Hydrocortisone (rectal)

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# Overview
Hydrocortisone (rectal) is a anti inflammatory and corticosteroid that is FDA approved for the treatment of inflamed hemorrhoids, post-irradiation (factitial) proctitis chronic ulcerative colitis, cryptitis
and other inflammatory conditions of anorectum and pruritus ani.   Common adverse reactions include burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis and secondary infection.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Hydrocortisone acetate suppositories are indicated for use 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.

### Dosing Information
- For rectal administration. Detach one suppository from strip of suppositories. Remove the wrapper. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

## Off-Label Use and Dosage (Adult)

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

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Hydrocortisone (rectal) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Hydrocortisone (rectal) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hydrocortisone (rectal) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Hydrocortisone (rectal) in pediatric patients.

# Contraindications
- Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

# Warnings

### PRECAUTIONS:
- Do not use hydrocortisone acetate suppositories unless adequate proctologic examination is made.
- If irritation develops, the product should be discontinued and appropriate therapy instituted.
- In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, hydrocortisone acetate should be discontinued until the infection has been adequately controlled.

# Adverse Reactions

## Clinical Trials Experience
- The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.

## Postmarketing Experience
There is limited information regarding Hydrocortisone (rectal) Postmarketing Experience in the drug label.

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

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well controlled studies in pregnant women. Hydrocortisone acetate suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydrocortisone (rectal) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Hydrocortisone (rectal) during labor and delivery.

### Nursing Mothers
- It is not known whether this drug is excreted in human milk and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocortisone acetate suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

### Pediatric Use
There is no FDA guidance on the use of Hydrocortisone (rectal) in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Hydrocortisone (rectal) in geriatric settings.

### Gender
There is no FDA guidance on the use of Hydrocortisone (rectal) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Hydrocortisone (rectal) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Hydrocortisone (rectal) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Hydrocortisone (rectal) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Hydrocortisone (rectal) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Hydrocortisone (rectal) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
There is limited information regarding Hydrocortisone (rectal) Administration in the drug label.

### Monitoring
There is limited information regarding Hydrocortisone (rectal) Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Hydrocortisone (rectal) and IV administrations.

# Overdosage
- If signs and symptoms of systemic overdosage occur, discontinue use.

# Pharmacology

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

## Structure
- DESCRIPTION: Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene 3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11) with the following structural formula:

## Pharmacodynamics
There is limited information regarding Hydrocortisone (rectal) Pharmacodynamics in the drug label.

## Pharmacokinetics
- In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.

## Nonclinical Toxicology
There is limited information regarding Hydrocortisone (rectal) Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Hydrocortisone (rectal) Clinical Studies in the drug label.

# How Supplied
Hydrocortisone acetate suppository is off-white, smooth surfaced and rod shaped with one pointed end.
Box of 12 suppositories  NDC 67877-312-12
Box of 24 suppositories  NDC 67877-312-24
Caution: Federal law prohibits dispensing without prescription.
Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07665                                                               
Rev. 08/13

## Storage
Store between 1530C (5986F). Protect from freezing.

# Images

## Drug Images

## Package and Label Display Panel
ASCEND
Laboratories, LLC
NDC 67877-312-24
Hydrocortisone
Acetate
Suppositories
25 mg
For Rectal Administration
Rx Only                        
24 Adult
Suppositories

# Patient Counseling Information
There is limited information regarding Hydrocortisone (rectal) Patient Counseling Information in the drug label.

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

# Brand Names
There is limited information regarding Hydrocortisone (rectal) Brand Names in the drug label.

# Look-Alike Drug Names
There is limited information regarding Hydrocortisone (rectal) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price