- 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.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Cystic fibrosis |
|---|
|
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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.
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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.
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Expectorants | ||
|---|---|---|
| R05CA | ||
| Mucolytics | ||
|---|---|---|
| R05CB | ||
| R05CB01 | ||
| R05CB06 | ||
| R05CB02 | ||
| R05CB13 | ||
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References
- Pharmaxis Pharmaceuticals Limited, SmPC Bronchitol (EU/1/12/760/001-002) 25-09-2015, www.geneesmiddeleninformatiebank.nl
- 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
- 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
- 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
- Nevitt SJ. et al, Inhaled mannitol for cystic fibrosis., Cochrane Database Syst Rev, 2020 , May 1, 5(5), CD008649
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Changes
Changes
