Medication Guide App

Ulesfia

Generic Name: Benzyl Alcohol
Class: Scabicides and Pediculicides
VA Class: AP300
Chemical Name: Benzenemethanol; Benzyl alcohol
Molecular Formula: C7H8O
CAS Number: 100-51-6

Introduction

Aromatic alcohol;4 7 10 pediculicide.1 2 4 10

Uses for Ulesfia

Pediculosis

Topical treatment of pediculosis capitis (head lice infestation) in adults and pediatric patients ≥6 months of age.1 2

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AAP usually recommends topical permethrin 1% or topical pyrethrins with piperonyl butoxide for initial treatment;3 these experts state benzyl alcohol 5% may be considered for patients ≥6 months of age in geographic areas with known resistance to permethrin or pyrethrins or for a documented infestation that did not respond to permethrin or pyrethrins.3

Ulesfia Dosage and Administration

General

Measures to Avoid Reinfestation and Transmission

  • To avoid reinfestation or transmission of lice, most experts recommend that clothing, hats, bed linen, and towels that were worn or used by the infested individual during the 2 days prior to treatment should be decontaminated (machine-washed in hot water and dried in a hot dryer).1 3 4

  • Items that cannot be laundered can be dry-cleaned or sealed in a plastic bag for 2 weeks.3 4

  • Decontaminate combs, brushes, and hair clips used by the infested individual by soaking in hot water (>54°C) for 5–10 minutes.1 3 4

  • Thoroughly vacuum car seats, upholstered furniture, and floors of rooms inhabited by infested individual.3 4 Fumigation of living areas is not necessary.3 4

  • Other family members and close contacts of the infested individual should be evaluated and treated if lice infestation is present.3 4 Some clinicians suggest treating family members who share a bed with the infested individual, even if no live lice are found on this family member.3 4 Ideally, treat all infested household members and close contacts at the same time.4

  • A fine-toothed or nit comb may be used to remove any remaining nits (eggs) or nit shells from the hair.1 3 4 Some clinicians do not consider nit removal necessary since only live lice can be transmitted, but recommend it for aesthetic reasons and to decrease diagnostic confusion and unnecessary retreatment.3 Other clinicians recommend removal of nits (especially those within 1 cm of the scalp) to decrease risk of reinfestation since no pediculicide is 100% ovicidal and potentially viable nits may remain on the hair after treatment.3 Although many schools will not allow children with nits to attend, AAP and other experts consider these no-nit policies excessive.3

Administration

Topical Administration

Apply topically to scalp hair as a 5% lotion.1

For external use only.1 Do not administer orally or intravaginally; do not apply topically to eyes.1

Apply to dry scalp hair in amount sufficient to completely saturate scalp and hair.1 (See Dosage under Dosage and Administration.) Massage into the hair and scalp, including areas on back of neck and behind ears.1 Leave lotion on hair and scalp for 10 minutes, then thoroughly rinse off with warm (not hot) water.1 3 Minimize exposing other areas of skin by performing rinse at a sink (rather than in shower or bath).3 Hair may be shampooed after lotion is rinsed off.1

Avoid contact with eyes.1 Eyes should be closed tightly and covered with a soft towel or washcloth while the lotion is applied to or washed off of scalp hair.1 If contact with the eyes occurs, immediately flush with water.1

Supervise pediatric patients during lotion application;1 an adult should apply and rinse the lotion for the child.1

Wash hands thoroughly after applying lotion.1

Dosage

Pediatric Patients

Pediculosis
Pediculosis Capitis (Head Lice Infestation)
Topical

Infants and children ≥6 months of age: Manufacturer recommends 2 applications given 7 days apart.1

Apply to dry scalp hair in an amount sufficient to thoroughly saturate hair and scalp, including areas on back of neck and behind ears.1 Recommended amount of lotion for each application depends on hair length (see Table 1).1 Lotion will drip when adequate coverage achieved.1 (See Administration under Dosage and Administration.)After 10 minutes, thoroughly rinse lotion off with warm water.1 Repeat application 7 days after initial application.1

Table 1. Recommended Volume of Benzyl Alcohol 5% Lotion Based on Hair Length.1

Hair Length

Volume of Benzyl Alcohol 5% Lotion per Application

Equivalent Number of 4- Ounce Bottles

Equivalent Number of 8- Ounce Bottles

Short (<2 inches)

4–6 ounces

1–1.5 bottles

0.5–0.75 bottle

Short (2–4 inches)

6–8 ounces

1.5–2 bottles

0.75–1 bottle

Medium (4–8 inches)

8–12 ounces

2–3 bottles

1–1.5 bottles

Medium (8–16 inches)

12–24 ounces

3–6 bottles

1.5–3 bottles

Long (16–22 inches)

24–32 ounces

6–8 bottles

3–4 bottles

Long (>22 inches)

32–48 ounces

8–12 bottles

4–6 bottles

Adults

Pediculosis
Pediculosis Capitis (Head Lice Infestation)
Topical

Manufacturer recommends 2 applications given 7 days apart.1

Apply to dry scalp hair in an amount sufficient to thoroughly saturate hair and scalp, including areas on back of neck and behind ears.1 Recommended amount of lotion for each application depends on hair length (see Table 1).1 Lotion will drip when adequate coverage achieved.1 (See Administration under Dosage and Administration.)After 10 minutes, thoroughly rinse lotion off with warm water.1 Repeat application 7 days after initial application.1

Special Populations

No special population dosage recommendations.1

Cautions for Ulesfia

Contraindications

  • No known contraindications.1

Warnings/Precautions

Neonatal Toxicity

Risk of gasping syndrome if used in neonates (i.e., infants <1 month of age or preterm infants with corrected age <44 weeks).1

Gasping syndrome has been associated with IV administration of products containing benzyl alcohol.1 10 Syndrome consists of severe metabolic acidosis, gasping respirations, progressive hypotension, seizures, CNS depression, intraventricular hemorrhage, and death in preterm, low-birthweight infants.1 10

Systemic exposure following topical application of benzyl alcohol 5% lotion expected to be lower than that associated with gasping syndrome;1 8 however, neonates and infants <6 months of age may be at risk of increased systemic absorption and the lower limit for toxicity is unknown.1 (See Pediatric Use under Cautions and see Special Populations under Pharmacokinetics.)

Ocular Irritation

May cause ocular irritation; avoid contact with eyes.1

Eyes should be closed tightly and covered with a soft towel or washcloth while the lotion is applied to or washed off of scalp hair.1

If lotion comes into contact with eyes, immediately flush with water.1 Persistent irritation warrants medical evaluation.1

Sensitivity Reactions

May cause allergic or contact dermatitis.1 7 10

Delayed-type contact dermatitis and immediate sensitivity reactions (e.g., urticaria, angioedema) reported rarely in patients receiving topical products containing benzyl alcohol as a preservative.7

Local Effects

Pruritus, erythema, and pyoderma reported more frequently with benzyl alcohol 5% lotion than with lotion vehicle alone.1 2

Application site reactions (i.e., irritation, anesthesia, hypoesthesia, pain) reported.1

May cause irritant dermatitis.1 7 10 Nonimmune contact reactions (e.g., urticaria, erythema, pruritus, angioedema) reported in patients receiving products containing benzyl alcohol.7 10

Specific Populations

Pregnancy

Category B.1

Lactation

Not known whether distributed into milk after topical application.1 Use with caution in nursing women.1

Pediatric Use

Safety and efficacy not established in infants <6 months of age;1 systemic absorption may be increased in this age group.1 (See Absorption under Pharmacokinetics.)Use only in infants and children ≥6 months of age.1

Neonates may be at risk of gasping syndrome.1 (See Neonatal Toxicity under Cautions.)

Keep out of reach of children;1 use in children only under the direct supervision of an adult.1

Geriatric Use

Safety not established in patients >60 years of age.1

Common Adverse Effects

Pruritus, erythema, pyoderma, ocular irritation, application site symptoms (irritation, anesthesia, hypoesthesia).1

Interactions for Ulesfia

No formal drug interaction studies to date.1

Ulesfia Pharmacokinetics

Absorption

Bioavailability

Low plasma concentrations achieved following topical application.1 8

In 19 children 6 months to 11 years of age with head lice infestation, only 4 (21%) had detectable plasma concentrations of benzyl alcohol (1.63–2.99 mcg/mL) after 30 minutes of scalp exposure to benzyl alcohol 5% lotion (3 times the recommended exposure period).1 8 Plasma concentrations were below the quantifiable limit (i.e., <1 mcg/mL) in all patients 3 hours after treatment.8

Special Populations

Infants <6 months of age may be at risk of increased systemic absorption of benzyl alcohol following topical application because of high ratio of skin surface area to body mass and possibility of immature skin barrier.1

Distribution

Extent

Following topical application, not known whether benzyl alcohol crosses the placenta or is distributed into milk.1

Elimination

Metabolism

Systemically absorbed benzyl alcohol is metabolized via oxidation to benzoic acid, which is then conjugated with glycine in the liver to form hippuric acid.10

Elimination Route

Excreted in urine as hippuric acid.10

Stability

Storage

Topical

Lotion

20–25°C (may be exposed to 15–30°C); do not freeze.1

Keep out of reach of children.1 (See Pediatric Use under Cautions.)

Actions and Spectrum

  • Used as a pediculicide; lacks ovicidal activity.1

  • In vitro studies indicate benzyl alcohol inhibits closure of louse respiratory spiracles, which allows the lotion vehicle to obstruct the spiracles and cause louse asphyxiation and death.1

  • Because of the mechanism of action, resistance to benzyl alcohol not expected to develop in lice.2 5

Advice to Patients

  • Advise patients to follow instructions for application and removal of lotion, including amount of lotion required and how long lotion is left on hair.1 Importance of second application 7 days after the initial application.1

  • Importance of adult supervision and assistance during treatment of children.1

  • Advise patient that the lotion is for topical use on scalp and scalp hair only and to avoid contact with eyes.1 Importance of washing hands after application.1

  • Advise patient that benzyl alcohol 5% lotion should not be administered orally or intravaginally.1 If inadvertently ingested, patients should seek immediate medical attention.1

  • Importance of informing clinician of existing dermatologic conditions or sensitivities prior to treatment.1

  • Advise patients that eye or skin irritation or contact sensitization may occur.1 If irritation develops, patient should immediately flush the affected area with water and contact clinician.1

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., dermatologic conditions).

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Benzyl Alcohol

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Lotion

5%

Ulesfia

Shionogi Pharma

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ulesfia 5% Lotion (SHIONOGI PHARMA): 227/$62.99 or 681/$176.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions January 30, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Shionogi Pharma, Inc. Ulesfia (benzyl alcohol) lotion prescribing information. Atlanta, GA; 2010 Dec.

2. Meinking TL, Villar ME, Vicaria M et al. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010; 27:19-24. [PubMed 20199404]

3. Frankowski BL, Bocchini JA, Council on School Health and Committee on Infectious Diseases. Head lice. Pediatrics. 2010; 126:392-403. [PubMed 20660553]

4. Centers for Disease Control and Prevention. Head lice treatment. From CDC website. Accessed 2011 Aug 8.

5. . Benzyl alcohol lotion for head lice. Med Lett Drugs Ther. 2009; 51:57-8.

6. Hussar DA. New drugs: tapentadol hydrochloride, tolvaptan, and benzyl alcohol. J Am Pharm Assoc (2003). 2009 Sep-Oct; 49:704-8.

7. Curry EJ, Warshaw EM. Benzyl alcohol allergy: importance of patch testing with personal products. Dermatitis. 2005; 16:203-8. [PubMed 16536335]

8. Adebowale A, Bashaw D (Center for Drug Evaluation and Research). Drug Approval Package: Benzyl Alcohol Lotion: Clinical Pharmacology Review. From FDA website. Accessed 2010 Oct 21.

9. Walker S. Center for Drug Evaluation and Research. Drug approval package: benzyl alcohol lotion: summary review. From FDA website. Accessed 2010 Oct 21.

10. Nair B. Final report on the safety assessment of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate. Int J Toxicol. 2001; 20 Suppl 3:23-50. [PubMed 11766131]

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