ALA SCALP- hydrocortisone acetate lotion

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

제공처:

Crown Laboratories

INN (국제 이름):

HYDROCORTISONE ACETATE

구성:

HYDROCORTISONE ACETATE 20 mg in 1 mL

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Hydrocortisone Lotion is 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-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 corticosteroids to pedi

제품 요약:

ALA-SCALP (Hydrocortisone Lotion USP) 2% is supplied in: 1 fl oz (29.6 mL) NDC 0316-0140-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured and Distributed by: CROWN LABORATORIES, INC. Johnson City, TN, 37604 Printed in USA REVISED: FEB 2018 P8003.03

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ALA SCALP- HYDROCORTISONE ACETATE LOTION
CROWN LABORATORIES
----------
ALA SCALP
ALA-SCALP
HYDROCORTISONE LOTION USP, 2%
P8003.03
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPTHALMIC USE
DESCRIPTION
Topical corticosteroids constitute a class of primarily synthetic
steroids used a 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, (11ß)-. Its structural
formula is:
Each mL of ALA-SCALP (Hydrocortisone Lotion USP), 2% contains 20 mg
hydrocortisone USP in a
vehicle of isopropyl alcohol, polysorbate 20, purified water,
propylene glycol, and benzalkonium
chloride.
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
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. Corticosteroids
are bound to plasma proteins in
varying degrees. Corticosteroids are metabolized primarily in the