Mannitol inhalation (bronchial challenge)
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: RISK OF SEVERE BRONCHOSPASM 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. Bronchial challenge testing with ARIDOL 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 (such as 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 ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV 1 <1-1.5 liters or <70% of the predicted values) [ see Warnings and Precautions ( 5.1 ) ]. 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., FEV 1 <1-1.5 liters or <70% of the predicted values) ( 5.1 )
Dosing in kidney impairment
Hepatic and Renal Impairment Formal pharmacokinetic studies with mannitol, the active ingredient, in ARIDOL, have not been conducted in patients with hepatic or renal impairment. However, an increase in systemic exposure of mannitol can be expected in patients with renal impairment based on the kidney being its primary route of elimination.
Given parenterally, mannitol is used as an osmotic diuretic in a variety of clinical situations including acute renal failure where the osmotic effects of mannitol inhibit the rate of water re-absorption and maintain the rate of urine production.
Preparation and administration
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. See the ARIDOL Bronchial Challenge Test Kit instructions for complete instructions on the dosing and spirometry procedures. a.
A nose clip may be used if preferred. If so, apply nose clip to the patient and direct the patient to breathe through the mouth b. Insert 0 mg capsule into inhalation device. Puncture capsule by depressing buttons on side of device slowly, and ONCE ONLY (a second puncture may fragment the capsules) c. The patient should exhale completely, before inhaling from device in a controlled deep inspiration d.
At the end of deep inspiration, start 60 second timer, subject should hold breath for 5 seconds and exhale through mouth before removal of nose clip e. At the end of 60 seconds, measure the FEV 1 in duplicate (the measurement after inhaling the 0 mg capsule is the baseline FEV 1 ) f. Repeat steps a-e following the mannitol capsule dose steps from Table 1 below until the patient has a positive response or 635 mg of mannitol has been administered (negative test) [See table below.] 8 160 475 4 x 40 mg 9 160 635 4 x 40 mg
Drug interactions
Check mannitol inhalation (bronchial challenge) against a medication listLabel text (1 paragraph)
No formal drug-drug interaction studies were conducted with mannitol, the active ingredient in ARIDOL.
Contraindications
4 CONTRAINDICATIONS 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 ( 5.2 )]. 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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for mannitol inhalation (bronchial challenge). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
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 maximum recommended daily inhalation dose (MRDID) in humans (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively Data Animal Data In animal reproduction studies, oral administration of mannitol to pregnant rats and mice during the period of organogenesis did not cause fetal structural alterations. The mannitol dose in rats and mice was approximately 20 and 10 times the maximum recommended human daily inhalation dose (MRDID) in humans, respectively, (on a mg/m2 basis at maternal doses of 1600 mg/kg/day in both species).
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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