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Therapeutic Class OverviewScabicides and PediculicidesINTRODUCTION Scabies and pediculosis are infestations of the skin caused by ectoparasites. Scabies is caused by the parasitic miteSarcoptes scabiei and often results in an intense pruritic eruption and itching. Pediculi or lice can cause infestationseither on the head (Pediculus humanus capitis), body (Pediculus humanus corporis), or the pubic region (Pthirus pubis).These skin conditions are common causes of skin rash and pruritus (Roos et al 2001, Wendel et al 2002). Head liceinfestation crosses all social and geographic boundaries and generally affects children, primarily females, aged 3 to 12years (Feldmeier 2012). Scabies occur in both sexes, at all ages, and in all ethnic and socioeconomic groups; however,one epidemiologic study reported a higher prevalence in urban areas among women and children (Chosidow 2006,Downs et al 1999). The topical agents indicated for the management of scabies and lice are listed in Table 1. All of the agents included inthis review are Food and Drug Administration (FDA)-approved for the treatment of head lice with the exception of Crotan(crotamiton), which is only indicated to treat scabies. Lindane lotion indicated to treat scabies has been discontinued; theshampoo is still available for the treatment of lice. Ulesfia (benzyl alcohol) was FDA-approved in 2009; however, inSeptember 2019, it was announced that this product would be discontinued due to a business decision and as of April2020, the product was discontinued in Medi-Span (FDA drug shortages 2019, Medi-Span Price Rx 2021). Thus, contentrelated to Ulesfia is not included in this review. The ideal agent for the treatment of head lice is one with high pediculicidal (capable of killing lice) and ovicidal (capableof killing eggs) activity with minimal toxicity (Villegas et al 2012). With some products that are not ovicidal, retreatmentmay be recommended in order to kill any newly hatched lice before they can produce new eggs (Devore et al 2015,Centers for Disease Control and Prevention [CDC] 2019[b]). Piperonyl butoxide/pyrethrins and permethrin are pediculicidal, but not ovicidal; retreatment in 9 to 10 days may berecommended (CDC 2019[b]). Malathion is pediculicidal and partially ovicidal, but it is malodorous, requires 8 to 12 hours of application, and ishighly flammable. Retreatment is recommended in 7 to 9 days if live lice are still present (CDC 2019[b]). Spinosad kills live lice and unhatched eggs, retreatment is usually not necessary unless live lice are seen after 7 days(CDC 2019[b]). Ivermectin lotion is not ovicidal but appears to prevent nymphs from surviving; retreatment is generally not needed(CDC 2019[b]). Lindane is neurotoxic and is not recommended as an initial treatment option. If used, retreatment should be avoided(CDC 2019[b]). The American Academy of Pediatrics (AAP) no longer recommends use of lindane (AAP Red Book2018). Abametapir is a metalloproteinase inhibitor which inhibits processes critical to egg development and the survival oflice. It is approved as a single-application product (Xeglyze prescribing information 2020). Some data suggest a growing resistance to permethrin in the United States for the treatment of head lice, with recentstudies stating that the effectiveness of permethrin has declined to 25% and resistance to pyrethrins is widespread(Koch et al 2016, The Medical Letter 2016). However, the AAP states that 1% permethrin or pyrethrins are reasonablefirst choices for primary treatment unless resistance to these products has been proven in the community (Devore et al2015). The CDC notes that resistance to 1% permethrin and piperonyl butoxide/pyrethrins has been reported but itsprevalence is unknown (CDC 2019[b]). For head lice, malathion lotion (in patients who are 6 years of age or older), spinosad suspension, and ivermectinlotion are available as additional options (AAP Red Book 2018, CDC 2019[b], Devore et al 2015). For scabies, 5% permethrin cream is effective and recommended as a first-line agent (AAP Red Book 2018). Crotamitonis an alternative, but frequent treatment failures have been reported. Oral ivermectin may be considered for patients whofail treatment or for those who cannot tolerate topical therapies, but is not indicated for this use (CDC 2019[d]). Medispan class: Scabicides and pediculicides and scabicide combinations.Data as of February 14, 2021 AKS/AVDPage 1 of 9This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorizedrecipients. The contents of the therapeutic class overviews on this website ("Content") are for informational purposes only. The Content is not intendedto be a substitute for professional medical advice, diagnosis, or treatment. Patients should always seek the advice of a physician or other qualified healthprovider with any questions regarding a medical condition. Clinicians should refer to the full prescribing information and published resources whenmaking medical decisions.

Table 1. Medications Included Within Class ReviewDrugCrotan (crotamiton) 10% lotionLindane 1% shampooNatroba (spinosad) 0.9% external suspensionOvide (malathion) 0.5% lotionElimite (permethrin) 5% creamPermethrin†Piperonyl butoxide and pyrethrins†Sklice (ivermectin) 0.5% lotion ‡§Xeglyze (abametapir) 0.74% lotion Generic Availability * -*Originator brand, Eurax lotion, has been discontinued. Crotan was approved through the abbreviated new drug application (ANDA) pathway and is nowa single-source product.†Over-the-counter (OTC) product; available formulations vary.‡The FDA has approved Sklice for OTC use, and the prescription product will be phased out. The specific timing of the switch to OTC availability ispending.§Additional ivermectin products include a 1% cream (Soolantra) indicated for rosacea and an oral tablet (Stromectol) indicated for strongyloidiasis andonchocerciasis. Launch plans are pending.([email protected] 2021, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations ir)PermethrinOvide(malathion)Natroba(spinosad) ¶ ‡ ‡ §# **Head lice *Pubic (crab) lice *Body licePiperonylbutoxide iton)Table 2. Food and Drug Administration Approved Indications ‡ † # ¶ ¶*Lindane shampoo is indicated only for patients who cannot tolerate or have failed treatment with other approved therapies.† In patients 6 years of age‡ In patients 6 months of age§ Permethrin 5% cream is indicated for the treatment of scabies. Permethrin 1% lotion/cream rinse is indicated for the treatment of head lice.# In patients 2 months of age¶ In patients 2 years of age**Safety and effectiveness in children have not been established.(Clinical Pharmacology 2021; Prescribing information: Crotan 2020, Elimite 2016, Lindane 2019, Natroba 2014, Ovide2018, Sklice 2017, Xeglyze 2020) Information on indications, mechanism of action, pharmacokinetics, dosing, and safety has been obtained from theprescribing information for the individual products, except where noted otherwise.Data as of February 14, 2021 AKS/AVDPage 2 of 9This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorizedrecipients. The contents of the therapeutic class overviews on this website ("Content") are for informational purposes only. The Content is not intendedto be a substitute for professional medical advice, diagnosis, or treatment. Patients should always seek the advice of a physician or other qualified healthprovider with any questions regarding a medical condition. Clinicians should refer to the full prescribing information and published resources whenmaking medical decisions.

CLINICAL EFFICACY SUMMARYScabies In studies comparing various topical agents for the treatment of scabies, a higher cure rate has been reported withpermethrin compared to crotamiton and lindane (Amer et al 1992, Haustein et al 1989, Rao et al 2019, Schultz et al1990, Taplin et al 1986[b], Taplin et al 1990, Zargari et al 2006). In the largest study (N 467), Schultz et al reportedthat there was a trend toward a higher cure rate with permethrin compared to lindane; however, the difference was notstatistically significant (Schultz et al 1990). In a single-blind, randomized controlled trial comparing ivermectin tocrotamiton (N 340), 2 applications of ivermectin were as effective as a single application of crotamiton cream for thetreatment of scabies at 2 weeks. After repeating therapy, ivermectin was superior to crotamiton cream at 4 weeks followup (Goldust et al 2014). Both lindane and permethrin have also been compared to oral ivermectin for the treatment of scabies. Numerous studieshave demonstrated a significantly lower cure rate after 4 weeks with lindane compared to oral ivermectin (Goldust et al2013, Madan et al 2001, Mohebbipour et al 2013). However, another study found similar efficacy between the 2 agentsat days 15 and 29 after treatment (Chouela et al 1999). Results from another study found that after a single application,permethrin was associated with a higher cure rate compared to ivermectin (Usha et al 2000). A Cochrane review evaluated 15 studies comparing topical permethrin, topical ivermectin, and oral ivermectin forscabies (Rosumeck et al 2018). The meta-analysis found no clear differences in rate of complete clearance of scabiesbetween products, with the exception of the rate of complete clearance after 1 week when comparing topical permethrinto oral ivermectin (relative risk 0.65, 95% confidence interval [CI] 0.54 to 0.78). However, at weeks 2 and 4, there wasno difference in the rate of complete clearance for that comparison. Rates of adverse events were similar between allevaluated therapies. A meta-analysis evaluated 52 studies comparing treatments for scabies to each other or placebo. These treatmentsincluded sulfur, benzyl benzoate, lindane, malathion, crotamiton, permethrin, oral or topical ivermectin, synergizedpyrethrins, or herbal treatments. The primary outcome was either clinical or microscopic cure. Secondary outcomesincluded persistent itching and adverse events. Results of the direct meta-analysis demonstrated permethrin to besignificantly better at achieving cure than oral ivermectin, lindane and crotamiton at 1 to 2 weeks and 3 to 6 weeks. Oralivermectin demonstrated better cure rates than lindane. For persistent itching, oral ivermectin was significantly betterthan benzyl benzoate and lindane; permethrin was significantly better than lindane. No significant differences betweentreatments were observed in adverse events. According to the network meta-analysis, the highest probability of cure at 3to 6 weeks was associated with permethrin oral ivermectin followed by permethrin alone and topical ivermectin.Topical ivermectin followed by permethrin were the highest ranked for reducing persistent itching. The agents with thelowest probability for adverse events were synthetic pyrethrins, malathion, and oral ivermectin. Sulfur ranked highest inthe probability for adverse events followed by permethrin oral ivermectin (Thadanipon 2019).Lice Permethrin has demonstrated a higher rate of treatment success compared to lindane in the treatment of lice following asingle application (Bowerman et al 1987, Brandenburg et al 1986, Kalter et al 1987, Taplin et al 1986[a]). Compared tothe combination of pyrethrins and piperonyl butoxide, permethrin has been shown to be significantly more efficacious(Carson et al 1988, DiNapoli et al 1988). Carson et al reported a cure rate of 96.3% for permethrin and a cure rate of45.2% for the combination of pyrethrins and piperonyl butoxide at 7 days following treatment (p 0.005) (Carson et al1988). In 2 studies, malathion has been reported to have higher rates of cure when compared to permethrin (Meinking etal 2004, Meinking et al 2007). Two identical, vehicle-controlled studies demonstrating the safety and efficacy of ivermectin lotion in the treatment ofhead lice were completed in 289 index patients (6 months of age and older). The 2 studies showed that a higherpercentage of patients treated with ivermectin lotion, without nit combing, were treatment responders (free of live lice atday 2, which was sustained through days 8 and 15) following a single application compared to vehicle application (studyA: 76.1 vs 16.2% at day 15, respectively; study B: 71.4 vs. 18.9% at day 15, respectively; p 0.001 for eachcomparison). In an extended study population with 781 patients, higher treatment response was seen with ivermectinwhen compared to vehicle application (combined study results for day 15: 73.8 vs 17.6%, respectively; p 0.001 foreach comparison) (Pariser et al 2012). Spinosad has been evaluated in 2 randomized, active-controlled trials of 1038 patients aged 6 months or older with anactive head lice infestation. Patients received spinosad without nit combing or permethrin 1% topical solution with nitcombing. Fourteen days following treatment, the spinosad without nit combing treatment arm had a greater proportion ofData as of February 14, 2021 AKS/AVDPage 3 of 9This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorizedrecipients. The contents of the therapeutic class overviews on this website ("Content") are for informational purposes only. The Content is not intendedto be a substitute for professional medical advice, diagnosis, or treatment. Patients should always seek the advice of a physician or other qualified healthprovider with any questions regarding a medical condition. Clinicians should refer to the full prescribing information and published resources whenmaking medical decisions.

lice-free patients compared to permethrin with nit combing (study A: 84.6 vs 44.9%, respectively; study B: 86.7 vs42.9%, respectively; p 0.001 for both trials). Moreover, the majority of patients treated with spinosad required only 1course of treatment, compared to the majority of permethrin-treated patients who required 2 courses of treatment (pvalues not reported) (Stough et al 2009). Abametapir without nit combing was evaluated in 2 double-blind, vehicle-controlled studies in 704 patients aged 6months with head lice. All patients received a single application of either abametapir or vehicle control and wereevaluated through 14 days. For the evaluation of efficacy, the youngest patient from each household was considered tobe the index patient of the household (n 216). Other enrolled infested household members received the sametreatment as the youngest subject and were evaluated for all efficacy and safety parameters. Efficacy was assessed asthe proportion of index patients who were free of live lice at all follow-up visits on days 1, 7, and 14. In study 1, theproportion of index patients free of live lice at all visits was 81.1% with abametapir vs 50.9% with vehicle (p 0.001). Instudy 2, the proportion of index patients free of live lice at all visits was 81.8% with abametapir vs 47.2% with vehicle (p 0.001). The most frequently reported adverse events were erythema (4%), rash (3.2%), and skin burning sensation(2.6%) (Bowles et al 2018).CLINICAL GUIDELINESScabies Treatment guidelines from the CDC and the AAP state that permethrin 5% cream is the drug of choice for children 2months of age and older with scabies. Crotamiton is available as another option for adult patients, but frequent treatmentfailures have been reported with this agent. Oral ivermectin may be considered for patients who fail treatment or forthose who cannot tolerate topical therapies. Lindane is not recommended due to safety concerns, and the lotionformulation that was FDA-approved for scabies has been discontinued (AAP Red Book 2018, CDC 2015, CDC 2019[d],Clinical Pharmacology 2021). Crusted scabies should be treated using oral ivermectin in combination with a topical agent (CDC 2019[d]). Household members and sexual contacts of the affected individual should be treated even if they do not have any signsof an infestation, as it can take 4 to 8 weeks for symptoms to develop. To prevent re-infestation, all patients should betreated at the same time (CDC 2019[d]). All clothing, bedding, and towels require decontamination by laundering in hot water and drying in a hot dryer, drycleaning, or sealing in a plastic bag for 72 hours. The use of a fumigant or insecticide spray is not recommended (CDC2019[d]).Lice The CDC and the AAP recommend over-the-counter permethrin 1% or piperonyl butoxide/pyrethrin as antiparasitictherapy for the treatment of head lice. However, resistance to these compounds has been documented and cliniciansshould be aware of regional patterns of clinical resistance. According to the AAP, 1% permethrin or pyrethrins are areasonable first choice for treatment of head lice unless resistance to these products has been proven in the community(Devore et al 2015). Malathion (in patients 6 years of age or older), benzyl alcohol (no longer marketed), spinosadsuspension, or ivermectin lotion may be used for the treatment of head lice when treatment with permethrin 1% orpiperonyl butoxide/pyrethrin fails despite correct use (AAP Red Book 2018). The CDC lists each of these over-thecounter and prescription products as appropriate options without stating a treatment preference (CDC 2019[b]). The AAP no longer recommends lindane for use as treatment for head lice. Similarly, lindane is not recommended bythe CDC as a first-line treatment. According to the CDC, overuse, misuse, or accidentally swallowing lindane can betoxic to the nervous system; its use should be restricted to patients for whom prior treatments have failed or whocannot tolerate other medications that pose less risk. Lindane should not be used to treat premature infants, personswith human immunodeficiency virus, a seizure disorder, persons who have very irritated skin or sores where thelindane will be applied, women who are pregnant or breastfeeding, infants, children, the elderly, and persons whoweigh less than 110 pounds. Retreatment with lindane should be avoided. All clothing, bedding, and towels should be laundered in hot water and dried in a hot dryer to avoid another infestation.Items that cannot be washed can be dry-cleaned or sealed in a plastic bag for 2 weeks; combs and brushes should besoaked in hot water (at least 130 degrees Fahrenheit) for 5 to 10 minutes. The use of fumigants is not recommended(CDC 2019[a], CDC 2019[b], CDC 2019[c]).Data as of February 14, 2021 AKS/AVDPage 4 of 9This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorizedrecipients. The contents of the therapeutic class overviews on this website ("Content") are for informational purposes only. The Content is not intendedto be a substitute for professional medical advice, diagnosis, or treatment. Patients should always seek the advice of a physician or other qualified healthprovider with any questions regarding a medical condition. Clinicians should refer to the full prescribing information and published resources whenmaking medical decisions.

Non-pharmacological tactics should be used to treat body lice, such as laundering clothing and bedding in hot water aswell as regular bathing. If the prescriber determines that pharmacological treatment is necessary, the choice ofpediculicide should follow the same guidelines as used for head lice (CDC 2019[a]). The CDC recommends permethrin 1% or the combination of piperonyl butoxide and pyrethrins as safe and effectivetherapies for pubic lice. Lindane shampoo is not recommended as a first-line therapy due to toxicities (CDC 2019[c]).SAFETY SUMMARY Lindane carries a boxed warning for neurologic toxicity, contraindications, and proper use. Lindane should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications. Neurologic toxicity has been reported with lindane use, including seizures and deaths; use with caution in infants,children, the elderly, individuals with other skin conditions, and individuals who weigh less than 110 pounds (50 kg). Lindane is contraindicated in premature infants and individuals with known uncontrolled seizure disorders. Patients should be instructed on the proper use of lindane including amount to apply, how long to leave on, andavoiding retreatment. Lindane is contraindicated in patients with crusted (Norwegian) scabies and other skin conditions such as atopicdermatitis or psoriasis that may increase systemic absorption of the drug. Malathion lotion is contraindicated in neonates and infants because their scalps are more permeable and may haveincreased absorption of malathion. Malathion lotion is flammable; patients should be instructed to allow hair to drynaturally after application and avoid use of any electric heat source. All topical scabicide and pediculicide products are contraindicated in patients with a sensitivity or allergy to any active orinactive ingredient in the product. For the class, adverse events are mostly dermatological in nature. Lindane should be used with caution with any drug that is known to lower the seizure threshold. Drug interactions for theremaining products in this class are minimal due to the topical application. Natroba and Xeglyze contain benzyl alcohol, which has been associated with serious and fatal adverse reactionsincluding “gasping syndrome” in neonates and low birth weight infants. In order to prevent accidental ingestion inpediatric patients, these agents should only be administered under direct supervision of an adult. Products have not been evaluated in the elderly; caution should be exercised when used in this population.Table 3. Specific PopulationsDrugPregnancyCrotan (crotamiton)Category C*LindaneCategory C*Natroba (spinosad)Category B*Ovide (malathion)Category B*Nursing MothersLactation information is notavailable from the manufacturerso it is unknown whether excretedin breast milk; use with caution.Enters breast milk; use iscontraindicated. Discard milk forat least 24 hours after application.Spinosad is not present in breastmilk. However, Natroba alsocontains benzyl alcohol whichmay be systemically absorbedthrough the skin. Use only ifbenefits outweigh the risks anddiscard breast milk for at least 8hours after use.Unknown whether excreted inbreast milk; use with caution.PediatricsSafety and effectiveness inpediatric patients have notbeen established.Avoid use in infants and youngchildren due to a higherincidence of adverse reactionsand risk of toxicity in this agegroup.Should not be used in childrenyounger than 6 months old dueto risk of benzyl alcoholtoxicity.Should not be used in childrenyounger than 6 years old.Data as of February 14, 2021 AKS/AVDPage 5 of 9This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorizedrecipients. The contents of the therapeutic class overviews on this website ("Content") are for informational purposes only. The Content is not intendedto be a substitute for professional medical advice, diagnosis, or treatment. Patients should always seek the advice of a physician or other qualified healthprovider with any questions regarding a medical condition. Clinicians should refer to the full prescribing information and published resources whenmaking medical decisions.

DrugPermethrinPregnancyCategory B*Nursing MothersUnknown whether excreted inbreast milk; due to tumorigenicpotential in animal studies,consider discontinuing nursingtemporarily or withholding thedrug while nursingUnknown whether excreted inbreast milk; use with caution.PediatricsShould not be used in childrenyounger than 2 months old.Piperonyl butoxide andpyrethrinsCategory C*Sklice (ivermectin)Unclassified†: Nostudies evaluating usein pregnant women.Observational studieshave not revealedadverse effects, butthese studies cannotdefinitively rule out anydrug-associated risk.Following oral administration, it isexcreted in human milk in lowamounts; this has not beenevaluated following topicaladministration.Should not be used in childrenyounger than 6 months old.Xeglyze (abametapir)Unclassified†: NoUnknown whether excreted instudies evaluating usebreast milk; use with caution.in pregnant women.Animal model studieshave not revealedadverse effects in allstudies. These studiescannot definitively ruleout any drug-associatedrisk.Should not be used in childrenyounger than 2 years old.Should not be used in childrenyounger than 6 months old.*Pregnancy Category B No evidence of risk in humans, but there remains a remote possibility. Animal reproduction studies have failed to demonstratea risk to the fetus, and there are no adequate and well-controlled studies in pregnant women. Pregnancy Category C Risk cannot be ruled out. Animalreproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefitsmay warrant use of the drug in pregnant women despite potential risks.†In accordance with the FDA’s Pregnancy and Lactation Labeling Rule (PLLR), this product is not currently assigned a Pregnancy Category. Consultproduct prescribing information for details.DOSING AND ADMINISTRATIONTable 4. Dosing and AdministrationAvailableDrugFormulationsCrotan eUsual RecommendedFrequencyApply thoroughly from chin totoes, including skin folds andunder fingernails; a secondapplication is recommended 24hours later. A cleansing bathshould be taken 48 hours afterthe last application.Apply to dry hair and leave inplace for 4 minutes. Then add asmall amount of water until agood lather forms andimmediately rinse. Retreatmentis not recommended.CommentsData as of February 14, 2021 AKS/AVDPage 6 of 9This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorizedrecipients. The contents of the therapeutic class overviews on this website ("Content") are for informational purposes only. The Content is not intendedto be a substitute for professional medical advice, diagnosis, or treatment. Patients should always seek the advice of a physician or other qualified healthprovider with any questions regarding a medical condition. Clinicians should refer to the full prescribing information and published resources whenmaking medical decisions.

Natroba ide (malathion)LotionTopicalPermethrinAerosol, cream, Topicalcrème rinse,lotionScabies: Apply 5% cream fromhead to soles of feet. Wash offafter 8 to 14 hours. Applicationmay be repeated after 14 days iflive mites are still present.Piperonyl butoxide andpyrethrinsShampoo,crème rinseTopicalSklice (ivermectin)LotionTopicalApply to hair and scalp. Leave on If first application is appliedfor no more than 10 minutes then on wet hair, reapply after 24rinse. Treatment should behours.repeated after 7 to 10 days ondry hair.Apply to dry hair and scalp.Leave on for 10 minutes thenrinse with water. Wait 24 hoursbefore using shampoo. Forsingle use only; do not re-treat.Xeglyze (abametapir)*LotionTopicalDrugSee the current prescribing information for full details*Launch plans are pending.RouteUsual RecommendedFrequencyApply to dry scalp and hair; washoff after 10 minutes. A secondtreatment may be applied after 7days if live lice are still seen.Apply to dry hair. Leave on 8 to12 hours then shampoo andrinse. May repeat with a secondapplication after 7 to 9 days if liceare still present.CommentsProduct is flammable; avoidsmoking, open flame, andhair dryers. Allow hair to drynaturally and uncovered.The 5% cream formulationis approved for scabies andis available by prescriptiononly; the 1% crème rinseand lotion are approved forhead lice and are availableLice: Apply 1% crème rinse/lotion OTC.on the scalp and damp hair.Leave on for 10 minutes thenrinse with water. May repeat after7 days if live lice are still present.Apply to dry hair and scalp.Leave on for 10 minutes thenrinse.CONCLUSION There are a number of effective topical scabicide and pediculicide agents available including Crotan (crotamiton),lindane, Ovide (malathion), Natroba (spinosad), permethrin, piperonyl butoxide with pyrethrins, Sklice (ivermectin), andXeglyze (abametapir). Permethrin may be used as a first-line therapy for treatment of scabies and lice, despiteincreasing resistance in the United States (Downs et al 1999, CDC 2019[b], CDC 2019[d], Devore et al 2015). Permethrin 1% and the combination of pyrethrins and piperonyl butoxide are available OTC; the remaining agents areavailable by prescription (CDC 2019[b]). The FDA has approved Sklice for OTC use, and the prescription product will bephased out; the specific timing of the switch to OTC availability is pending. According to the AAP, 1% permethrin or pyrethrins are reasonable first choices for treatment of head lice unlessresistance to these products has been proven in the community (Devore et al 2015). Malathion (in patients 6 years ofage or older), benzyl alcohol (no longer marketed), spinosad suspension, or ivermectin lotion may also be used (CDC2019[b]). Lindane, a well-known older agent, is reserved as second-line therapy and carries a boxed warning describingData as of February 14, 2021 AKS/AVDPage 7 of 9This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorizedrecipients. The contents of the therapeutic class overviews on this website ("Content") are for informational purposes

It is approved as a single-application product (Xeglyze prescribing information 2020). Some data suggest a growing resistance to permethrin in the United States for the treatment of head lice, with recent . (Soolantra) indicated for rosacea and an oral tablet (Strom