HYDROCORTISONE cream

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

제공처:

Crown Laboratories

INN (International Name):

Hydrocortisone

구성:

Hydrocortisone 10 mg in 1 g

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Not for ophthalmic use Rx Only Topcial corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topcial corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenaI (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of top

제품 요약:

Hydrocortisone Cream USP, 1% is supplied in: 1 ounce (28.4 grams) tube NDC 0316-0186-01 454 grams jar NDC 0316-0186-16 Hydrocortisone Cream USP, 2.5% is supplied in: 20 grams tube NDC 0316-0193-20 30 grams tube NDC 0316-0193-30 454 grams jar NDC 0316-0193-16 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 PRINTED IN USA ​Revised Dec 2017 P6306.03

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

HYDROCORTISONE- HYDROCORTISONE CREAM
CROWN LABORATORIES
----------
HYDROCORTISONE CREAM USP, 1%, 2.5%
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-
inflammatory and antipruritic agents. Hydrocortisone is a member of
this class.
Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17,
21-trihydroxy-, (11β)-. Its
molecular formula is C
H
O
and molecular weight is 362.47. Its structural formula
is:
Each gram of Hydrocortisone Cream USP, 1% contains 10 mg
hydrocortisone USP in a
cream base consisting of purified water, cetyl alcohol, glycerin,
stearyl alcohol, propylene
glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.
Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg
hydrocortisone USP in
a cream base consisting of purified water, cetyl alcohol, glycerin,
stearyl alcohol,
propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic
acid.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the 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
21
30
5
evidence to suggest that a recognizable correlation exists between
vasoconstrictor
potency and therapeutic efficacy in man.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors including the vehicle, the integrity of the epidermal barrier,
and the use of
occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or
other disease processes in the skin increase percutaneous absorption.
Occlusive
dressings substantially increase the percutaneous absorption of
topical corticosteroids.
Thus, occlusive dressings may be a valuable therapeutic adjunct for
treatment