Hydrocortisone (ointment)

Hydrocortisone (ointment)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Hydrocortisone (ointment) is a anti-inflammatory agent that is FDA approved for the treatment of itching associated with minor skin irritations and rashes due to eczema, insect bites, soaps and detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, poison ivy, oak or sumac and for external genital, feminine and anal itching. Common adverse reactions include itchness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Uses:

• for temporary relief of itching associated with minor skin irritations and rashes due to:

• eczema
• insect bites
• soaps and detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• poison ivy, oak or sumac
• for external genital, feminine and anal itching
• other uses of this product should be only under the advice and supervision of a doctor

• Dosing information

• For minor skin irritations and rashes

• adults: apply to affected area not more than 3 to 4 times daily.

• For external anal itching:

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Hydrocortisone (ointment) in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Cortisol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Uses:

• for temporary relief of itching associated with minor skin irritations and rashes

• Dosing information

• For minor skin irritations and rashes

• children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

• For external anal itching:

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

• gently dry by patting or blotting with toilet tissue or soft cloth before application of this product

• children : under 12 years of age, consult a doctor.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Cortisol in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Cortisol in pediatric patients.

Contraindications

There is limited information regarding Hydrocortisone (ointment) Contraindications in the drug label.

Warnings

There is limited information regarding Hydrocortisone (ointment) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

• There is limited information regarding Clinical Trial Experience of Hydrocortisone (ointment) in the drug label.

Postmarketing Experience

• There is limited information regarding Postmarketing Experience of Hydrocortisone (ointment) in the drug label.

Drug Interactions

There is limited information regarding Hydrocortisone (ointment) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Hydrocortisone (ointment) in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydrocortisone (ointment) in women who are pregnant.

Labor and Delivery

• There is no FDA guidance on use of Hydrocortisone (ointment) during labor and delivery.

Nursing Mothers

• There is no FDA guidance on the use of Hydrocortisone (ointment) with respect to nursing mothers.

Pediatric Use

• There is no FDA guidance on the use of Hydrocortisone (ointment) with respect to pediatric patients.

Geriatic Use

• There is no FDA guidance on the use of Hydrocortisone (ointment) with respect to geriatric patients.

Gender

• There is no FDA guidance on the use of Hydrocortisone (ointment) with respect to specific gender populations.

Race

• There is no FDA guidance on the use of Hydrocortisone (ointment) with respect to specific racial populations.

Renal Impairment

• There is no FDA guidance on the use of Hydrocortisone (ointment) in patients with renal impairment.

Hepatic Impairment

• There is no FDA guidance on the use of Hydrocortisone (ointment) in patients with hepatic impairment.

Females of Reproductive Potential and Males

• There is no FDA guidance on the use of Hydrocortisone (ointment) in women of reproductive potentials and males.

Immunocompromised Patients

• There is no FDA guidance one the use of Hydrocortisone (ointment) in patients who are immunocompromised.

Administration and Monitoring

Administration

Directions:

• For minor skin irritations and rashes,

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

• For external anal itching:

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or soft cloth before application of this product
• children : under 12 years of age, consult a doctor.

• Other information:

• do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
• store at room temperature
• see crimp of tube for Lot Number and Expiration Date

Monitoring

• There is limited information regarding Monitoring of Hydrocortisone (ointment) in the drug label.

IV Compatibility

• There is limited information regarding IV Compatibility of Hydrocortisone (ointment) in the drug label.

Overdosage

There is limited information regarding Hydrocortisone (ointment) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

There is limited information regarding Hydrocortisone (ointment) Mechanism of Action in the drug label.

Structure

File:Hydrocortisone (ointment)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

• There is limited information regarding Pharmacodynamics of Hydrocortisone (ointment) in the drug label.

Pharmacokinetics

• There is limited information regarding Pharmacokinetics of Hydrocortisone (ointment) in the drug label.

Nonclinical Toxicology

• There is limited information regarding Nonclinical Toxicology of Hydrocortisone (ointment) in the drug label.

Clinical Studies

• There is limited information regarding Clinical Studies of Hydrocortisone (ointment) in the drug label.

How Supplied

There is limited information regarding Hydrocortisone (ointment) How Supplied in the drug label.

Storage

There is limited information regarding Hydrocortisone (ointment) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• There is limited information regarding Patient Counseling Information of Hydrocortisone (ointment) in the drug label.

Precautions with Alcohol

• Alcohol-Hydrocortisone (ointment) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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