Hydrocortisone Butyrate

Locoid Lipocream contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] for topical dermatologic use.

Chemically, hydrocortisone butyrate is C25H36O6. It has the following structural formula:

Hydrocortisone butyrate is a white to practically white powder with a molecular weight of 432.56. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform.

Each gram of Locoid Lipocream (hydrocortisone butyrate) contains 1 mg hydrocortisone butyrate in a hydrophilic base consisting of cetostearyl alcohol, ceteth-20, mineral oil, white petrolatum, citric acid, sodium citrate, propylparaben and butylparaben (preservatives) and water.

Hydrocortisone Butyrate may be found in some form under the following brand names:

• 1 Plus 1 F

• A-Hydrocort

• Acetasol HC

• Acticort 100

• Aeroseb-HC

• AK-Spore HC

• Ala-Cort

• Ala-Quin

• Ala-Scalp

• Alcortin

• Alcortin A

• Aloe Cort

• Analpram-HC

• Anamantle HC

• Antibiotic Ear

• Antibiotic-Cort Ear

• Anucort-HC

• Anusert HC-1

• Anusol HC

• Anusol HC-1

• Aquanil HC

• Aveeno Hydrocortisone Anti-Itch

• Balneol

• Beta HC

• Biocorneum

• Caldecort

• Carmol HC

• Cetacort

• Cipro HC

• Colocort

• Coly Mycin S

• Coraz

• Cort-Biotic

• Cort-Dome

• Cortaid

• CortAlo

• Cortane

• Cortane-B

• Cortatrigen

• Cortatrigen Modified

• Cortef

• Cortenema

• Cortic

• Corticaine

• Corticool

• Cortifoam

• Cortisil MDX

• Cortisporin

• Cortisporin Ointment

• Cortisporin-TC

• Cortizone-10

• Cortizone-10 Anal Itch Cream

• Cortizone-5

• Cortomycin

• Cortomycin Ointment

• Cotacort

• Dermacort

• Dermarest Dricort

• Dermarest Eczema

• Dermazene

• Dermol HC

• Dermolate

• Dermtex HC

• Drotic

• Ear-Eze

• Earsol-HC

• Easotic

• Encort

• Enzone

• Epifoam

• Excel Pet

• Exotic-HC

• Genasone/Aloe

• Gly-Cort

• Glytone Soothe Calming

• Gynecort

• HC AC/Aloe

• HC-Derma-Pax

• Hemril

• Hycort

• Hydrocort cream

• Hydrocort SS

• Hydrocortisone Pet Lotion

• Hydrocortisone-Aloe

• Hydrocortone

• Hydrocortone Acetate

• Hydrocortone Phosphate

• Hydroskin

• Hysone

• Hytone

• Instacort

• Instacort 10

• Itch-X Maximum Strength

• Ivocort

• Kera-HC

• Keratol HC

• Lacticare-HC

• Lazersporin-C

• Lidamantle HC

• Lidocort

• Locoid

• Mantadil

• Masporin Otic

• Maximum-H

• MiCort-HC

• Monistat Itch Relief

• MyOxin

• Neo-Cortef

• Neo-Polycin HC

• Neosporin Eczema

• Neotricin HC

• Neutrogena T-Scalp

• Nogenic HC

• Novacort

• Nucort

• Nupercainal HC 1%

• Nutracort

• NuZon

• Ocu-Cort

• Ocutricin HC

• Ophthocort

• Orabase HCA

• Oti-Sone

• Otic care

• Otic Ear Care

• Oticin HC

• Oticin HC Ear Drops

• Oticot HC

• Otimar

• Otirx

• Otobiotic

• Otocort Sterile Suspension

• Otomax HC

• Pandel

• Pedi-Cort V

• Pediaderm HC

• Pediotic

• Penecort

• Peranex

• PramCort

• Pramosone

• Preparation H Hydrocortisone

• ProCort

• Procort 1.85/1.15

• Procto-Kit

• Procto-Pak

• Proctocare-HC

• Proctocort

• Proctocream

• Proctocream HC

• Proctofoam-HC

• Proctosert HC

• Proctosol

• Proctozone HC

• Proctozone-H

• Propet

• Recort Plus

• Rectacort-HC

• Rederm

• Sarnol-HC

• Scalacort

• Scalp-Aid

• Scalp-Cort

• Scalpicin Itch Relief

• Senatec HC

• Sentry HC Dermasphere

• Solu-Cortef

• Steroform

• Terra-Cortril

• Texacort

• Theracort Anti-Itch

• Tri-Otic

• TriOxin

• Tucks HC

• U-Cort

• Vagisil Satin

• Vanoxide-HC

• Vasotate HC

• Vio-Tex-HC

• Vosol HC

• Vytone

• Westcort

• Xebcort

• Xerese

• Xyralid

• Yeast-X External

• Z-Pram

• ZyPram

Hydrocortisone Butyrate is part of the drug class:

• Corticosteroids, moderately potent group II

Take hydrocortisone butyrate exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Hydrocortisone Butyrate dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Hydrocortisone Butyrate is available in the following doses:

• Hydrocortisone Topical Butyrate 0.1% Topical Cream
• Hydrocortisone Topical Butyrate 0.1% Topical Ointment
• Hydrocortisone Topical Butyrate 0.1% Topical Solution
• Hydrocortisone Topical Butyrate Compounding Powder

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Hydrocortisone Butyrate Ointment, Cream and Topical Solution contain the topical corticosteroid, Hydrocortisone Butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C25H36O6; the molecular weight: 432.54; and the CAS registry number: 13609-67-1.

Its structural formula is:

Hydrocortisone Butyrate Ointment, 0.1%

Each gram of Hydrocortisone Butyrate ointment contains 1 mg of Hydrocortisone Butyrate in a base consisting of mineral oil and polyethylene.

Hydrocortisone Butyrate Cream USP, 0.1%

Each gram of Hydrocortisone Butyrate cream contains 1 mg of Hydrocortisone Butyrate in a hydrophilic base consisting of anhydrous citric acid, cetomacrogol 1000, cetostearyl alcohol, light mineral oil, propylparaben and butylparaben (preservatives), purified water, sodium citrate anhydrous and white petrolatum.

Hydrocortisone Butyrate Topical Solution, 0.1%

Each mL of Hydrocortisone Butyrate topical solution contains 1 mg of Hydrocortisone Butyrate in a vehicle consisting of citric acid monohydrate, glycerin, isopropyl alcohol (50% v/v), povidone, purified water and sodium citrate.

The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Hydrocortisone Butyrate Ointment, 0.1% or Hydrocortisone Butyrate Cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Hydrocortisone Butyrate Topical Solution, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.

STORAGE

Hydrocortisone Butyrate Ointment, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Hydrocortisone Butyrate Cream USP, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Hydrocortisone Butyrate Topical Solution, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: February 2015
70388-0215-2
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