Hydrocortisone Topical

Corticosteroid secreted by the adrenal cortex; topical anti-inflammatory agent.a

Storage

Topical

Room temperature; consult product information for specific recommendations.

Rectal

Room temperature; consult product information for specific recommendations.

• Antihemorrhoidal Agent
• Corticosteroid, Rectal
• Corticosteroid, Topical

Anal and genital itching (external): Use in postirradiation (factitial) proctitis, cryptitis, other inflammatory conditions of the anorectum; external genital, feminine, and anal itching.

Dermatoses: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (eg, eczema; psoriasis; poison ivy, oak, or sumac; insect bites; minor skin irritation; atopic dermatitis [mild to moderate]; seborrheic dermatitis).

Hemorrhoids: Use in inflamed hemorrhoids.

Ulcerative colitis (adjunctive therapy): Adjunctive treatment of ulcerative colitis, especially distal forms including ulcerative proctitis, ulcerative proctosigmoiditis, left-sided ulcerative colitis, and in some cases involving the transverse and ascending colons.

Anal and genital itching, external: Infants, Children, and Adolescents: Topical:

Hydrocortisone acetate (1% cream): Apply to affected area 2 to 4 times daily. Products for OTC use (self-medication) are not labeled for use in children <12 years.

Hydrocortisone base (1% cream, 1% gel, 1% lotion, 1% ointment): Apply to affected area 2 to 4 times daily. Products for OTC use (self-medication) are not labeled for use in children <12 years.

Atopic dermatitis: Infants ≥3 months, Children, and Adolescents: Topical: Hydrocortisone butyrate (lipid cream, lotion): Apply thin film to affected area twice daily.

Corticosteroid-responsive dermatosis (including psoriasis): Infants, Children, and Adolescents: Topical:

Hydrocortisone acetate (cream, lotion): Apply thin film to affected area 2 to 4 times daily. Products for OTC use (self-medication) are not labeled for use in children <2 years.

Hydrocortisone base (cream, gel, lotion, ointment, solution): Apply thin film to affected area 2 to 4 times daily. Products for OTC use (self-medication) are not labeled for use in children <2 years.

Hydrocortisone butyrate (cream, ointment, solution): Apply thin film to affected area 2 to 3 times daily.

Frequency not defined. Local adverse events presented. Adverse events similar to those observed with systemic absorption are also observed, especially following rectal use. Refer to the Hydrocortisone (Systemic) monograph for details.

Cream, ointment: Dermatologic: Acneiform eruption, atrophic striae, burning sensation of skin, folliculitis, hypertrichosis, hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, pruritus, secondary skin infection, skin atrophy, skin irritation, xeroderma

Enema:

Central nervous system: Localized burning

Hematologic & oncologic: Rectal hemorrhage

Local: Local pain

Suppositories:

Central nervous system: Localized burning

Dermatologic: Allergic contact dermatitis, folliculitis, hypopigmentation, pruritus, xeroderma

Infection: Secondary infection

Serum glucose, electrolytes; blood pressure, weight, presence of infection; monitor IOP with therapy >6 weeks; bone mineral density, growth in children

Usual Adult Dose for Dermatitis:

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Adult Dose for Eczema:

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Adult Dose for Psoriasis:

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Adult Dose for Pruritus:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Adult Dose for Proctitis:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Adult Dose for Ulcerative Colitis:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Adult Dose for Hemorrhoids:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Pediatric Dose for Dermatitis:

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Pediatric Dose for Eczema:

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Pediatric Dose for Psoriasis:

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Usual Pediatric Dose for Pruritus:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Pediatric Dose for Proctitis:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Pediatric Dose for Ulcerative Colitis:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Pediatric Dose for Hemorrhoids:

Rectal Suppository: 25 mg inserted rectally once or twice a day
Maximum dose: The dose may be increased to 75 mg or 100 mg a day as needed.
Rectal foam: One applicatorful (80 mg) rectally once or twice a day
Cream: Apply three to four times a day

Comments:
-Rectal foam therapy should be continued for approximately 2 weeks.
-Sigmoidoscopy is recommended to judge dosage adjustment, duration of therapy, and rate of improvement.

Uses:
-Suppository: In inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani
-Foam: Treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas
-Cream: Temporary relief of external anal itching; temporary relief of itching associated with minor skin irritations and rashes

Usual Pediatric Dose for Atopic Dermatitis:

Apply a thin film to the affected skin areas two times a day

Comments:
-Cream should not be used with occlusive dressings or applied in the diaper area unless directed by a healthcare provider.

Use: Treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age

Redness, burning, or itching at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: rectal bleeding, change in skin appearance (e.g., color, thickness), skin redness/tenderness/pus or other signs of infection.

Rarely, it is possible this medication will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Tell your doctor right away if any of these rare but very serious side effects occur: signs of serious infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (e.g., cortisol levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Missed Dose

If you miss a dose, use it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C). Do not refrigerate. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.