SKLICE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SKLICE (SKLICE).
Inhibits gamma-aminobutyric acid (GABA)-gated chloride channels in lice, leading to hyperexcitation and death.
| Metabolism | Not extensively metabolized; primarily excreted unchanged in feces via bile. |
| Excretion | Ivermectin (SKLICE) is primarily excreted in feces (approximately 90%) as unchanged drug and metabolites, with less than 1% of the administered dose excreted in urine. Biliary excretion of metabolites is significant. |
| Half-life | The terminal elimination half-life of ivermectin is approximately 18 hours (range 12-24 hours) in healthy adults. In patients with onchocerciasis, the half-life may be prolonged due to enterohepatic recycling and continuous release from tissue depots. |
| Protein binding | Ivermectin is approximately 93% bound to plasma proteins, primarily albumin and to a lesser extent alpha-1-acid glycoprotein. |
| Volume of Distribution | The volume of distribution (Vd) of ivermectin is approximately 3.1 L/kg, indicating extensive tissue distribution and accumulation in adipose tissue, skin, and other organs. |
| Bioavailability | Oral bioavailability of ivermectin is approximately 60-70% due to first-pass metabolism. The drug is not administered parenterally in humans. Oral tablets (3 mg) have a high relative bioavailability compared to the oral solution. |
| Onset of Action | Oral administration: Onset of clinical effect (e.g., reduction in microfilariae count) occurs within 2-4 hours, with maximal reduction achieved by 2-4 days. For scabies, clinical improvement may be noted within 1-2 weeks. |
| Duration of Action | A single oral dose of ivermectin provides sustained reduction of microfilariae for 6-12 months in onchocerciasis, and is effective against scabies for 2-4 weeks. Repeat dosing may be required for complete eradication of ectoparasites. |
For Pediculus capitis infestation: Apply topical lotion (0.5% ivermectin) to dry hair and scalp in an amount sufficient to thoroughly coat the hair and scalp, leave for 10 minutes, then rinse with water. Use a single application; a second application may be considered if live lice are seen 7 days after first treatment.
| Dosage form | LOTION |
| Renal impairment | No formal renal adjustment guidelines established. Ivermectin is highly protein-bound and hepatically metabolized; renal excretion is minimal. However, use with caution in severe renal impairment (CrCl <30 mL/min) due to limited data. |
| Liver impairment | No formal hepatic adjustment guidelines. Ivermectin is extensively metabolized in the liver. Use with caution in Child-Pugh class C (severe hepatic impairment) as exposure may be increased. |
| Pediatric use | Approved for children aged ≥6 months. Apply same topical regimen as adults: 0.5% lotion to dry hair and scalp for 10 minutes then rinse. Safety and efficacy in infants <6 months not established. |
| Geriatric use | No specific dose adjustment required in elderly patients with normal hepatic and renal function. Apply same topical regimen as adults. Consider increased risk of adverse effects due to age-related physiological changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SKLICE (SKLICE).
| Breastfeeding | Excreted in breast milk; M/P ratio not established. Desmethyldiazepam (active metabolite) accumulates in nursing infants. Avoid breastfeeding; if essential, monitor infant for sedation, poor feeding, and hypotonia. |
| Teratogenic Risk | Pregnancy category C. Insufficient human data; animal studies show embryo-fetal toxicity at maternally toxic doses. In first trimester: not recommended unless clearly needed. Second and third trimesters: avoid due to potential neonatal CNS depression (active metabolite oxazepam). |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to spinosad or any component of the formulation."]
| Precautions | ["Avoid contact with eyes and mucous membranes.","Do not use on children younger than 6 months.","Not for oral ingestion; topical use only.","Discontinue if irritation or allergic reaction occurs."] |
Loading safety data…
| Fetal Monitoring |
| No specific fetal monitoring required. Monitor maternal liver function, renal function, and signs of CNS depression. For chronic use, consider fetal growth scans due to risk of low birth weight. |
| Fertility Effects | No known detrimental effects on fertility in animal studies. In humans, no direct evidence of impaired fertility. Use with caution in women attempting conception due to teratogenicity concerns. |