Medicine guide

Proctocort

30 mg · Suppository

Prescription only
Corticosteroid

Active substance: Hydrocortisone Acetate
Used in: Hormones, such as thyroid and steroids
Made by: Salix Pharmaceuticals, Inc
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-09-17

What it is

Corticosteroid

Used for

Proctocort ® Suppositories are indicated for use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory…

Do not take it if

Proctocort ® Suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

47other products contain Hydrocortisone Acetate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Proctocort ® Suppositories are indicated for use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.

From the official label · 2024-09-17 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-09-17

Do not take it if

Proctocort ® Suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

For rectal administration.
Detach one suppository from strip of suppositories.
Remove the foil 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Do not use Proctocort ® 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 anti-bacterial agent should be instituted.
If a favorable response does not occur promptly, Proctocort ® Suppositories should be discontinued until the infection has been adequately controlled.
Carcinogenesis :
No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.
Pregnancy Category 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.
Proctocort ® 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.
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 Proctocort ® 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.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

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

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Quoted from the official label, section “Drug Abuse and Dependence”.

Side effects

The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

Box of 12 suppositories - 30 mg - NDC 65649-511-12 Box of 24 suppositories - 30 mg - NDC 65649-511-24
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Store away from heat.
PROTECT FROM FREEZING.
Distributed by:
Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Proctocort is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2024 Salix Pharmaceuticals, Inc. or its affiliates Rev. 07/2024 9521401

Quoted from the official label, section “How Supplied”.

What is in it

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:
Each rectal suppository contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable oil base.
Proctocort Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (10)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 10 of 10

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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European UnionNo exact match for this strength and form

Every strength and form (3)

FranceNo exact match for this strength and form

Every strength and form (5)

CanadaNo exact match for this strength and form

Every strength and form (7)

Details

Made by	Salix Pharmaceuticals, Inc
Active substance	Hydrocortisone Acetate
Used in	Hormones, such as thyroid and steroids
Strength	30 mg
Form	Suppository
Route	Rectal
Packs	12 SUPPOSITORY in 1 BOX · 24 SUPPOSITORY in 1 BOX
NDC	65649-511

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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