Ulesfia

ULESFIA- benzyl alcohol lotion
Concordia Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

1.1 Indication

ULESFIA ® Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

1.2 Limitation of Use

ULESFIA ® Lotion does not have ovocidal activity.

1.3 Adjunctive Measures

ULESFIA ® Lotion should be used 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.

2 DOSAGE AND ADMINISTRATION

ULESFIA® Lotion is not for oral, ophthalmic, or intravaginal use.

Using the guidelines in Table 1, 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 application after 7 days. Avoid contact with eyes.

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

3 DOSAGE FORM S AND STRENGTH S

ULESFIA® Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion).

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5. 1 Neonatal Toxicity

Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome consisting of severe metabolic acidosis, gasping respirations, progressive hypotension, seizures, central nervous system depression, intraventricular hemorrhage, and death in preterm, low birth weight infants. Neonates (i.e. patients less than 1 month of age or preterm infants with a corrected age of less than 44 weeks) could be at risk for gasping syndrome if treated with ULESFIA ® Lotion [see Use in Specific Populations ( 8.4)].

5.2 Eye Irritation

Avoid eye exposure. ULESFIA ® Lotion may cause eye irritation. If ULESFIA ® Lotion comes in contact with the eyes, flush them immediately with water. If irritation persists, consult a physician.

5. 3 Contact Derm a titis

ULESFIA ® Lotion may cause allergic or irritant dermatitis.

5.4 Use in Children

ULESFIA ® Lotion should only be used on children (6 months of age and older) under the direct supervision of an adult. Keep out of reach of children.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The rates of adverse reactions below were derived from two randomized, multi-center, vehicle-controlled clinical trials and one open-label study in subjects with head lice infestation.

Skin, scalp, and ocular irritation were monitored in the clinical trials. All subjects were queried about the presence of skin and scalp symptoms; the results are presented in Table 2.

Table 2: Monitored Adverse Reactions — Application Site Symptoms
Event ULESFIA ® Lotion Vehicle
Application site Irritation 2% (11/478) 1% (2/336)
Application site anesthesia &hypoesthesia 2% (10/478) 0% (0/336)
Pain 1% (5/478) 0% (1/336)

The subset of subjects who did not have pruritus, erythema, edema or pyoderma of skin and scalp, or ocular irritation prior to treatment were assessed for these signs and symptoms after treatment; the results are presented in Table 3.

Table 3: Monitored Adverse Reactions — Pruritus, Erythema, Pyoderma and Ocular Irritation with Onset After Treatment
Signs/Symptoms ULESFIA ® Lotion Vehicle
Pruritus 12% (14/116) 4% (3/67)
Erythema 10% (32/309) 9% (19/217)
Pyoderma 7% (22/308) 4% (10/230)
Ocular irritation 6% (26/428) 1% (3/313)

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: application site dryness, application site excoriation, paraesthesia, application site dermatitis, excoriation, thermal burn, dandruff, erythema, rash, and skin exfoliation.

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