Pharmacokinetics in children

No information

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

Fungal infection
Oral ≥ 2 years and 15 up to 20 kg 62.5 mg/day in 1 dose ≥ 2 years and 20 up to 40 kg 125 mg/day in 1 dose ≥ 2 years and ≥ 40 kg 250 mg/day in 1 dose

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Dose adjustment not needed

GFR 30-50 ml/min/1.73 m2

50 percentage of single dose and dosing interval : 24 uur

GFR 10-30 ml/min/1.73 m2

50 percentage of single dose and dosing interval : 24 uur

GFR < 10 ml/min/1.73 m2

A general recommendation is not provided

Clinical consequences

With impaired renal function, the half-life of terbinafine is prolonged. This may possibly increase the risk of adverse reactions.

Clinical effects:
The clinical relevance of the longer half-life is not clear.

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

Side effects

No information is present at this moment.

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

• DERMATOLOGICALS
• ANTIFUNGALS FOR DERMATOLOGICAL USE

ANTIFUNGALS FOR SYSTEMIC USE

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

Antifungals for systemic use
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References

1. Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
2. Mylan BV, SPC Terbinafine tabletten (RVG 28796) 18-07-2018, www.geneesmiddeleninformatiebank.nl
3. AbZ-Pharma GmbH, SmPC Terbinafin AbZ 250 mg Tabletten (61642.00.00), 06/2014
4. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021

Changes

Therapeutic Drug Monitoring

Overdose