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Aridol

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Aridol

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Severe Bronchospasm

Mannitol, the active ingredient in ARIDOL (mannitol inhalation powder) , acts as a bronchoconstrictor and may cause severe bronchospasm in susceptible patients. The test 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. Patients should not be left unattended during the bronchial challenge test. Medications and equipment to treat severe bronchospasm must be present in the testing area.

If a patient has a ≥ 10% reduction in FEV1 (from pre-challenge FEV1) on administration of the 0 mg capsule, the ARIDOL (mannitol inhalation powder) bronchial challenge test should be discontinued and the patient should be given a dose of a short acting inhaled beta-agonist and monitored accordingly.

Patients with either a positive response to bronchial challenge testing with ARIDOL (mannitol inhalation powder) or significant respiratory symptoms should receive a short acting inhaled beta-agonist. Subjects should be monitored until fully recovered to within baseline.

Subjects with Co-morbid Conditions

Bronchial challenge testing with ARIDOL (mannitol inhalation powder) should be performed with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL (mannitol inhalation powder) such as 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In 2-year carcinogenicity studies in rats and mice mannitol did not show evidence of carcinogenicity at oral dietary concentrations up to 5% (or 7,500 mg/kg on a mg/kg basis). These doses were approximately 55 and 30 times the MRHDID, respectively, on a mg/m² basis.

Mannitol tested negative in the following assays: bacterial gene mutation assay, in vitro mouse lymphoma assay, in vitro chromosomal aberration assay in WI-38 human cells, in vivo chromosomal aberration assay in rat bone marrow, in vivo dominant lethal assay in rats, and in vivo mouse micronucleus assay.

The effect of inhaled mannitol on fertility has not been investigated.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled clinical studies of mannitol in pregnant women. Bronchial challenge testing with ARIDOL (mannitol inhalation powder) should be performed during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Teratogenic Effects

Mannitol was not teratogenic. Mannitol did not cause any embryofetal malformations when given to pregnant rats and mice at oral doses approximately 20 and 10 times the maximum recommended human daily inhalation dose (MRHDID) in adults, respectively, on a mg/m² basis [see Animal Toxicology and/or Pharmacology].

Labor and Delivery

The effects of a possible hyperresponsiveness reaction on a mother or child during labor or delivery are not known, and therefore bronchial challenge testing with ARIDOL (mannitol inhalation powder) should not be administered during labor or delivery.

Nursing Mothers

It is not known whether mannitol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when mannitol is given to a nursing mother.

Pediatric Use

A total of 246 children and adolescents ages 6 to 17 years were studied in the two clinical trials [see Clinical Studies].

The mean and median maximum percentage reduction in FEV1 in patients with a positive ARIDOL (mannitol inhalation powder) challenge test in children and adolescents 6 to 17 years of age (19% and 18%, respectively) showed no apparent difference compared to the adult population (19% and 18%, respectively).

The safety profile of the ARIDOL (mannitol inhalation powder) bronchial challenge test in children and adolescents 6 to 17 years of age was similar to the adult population in two clinical studies [see ADVERSE REACTIONS].

Bronchial challenge testing with ARIDOL (mannitol inhalation powder) should not be performed in children less than 6 years of age due to their inability to provide reliable spirometric measurements.

Geriatric Use

There was insufficient number of subjects 50 years of age and older in the clinical program. Therefore, the safety and efficacy of bronchial challenge testing with ARIDOL (mannitol inhalation powder) in the older population cannot be adequately assessed. It is unknown whether any differences in the safety and efficacy of bronchial challenge testing with ARIDOL (mannitol inhalation powder) exist between subjects 50 years of age and older and younger subjects.

Hepatic and Renal Impairment

Formal pharmacokinetic studies with mannitol, the active ingredient, in ARIDOL (mannitol inhalation powder) , 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.

Last reviewed on RxList: 10/29/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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