- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information
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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
| Tuberculosis |
|---|
| Infection by atypical mycobacteria (e.g. lymphadenitis colli) |
|---|
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Renal impaiment in children > 3 months
- GFR ≥ 50: dose adjustment not necessary.
- GFR 10-30: 100% of normal reversal dose, 3x per week, guided by ethambutol level.
- GFR <10: 100% of normal reversal dose, 3x per week, guided by ethambutol level.
Clinical consequences
With impaired renal function, the half-life of ethambutol is prolonged. This increases the risk of adverse reactions.
Clinical effects:
Neuritis optica may occur, especially with daily doses from 25 mg/kg body weight (dose-dependent toxicity), with prolonged use, in renal impairment, or in diabetic patients with retinopathy. The symptoms are decreased visual acuity, disturbed color sense (especially red-green) and partial loss of visual field. These symptoms are usually reversible with immediate discontinuation of therapy; failure to discontinue in a timely manner may result in blindness.
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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
Hepatotoxicity and neuropathies.
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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 in children
Regular checks of the eyes are recommended because of the potential for optic neuritis to occur.
It has been observed in multiple studies that ethambutol levels in children are on average lower than in adults receiving the same dosage per kg body weight. This may be caused by decreased absorption in children compared with adults. Monitoring of the ethambutol levels is desirable when treating children.(SmPC)
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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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| Antibiotics | ||
|---|---|---|
| J04AB02 | ||
| Hydrazides | ||
|---|---|---|
| J04AC01 | ||
| Other drugs for treatment of tuberculosis | ||
|---|---|---|
| J04AK05 | ||
| J04AK06 | ||
| J04AK01 | ||
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References
- Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
- Furth van AM et al, Werkboek Infectieziekten bij Kinderen, VU Uitgeverij, 1999
- Teofarma, SmPC Myambutol (RVG 06455) 28-12-2015, www.geneesmiddeleninformatiebank.nl
- NVALT, Richtlijn medicamenteuze behandeling van tuberculose, 2 okt 2014
- NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
- Esteve Pharmaceuticals GmbH, SmPC EMB-Fatol (6193016.00.02), 11/2021
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Changes
Changes
