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Mannitol (Oral Inhalation)

Pronunciation

(MAN i tole)

Index Terms

  • D-Mannitol

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Kit, Inhalation:

Aridol: [DSC]

Brand Names: U.S.

  • Aridol [DSC]

Pharmacologic Category

  • Diagnostic Agent

Pharmacology

The mechanisms of bronchoconstriction are unknown.

Distribution

34.3 L (based on IV administration)

Metabolism

Minimally hepatic to glycogen

Excretion

Urine (~55% to 87% as unchanged drug)

Time to Peak

Plasma: Inhaled: 1.5 hours

Half-Life Elimination

Terminal: 4.7 hours

Use: Labeled Indications

Assessment of bronchial hyper-responsiveness: For the assessment of bronchial hyper-responsiveness in patients 6 years and older who do not have clinically apparent asthma.

Contraindications

Hypersensitivity to mannitol, gelatin, or any component of the formulation; conditions that may be compromised by induced bronchospasm or repeated spirometry (eg, aortic or cerebral aneurysm, uncontrolled hypertension, recent MI or cerebral vascular accident)

Dosing: Adult

Assessment of bronchial hyper-responsiveness: Inhalation: Administer in a stepwise fashion (measuring FEV1 in duplicate after each administration) until the patient has a positive response or 635 mg of mannitol has been administered (whichever comes first).

Positive test: 15% reduction in FEV1 from baseline or 10% incremental reduction in FEV1 between consecutive doses

Negative test: Administration of full dose (635 mg) without reduction in FEV1 sufficient to meet criteria for a positive test

Administration should be as follows:

Stepwise Administration Schedule

Dose #

Dose (mg)

Cumulative Dose (mg)

Capsules/Dose

1

0

0

1

2

5

5

1

3

10

15

1

4

20

35

1

5

40

75

1

6

80

155

2 x 40 mg caps

7

160

315

4 x 40 mg caps

8

160

475

4 x 40 mg caps

9

160

635

4 x 40 mg caps

Table has been converted to the following text.

Stepwise Administration Schedule:

Dose 1: 0 mg (1 capsule/dose); Cumulative dose: 0 mg

Dose 2: 5 mg (1 capsule/dose); Cumulative dose: 5 mg

Dose 3: 10 mg (1 capsule/dose); Cumulative dose: 15 mg

Dose 4: 20 mg (1 capsule/dose); Cumulative dose: 35 mg

Dose 5: 40 mg (1 capsule/dose); Cumulative dose: 75 mg

Dose 6: 80 mg (2 x 40 mg caps); Cumulative dose: 155 mg

Dose 7: 160 mg (4 x 40 mg caps); Cumulative dose: 315 mg

Dose 8: 160 mg (4 x 40 mg caps); Cumulative dose: 475 mg

Dose 9: 160 mg (4 x 40 mg caps); Cumulative dose: 635 mg

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Assessment of bronchial hyper-responsiveness: Inhalation: Children ≥6 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

Inhalation: Administer using supplied single patient use inhaler; do not puncture capsule more than once; do not swallow capsules. A nose clip may be used if preferred. The patient should exhale completely, followed by a controlled rapid deep inspiration from the device; hold breath for 5 seconds and exhale through the mouth. Measure FEV1 in duplicate 60 seconds after inhalation; repeat process until positive response or full dose (635 mg) has been administered.

Storage

Powder for inhalation: Store at <25°C (<77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Do not freeze.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

1% to 10%:

Cardiovascular: Chest discomfort (1%)

Central nervous system: Headache (adults 6%; children 3%), dizziness (1%)

Gastrointestinal: Nausea (adults 2%; children 3%), throat irritation (2%), retching (1%)

Respiratory: Cough (2%), pharyngolaryngeal pain (adults 2%; children 4%), rhinorrhea (2%), dyspnea (1%), wheezing (1%)

<1% (Limited to important or life-threatening): FEV1 decreased, gagging

ALERT: U.S. Boxed Warning

Risk of severe bronchospasm (powder for inhalation):

Mannitol acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with mannitol is for diagnostic purposes only. Bronchial challenge testing with mannitol should only be conducted by trained professionals under the supervision of a health care provider familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (eg, short-acting inhaled beta-agonists) 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 mannitol should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (eg, forced expiratory volume at 1 second [FEV1] less than 1 to 1.5 L or less than 70% of the predicted values).

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: [US Boxed Warning] Use may result in severe bronchospasm; use only for bronchial challenge testing. Testing should only be done by trained professionals. Not for use in patients with asthma or very low baseline pulmonary function. Medications (eg, short-acting inhaled beta-agonist) and equipment for the treatment of severe bronchospasm should be readily available. Use with caution in patients with conditions that may increase sensitivity to bronchoconstriction (eg, severe cough, ventilatory impairment, spirometry-induced bronchoconstriction, hemoptysis of unknown origin, pneumothorax, recent abdominal, thoracic, or intraocular surgery, unstable angina, active upper or lower respiratory tract infection). Patients who have ≥10% reduction in FEV1 on administration of the 0 mg capsule, patients with a positive response to bronchial challenge testing, or patients who develop significant respiratory symptoms should receive short acting inhaled beta-agonist; monitor until full recovery to baseline. Bronchial challenge testing should not be performed in children <6 years of age as these patients are unable to provide reliable spirometric results.

Monitoring Parameters

Standard spirometry prior to bronchial challenge test; FEV1 in duplicate 60 seconds after administration of each step of test

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience rhinorrhea, nausea, or xerostomia. Have patient report immediately to prescriber dyspnea, severe dizziness, syncope, considerable headache, angina, tachycardia, signs of fluid and electrolyte imbalance, vision changes, significant edema, chills, or injection site pain or irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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