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  • CLASSES

    Ectoparasiticides, Including Scabicides

    DEA CLASS

    Rx

    DESCRIPTION

    Benzyl alcohol lotion is a topical pediculicide.
    Used for the treatment of pediculosis capitis (i.e., head lice).
    Amount of lotion to use depends on hair length; always repeat treatment in 7 days.

    COMMON BRAND NAMES

    Ulesfia

    HOW SUPPLIED

    Ulesfia Topical Lotion: 5%

    DOSAGE & INDICATIONS

    For the topical treatment of pediculosis capitis (head lice infestation) due to Pediculus capitis.
    Topical dosage

    NOTE: The amount of lotion that should be used for each treatment is determined by the length of hair to be treated.

    Adults, Adolescents, Children, and Infants >= 6 months with short hair (0—2 inches)

    Apply 4 to 6 ounces (one-half to three-quarters bottle) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

    Adults Adolescents, Children, and Infants >= 6 months with short hair (2 to 4 inches)

    Apply 6 to 8 ounces (three-quarters to one bottle) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

    Adults, Adolescents, Children, and Infants >= 6 months with medium hair (4 to 8 inches)

    Apply 8 to 12 ounces (1 to 1.5 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

    Adults, Adolescents, Children, and Infants >= 6 months with medium hair (8 to 16 inches)

    Apply 12 to 24 ounces (1.5 to 3 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

    Adults, Adolescents, Children, and Infants >= 6 months with long hair (16 to 22 inches)

    Apply 24 to 32 ounces (3 to 4 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

    Adults, Adolescents, Children, and Infants >= 6 months with long hair (> 22 inches)

    Apply 32 to 48 ounces (4 to 6 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

    MAXIMUM DOSAGE

    Adults

    <= 60 years: 1 application/week.
    > 60 years: Safety has not been established.

    Geriatric

    Safety has not been established.

    Adolescents

    1 application/week.

    Children

    1 application/week.

    Infants

    >= 6 months: 1 application/week.
    < 6 months: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    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
    Cream/Ointment/Lotion Formulations

    Application of Ulesfia (benzyl alcohol) topical lotion:
    Benzyl alcohol lotion is administered topically to the scalp. It is not for oral, ophthalmic, or intravaginal use.
    Cover the face and eyes of the child or patient with a towel and keep their eyes closed tightly.
    Apply lotion directly to dry hair. Lotion must cover the entire scalp and all scalp hair. An adult should apply the lotion to a child or other patient needing assistance.
    Massage the lotion into the hair and scalp. When the head is completely covered with enough lotion, dripping will happen. Protect the eyes and skin from these drips with the towel.
    Be sure to apply lotion to the area behind the ears.
    Be sure to apply lotion to the back of the neck.
    If not enough lotion is used, some lice may escape treatment. It is important to use the full amount of lotion prescribed.
    Allow lotion to stay on the hair for 10 minutes. Use a timer or clock. Start timing after completely covering the hair and scalp with lotion.
    After 10 minutes, completely rinse lotion from hair and scalp with water.
    Wash your hands after application.
    Hair may be shampooed right after the treatment.
    One week (7 days) after the first treatment, repeat the steps above to help get rid of lice that hatched from eggs.
    A lice comb may be used to remove the dead lice after both treatments.
    Use lotion 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.

    STORAGE

    Ulesfia:
    - Do not freeze
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Benzyl alcohol hypersensitivity, ocular exposure

    Use benzyl alcohol lotion with caution in any patient with a known benzyl alcohol hypersensitivity or reaction to any of the product components. Allergic or contact dermatitis may occur. Also avoid ocular exposure to benzyl alcohol. Benzyl alcohol may cause eye irritation. If contact with the eyes occurs, instruct patients to flush immediately with water and contact a health care professional if irritation persists.

    Geriatric

    The safety of topical benzyl alcohol lotion has not been established in geriatric patients over 60 years.

    Infants, neonates, premature neonates

    The safety and efficacy of benzyl alcohol lotion has not been established in neonates (including premature neonates) and infants less than 6 months of age. Infants under 6 months of age exhibit the potential for increased systemic absorption due to a high ratio of skin surface area to body mass and an immature skin barrier. Products with benzyl alcohol should not be used in neonates. Benzyl alcohol has been associated with 'gasping syndrome' in neonatal populations, characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high blood and urine concentrations of benzyl alcohol and its metabolites. Additional symptoms may include gradual neurologic deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic failure, renal failure, hypotension, bradycardia, and cardiovascular collapse.

    Pregnancy

    Benzyl alcohol lotion is classified in FDA pregnancy Category B. Animal studies of benzyl alcohol lotion produced no evidence of developmental toxicity. There are no adequate and well-controlled studies in pregnant women. Thus, it is not known whether this drug will cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to a pregnant woman with caution and only if clearly needed.

    Breast-feeding

    According to the manufacturer, it is not known whether benzyl alcohol is excreted in human milk following topical maternal application. Because some systemic absorption of benzyl alcohol may occur after topical application, caution should be exercised when benzyl alcohol is administered to a nursing mother. 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 ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Moderate

    erythema / Early / 7.0-10.0
    hyperesthesia / Delayed / 1.0-1.0
    contact dermatitis / Delayed / 0.1-1.0

    Mild

    pruritus / Rapid / 12.0-12.0
    ocular irritation / Rapid / 6.0-6.0
    skin irritation / Early / 2.0-2.0
    hypoesthesia / Delayed / 2.0-2.0
    xerosis / Delayed / 0.1-1.0
    paresthesias / Delayed / 0.1-1.0
    rash (unspecified) / Early / 0.1-1.0

    DRUG INTERACTIONS

    There are no drug interactions associated with Benzyl Alcohol products.

    PREGNANCY AND LACTATION

    Pregnancy

    Benzyl alcohol lotion is classified in FDA pregnancy Category B. Animal studies of benzyl alcohol lotion produced no evidence of developmental toxicity. There are no adequate and well-controlled studies in pregnant women. Thus, it is not known whether this drug will cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to a pregnant woman with caution and only if clearly needed.

    According to the manufacturer, it is not known whether benzyl alcohol is excreted in human milk following topical maternal application. Because some systemic absorption of benzyl alcohol may occur after topical application, caution should be exercised when benzyl alcohol is administered to a nursing mother. 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 ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Benzyl alcohol inhibits lice from closing their respiratory spiracles, which results in obstruction of the spiracles by the vehicle and subsequent asphyxiation of the lice. Benzyl alcohol does not have ovicidal activity.

    PHARMACOKINETICS

    Benzyl alcohol is administered topically to the hair and scalp. The metabolism and excretion of locally applied benzyl alcohol is unknown.

    Topical Route

    The topical absorption of benzyl alcohol was studied in nineteen pediatric subjects with head lice infestation. The subjects were divided into 2 age groups: 6 months to 3 years, and 4 to 11 years. Quantifiable amounts of benzyl alcohol were found in the plasma of 4 patients after topical application of benzyl alcohol lotion for an exposure period 3 times greater than the normal exposure period. Of 102 analyzed samples, three subjects in the younger age group had plasma concentrations ranging from 1.97 to 2.99 mcg/mL one-half hour after treatment and one subject in the older age group had a plasma concentration of 1.63 mcg/mL 1 hour after treatment.