Test kit

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. 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. …

• 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 Overview 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 (FEV 1 )
• Prior to bronchial challenge testing with ARIDOL, standard spirometry should be performed and the reproducibility of the resting FEV 1 established
• Administration Instructions An overview of the testing procedure can be found below
• The ARIDOL bronchial challenge test should only be used with the provided inhaler
• All remaining unused (opened and unopened) blister packs and the inhaler should be properly discarded at the completion of the test. …

Inhalation powder: 0 mg, 5 mg, 10 mg, 20 mg, and 40 mg of mannitol dry powder per capsule in 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 mannitol for oral inhalation as described below: Blister pack "1" : Marked 1 - 1 x empty clear capsule printed with two w …

• 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
• The use of ARIDOL for this indication is supported by evidence from two clinical studies that included 246
• Pediatric patients 6 to 17 years of age [ see Clinical Studies ]. …

Clinical studies of ARIDOL did not include sufficient numbers of patients 50 years of age and older to determine whether they respond differently from younger adult patients.

• 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 [see Warnings and Precautions ]
• Patients 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 …

• ARIDOL 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 ]. …

No formal drug-drug interaction studies were conducted with mannitol, the active ingredient in ARIDOL.

& 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. …

The following clinically significant adverse reaction is described elsewhere in the labeling: • Severe Bronchospasm [ see Warnings and Precautions ( 5.1 )]. 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. …

8.1 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. Based on animal reproduction studies, no evidence of structural alterations was observed when mannitol was orally administered to pregnant rats and mice during organogenesis at doses up to approximately 20 and 10 times, respectively, the maximu …

Susceptible persons may experience excessive bronchospasm from an overdosage. If such bronchospasm occurs, immediately administer a short-acting inhaled beta-agonist and other medical treatments such as oxygen, as necessary.

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.