Pharmacokinetics in children

Pharmacokinetic studies in children are lacking. In adults, permethrin has an absorption rate of 0.5-1%, with its distribution mainly confined to the skin. It is metabolized through ester hydrolysis in the skin and liver into inactive metabolites, which are subsequently excreted in the urine. The highest concentrations of permethrin are found in the urine within the first 48 hours post-application, and there is no accumulation observed with weekly use [SmPC]

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

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

Reported side effects in children include eczematous reactions, itching, erythema, and xerosis. Neurologic side effects have not been reported. [Thomas  2018; Sharma 2014; Hoffmann 2019; Riebenbauer2022]

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

Instructions for application:

< 12 years:

• also treat the face, neck, scalp and ears.
• Pay special attention to the eyebrows, lubricate them well. Do not apply too close to the eyes and mouth. If contact with mucous membranes has occurred: rinse with plenty of water and if possible with soap. Put on gloves for children up to 2 years (and socks for babies) to prevent skin-to-mouth contact.
• Re-apply after diaper changes or after using the toilet

• The following approximate amounts are needed to lubricate the entire body surface:

  (Pre)term neonate – 2 months: 3.75 g

  2 months – 6 years: 7.5 g

  6 up to 12 years: 15 g

≥ 12 years :

• apply the cream all over the body from the edge of the jaw to under the soles of the feet, but not on the head. Pay special attention to areas between fingers and toes, wrists, armpits, external genitalia, buttocks and under the nails of fingers and toes (use a soft toothbrush for this if necessary).
• Re-apply after using the toilet

• The following approximate amounts are needed to lubricate the entire body surface:

  > 12 years: 30 g

Solution: Use with caution on babies under 4 weeks of age with open wounds or extensive skin injuries or damage (such as burns). [SmPC InfectoPedicul®]

In case of overdose, systemic effects such as nausea, headache, dizziness and fatigue, in severe cases, tingling, numbness, hyperexcitability and cramps may occur after excessive topical administration and accidental oral ingestion by (small) children.

 [SmPC permethrin-biomo® Lösung 0,5%, SmPC permethrin-biomo® Creme 5 %]

Interactions

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

• ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
• ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS

ECTOPARASITICIDES, INCL. SCABICIDES

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

References

1. Omega Pharma, SPC Loxazol (RVG 13969) 20-08-2015, www.geneesmiddeleninformatiebank.nl
2. GlaxoSmithKline, SmPC Loxazol creme 50 mg/g (RVG14487) 16-04-2020, www.geneesmiddeleninformatiebank.nl
3. Nederlands Huisartsen Genootschap (NHG), Behandelrichtlijn Scabies, https://richtlijnen.nhg.org/behandelrichtlijnen/scabies#volledige-tekst, April 2023
4. RijksInstituut voor Volksgezondheid en Milieu (RIVM)- (Landelijke Coördinatie Infectieziektebestrijding, Richtlijn Scabies , https://lci.rivm.nl/richtlijnen/scabies, Dec 2022
5. Lobo Y, Wheller L., A narrative review of the roles of topical permethrin and oral ivermectin in the management of infantile scabies. , Australas J Dermatol., 2021, 62(3), 267-77
6. Hoffmann JC, et al. , Topical scabies therapy with permethrin is effective and well tolerated in infants younger than two months., J Dtsch Dermatol Ges, 2019, 17(6), 597-600
7. Quarterman MJ, Lesher JL, Jr., Neonatal scabies treated with permethrin 5% cream., Pediatr Dermatol., 1994, 11(3), 264-6
8. INFECTOPHARM Arnzeimittel und Consilium GmbH. , SmPC Permetrine InfectoPharm, 50 mg/g, crème (RVG 127560) 06-07-2022, www.geneesmiddelinformatiebank.nl
9. Thomas J, et al., Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children: protocol for a randomised controlled trial., BMJ Open, 2018, 8(5), e018507
10. Subramaniam S, et al., A papulopustular, vesicular, crusted rash in a 4-week-old neonate., Pediatr Emerg Care. , 2013, 29(11), 1210-2
11. Sharma CM, et al., Neonatal Scabies; An Uncommon Entity, Journal of Clinical Neonatology., 2014, 3(4), 232-3
12. Singhal AK, et al., A case report of neonatal scabies., Indian Journal of Paediatric Dermatology. , 2017, 18(2), 104-6
13. Arun Babu T, et al, Neonatal Norwegian scabies, Trop Doct, 2023, 53(1), 199-201
14. Hortala M, et al., Erythroderma in a 1-month-old boy., Eur J Pediatr., 2007, 166(9), 979-80
15. Romani L, et al., Mass Drug Administration for Scabies Control in a Population with Endemic Disease., N Engl J Med., 2015, 373(24), 2305-13

Changes

Therapeutic Drug Monitoring

Overdose