Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 12 July 2017

Indication(s)

1 INDICATIONS AND USAGE SKLICE Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older. (1) 1.1 Indication SKLICE® Lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older. 1.2 Adjunctive Measures SKLICE Lotion should be used in the context of an overall lice management program: Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels. Wash personal care items such as combs, brushes and hair clips in hot water. A fine-tooth comb or special nit comb may be used to remove dead lice and nits.

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None. (4)
Adverse reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence <1%) are conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation. (6) To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals, LLC at 1-866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to a single 10 minute treatment of SKLICE Lotion in 379 patients, ages 6 months and older, in placebo-controlled trials. Of these subjects, 47 subjects were age 6 months to 4 years, 179 subjects were age 4 to 12 years, 56 subjects were age 12 to 16 years and 97 subjects were age 16 or older. Adverse reactions, reported in less than 1% of subjects treated with SKLICE Lotion, include conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For topical use only. SKLICE Lotion is not for oral, ophthalmic, or intravaginal use. Apply SKLICE Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. Leave SKLICE Lotion on the hair and scalp for 10 minutes, and then rinse off with water. It is recommended to wait 24 hours before applying shampoo to hair and scalp. The tube is intended for single use; discard any unused portion. Avoid contact with eyes. For topical use only. Not for oral, ophthalmic or intravaginal use. (2) Apply SKLICE Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. (2) After 10 minutes, rinse off with water. (2) For single use. Discard any unused portion. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS Safety and effectiveness in pediatric patients below the age of 6 months have not been established. (8.4) 8.1 Pregnancy Risk Summary There are no studies with the use of SKLICE Lotion in pregnant women. Epidemiologic studies with the use of oral ivermectin during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester (see Data). However, systemic exposure from topical use of ivermectin is much lower than that from oral use [see Clinical Pharmacology (12.3)]. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant mice, rats and rabbits during the period of organogenesis only at or near doses that were maternally toxic to the pregnant females [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Four published epidemiology studies, all performed in rural Africa to treat soil-transmitted helminths, evaluated pregnancy outcomes in a total of 744 women exposed to oral ivermectin in various stages of pregnancy. In the largest of these studies, 397 women in their second trimester of pregnancy were treated open-label with single doses of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths and compared with a pregnant, non-treated population. No differences in pregnancy outcomes were observed between treated and untreated populations. These studies cannot definitively establish or exclude the absence of any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester. Animal Data No comparisons of animal exposure with human exposure are made due to the low systemic exposure noted in the clinical pharmacokinetic study [see Clinical Pharmacology (12.3)]. Systemic embryofetal development studies were conducted in mice, rats and rabbits. Oral doses of ivermectin at 0.1, 0.2, 0.4, 0.8, and 1.6 mg/kg/day were administered during the period of organogenesis to pregnant female mice. Maternal death occurred at 0.4 mg/kg/day and above. Cleft palate occurred in the fetuses from the 0.4, 0.8, and 1.6 mg/kg/day groups. Exencephaly was seen in the fetuses from the 0.8 mg/kg group. Oral doses of ivermectin at 2.5, 5, and 10 mg/kg/day were administered during the period of organogenesis to pregnant female rats. Maternal death and pre-implantation loss occurred at 10 mg/kg/day. Cleft palate and wavy ribs were seen in fetuses from the 10 mg/kg/day group. Oral doses of ivermectin at 1.5, 3, and 6 mg/kg/day were administered during the period of organogenesis to pregnant female rabbits. Maternal toxicity and abortion occurred at 6 mg/kg/day. Cleft palate and clubbed forepaws occurred in the fetuses from the 3 and 6 mg/kg groups. These teratogenic effects were found only at or near doses that were maternally toxic to the pregnant female. Therefore, ivermectin does not appear to be selectively fetotoxic to the developing fetus. 8.2 Lactation Risk Summary There is information available on the presence of ivermectin in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin. However, there is insufficient information from this study to determine the effects of ivermectin on the breastfed infant or the effects of ivermectin on milk production. Topical ivermectin systemic exposure is much lower than that for oral ivermectin [see Clinical Pharmacology (12.3)]. Furthermore, the amount of ivermectin present in human milk after topical application of SKLICE to lactating women has not been studied. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SKLICE Lotion and any potential adverse effects on the breastfed infant from SKLICE Lotion or from the underlying maternal condition. Clinical Considerations Advise a lactating woman to avoid accidental transfer of SKLICE Lotion to breast area where the infant might directly ingest the drug. 8.4 Pediatric Use The safety and effectiveness of SKLICE Lotion have been established for pediatric patients 6 months of age and older [see Clinical Pharmacology (12.3) and Clinical Studies (14)]. The safety of SKLICE Lotion has not been established in pediatric patients below the age of 6 months. SKLICE Lotion is not recommended in pediatric patients under 6 months of age because of the potential increased systemic absorption due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier and risk of ivermectin toxicity. 8.5 Geriatric Use Clinical studies of SKLICE Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

More information

Category Value
Authorisation number NDA202736
Agency product number 8883YP2R6D
Orphan designation No
Product NDC 24338-183
Date Last Revised 26-06-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1298427
Storage and handling Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP controlled room temperature]. Do not freeze.
Marketing authorisation holder Arbor Pharmaceuticals