HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- hydrocortisone acetate and pramoxine hydrochloride cream

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ), Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)

متاح من:

Westminster Pharmaceuticals, LLC

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ملخص المنتج:

Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows: 1 oz tube (NDC 69367-285-01) Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. To report a serious adverse event or obtain product information, call 1-844-221-7294.

الوضع إذن:

unapproved drug other

خصائص المنتج

HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- HYDROCORTISONE ACETATE
AND PRAMOXINE HYDROCHLORIDE CREAM
WESTMINSTER PHARMACEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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HYDROCORTISONE ACETATE 2.5%
PRAMOXINE HCL 1% CREAM
RX ONLY
DESCRIPTION
Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is a topical
preparation containing
hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in
a hydrophilic cream base
containing ceteareth-6, ceteareth-25, cetyl alcohol, glyceryl stearate
SE, mineral oil, phenoxyethanol,
propylene glycol, purified water, stearyl alcohol, xanthan gum.
Topical corticosteroids are anti-inflammatory and anti-pruritic
agents. The structural formula, the
chemical name, molecular formula and molecular weight for the active
ingredients are presented below.
hydrocortisone acetate
Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-
C
H O ; mol. wt: 404.50
pramoxine hydrochloride
4-(3-(butoxyphenoxy)propyl)morpholine hydrochloride
C
H NO .HCl; mol. wt: 329.87
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of topical corticosteroids
is unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
23
32
6
17
27
3
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
Pramoxine hydrochloride is a topical anesthetic agent which provides
temporary relief from itching and
pain. It acts by stabilizing the neuronal membrane of nerve endings
with which it comes into contact.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including the vehicle, the integ