Hydrocortisone (rectal)

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Hydrocortisone (rectal)
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: Adeel Jamil, M.D. [2]

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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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

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Hydrocortisone (rectal)
Systematic (IUPAC) name
(11β)-11,17,21-trihydroxypregn-4-ene-3,20-dione
Identifiers
CAS number 50-23-7
ATC code A01AC03 A07EA02 (WHO) C05AA01 (WHO) D07AA02 (WHO) H02AB09 (WHO) S01BA02 (WHO) S02BA01 (WHO)
PubChem 5754
DrugBank DB00741
Chemical data
Formula C21H30O5 
Mol. mass 362.460 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Licence data

US

Pregnancy cat.

A(AU) C(US)

Legal status

?(AU) POM(UK) ?(US)

Routes Oral tablets, intravenous, topical, rectal

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-(11β) with the following structural formula:
This image is provided by the National Library of Medicine.

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 15°–30°C (59°–86°F). Protect from freezing.

Images

Drug Images

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

ASCEND Laboratories, LLC NDC 67877-312-24

Hydrocortisone Acetate Suppositories 25 mg

For Rectal Administration

Rx Only 24 Adult Suppositories

This image is provided by the National Library of Medicine.

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

References

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


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