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Ulesfia® (benzyl alcohol) Lotion

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DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED

(DESCRIPTION) top of page

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ULESFIA® Lotion safely and effectively. See full prescribing information for ULESFIA Lotion.

Ulesfia (benzyl alcohol) Lotion
For topical use only
Initial U.S. Approval: 2009

DESCRIPTION
Ulesfia (benzyl alcohol) Lotion is supplied as a white topical lotion containing benzyl alcohol, 5%. Inactive ingredients in this formulation are water, mineral oil, sorbitan monooleate, polysorbate 80, carbomer 934P and trolamine.

The active ingredient, benzyl alcohol, is a clear, colorless liquid with a mild aromatic odor. Benzyl alcohol has a molecular mass of 108.14 g/mol. The molecular formula is C7H8O.

CLINICAL PHARMACOLOGY: top of page

CLINICAL PHARMACOLOGY

Mechanism of Action
In vitro studies of the effect of Ulesfia Lotion on native, captured lice suggest that benzyl alcohol inhibits lice from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.

Pharmacokinetics
The absorption of benzyl alcohol from Ulesfia Lotion was evaluated in 19 subjects with head lice infestation. Subjects were divided into two age groups: 6 months to 3 years and 4 to 11 years. Ulesfia Lotion was applied for an exaggerated exposure period (3 times the normal exposure period). Benzyl alcohol was quantified in a single plasma sample in 4 out of 19 subjects (21%): three subjects in the 6 months to 3 years age group at 0.5 hour post-treatment (ranging from 1.97 to 2.99 mcg/mL) and one subject in the 4 to 11 year age group (1.63 mcg/mL) at 1 hour post-treatment out of a total of 102 samples analyzed.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE
--Ulesfia Lotion is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

--Ulesfia Lotion does not have ovocidal activity.

CONTRAINDICATIONS top of page

None.

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS

--Neonatal toxicity: Risk of gasping syndrome if benzyl alcohol is used in neonates.
--Eye irritation: Avoid eye exposure. Flush immediately with water if Ulesfia Lotion comes into contact with eyes.
--Contact dermatitis: May occur with Ulesfia Lotion.
--Use in children: Ulesfia Lotion should only be used on children under the direct supervision of an adult. Keep out of reach of children.


DRUG INTERACTIONS
Drug interaction studies were not conducted.

USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety in pediatric patients under six months of age has not been established.

ADVERSE REACTIONS top of page

Most common adverse reactions (> 1% and more common than with placebo): ocular irritation, application site irritation, and application site anesthesia and hypoesthesia.

To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Pharma, Inc. Drug Safety at 1-800-849-9707 ext. 1454 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION

Ulesfia Lotion is not for oral, ophthalmic, or intravaginal use.

Using the guideline in Table1, apply sufficient Ulesfia Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat treatment after 7 days. Avoid contact with eyes.

Table 1: Ulesfia Lotion Usage Guideline
Hair Length Amount of Ulesfia Lotion per Application
Ounces 4 oz bottle 8 oz bottle
Short 0-2 inches 4-6 oz 1-1 ½ bottles ½-¾ bottle
2-4 inches 6-8 oz 1 ½-2 bottles ¾-1 bottle
Medium 4-8 inches 8-12 oz 2-3 bottles 1-1½ bottles
8-16 inches 12-24 oz 3-6 bottles 1½-3 bottles
Long 16-22 inches 24-32 oz 6-8 bottles 3-4 bottles
Over 22 inches 32-48 oz 8-12 bottles 4-6 bottles

HOW SUPPLIED top of page

HOW SUPPLIED/STORAGE AND HANDLING

Ulesfia Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion) supplied as 4 fl oz (113 g) (NDC 59630-780-04) or as 8 fl oz (227 g) (NDC 59630-780-08) in polypropylene bottles.

Store at 20º - 25º C (68º - 77º F); excursions permitted to 15º - 30º C (59º - 86º F) [See USP controlled room temperature]..

Do not freeze. Keep out of reach of children.

REFERENCE

Package Insert data: 
Ulesfia
(benzyl alcohol)
Lotion, 5%

8 oz. (227 g)
Rx ONLY

For topical use on the scalp
hair and scalp only.

SHIONOGI PHARMA, INC.

DISTRIBUTED BY:
Shionogi Pharma, Inc.
Atlanta, GA 30328

MANUFACTURED BY:
Contract Pharmaceuticals Limited
Mississauga, ON L5N 6L6
Made in Canada
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