ULESFIA- benzyl alcohol lotion

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)

Доступна з:

Lachlan Pharmaceuticals

ІПН (Міжнародна Ім'я):

BENZYL ALCOHOL

Склад:

BENZYL ALCOHOL 50 mg in 1 g

Адміністрація маршрут:

TOPICAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

      ULESFIA®  Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.        ULESFIA®  Lotion does not have ovocidal activity.       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.       None.       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 studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.       No comparisons of animal exposure with human exposure are provided in this labeling due to the low systemic exposure noted in

Огляд продуктів:

ULESFIA®  Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion)        ● NDC 69202-780-08 as an 8 fl oz (227 g) in a polypropylene bottle       ● NDC 69202-780-88 as a package containing two individual 8 fl oz (NDC 69202-780-08) polypropylene bottles with a nit comb       Store at 20º C - 25º C (68º F - 77º F); excursions permitted to 15º C - 30º C (59º F - 86º F) [See USP controlled room temperature].       Do not freeze.

Статус Авторизація:

New Drug Application

Характеристики продукта

ULESFIA - BENZYL ALCOHOL LOTION
LACHLAN PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULESFIA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ULESFIA .
ULESFIA (BENZYL ALCOHOL) LOTION, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2009
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. (1.1)
ULESFIA Lotion does not have ovocidal activity. (1.2)
DOSAGE AND ADMINISTRATION
Apply ULESFIA Lotion to dry hair, using enough to completely saturate
the scalp and hair. (2)
Rinse off with water after 10 minutes. (2)
Repeat application in 7 days. (2)
TABLE 1: ULESFIA LOTION USAGE
GUIDE LINE
Hair Length
Amount of
ULESFIA Lotion
per Application
OUNCES 8 OZ BOTTLE
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 oz1-1½ bottles
8-16 inches 12-24 oz1½-3 bottles
Long
16-22 inches 24-32 oz 3-4 bottles
Over 22 inches 32-48 oz 4-6 bottles
DOSAGE FORMS AND STRENGTHS
Lotion, 5% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Neonatal toxicity: Risk of gasping syndrome if benzyl alcohol is used
in neonates. (5.1)
Eye irritation: Avoid eye exposure. Flush immediately with water if
ULESFIA Lotion comes into contact with eyes.
(5.2)
Contact dermatitis: May occur with ULESFIA Lotion. (5.3)
Use in children: ULESFIA Lotion should only be used on children under
the direct supervision of an adult. Keep out of
reach of children. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (> 1% and more common than with
placebo): ocular irritation, application site irritation,
and application site anesthesia and hypoesthesia. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LACHLAN PHARMACEUTICALS
AT 1-866-416-9637 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Drug interaction studies were not conducted. (7)
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety in pediatric patients under si