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Mannitol (oral inhalation): Drug information

Mannitol (oral inhalation): Drug information
(For additional information see "Mannitol (oral inhalation): Patient drug information" and see "Mannitol (oral inhalation): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Risk of severe bronchospasm (Aridol):

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).

Brand Names: US
  • Aridol;
  • Bronchitol;
  • Bronchitol Tolerance Test
Brand Names: Canada
  • Aridol
Pharmacologic Category
  • Diagnostic Agent;
  • Mucolytic Agent
Dosing: Adult
Assessment of bronchial hyperresponsiveness

Assessment of bronchial hyperresponsiveness (Aridol): Oral inhalation: Dry powder inhaler (capsule): 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

Cystic fibrosis, maintenance

Cystic fibrosis, maintenance (Bronchitol):

Note: Use only in patients who have passed the Bronchitol tolerance test; if bronchospasm occurs, discontinue immediately.

Oral inhalation: Dry powder inhaler (capsule): 400 mg inhaled (contents of 10 capsules) twice a day (morning and evening), with the later dose taken 2 to 3 hours before bedtime; administer a short-acting bronchodilator 5 to 15 minutes before every dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, drug is primarily renally eliminated and systemic exposure may be increased; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Mannitol (oral inhalation): Pediatric drug information")

Bronchial hyper-responsiveness assessment

Bronchial hyper-responsiveness assessment: Aridol: Children ≥6 years and Adolescents: Oral inhalation: Dry powder inhaler (capsule): Administer in a stepwise fashion (measuring FEV1 in duplicate at baseline and 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

Cystic fibrosis, maintenance

Cystic fibrosis (CF), maintenance: Bronchitol:

Note: Use only in patients who have passed the Bronchitol tolerance test (BTT); refer to manufacturer labeling for detailed instructions on BTT administration. Administer a short-acting bronchodilator 5 to 15 minutes before every dose. If bronchospasm occurs at any point, discontinue immediately.

Children ≥6 years and Adolescents <18 years: Limited data available: Oral inhalation: Dry powder inhaler (capsule): 400 mg (contents of 10 capsules) inhaled twice daily. Dosing based on a randomized, placebo-controlled crossover trial in patients with CF (n=92; mean age: 12 ± 3 years; range: 6 to 17 years); after 8 weeks of treatment, results showed mannitol showed significant improvement in lung function and pulmonary exacerbations were decreased (De Boek 2017).

Adolescents ≥18 years: Oral inhalation: Dry powder inhaler (capsule): 400 mg (contents of 10 capsules) twice daily (morning and evening), with the later dose taken 2 to 3 hours before bedtime.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, drug is primarily renally eliminated and systemic exposure may be increased; use with caution in patients with underlying renal disease.

Dosing: Hepatic Impairment: Pediatric

No adjustment required.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Diagnostic Agent:

1% to 10%:

Cardiovascular: Chest discomfort (1%)

Gastrointestinal: Nausea (2% to 3%), retching (1%)

Nervous system: Dizziness (1%), headache (3% to 6%)

Respiratory: Cough (2%), dyspnea (1%), pharyngolaryngeal pain (2% to 4%), rhinorrhea (2%), throat irritation (2%), wheezing (1%)

Cystic fibrosis:

>10%: Respiratory: Cough (15%), exacerbation of pulmonary disease (exacerbation of cystic fibrosis, can be serious: 13% to 32%)

1% to 10%:

Gastrointestinal: Vomiting (3%)

Neuromuscular & skeletal: Arthralgia (3%)

Respiratory: Hemoptysis (10%), increased bronchial sections (bacterial: 7%), oropharyngeal pain (7%)

Miscellaneous: Fever (5%)

Frequency not defined (all indications): Respiratory: Bronchospasm, reduced forced expiratory volume

Postmarketing (all indications): Gastrointestinal: Gag reflex

Contraindications

Hypersensitivity to mannitol, gelatin, or any component of the formulation.

Aridol: Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers (eg, aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident).

Bronchitol: Failure to pass the Bronchitol tolerance test.

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Aridol: [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 (eg, FEV1 <1 to 1.5 L or <70% of the predicted values). 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.

- Bronchitol: Use may cause severe bronchospasm; perform the Bronchitol tolerance test prior to use under the supervision of trained professionals. Do not use in patients who fail the Bronchitol tolerance test; patients who pass the tolerance test may still experience bronchospasm with maintenance use and should premedicate with inhaled short-acting bronchodilators. If bronchospasm occurs, discontinue use immediately.

• Hemoptysis: May occur with use; use with caution in patients with history of significant hemoptysis episodes (volume >60 mL); discontinue if hemoptysis occurs.

Disease-related concerns:

• Renal impairment: Drug is primarily renally eliminated and systemic exposure may be increased; use with caution in patient with renal impairment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Inhalation:

Bronchitol: 40 mg

Bronchitol Tolerance Test: 40 mg

Kit, Inhalation:

Aridol: Graduated dose; 0 mg (1), 5 mg (1), 10 mg (1), 20 mg (1), 40 mg (15)

Generic Equivalent Available: US

No

Pricing: US

Capsules (Bronchitol Inhalation)

40 mg (per each): $7.83

Capsules (Bronchitol Tolerance Test Inhalation)

40 mg (per each): $7.84

Kit (Aridol Inhalation)

0 & 5 & 10 &20 & 40 MG (per each): $7.89

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Inhalation:

Aridol: Graduated dose; 0 mg (1), 5 mg (1), 10 mg (1), 20 mg (1), 40 mg (15)

Administration: Adult

Oral inhalation: For oral inhalation only; do not swallow capsules.

Aridol: Administer using supplied single patient use inhaler; do not puncture capsule more than once. 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.

Bronchitol: Prior to initial use, perform the Bronchitol tolerance test (BTT) (see manufacturer's labeling for more detailed information). For patients who have passed the BTT, administer morning and night (2 to 3 hours before bedtime) doses using the supplied inhaler 5 to 15 minutes after administering a short-acting bronchodilator. Place 1 capsule in inhaler chamber; turn mouthpiece until it locks in place; push both buttons on side at same time and release. Exhale fully, then close lips around mouthpiece and take a steady deep breath; hold breath for 5 seconds before exhaling (do not exhale into inhaler). Open inhaler to see if any powder is left in capsule; repeat inhalation process if powder is still left; if empty, throw capsule away. Discard and replace inhaler after 7 days of use. May wash inhaler if needed; allow to thoroughly air dry before next use. Refer to manufacturer's labeling for more detailed information.

Administration: Pediatric

Oral inhalation: For oral inhalation only via inhaler; do not swallow capsules.

Aridol: 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.

Bronchitol: Note: Only use in patients who have passed the Bronchitol tolerance test (BTT) (see manufacturer's labeling for more detailed information).

Prior to a mannitol dose, administer a bronchodilator 5 to 15 minutes before. Administer mannitol morning and night (2 to 3 hours before bedtime) doses using the supplied inhaler. Place 1 capsule in inhaler chamber; turn mouthpiece until it locks in place; push both buttons on side at same time and release. Exhale fully (do not exhale into inhaler), then close lips around mouthpiece and take a steady deep breath inhaling the powder; hold breath for 5 seconds before exhaling. Open inhaler to see if any powder is left in capsule; repeat inhalation process if powder is still left; if empty throw capsule away. Repeat process to complete the total dose (400 mg) of 10 capsules. Discard and replace inhaler after 7 days of use. May wash inhaler if needed; allow to thoroughly air dry before next use. Refer to manufacturer's labeling for more detailed information.

Use: Labeled Indications

Assessment of bronchial hyper responsiveness (Aridol): For the assessment of bronchial hyperresponsiveness in patients ≥6 years of age who do not have clinically apparent asthma.

Cystic fibrosis, maintenance (Bronchitol): As add-on maintenance therapy to improve pulmonary function in adult patients ≥18 years of age with cystic fibrosis.

Limitations of use: Use Bronchitol only in adults with cystic fibrosis who have passed the Bronchitol tolerance test. Aridol is not a standalone test or a screening test for asthma; bronchial challenge testing with mannitol should be used only as part of an overall assessment of asthma.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Breastfeeding Considerations

It is not known if mannitol is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Standard spirometry prior to bronchial challenge test (Aridol) and tolerance test (Bronchitol); FEV1 in duplicate 60 seconds after administration of each step of test (Aridol); SpO2 and FEV1 monitoring is required during administration of Bronchitol tolerance test; bronchospasm; hemoptysis (patients with a history of hemoptysis).

Mechanism of Action

The mechanisms of bronchoconstriction to assess hyperresponsiveness or in improving pulmonary function in cystic fibrosis patients are unknown.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: 34.3 L (based on IV administration)

Metabolism: Minimally hepatic to glycogen

Bioavailability: Inhaled: 59% (relative to oral administration: 96%)

Half-life elimination: Terminal: 4.7 hours

Time to peak, plasma: Inhaled: 1.5 hours

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Bronchitol;
  • (AU) Australia: Bronchitol;
  • (CZ) Czech Republic: Bronchitol;
  • (DE) Germany: Aridol | Bronchitol;
  • (EE) Estonia: Bronchitol;
  • (ES) Spain: Osmohale;
  • (GB) United Kingdom: Bronchitol;
  • (GR) Greece: Aridol | Bronchitol;
  • (HU) Hungary: Bronchitol;
  • (IT) Italy: Bronchitol;
  • (KR) Korea, Republic of: Aridol;
  • (NL) Netherlands: Osmohale;
  • (NO) Norway: Bronchitol;
  • (PR) Puerto Rico: Aridol | Bronchitol;
  • (RU) Russian Federation: Bronchitol pharmaxis;
  • (SE) Sweden: Aridol | Bronchitol;
  • (UG) Uganda: Axatol
  1. Aridol (mannitol) [prescribing information]. Coral Springs, FL: Methapharm Inc; November 2021.
  2. Bronchitol (mannitol) [prescribing information]. Cary, NC: Chiesi USA Inc; October 2020.
  3. Bronchitol (mannitol) [product information]. Frenchs Forest, NSW, Australia: Pharmaxis Ltd; October 2015.
  4. De Boeck K, Haarman E, Hull J, et al. Inhaled dry powder mannitol in children with cystic fibrosis: a randomised efficacy and safety trial. J Cyst Fibros. 2017;16(3):380-387. [PubMed 28258928]
  5. Expert Panel Report 3. Guidelines for the Diagnosis and Management of Asthma. Clinical Practice Guidelines. National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
  6. Leuppi JD, Brannan JD, Anderson SD. Bronchial Provocation Tests: The Rationale for Using Inhaled Mannitol as a Test for Airway Hyperresponsiveness. Swiss Med Wkly. 2002;132(13-14):151-158. [PubMed 12070787]
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