HYDROCORTISONE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 25 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Hydrocortisone Lotion USP, 2.5% is available as follows: 4 fl oz (118 mL) bottle (NDC 54868-5893-0) 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 PERRIGO BRONX, NEW YORK 10457 DISTRIBUTED BY PERRIGO ALLEGAN, MI 49010 Rev. 10/10 RELABELING OF "ADDITIONAL" BARCODE LABEL BY: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE - HYDROCORTISONE LOTION
PHYSICIANS TOTAL CARE, INC.
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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 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
21
30
5
therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE
AND ADMINISTRATION).
Once absorbed through the