Dosing and uses of Aridol (mannitol inhalation)
Adult dosage forms and strengths
dry powder capsules for inhalation
- 0mg, 5mg, 10mg, 20mg, and 40mg per kit
Airway Hyperreactivity Assessment
Indicated for the assessment of bronchial hyperresponsiveness in patients who do not have clinically apparent asthma
Administer sequentially increasing doses via inhalation while measuring forced expiratory volume in 1 second (FEV1)
A positive response is achieved when the patient experiences a 15% reduction in FEV1 from (0 mg) baseline (or a 10% incremental reduction in FEV1 between consecutive doses)
Patients with either a positive response to bronchial challenge testing or significant respiratory symptoms should receive a standard dose of a short-acting inhaled beta-agonist and monitored until fully recovered to within baseline
Sequential doses
- Increased sequential dosing continues until a positive response observed or 635 mg cumulative dose is administered without response (negative test)
- Dose #1: 0 mg
- Dose #2: 5 mg
- Dose #3: 10 mg (cumulative dose 15 mg)
- Dose #4: 20 mg (cumulative dose 35 mg)
- Dose #5: 40 mg (cumulative dose 75 mg)
- Dose #6: 80 mg (cumulative dose 155 mg)
- Dose #7: 160 mg (cumulative dose 315 mg); may repeat this dose if needed 2 more times for a cumulative dose of 635 mg
Pediatric dosage forms and strengths
dry powder capsules for inhalation
- 0mg, 5mg, 10mg, 20mg, and 40mg per kit
Airway Hyperreactivity Assessment
Indicated for the assessment of bronchial hyperresponsiveness in patients who do not have clinically apparent asthma
<6 years: Safety and efficacy not established
6 years or older: As adults
Administer sequentially increasing doses via inhalation while measuring forced expiratory volume in 1 second (FEV1)
A positive response is achieved when the patient experiences a 15% reduction in FEV1 from (0 mg) baseline (or a 10% incremental reduction in FEV1 between consecutive doses)
Patients with either a positive response to bronchial challenge testing or significant respiratory symptoms should receive a standard dose of a short-acting inhaled beta-agonist and monitored until fully recovered to within baseline
Sequential doses
- Increased sequential dosing continues until a positive response observed or 635 mg cumulative dose is administered without response (negative test)
- Dose #1: 0 mg
- Dose #2: 5 mg
- Dose #3: 10 mg (cumulative dose 15 mg)
- Dose #4: 20 mg (cumulative dose 35 mg)
- Dose #5: 40 mg (cumulative dose 75 mg)
- Dose #6: 80 mg (cumulative dose 155 mg)
- Dose #7: 160 mg (cumulative dose 315 mg); may repeat this dose if needed 2 more times for a cumulative dose of 635 mg
Aridol (mannitol inhalation) adverse (side) effects
1-10%
Headache (6%); children (3%)
Pharyngolaryngeal pain (2%); children (4%)
Throat irritation (2%)
Nausea (2%); children (3%)
Cough (2%)
Rhinorrhea (2%)
Dyspnea (1%)
Chest discomfort (1%)
Wheezing (1%)
Retching (1%)
Dizziness (1%)
Warnings
Black box warnings
Mannitol, the active ingredient, acts as a bronchoconstrictor and may cause severe bronchospasm
Bronchial challenge testing with mannitol inhalation is for diagnostic purposes only
Bronchial challenge testing should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm
Medications (eg, short-acting inhaled beta¬ agonist) and equipment to treat severe bronchospasm must be present in the testing area; if severe bronchospasm occurs it should be treated immediately by administration of a short-acting inhaled beta-agonist
Because of the potential for severe bronchoconstriction, the bronchial challenge testing with should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (eg, FEV1 <1-1.5 L or <70% of the predicted values)
Contraindications
Hypersensitivity
Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers (eg, aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction, cerebral vascular accident)
Cautions
Not a stand-alone test or a screening test for asthma; bronchial challenge testing should be used only as part of a physician’s overall assessment of asthma
May cause severe bronchospasm in susceptible patients (see Black box warnings)
If a patient has a 10% or more reduction in FEV1 (from prechallenge FEV1) on administration of the 0 mg capsule, discontinued test administer short-acting inhaled beta-agonist and monitored accordingly
Patients with either a positive response to bronchial challenge testing with or significant respiratory symptoms should receive a short-acting inhaled beta-agonist
Caution with conditions that may increase sensitivity to the bronchoconstricting or other potential effects (eg, 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)
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk, caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Aridol (mannitol inhalation)
Half-Life: 4.7 hr
Absorption: 59%
Vd: 34.3 L
Peak Plasma Time: 1.5 hr
Peak Plasma Concentration: 13 mcg/mL (following 635 mg cumulative dose)
AUC: 73.15 mcg•hr/mL
Protein Bound: %
Metabolism: negligible
Clearance: 5.1 L/hr
Excretion: urine (55%) as unchanged drug
Mechanism of action
Mannitol is a sugar alcohol, and when inhaled may cause bronchoconstriction; the precise mechanism by which bronchoconstriction occurs is unknown
