AZELEX- azelaic acid cream

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Almirall, LLC

Начин на приложение:

CUTANEOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris. AZELEX ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Каталог на резюме:

AZELEX ® cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes: 30 g - NDC 16110-869-30 50 g - NDC 16110-869-50 Storage: Protect from freezing. Store product on its side. Store at 15°-30° C (59°-86° F). Revised: 02/2024 Distributed by Almirall, LLC, Malvern, PA 19355, U.S.A. © 2019 Almirall. All right reserved. ® marks owned by Almirall, LLC. Made in Italy by LEO Pharma Manufacturing Italy S.r.l., Segrate (Milan), Italy

Статус Оторизация:

New Drug Application

Данни за продукта

AZELEX- AZELAIC ACID CREAM
ALMIRALL, LLC
----------
AZELEX
(AZELAIC ACID CREAM) 20%
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION
AZELEX (azelaic acid cream) 20% contains azelaic acid, a naturally
occurring saturated
dicarboxylic acid.
Structural Formula: HOOC-(CH ) -COOH
Chemical Name: 1,7-heptanedicarboxylic acid
Empirical Formula: C H
O
Molecular Weight: 188.22
ACTIVE INGREDIENT: Each gram of AZELEX contains azelaic acid.........
0.2 g (20%
w/w).
INACTIVE INGREDIENTS: cetearyl octanoate; cetostearyl alcohol;
glycerin; glyceryl mono
and dipalmitostearate; glyceryl monostearate; isopropyl myristate;
PEG-30 stearate;
propylene glycol; and purified water. Benzoic acid is present as a
preservative.
CLINICAL PHARMACOLOGY
The exact mechanism of action of azelaic acid is not known. The
following _in vitro_ data
are available, but their clinical significance is unknown. Azelaic
acid has been shown to
possess antimicrobial activity against _Propionibacterium acnes_ and
_Staphylococcus_
_epidermidis._ The antimicrobial action may be attributable to
inhibition of microbial cellular
protein synthesis.
A normalization of keratinization leading to an anticomedonal effect
of azelaic acid may
also contribute to its clinical activity. Electron microscopic and
immunohistochemical
evaluation of skin biopsies from human subjects treated with AZELEX
cream
demonstrated a reduction in the thickness of the stratum corneum, a
reduction in
number and size of keratohyalin granules, and a reduction in the
amount and
distribution of filaggrin (a protein component of keratohyalin) in
epidermal layers. This is
suggestive of the ability to decrease microcomedo formation.
PHARMACOKINETICS
Following a single application of AZELEX cream to human skin _in
vitro_, azelaic acid
penetrates into the stratum corneum (approximately 3 to 5% of the
applied dose) and
other viable skin layers (up to 10% of the dose is found in the
epidermis and dermis).
Negligible cutaneous metabolism occurs after topical application.
Approximately 4% of
the