HYDROCORTISONE lotion

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

HYDROCORTISONE

구성:

HYDROCORTISONE 25 mg in 1 mL

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

Hydrocortisone Lotion USP, 2.5% is available as follows: 2 fl oz (59 mL) bottle (NDC 45802-937 -16) 4 fl oz (118 mL) bottle (NDC 45802-937 -26) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children. Manufactured by Padagis Yeruham, Israel www.padagis.com Rev 03-23

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

HYDROCORTISONE- HYDROCORTISONE LOTION
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
HYDROCORTISONE LOTION USP, 2.5%
RX ONLY
DESCRIPTION
Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of
hydrocortisone, USP in
a vehicle consisting of carbomer homopolymer type C, ceteareth-20,
cetyl alcohol,
dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate,
isopropyl palmitate,
lactic acid, light mineral oil, myristyl alcohol, myristyl lactate,
PEG-100 stearate, purified
water, sodium hydroxide, sodium PCA, and stearyl alcohol. Chemically,
hydrocortisone is
[Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11ß)-] with the
molecular formula
C
H
O and is represented by the following structural formula:
Its molecular weight is 362.46 and its CAS Registry Number is 50-23-7.
The topical
corticosteroids, including hydrocortisone, constitute a class of
primarily synthetic
steroids used as anti-inflammatory and antipruritic agents.
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
21
30
5
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 ADMIN