VANIQA- eflornithine hydrochloride cream

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

EFLORNITHINE HYDROCHLORIDE (UNII: 4NH22NDW9H) (EFLORNITHINE - UNII:ZQN1G5V6SR)

थमां उपलब्ध:

Allergan, Inc.

INN (इंटरनेशनल नाम):

EFLORNITHINE HYDROCHLORIDE

रचना:

EFLORNITHINE HYDROCHLORIDE ANHYDROUS 139 mg in 1 g

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

VANIQA ®   (eflornithine hydrochloride) cream, 13.9% is indicated for the reduction of unwanted facial hair in women. VANIQA ® has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement. VANIQA ® is contraindicated in patients with a history of sensitivity to any components of the preparation.

उत्पाद समीक्षा:

VANIQA ® (eflornithine hydrochloride) cream, 13.9% is available as: 45 gram tube NDC 0023-4857-45 Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Do not freeze. See tube crimp and carton end for expiration date and lot number. Revised:   1 /201 8 Rx o nly Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners. 73326US11 -----Cut Here ----------------------------------------------------------------------------------------------------------------

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

VANIQA- EFLORNITHINE HYDROCHLORIDE CREAM
ALLERGAN, INC.
----------
VANIQA
(EFLORNITHINE HYDROCHLORIDE) CREAM, 13.9%
FOR TOPICAL DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
DESCRIPTION
VANIQA is a cream containing 13.9% (139 mg/g) of anhydrous
eflornithine hydrochloride as
eflornithine hydrochloride monohydrate (150 mg/g).
Chemically, eflornithine hydrochloride is (±) -2-(difluoromethyl)
ornithine monohydrochloride
monohydrate, with the empirical formula C H F N O • HCl•H O, a
molecular weight of 236.65 and
the following structural formula:
Anhydrous eflornithine hydrochloride has an empirical formula C H F N
O • HCl and a molecular
weight of 218.65.
Other ingredients include: ceteareth-20; cetearyl alcohol;
dimethicone; glyceryl stearate;
methylparaben; mineral oil; PEG-100 stearate; phenoxyethanol;
propylparaben; stearyl alcohol; and
water.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
There are no studies examining the inhibition of the enzyme ornithine
decarboxylase (ODC) in human
skin following the application of topical eflornithine. However, there
are studies in the literature that
report the inhibition of ODC activity in skin following oral
eflornithine. It is postulated that topical
eflornithine hydrochloride irreversibly inhibits skin ODC activity.
This enzyme is necessary in the
synthesis of polyamines. Animal data indicate that inhibition of
ornithine decarboxylase inhibits cell
division and synthetic functions, which affect the rate of hair
growth. VANIQA (eflornithine
hydrochloride) cream, 13.9% has been shown to retard the rate of hair
growth in non-clinical and
clinical studies.
PHARMACOKINETICS
The mean percutaneous absorption of eflornithine in women with
unwanted facial hair, from a 13.9%
w/w cream formulation, is less than 1% of the radioactive dose,
following either single or multiple
doses under conditions of clinical use, that included shaving within 2
hours before radiolabeled dose
application in addition to other forms of cutting or plucking, and
tweezing to rem