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  • CLASSES

    Ectoparasiticides, Including Scabicides
    Insecticides and Repellents
    Topical Scabacides

    DEA CLASS

    Rx, OTC

    DESCRIPTION

    Synthetic pyrethroid used primarily as topical scabicide and pediculicide; residual activity after rinsing; ovicidal; 97-99% cure rate for head lice; better tolerated than lindane; available OTC.

    COMMON BRAND NAMES

    Acticin, Elimite, Nix Lice Killing Creme Rinse

    HOW SUPPLIED

    Acticin/Elimite/Permethrin Topical Cream: 5%
    Nix Lice Killing Creme Rinse Topical Lotion: 1%

    DOSAGE & INDICATIONS

    For the treatment of pediculosis.
    NOTE: For proper treatment of pediculosis, nits (eggs) should be removed with a nit comb. Also, all personal headgear, scarfs, coats, and bed linen should be disinfected by machine washing in hot water and drying using the hot cycle of a dryer for at least 20 minutes. Personal articles that cannot be washed may be dry-cleaned, sealed in a plastic bag for 4 weeks, or sprayed with a product specifically designed for this purpose. Personal combs and brushes may be disinfected by soaking in hot water (above 130 degrees F) for 5 to 10 minutes.
    For the treatment of pediculosis capitis (head lice infestation) due to Pediculus capitis.
    Topical dosage
    Adults, Adolescents, Children, and Infants >= 2 months

    Shampoo hair with regular shampoo, rinse and towel dry. Then, apply permethrin 1% lotion sufficient to saturate the hair and scalp (usually 25 to 30 mL), especially behind the ears and on the nape of the neck. Leave on hair for 10 minutes but no longer. Then, rinse thoroughly with water. Retreatment is required in less than 1% to 2% of patients. If live lice are seen 7 days or more after the first application, a second treatment should be given. In cases of multiple treatment failures or resistance, combination therapy may be an effective alternative. In 1 study, 115 children aged 2 to 13 years randomly received 1 of 3 treatment regimens: topical 1% permethrin, SMX-TMP (5 mg/kg/dose [based on the trimethoprim component] PO twice daily for 10 days), or the combination of topical 1% permethrin and oral SMX-TMP. At 2-week follow-up, the success rates were 79.5%, 83%, and 95%, respectively. At 4-weeks, the success rates were 72%, 78%, and 92.5%, respectively. Oral SMX-TMP either alone or combined with topical 1% permethrin was an effective alternative for head lice infestation; however, this therapy should be reserved for cases of resistant lice or multiple treatment failures.

    For the treatment of pediculosis pubis†.
    Topical dosage
    Adults

    The CDC recommends applying permethrin 1% cream rinse topically to affected areas and washed off after 10 minutes. Patients should be evaluated 1 week after therapy and retreatment may be necessary.

    For pediculosis prophylaxis.
    NOTE: Prophylaxis is only recommended for individuals exposed to head lice epidemics in which at least 20% of the population at an institution are infested and for immediate household members of the infested individuals.
    Topical dosage
    Adults, Adolescents, Children, and Infants >= 2 months

    Shampoo hair with regular shampoo, rinse and towel dry. Then, apply topical permethrin 1% lotion sufficient to saturate the hair and scalp (usually 25 to 30 mL), especially behind the ears and on the nape of the neck. Leave on hair for 10 minutes but no longer. Then, rinse thoroughly with water. One application has been shown to protect more than 95% of patients against reinfestation for at least 2 weeks. In epidemic settings, a second prophylactic application is recommended 2 weeks after the first since the life cycle of a head louse is approximately 4 weeks.

    For the treatment scabies infection, including crusted (Norwegian) scabies†.
    For the treatment of crusted (Norwegian) scabies†.
    Topical dosage (Permethrin 5% cream)
    Adults

    The CDC recommends ivermectin oral dosing along with the use of a topical scabicide. The CDC recommends a full body application (all body parts from neck down) of permethrin 5% cream topically daily for 7 days and then 2 times weekly until release from care or cure in combination with oral ivermectin. Ivermectin (200 mcg/kg PO) is given as 5 doses (approximately days 1, 2, 8, 9, and 15), with consideration of 2 additional doses (approximately days 22 and 29) for severe infestations. A topical keratolytic cream may also be used to help reduce the crusting of the skin. Re-treatment 2 weeks after the initial treatment regimen can be considered for those persons who are still symptomatic or when live mites are observed. Use of an alternative regimen is recommended for those persons who do not respond initially to the recommended treatment. Optimal regimens are not yet determined.

    Topical dosage (Permethrin 5% cream)
    Adults, Adolescents, Children, and Infants 2 months and older

    Massage 5% topical cream into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for the average adult. Wash cream off after 8 to 14 hours. One application is generally curative. Although pruritus may persist after treatment, this is rarely a sign of treatment failure and is not an indication for retreatment. Retreatment is indicated if living mites persist after 7 to 14 days of initial treatment.

    †Indicates off-label use

    MAXIMUM DOSAGE

    One application to affected area; do not repeat for >= 7 days.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Topical Administration

    Permethrin is administered topically. Avoid getting into the eyes. Do not ingest.

    Cream/Ointment/Lotion Formulations

    Elimite topical cream: For the treatment of scabies, thoroughly massage cream into the skin from the head to the soles of the feet. Remove by washing after 8—14 hours.

    Other Topical Formulations

    Nix Creme Rinse: Shake well before using. For the treatment of head lice, apply a sufficient amount to saturate the hair and scalp, especially behind the ears and on the nape of the neck. Leave on hair for 10 minutes. Then, rinse thoroughly with water.

    STORAGE

    Generic:
    - Avoid extreme temperatures
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    - Store upright
    Acticin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Elimite:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Nix Lice Killing Creme Rinse:
    - Store between 68 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Use permethrin with caution in patients with hypersensitivity to other synthetic pyrethroids or pyrethrins, or to chrysanthemums. Many veterinary or household insecticides contain permethrin or other synthetic pyrethroids. Thus, permethrin should be used with caution in patients sensitive to these insecticides.
     
    In cases of pediculosis capitis, self-medication of permethrin is not recommended if infestation of the eyebrows or eyelashes occurs. A physician should be consulted in these situations.
     
    Permethrin was not mutagenic when evaluated in several in vitro and in vivo genetic toxicity studies.

    Ocular exposure

    Permethrin-containing products are for external use only. In the event of ocular exposure, immediately flush eye with water.

    Infants, neonates

    Safe and effective use of permethrin has not been established in neonates or infants less than 2 months of age.

    Pregnancy

    Permethrin is classified as pregnancy category B. Reproductive studies in animals revealed no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Thus, permethrin should be used during pregnancy only if clearly needed.

    Breast-feeding

    It is not known if permethrin is excreted in human milk. However, absorption of permethrin from the skin is minimal and is rapidly metabolized to inactive metabolites. The Centers for Disease Control and Prevention (CDC) recommends permethrin for use in breast-feeding patients with lice and scabies. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Moderate

    erythema / Early / 1.0-2.0
    edema / Delayed / Incidence not known

    Mild

    skin irritation / Early / 10.0-10.0
    pruritus / Rapid / 7.0-7.0
    rash / Early / 1.0-2.0
    hypoesthesia / Delayed / 1.0-2.0

    DRUG INTERACTIONS

    There are no drug interactions associated with Permethrin products.

    PREGNANCY AND LACTATION

    Pregnancy

    Permethrin is classified as pregnancy category B. Reproductive studies in animals revealed no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Thus, permethrin should be used during pregnancy only if clearly needed.

    It is not known if permethrin is excreted in human milk. However, absorption of permethrin from the skin is minimal and is rapidly metabolized to inactive metabolites. The Centers for Disease Control and Prevention (CDC) recommends permethrin for use in breast-feeding patients with lice and scabies. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action: Permethrin is active against a broad range of pests, including lice, ticks, fleas, mites, and other arthropods. Permethrin acts on the nerve cell membrane to disrupt the sodium channel current that regulates the polarization of the membrane. This results in delayed repolarization and subsequent paralysis and death of the parasites. Permethrin exhibits residual ovicidal activity after rinsing.

    PHARMACOKINETICS

    Permethrin is applied topically. The drug is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in urine.

    Topical Route

    Although the amount of permethrin absorbed after a single application of 5% cream has not been precisely determined, data indicate that 2% or less of the amount of drug applied is absorbed in patients with moderate to severe scabies.