Bronchitol

Last updated on RxList: 7/21/2021
Bronchitol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Bronchitol?

Bronchitol (mannitol) is a sugar alcohol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.

What Are Side Effects of Bronchitol?

Side effects of Bronchitol include:

Dosage for Bronchitol

The dose of Bronchitol to treat cystic fibrosis is 400 mg (10 capsules) twice a day by oral inhalation, in the morning and evening, with the later dose taken 2-3 hours before bedtime. Use Bronchitol only in adults who have passed the Bronchitol Tolerance Test.

Bronchitol In Children

SBronchitol is not indicated for use in children and adolescents. The safety and effectivenss of Bronchitol have not been established in pediatric patients for cystic fibrosis.

What Drugs, Substances, or Supplements Interact with Bronchitol?

Bronchitol may interact with other medicines.

Tell your doctor all medications and supplements you use.

Bronchitol During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Bronchitol; it is unknow how it would affect a fetus. It is unknown if Bronchitol passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Bronchitol (mannitol) Inhalation Powder, for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bronchitol Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine; or
  • if you cough up large amounts of blood.

Common side effects of Bronchitol may include:

  • pain or irritation in your mouth or throat;
  • trouble swallowing;
  • fever; or
  • vomiting.

Common side effects of Aridol may include:

  • wheezing, trouble breathing, chest discomfort;
  • cough, throat pain or irritation;
  • runny nose;
  • headache, dizziness; or
  • nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Bronchitol ( Mannitol Inhalation Powder, for Oral Inhalation Use)

Bronchitol Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Hemoptysis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The overall safety profile for BRONCHITOL is based on data from 1,020 CF patients from three 26-week, randomized, double-blind, controlled trials (Trials 1, 2, and 3). While CF patients aged 6 to 17 years were included in two of the three trials, BRONCHITOL is not indicated for use in this age group [see INDICATIONS, Use In Specific Populations]. The safety data described below are based on 761 adult patients who received at least one dose of study drug in the three trials.

Of the 761 adult patients, 45% of patients were female and 98% were Caucasian; 414 received BRONCHITOL and 347 received control (50 mg inhaled mannitol) for up to 26 weeks. Adult patients treated with BRONCHITOL were ages 18 to 59 years with a mean baseline FEV1of 62.0% of predicted.

In these three trials, the proportion of adult patients who prematurely discontinued study drug due to adverse reactions was 12.3% for patients treated with BRONCHITOL and 8.6% for patients treated with control. Serious adverse reactions occurred in 18.8% of patients treated with BRONCHITOL and 18.4% of patients treated with control. Serious adverse reactions occurring with greater than 1% incidence and more frequently in BRONCHITOL-treated adult patients compared to control-treated patients were CF exacerbations (13.3% vs. 11.2%), hemoptysis (1.4% vs. 1.2%) and lower respiratory tract infection (1.2% vs 0.9%).

The incidence of Adverse Reactions in adults during the 26 week treatment period with BRONCHITOL across the three trials is shown in Table 1.

Table 1. Adverse Reactions Occurring With ≥3% Incidence and More Common Than Control in Adult CF Patients (Trials 1, 2, and 3)

Primary System Organ Class
   Preferred Term
BRONCHITOL
N = 414
%
CONTROL
N = 347
%
Respiratory, thoracic, and mediastinal disorders
  Cough15.010.7
  Hemoptysis10.49.5
  Oropharyngeal pain7.04.3
Gastrointestinal disorders
  Vomiting3.11.4
Investigations
  Bacteria sputum identified6.84.6
General disorders and administrative site conditions
  Pyrexia4.62.3
Musculoskeletal and connective tissue disorders
  Arthralgia3.12.6

In Trials 1, 2, and 3, exacerbations of cystic fibrosis (reported as condition aggravated) occurred in 132 of 414 (32%) adult patients receiving BRONCHITOL and in 114 of 347 (33%) adult patients receiving control (50 mg inhaled mannitol). Exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 55 of 414 adult patients (13%) receiving BRONCHITOL and in 39 of 347 adult patients (11%) receiving control. Within the U.S. adult subgroup (comprising 27% of adults enrolled), exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 23 of 110 (21%) patients receiving BRONCHITOL and in 10 of 93 (11%) patients receiving control. Among the non-U.S. adult subgroup (comprising 73% of adults enrolled), exacerbations of cystic fibrosis reported as serious adverse reactions occurred in 11% of patients in each treatment arm.

Read the entire FDA prescribing information for Bronchitol ( Mannitol Inhalation Powder, for Oral Inhalation Use)

© Bronchitol Patient Information is supplied by Cerner Multum, Inc. and Bronchitol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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