ELIMITE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ELIMITE (ELIMITE).
Permethrin is a synthetic pyrethroid that acts on the nervous system of arthropods by prolonging the inactivation of voltage-gated sodium channels, leading to paralysis and death of the ectoparasite.
| Metabolism | Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites, primarily in the liver; excretion is via urine. |
| Excretion | Primarily renal excretion of unchanged drug and metabolites; <2% of topical dose recovered in urine. |
| Half-life | Terminal elimination half-life: 17–22 hours (after topical application); permethrin is slowly absorbed and metabolized. |
| Protein binding | >90% bound to plasma proteins, primarily albumin and lipoproteins. |
| Volume of Distribution | Approximately 2–3 L/kg after systemic absorption, indicating extensive tissue distribution. |
| Bioavailability | Topical: approximately 2% absorbed systemically; oral bioavailability not applicable (not administered orally). |
| Onset of Action | Topical: clinical effect (pruritus relief) within 24–48 hours after single application; scabies mite death occurs within minutes of contact. |
| Duration of Action | Single topical application provides effective scabies treatment for up to 14 days; residual activity on skin may persist for 1–2 weeks. |
Permethrin 5% cream, apply a thin layer to the entire body from the neck down, leave on for 8–14 hours, then wash off. Single application is typical; repeat in 7 days if live mites are observed.
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required for renal impairment. Systemic absorption is minimal. |
| Liver impairment | No dose adjustment required for hepatic impairment based on Child-Pugh classification. |
| Pediatric use | Children ≥2 months: Apply same 5% cream as adults; for infants 2 months to 2 years, apply to scalp, face (avoid eyes and mouth), neck, trunk, and extremities; leave on 8–14 hours; repeat in 7 days if needed. |
| Geriatric use | No specific dose adjustment; use standard adult dosing. Avoid prolonged application in frail elderly with compromised skin barrier. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ELIMITE (ELIMITE).
| Breastfeeding | Permethrin is excreted in human breast milk in small amounts; the M/P ratio is not established. The American Academy of Pediatrics considers topical permethrin therapy compatible with breastfeeding. Advise to avoid application to breast area to prevent infant ingestion. |
| Teratogenic Risk | FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic effects, but there are no adequate and well-controlled studies in pregnant women. Permethrin is poorly absorbed through skin, minimizing systemic exposure. Use only if clearly needed, especially during first trimester. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to permethrin, any pyrethroid, or any component of the formulation."]
| Precautions | ["Avoid contact with eyes, mucous membranes, and open wounds.","Discontinue if hypersensitivity or irritation occurs.","Use with caution in patients with severe excoriation or broken skin.","Not recommended for use in children under 2 months of age unless directed by a physician."] |
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| Fetal Monitoring |
| No specific monitoring required beyond routine prenatal care. Observe for local skin reactions or hypersensitivity. No fetal monitoring indicated due to minimal systemic absorption. |
| Fertility Effects | No known adverse effects on fertility based on animal studies and clinical data. No reported impact on spermatogenesis or oogenesis. |