Download Hydrocortisone, Hydrocortisone Acetate

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> Skin and Mucous Membrane Agents 84:00
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> Anti-inflammatory Agents 84:06
Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone
Buteprate, Hydrocortisone Butyrate, Hydrocortisone
Valerate (Topical)
Sub-sections

Introduction

Uses

Dosage and Administration

Chemistry and Stability

Additional Information

Preparations
Drug Nomenclature
Generic Name: Hydrocortisone
CAS Number: 50-23-7
Synonyms: Cortisol; Compound F
Drug Nomenclature
Generic Name: Hydrocortisone Acetate
CAS Number: 50-03-3
Synonyms: Cortisol Acetate
Drug Nomenclature
Generic Name: Hydrocortisone Butyrate
CAS Number: 13609-67-1
Drug Nomenclature
Generic Name: Hydrocortisone Valerate
CAS Number: 57524-89-7
Synonyms: Cortisol Valerate
Synonyms: A-hydrocort inj 1000mg/8ml; A-hydrocort inj 100mg/2ml; Ahydrocort inj 250mg/2ml; A-hydrocort inj 500mg/4ml; Barriere hc; Cortate
crm 1%; Cortate ont 1%; Cortef tablets 10mg; Cortef tablets 20 mg;
Cortenema; Cortisporin (combination product); Cortisporin (combination
product); Cortoderm ont 1%; Emo cort cream 1%; Emo cort cream 2.5%;
Emo cort lotion 1%; Emo cort lotion 2.5%; Emo cort sol 2.5% usp; Hycort
retention enema 100mg/60ml; Hydrocortisone sod succinate inj 100mg/vial;
Hydrocortisone sod succinate inj 250mg/vial; Hydrocortisone sodium succin
inj 500mg/vial; Hydrocortisone sodium succinate inj 1gm/vial; NOVOhydrocort crm 1%; Pramox hc cream (combination product); Pramox hc
lotion (combination product); Prevex hc cream 1%; Proctol ointment
(combination product); Proctol suppositories (combination product);
Proctosedyl ointment (combination product); Proctosedyl suppositories
(combination product); RATIO-proctosone (combination product); Sandoz
cortimyxin (combination product); Sandoz cortimyxin (combination
product); Sandoz proctomyxin hc (combination product); Sandoz
proctomyxin hc suppositories (combination product); Sarna hc; Solu-cortef 1
gm act-o-vial; Solu-cortef 100 mg act-o-vial; Solu-cortef 250 mg act-o-vial;
Solu-cortef 500 mg act-o-vial; Spor-hc otic susp (combination product);
Sterex crm plus (combination product); Sterex lot plus (combination
product); Vioform hydrocortisone (combination product)
Introduction
Hydrocortisone is a corticosteroid secreted by the adrenal cortex.
See also: Topical Corticosteroids General Statement (Uses)
Uses
Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters
share the actions of other topical corticosteroids and are used for the relief
of inflammatory manifestations of corticosteroid-responsive dermatoses,
including dermatoses of the anogenital areas. Nonprescription preparations
containing 0.5% hydrocortisone or hydrocortisone acetate are used for the
temporary relief of minor skin irritations, itching, and rashes caused by
eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac,
soaps, detergents, cosmetics, or jewelry; for temporary relief of itchy anal
and/or genital areas; and for temporary relief of itching and minor scalp
irritation caused by scalp dermatitis. Hydrocortisone acetate also is used as
a paste for adjunctive treatment to provide temporary relief of symptoms
associated with oral inflammatory or ulcerative lesions resulting from
trauma.
Hydrocortisone also is administered rectally as a retention enema for the
adjunctive treatment of mild or moderate acute ulcerative colitis limited to
the rectosigmoid or left colon and, to a lesser extent, in some patients with
mild ulcerative colitis of the transverse or descending colon. Hydrocortisone
acetate is administered rectally as a suppository or an aerosol foam
suspension for the adjunctive treatment of ulcerative colitis of the rectum.
As rectal suppositories, hydrocortisone acetate is used in the treatment of
other inflammatory conditions of the anorectum (e.g., inflamed hemorrhoids,
postirradiation or factitial proctitis, cryptitis, pruritus ani).
For EENT and systemic uses of hydrocortisone, see 52:08 and 68:04,
respectively.
See also: Topical Corticosteroids General Statement (Dosage and
Administration)
Dosage and Administration
Hydrocortisone and its acetate, buteprate, butyrate, and valerate esters are
applied topically. Dermatologic preparations of the drugs are applied
sparingly in thin films and are rubbed gently into the affected area 1–4 times
daily. Rectal creams and ointments of the drugs are applied externally to the
anal area. Some commercially available creams may be applied externally to
the anogenital areas. Nonprescription preparations of the drugs should not
be used for self-medication for longer than 7 days; if the condition worsens
or symptoms persist, the drug should be discontinued and a physician
consulted. Nonprescription preparations of the drugs should not be used in
children younger than 2 years of age unless directed and supervised by a
physician.
For dermatoses of the scalp, the hair may be parted and a small amount of
lotion applied directly to the affected area and rubbed gently into the scalp.
Usual hair care should be maintained, but the lotion should not be washed
out immediately after application. Alternatively, for dermatoses of the scalp,
hydrocortisone aerosol is applied to the dry scalp after shampooing. When
the aerosol is used for other dermatoses, each 10-cm2 of affected area is
sprayed for 1–2 seconds from a distance of about 15 cm 2 or 3 times daily.
Occlusive dressings may be used for severe or resistant dermatoses.
For use in the mouth, a small amount of 0.5% hydrocortisone acetate paste
is pressed to the lesion without rubbing until a thin film develops. The paste
is applied 2 or 3 times daily after meals and at bedtime. If substantial
regeneration or repair of the oral tissues does not occur after 7 days of
treatment, further investigation of the etiology of the oral lesions should be
undertaken.
Hydrocortisone is administered rectally as a retention enema, and
hydrocortisone acetate is given rectally as a suppository or an aerosol foam
suspension according to the manufacturers’ instructions. Patients should be
advised that hydrocortisone acetate suppositories may stain fabric so that
they can take appropriate precautionary measures. For the adjunctive
treatment of ulcerative colitis, 100 mg of hydrocortisone is administered
nightly as a retention enema. The patient should lie on his left side during
and for 30 minutes after administration of the retention enema so that the
drug will distribute throughout the left colon; the enema should be retained
for at least 1 hour and preferably all night. Some clinicians administer 100
mg as a retention enema twice daily followed by 100 mg nightly when
improvement occurs. The drug is usually given for 21 days or until clinical
and proctologic remissions are achieved. Clinical symptoms may improve in
3–5 days, followed by proctologic improvement; in some cases, 2–3 months
of therapy may be required to attain a proctologic remission. Therapy with
hydrocortisone retention enema should be discontinued if clinical or
proctologic improvement does not occur within 2–3 weeks. Following
treatment for longer than 21 days, therapy with hydrocortisone enema
should be withdrawn gradually by giving the drug every other night for 2–3
weeks and then discontinuing it.
In patients with ulcerative proctitis of the distal rectum who cannot retain
corticosteroid enemas, 90 mg of hydrocortisone acetate (1 applicatorful of a
10% aerosol foam suspension) may be given rectally 1 or 2 times daily for
2–3 weeks and then, if necessary, every other day until clinical and
proctologic improvements occur; symptoms may improve within 5–7 days.
For the adjunctive treatment of ulcerative colitis of the rectum and other
inflammatory conditions of the anorectum, 25 mg of hydrocortisone acetate
as a suppository may be administered rectally in the morning and at night
for 2 weeks; in severe proctitis, 25 mg may be given 3 times daily or 50 mg
may be given twice daily. For the adjunctive treatment of postirradiation or
factitial proctitis, therapy is generally continued for 6–8 weeks or less if an
adequate response is attained. Alternatively, for the symptomatic treatment
of internal hemorrhoids and the adjunctive treatment of other inflammatory
conditions of the anorectum, 10 mg of hydrocortisone acetate as a
suppository may be administered rectally in the morning and at night for 2–
6 days.
See also: Topical Corticosteroids General Statement (Cautions)
See also: Topical Corticosteroids General Statement (Pharmacology)
See also: Topical Corticosteroids General Statement (Pharmacokinetics)
See also: Topical Corticosteroids General Statement (Chemistry and
Stability)
Chemistry and Stability
Chemistry
Hydrocortisone is a corticosteroid secreted by the adrenal cortex.
Hydrocortisone and hydrocortisone acetate occur as white to practically
white, crystalline powders; hydrocortisone valerate occurs as a white
crystalline powder. Hydrocortisone is very slightly soluble in water and
sparingly soluble in alcohol. Hydrocortisone acetate and hydrocortisone
valerate are insoluble in water and slightly soluble in alcohol.
Stability
Hydrocortisone preparations should be stored according to the
manufacturer’s directions.
Additional Information
For further information on chemistry, pharmacology, absorption, uses,
cautions, methods of dermatologic application, and use of occlusive
dressings in therapy with hydrocortisone, see the Topical Corticosteroids
General Statement 84:06.
Preparations
Excipients in commercially available drug preparations may have clinically
important effects in some individuals; consult specific product labeling for
details.
Hydrocortisone
Dosage
Routes Forms
Bulk
Powder*
Rectal
Cream
Strengths Brand Names Manufacturer
1%
Proctocort®
Monarch
Suspension 100
Generic
Copley
mg/60 mL Name:
Hydrocortisone
Enema
Topical Cream
0.5%*
1%*
Cortizone®-5
Pfizer
Cortizone® for
Kids®
Pfizer
Ala-Cort®
Del-Ray
Cortaid®
Intensive
Therapy
Pfizer
Dosage
Routes Forms
Strengths Brand Names Manufacturer
Cortizone-10®
Pfizer
Cortizone-10®
External Anal
Itch Relief
Creme®
Pfizer
Dermacort®
Melaleuca
DermiCort®
Republic
HydroSKIN®
Rugby
Hytone®
Dermik
Penecort®
Allergan
Preparation H® Wyeth
Hydrocortisone
2.5%*
Anusol-HC®
Pfizer
Hytone®
Dermik
Gel
1%
CortaGel®
Norstar
Extra Strength
Lotion
0.5%*
HydroSKIN®
Rugby
1%*
Ala-Cort®
Del-Ray
Aquanil HC®
Person & Covey
Cetacort®
Healthpoint
HydroSKIN®
Rugby
LactiCare®-HC
Stiefel
Nutracort®
Healthpoint
Sarnol® HC
Stiefel
2%
Ala-Scalpt®
Del-Ray
2.5%
Generic
Glades, Major
Name:
Hydrocortisone
Lotion
Hytone®
Dermik
Dosage
Routes Forms
Strengths Brand Names Manufacturer
LactiCare®-HC
Stiefel
Nutracort®
Healthpoint
ProctoCream®- Physicians Total
HC
Care
Ointment
0.5%*
Cortizone®-5
Pfizer
1%*
Cortizone®-10
Pfizer
HydroSKIN®
Rugby
Hytone®
Dermik
2.5%*
Pledgets
0.5%
(saturated
with
solution)
Massengill®
GlaxoSmithKline
Medicated Soft
Cloth
Towelette®
Solution
Cortaid®
FastStick®
Maximum
Strength
1%
Pfizer
Cortaid® Spray Pfizer
Maximum
Strength
Cortizone®-10 Pfizer
Scalp Itch
Formula Liquid
2.5%
Penecort®
Allergan
Texacort®
Sirius
Texacort®
Sirius
* available from one or more manufacturer, distributor, and/or repackager
by generic (nonproprietary) name
Hydrocortisone Combinations
Dosage
Routes Forms
Brand
Strengths Names
Manufacturer
Topical Ointment 1% with
Cortisporin® Monarch
Bacitracin
Zinc 400
units (of
bacitracin)
per g,
Neomycin
Sulfate
0.5%
(0.35% of
neomycin),
and
Polymyxin
B Sulfate
5000 units
(of
polymyxin
B) per g
1% with
Neomycin
Sulfate
0.5%
(0.35% of
neomycin)*
Solution
1% with
Neosporin
Sulfate
0.5%
(0.35% of
neomycin),
and
Polymyxin
B Sulfate
10,000
units (of
polymyxin
B) per g
LazerSporin- Pedinol
C® (with
propylene
glycol)
* available from one or more manufacturer, distributor, and/or repackager
by generic (nonproprietary) name
Hydrocortisone is also commercially available in combination with
antihistamines, astringents, keratolytics, local anesthetics, and
vasoconstrictors.
Hydrocortisone Acetate
Dosage
Routes Forms
Bulk
Powder*
Rectal
Aerosol,
foam
suspension
Strengths
Brand Names
Manufacturer
10%
Cortifoam®
Schwarz
Anucort-HC®
G&W
Anu-Med® HC
Major
Anusol-HC®
Pfizer
Suppositories 25 mg
Hemorrhoidal®- Actavis, CMC,
HC
Sandoz,
Rugby, UDL
Hemril-HC®
Uniserts®
Upsher-Smith
Hydrocortisone
Acetate
Suppositories
Topical Cream
30 mg
Proctocort®
Monarch
0.5%
Corticaine®
UCB
0.5% (of
Cortaid®
hydrocortisone)* Sensitive Skin
Formula
Pfizer
1% (of
hydrocortisone)
Novartis
Caldecort®
Anti-Itch (with
propylene
glycol)
Dosage
Routes Forms
Strengths
Brand Names
Manufacturer
Cortaid®
Pfizer
Maximum
Strength (with
aloe and
methylparaben)
Dermarest®
DriCort®
Del
Dermtex® HC
(with menthol
1%)
Pfeiffer
Hydrocortisone
Acetate Cream
Nupercainal®
Novartis
Hydrocortisone
Anti-Itch
Cream (with
propylene
glycol)
Lotion
0.5% (of
Hydrocortisone
hydrocortisone)* Acetate Lotion
Ointment
0.5% (of
hydrocortisone)
Cortaid®
Sensitive Skin
Formula
Pfizer
1%
Anusert® HC-1
G&W
Gynecort® 10
Combe
Lanacort® 10
Combe
Anusol-HC®-1
Pfizer
Cortaid®
Maximum
Strength
Pfizer
1% (of
hydrocortisone)
Paste
0.5%
Orabase® HCA
Colgate
Solution
1%
Scalp-Aid®
Major
Scalpcort®
Clay-Park
Dosage
Routes Forms
Strengths
Brand Names
Manufacturer
Maximum
Strength
1% (of
hydrocortisone)
Dermtex® HC
Spray
Pfeiffer
* available from one or more manufacturer, distributor, and/or repackager
by generic (nonproprietary) name
Hydrocortisone Acetate Combinations
Dosage
Routes Forms
Rectal
Strengths
Brand
Names
Aerosol,
1% with
proctoFoam®foam
Pramoxine
HC
suspension Hydrochloride
1%
Topical Aerosol,
1% with
Epifoam®
foam
Pramoxine
suspension Hydrochloride
1%
Cream
Manufacturer
Schwarz
Schwarz
0.5% with
Mantadil®
Chlorcyclizine
Hydrochloride
2%
GlaxoSmithKline
0.5% with
Cortisporin®
Neomycin
Sulfate 0.5%
(0.35% of
neomycin)
and
Polymyxin B
Sulfate
10,000 units
(of polymyxin
B) per g
Monarch
1% with
Analpram-HC® Ferndale
Dosage
Routes Forms
Strengths
Brand
Names
Manufacturer
Enzone®
Forest
Pramosone®
Ferndale
Pramoxine
Hydrochloride
1%
proctoCream®- Schwarz
HC
Zone-A®
Cream
1% with Urea Carmol® HC
10%
Forest
Doak
2.5% with
Analpram-HC® Ferndale
Pramoxine
Hydrochloride
1%
Lotion
Pramosone®
Ferndale
1% with
Pramosone®
Pramoxine
Hydrochloride
1%
Ferndale
Zone-A®
Lotion
2.5% with
Pramosone®
Pramoxine
Hydrochloride
1%
Forest
Ferndale
Zone-A® Forte Forest
Lotion
Ointment
1% with
Pramosone®
Pramoxine
Hydrochloride
1%
Ferndale
2.5% with
Pramoxine
Ferndale
Pramosone®
Dosage
Routes Forms
Strengths
Brand
Names
Manufacturer
Hydrochloride
1%
Hydrocortisone acetate is also commercially available in combination with
antihistamines, astringents, keratolytics, local anesthetics, and
vasoconstrictors.
Hydrocortisone Buteprate
Dosage
Brand
Routes Forms Strengths Names Manufacturer
Topical Cream
0.1%
Pandel® Savage
Hydrocortisone Butyrate
Dosage
Routes Forms
Brand
Strengths Names Manufacturer
Topical Cream
0.1%
Locoid® Ferndale
Ointment 0.1%
Locoid® Ferndale
Solution
Locoid® Ferndale
0.1%
Hydrocortisone Valerate
Dosage
Routes Forms
Brand
Strengths Names
Topical Cream
0.2%
Westcort® WestwoodSquibb
Ointment 0.2%
Westcort® WestwoodSquibb
Comparative Pricing
Manufacturer
This pricing information is subject to change at the sole discretion of DS
Pharmacy. This pricing information was updated 02/2013. For the most
current and up-to-date pricing information, please visit www.drugstore.com.
Actual costs to patients will vary depending on the use of specific retail or
mail-order locations and health insurance copays.
Analpram-HC 1-2.5% Cream (FERNDALE LAB): 30/$118.33 or 90/$337.86
Analpram-HC 1-2.5% Lotion (FERNDALE LAB): 59/$116.04 or 177/$324.04
Analpram-HC Singles 1-2.5% Cream (FERNDALE LAB): 120/$232.54 or
360/$654.05
Anusol-HC 2.5% Cream (SALIX PHARMACEUTICALS): 30/$122.42 or
90/$325.26
Anusol-HC 25MG Suppositories (SALIX PHARMACEUTICALS): 12/$55.99 or
24/$96.97
Anusol-HC 25MG Suppositories (SALIX PHARMACEUTICALS): 24/$80.50 or
48/$149.45
Colocort 100MG/60ML Enema (PADDOCK): 60/$15.99 or 180/$35.97
Cortifoam 90MG Foam (MEDA PHARMACEUTICALS): 15/$260.00 or
45/$759.99
Hydrocortisone 0.5% Cream (FOUGERA): 28/$13.99 or 85/$19.97
Hydrocortisone 1% Cream (FOUGERA): 28/$16.99 or 85/$35.97
Hydrocortisone 1% Lotion (FOUGERA): 118/$13.99 or 236/$22.98
Hydrocortisone 100MG/60ML Enema (BRECKENRIDGE): 60/$15.99 or
120/$23.99
Hydrocortisone 2.5% Cream (FOUGERA): 30/$14.99 or 90/$44.97
Hydrocortisone 2.5% Ointment (FOUGERA): 28/$14.99 or 85/$39.97
Hydrocortisone Ace-Pramoxine 1-1% Cream (PERRIGO PHARMACEUTICALS):
30/$79.99 or 90/$219.98
Hydrocortisone Ace-Pramoxine 2.5-1% Cream (ACELLA
PHARMACEUTICALS): 28/$49.99 or 85/$139.97
Hydrocortisone Ace-Pramoxine 2.5-1% Cream (PERRIGO
PHARMACEUTICALS): 30/$51.99 or 90/$145.97
Hydrocortisone Acetate 1-1% Ointment (PERRIGO): 30/$12.99 or 60/$15.98
Hydrocortisone Acetate 25MG Suppositories (PADDOCK): 12/$15.00 or
24/$20.00
Hydrocortisone Butyrate 0.1% Cream (TARO): 15/$30.99 or 30/$52.87
Hydrocortisone Butyrate 0.1% Cream (TARO): 45/$53.99 or 90/$99.97
Hydrocortisone Butyrate 0.1% Solution (TARO): 60/$27.99 or 180/$59.97
Hydrocortisone Valerate 0.2% Cream (TARO): 15/$22.99 or 30/$35.97
Hydrocortisone Valerate 0.2% Cream (TARO): 45/$34.67 or 135/$100.93
Hydrocortisone Valerate 0.2% Cream (TARO): 60/$45.88 or 180/$129.50
Hydrocortisone Valerate 0.2% Ointment (TARO): 15/$50.99 or 45/$135.97
Hydrocortisone Valerate 0.2% Ointment (TARO): 45/$99.99 or 135/$279.96
Hydrocortisone Valerate 0.2% Ointment (TARO): 60/$119.98 or
180/$321.95
Locoid 0.1% Cream (TRIAX PHARMACEUTICALS): 15/$67.49 or 45/$180.77
Locoid 0.1% Cream (TRIAX PHARMACEUTICALS): 45/$182.99 or
135/$529.96
Locoid 0.1% Ointment (TRIAX PHARMACEUTICALS): 15/$62.04 or
45/$171.18
Locoid 0.1% Ointment (TRIAX PHARMACEUTICALS): 45/$164.29 or
135/$476.78
Locoid Lipocream 0.1% Cream (TRIAX PHARMACEUTICALS): 15/$86.51 or
45/$239.55
Locoid Lipocream 0.1% Cream (TRIAX PHARMACEUTICALS): 45/$230.98 or
90/$448.97
Locoid Lipocream 0.1% Cream (TRIAX PHARMACEUTICALS): 60/$299.78 or
180/$860.83
Pandel 0.1% Cream (PHARMADERM): 15/$77.99 or 45/$215.97
Pandel 0.1% Cream (PHARMADERM): 45/$139.99 or 135/$381.95
Pramosone 1-1% Cream (FERNDALE LAB): 28/$95.33 or 85/$245.45
Pramosone 1-1% Lotion (FERNDALE LAB): 59/$98.90 or 118/$183.98
Pramosone 1-1% Ointment (FERNDALE LAB): 28/$92.05 or 85/$248.37
Pramosone 1-2.5% Cream (FERNDALE LAB): 28/$89.82 or 57/$172.74
Pramosone 1-2.5% Cream (FERNDALE LAB): 57/$117.27 or 171/$346.20
Pramosone 1-2.5% Lotion (FERNDALE LAB): 118/$170.46 or 354/$496.34
Proctocort 1% Cream (SALIX PHARMACEUTICALS): 28/$140.29 or
85/$403.64
ProctoCream-HC 2.5% Cream (ALAVEN PHARMACEUTICAL): 30/$65.98 or
90/$173.06
Proctofoam HC 1-1% Foam (MEDA PHARMACEUTICALS): 10/$79.99 or
30/$219.96
Proctozone-HC 2.5% Cream (RISING PHARMACEUTICALS): 30/$22.99 or
90/$59.97
Vanoxide HC 5-0.5% Kit (SUMMERS LABS): 85/$60.99 or 255/$175.95
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions
November 2, 2012. American Society of Health-System Pharmacists, Inc.,
7272 Wisconsin Avenue, Bethesda, Maryland 20814.
AHFS Drug Information © American Society of Health-System Pharmacists 2013
MedicinesComplete © The Pharmaceutical Press 2014