FINACEA- azelaic acid gel FINACEA- azelaic acid kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)

Available from:

Intendis Inc.

INN (International Name):

AZELAIC ACID

Composition:

AZELAIC ACID 0.15 g in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing. FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.

Product summary:

FINACEA Gel, 15%, is supplied in tubes in the following size: FINACEA Gel, 15% – 50 g tube – NDC 10922-825-02 Storage Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Distributed under license; U.S. Patent No 6,534,070 www.myfinacea.com © 2010, Intendis, Inc. All rights reserved. July 2010 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: Intendis Morristown, NJ 07962 Intendis is part of the Bayer Group 6706803

Authorization status:

New Drug Application

Summary of Product characteristics

FINACEA- AZELAIC ACID GEL
FINACEA- AZELAIC ACID
INTENDIS INC.
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FINACEA
(AZELAIC ACID) GEL, 15%
FOR DERMATOLOGIC USE ONLY-NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL
USE
RX ONLY
DESCRIPTION
FINACEA (azelaic acid) Gel, 15%, contains azelaic acid, a naturally
occurring saturated dicarboxylic
acid. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid, with
the molecular formula C H
O , a
molecular weight of 188.22, and the structural formula:
Azelaic acid is a white, odorless crystalline solid that is poorly
soluble in water at 20°C (0.24%), but
freely soluble in boiling water and in ethanol.
Each gram of FINACEA Gel, 15%, contains 0.15 gm azelaic acid (15% w/w)
as the active ingredient in
an aqueous gel base containing benzoic acid (as a preservative),
disodium EDTA, lecithin, medium-
chain triglycerides, polyacrylic acid, polysorbate 80, propylene
glycol, purified water, and sodium
hydroxide to adjust pH.
CLINICAL PHARMACOLOGY
The mechanism(s) by which azelaic acid interferes with the pathogenic
events in rosacea are unknown.
PHARMACOKINETICS :
The percutaneous absorption of azelaic acid after topical application
of FINACEA Gel, 15%, could not
be reliably determined. Mean plasma azelaic acid concentrations in
rosacea patients treated with
FINACEA Gel, 15%, twice daily for at least 8 weeks are in the range of
42 to 63.1 ng/mL. These
values are within the maximum concentration range of 24.0 to 90.5
ng/mL observed in rosacea patients
treated with vehicle only. This indicates that FINACEA Gel, 15%, does
not increase plasma azelaic
acid concentration beyond the range derived from nutrition and
endogenous metabolism.
_In vitro_ and human data suggest negligible cutaneous metabolism of
H-azelaic acid 20% cream after
topical application. Azelaic acid is mainly excreted unchanged in the
urine, but undergoes some ß-
oxidation to shorter chain dicarboxylic acids.
CLINICAL STUDIES
FINACEA Gel, 15%, was evaluated for the treatment of mild to moderate
papulopustular rosacea in 2
clinical trials comprising a total o