code: , Item Abbreviation: Aridol , Generic Form: CAP
These highlights do not include all the information needed to use ARIDOL safely and effectively. See full prescribing information for ARIDOL.
ARIDOL® (mannitol inhalation powder) , for oral inhalation use
Bronchial Challenge Test Kit
Initial U.S. Approval: 1964
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)
INDICATIONS AND USAGE
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. (1)
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
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. (2)
The mannitol capsules supplied in the ARIDOL kit are to be used with the single patient use inhaler device (2). 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) (2)
Starting and maximum dose is the same for children (≥6 years old) and adults (2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: 0mg, 5mg, 10mg, 20mg, and 40mg of mannitol dry powder per capsule in a bronchial challenge test kit (2, 3)
CONTRAINDICATIONS
Known hypersensitivity to mannitol or to the gelatin used to make the capsules (4)
Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers (4)
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. (5.1)
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. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. (6.1)
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
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2023
