PROCTOCORT- hydrocortisone cream

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Salix Pharmaceuticals, Inc

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. Pediatric Use 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-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 topical

Tóm tắt sản phẩm:

Proctocort® (Hydrocortisone Cream USP), 1% is supplied in: 1 ounce (28.4 grams) tube NDC 65649-501-30  Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA PROCTOCORT® is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2019 Salix Pharmaceuticals, Inc. or its affiliates PRINTED IN USA Revised: Oct. 2019 P8800.04 9521701

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PROCTOCORT- HYDROCORTISONE CREAM
SALIX PHARMACEUTICALS, INC
----------
PROCTOCORT
HYDROCORTISONE CREAM USP, 1%
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primary 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 Proctocort
(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.
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
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
®
21
30
5
®
percutaneous absorption of topical corticosteroids. Thus, occlusive
dressings may be a valuable
therapeutic adjunct for treatment of resistant dermatoses. (see DOSAGE
AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to systemically administered corticosteroids. C