TAZORAC- tazarotene gel

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

TAZAROTENE (UNII: 81BDR9Y8PS) (TAZAROTENE - UNII:81BDR9Y8PS)

Dostopno od:

Physicians Total Care, Inc.

INN (mednarodno ime):

TAZAROTENE

Sestava:

TAZAROTENE 1 mg in 1 g

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

TAZORAC® (tazarotene) Gel 0.05% and 0.1% are indicated for the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement. TAZORAC® (tazarotene) Gel 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of TAZORAC® Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. Retinoids may cause fetal harm when administered to a pregnant woman. In rats, tazarotene 0.05% gel, administered topically during gestation days 6 through 17 at 0.25 mg/kg/day (1.5 mg/m2 /day) resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day (2.75 mg/m2 total body surface area/day) tazarotene gel during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. Systemic daily

Povzetek izdelek:

TAZORAC® (tazarotene) Gel is available in concentration of  0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 gm and 100 gm sizes. NOTE: TAZORAC® (tazarotene) Gel should be stored at 25°C (77°F): excursion permitted to 15-30°C (59-86°F). RX ONLY ® Marks owned by Allergan, Inc. U.S. Patent Numbers 5,089,509; 5,914,334 and 6,258,830 ALLERGAN Irvine, California 92612, USA ©2004 Allergan, Inc. Printed in USA 8606X, 8607XA January 2004 71722US10P Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146 Pharmacist: Please cut or tear at dotted line and provide this patient package insert to your customer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Status dovoljenje:

New Drug Application

Lastnosti izdelka

TAZORAC - TAZAROTENE GEL
PHYSICIANS TOTAL CARE, INC.
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FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
DESCRIPTION
TAZORAC Gel is a translucent, aqueous gel and contains the compound
tazarotene, a member of the
acetylenic class of retinoids. It is for topical dermatologic use
only. The active ingredient is
represented by the following structural formula:
CHEMICAL NAME:
Ethyl 6-[2-(4,4-dimethylthiochroman-6-yl) ethynyl] nicotinate
CONTAINS :
ACTIVE: Tazarotene................................... 0.05% or 0.1%
(w/w)
PRESERVATIVE: Benzyl alcohol.................................. 1.0%
(w/w)
INACTIVES: Ascorbic acid, butylated hydroxyanisole, butylated
hydroxytoluene, carbomer 934P, edetate
disodium, hexylene glycol, poloxamer 407, polyethylene glycol 400,
polysorbate 40, purified water,
and tromethamine.
CLINICAL PHARMACOLOGY
Tazarotene is a retinoid prodrug which is converted to its active
form, the cognate carboxylic acid of
tazarotene (AGN 190299), by rapid deesterification in animals and man.
AGN 190299 (“tazarotenic
acid”) binds to all three members of the retinoic acid receptor
(RAR) family: RARα, RARβ, and RARγ
but shows relative selectivity for RARβ, and RARγ and may modify
gene expression. The clinical
significance of these findings is unknown.
PSORIASIS: The mechanism of tazarotene action in psoriasis is not
defined. Topical tazarotene blocks
induction of mouse epidermal ornithine decarboxylase (ODC) activity,
which is associated with cell
proliferation and hyperplasia. In cell culture and _in vitro_ models
of skin, tazarotene suppresses
expression of MRP8, a marker of inflammation present in the epidermis
of psoriasis patients at high
levels. In human keratinocyte cultures, it inhibits cornified envelope
formation, whose build-up is an
element of the psoriatic scale. Tazarotene also induces the expression
of a gene which may be a growth
suppressor in human keratinocytes and which may inhibit epidermal
hyperproliferation in treated
plaques. However, the clinical signi