ULESFIA Lotion (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Cerecor, Inc.

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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. ...

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 ...

3. Dosage Forms and Strengths

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, ...

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 ...

7. Drug Interactions

Drug interaction studies were not conducted with ULESFIA Lotion.

8.1. Pregnancy

Pregnancy Category B. There are no adequate and well-controlled studies with topical benzyl alcohol in pregnant women. Reproduction studies conducted in rats and rabbits were negative. Because animal reproduction ...

8.3. Nursing Mothers

It is not known whether benzyl alcohol is excreted into human milk. Because some systemic absorption of topical benzyl alcohol may occur and because many drugs are excreted in human milk, caution should ...

8.4. Pediatric Use

The safety and effectiveness of ULESFIA Lotion was evaluated in two multicenter, randomized, double-blind, vehicle-controlled studies which were conducted in 628 subjects 6 months of age and older with ...

8.5. Geriatric Use

The safety of ULESFIA Lotion in patients over 60 years of age has not been established.

10. Overdosage

If oral ingestion occurs, seek medical advice immediately.

11. 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, ...

12.1. Mechanism of Action

<em>In vitro</em> 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 ...

12.3. 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 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of ULESFIA Lotion have not been conducted. No evidence of carcinogenic activity was noted for benzyl alcohol in 2 year oral carcinogenicity ...

14. Clinical Studies

Two multicenter, randomized, double-blind, vehicle-controlled studies were conducted in 628 subjects 6 months of age and older with active head lice infestation. For the evaluation of efficacy, the youngest ...

16.1. How Supplied

ULESFIA Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion) NDC 23594-780-08 as an 8 fl oz (227 g) in a polypropylene bottle NDC 23594-780-88 as a package containing two ...

16.2. Storage and Handling

Store at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF) [See USP controlled room temperature]. Do not freeze.

17. Patient Counseling Information

"See FDA-approved patient labeling (Patient Information)" Inform the patient and caregiver of the following instructions: Apply ULESFIA Lotion for 10 minutes as directed in the ULESFIA Lotion Usage Guideline ...