Mannitol inhalation

Generic name
Mannitol inhalation
Brand name
ATC Code
R05CB16

Mannitol inhalation

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

There is no information about the pharmacokinetic parameters for mannitol in children.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Cystic fibrosis
  • Inhalation
    • 12 years up to 18 years
      • Start with a test dose of 400 mg divided into 4 doses of 40, 80, 120, and 160 mg respectively. If no bronchial hyperreactivity is observed, proceed to maintenance dose: 800 mg/day in 2 doses.
      • Administer a bronchodilator 5-15 minutes prior to each dose.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

On the day of the screening: Uncommon: bronchospasm, discomfort/pain in the chest, vomiting (after coughing), odynophagia, retching.
Both during the treatment phase and on the day of the screening: Common: coughing. Uncommon: dizziness, nausea.
During the treatment phase: Common: headache, deteriorated condition, haemoptysis, pharyngolaryngeal pain, bacteria identified in the sputum, discomfort in the chest, wheezing, asthma, productive coughing, vomiting (after coughing). Uncommon: insomnia, earache, bronchitis, bronchopneumonia, dysphonia, hyperventilation, discolored sputum, throat irritation, pharyngitis, upper airway infection, dyspnoea, pruritus, pruritic rash, musculoskeletal pain in the chest, urinary incontinence, fever.


The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

EXPECTORANTIA, EXCL COMB.PREP. MET HOESTPRIKKELDEMP.MIDD.

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Expectorants
R05CA
Mucolytics
R05CB
R05CB01
R05CB06
R05CB02
R05CB13

References

  1. Pharmaxis Pharmaceuticals Limited, SmPC Bronchitol (EU/1/12/760/001-002) 25-09-2015, www.geneesmiddeleninformatiebank.nl
  2. Teper A, et al, Inhaled mannitol in patients with cystic fibrosis: A randomised open-label dose response trial, J Cyst Fibros, 2011, Jan, 10(1), 1-8
  3. Bilton D, et al, Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis, J Cyst Fibros, 2013, Jul, 12(4), 367-76
  4. Minasian C, et al, Comparison of inhaled mannitol, daily rhDNase and a combination of both in children with cystic fibrosis: a randomised trial, Thorax, 2010, Jan, 65(1), 51-6
  5. Nevitt SJ. et al, Inhaled mannitol for cystic fibrosis., Cochrane Database Syst Rev, 2020 , May 1, 5(5), CD008649

Changes

Therapeutic Drug Monitoring


Overdose