Colofoam

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Colofoam

Quick Facts

Property Description
Active Ingredient Hydrocortisone acetate
Form Aerosol Rectal Foam
Pharmacological Class Corticosteroid (Glucocorticoid)
Common Use Local anti-inflammatory action
Origin Synthetic steroid derivative

What Type of Medicine is Colofoam?

Colofoam is a prescription-only steroid medicine whose active component is hydrocortisone acetate, a synthetic adrenocortical steroid and ester derivative of naturally occurring cortisol. This medicine is classified as a glucocorticoid, a subset of corticosteroids. Glucocorticoids are clinically recognized for their powerful anti-inflammatory capabilities. A key distinguishing factor of Colofoam is its formulation strictly for topical use via the rectal route, which is essential for maximizing local drug action while minimizing the systemic exposure associated with general oral steroid use.

Composition and Unique Rectal Foam Formulation

The active ingredient, hydrocortisone acetate, is delivered as a unique aerosol rectal foam, making Colofoam a single-ingredient preparation. The preparation is distinguished by its muco-adherent hydrophilic base with stabilizers and propellants required to create the expanding foam. This specialized foam preparation is intended for use in the distal colon and rectum. This particular foam format offers a distinct advantage over liquid enemas or suppositories, as its ability to expand allows for more extensive and consistent coating over the mucosal surfaces.

General Purpose: Focused Anti-Inflammatory Action

The general purpose of this medicine is to provide intensive local anti-inflammatory relief to the lining of the lower bowel. The hydrocortisone acetate works directly to suppress the body’s localized inflammatory cascade, stabilizing cell membranes and inhibiting the release of chemical mediators that cause swelling and tissue irritation. By reducing these underlying biological processes, Colofoam helps to stabilize the irritated tissue and diminish the localized symptoms of inflammation.

Regulatory References

  1. MedlinePlus Drug Info

What side effects are possible with Colofoam?

Possible Side Effects and Safety Information

The safety profile of Colofoam, which contains the corticosteroid hydrocortisone acetate, is officially documented around two primary areas: local adverse reactions at the site of application and the potential for systemic effects from drug absorption.

Documented Adverse Reactions

Adverse reactions are classified in regulatory documents according to the body system affected. Reactions commonly reported in official labeling involve the administration site and include burning, itching, irritation, and dryness.

Less frequently, official documentation notes adverse effects categorized under Skin and Subcutaneous Tissue Disorders, such as acneiform eruptions, skin atrophy, and striae.

System-Organ Class Examples of Documented Effects
General/Local Burning, itching, irritation, pain at the site
Endocrine Disorders HPA axis suppression, Cushing's syndrome
Ophthalmic Disorders Glaucoma, cataracts (with prolonged use)

Systemic Safety Considerations

Due to the presence of a potent corticosteroid, prolonged or excessive use increases the risk of systemic absorption, which is associated with more serious adverse reactions. The most significant potential systemic risk documented in regulatory texts is Hypothalamic-Pituitary-Adrenal (HPA) axis suppression and the development of Cushing's syndrome.

Safety statements specify that pediatric patients may exhibit greater susceptibility to systemic toxicity and HPA axis suppression, potentially leading to growth retardation. Furthermore, the risk of serious systemic effects, including ophthalmic complications like glaucoma and cataracts, is explicitly linked to the duration of use.

Official restrictions state that the medicine is not to be used in individuals with known hypersensitivity to its components or in the presence of certain local infections (e.g., fungal, viral) at the site of application.

Overdose and Emergency Response

The officially documented overdose profile for Colofoam is defined by the potential for systemic absorption of its active corticosteroid component, hydrocortisone acetate, leading to toxicity. Prolonged or excessive use can result in systemic exposure sufficient to cause manifestations of Hypercorticism (Cushingoid state) and reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression. Documented clinical manifestations of overexposure may include various psychic derangements, such as severe depression, acute myopathy, and ocular effects like glaucoma or posterior subcapsular cataracts. Pediatric patients may demonstrate greater susceptibility to these systemic effects due to their body composition.

Serious outcomes associated with excessive systemic corticosteroid exposure include life-threatening conditions such as adrenocortical insufficiency, the risk of convulsions, and the potential for extitStrongyloides hyperinfection.

Management involves symptomatic and supportive treatment, as no specific antidote is known. To reverse HPA axis suppression, regulatory guidance suggests gradual drug withdrawal and periodic monitoring using tests like the ACTH stimulation test. Seek emergency medical attention immediately for severe symptoms such as passing out or trouble breathing. Seek medical advice at once if fever, signs of infection, or steroid withdrawal symptoms occur.

Therapeutic Uses of Colofoam

What Colofoam treats: main uses and benefits


The use of this rectal foam is to provide local anti-inflammatory support for conditions involving inflammatory processes confined to the distal portion of the large bowel and rectum. The medication is used as adjunctive therapy in the treatment of Ulcerative Proctitis and Proctosigmoiditis, which are forms of Ulcerative Colitis localized to the lower bowel. The medicine is commonly applied in clinical settings that involve acute or disruptive symptom patterns during disease flare-ups, applied across domains where additional symptomatic support is needed.

Symptom Management and Patient Comfort

Colofoam supports symptomatic relief by addressing specific symptom clusters that become more disruptive during flare-ups. This includes symptoms related to physical discomfort such as rectal pain, the sensation of urgency (tenesmus), and the appearance of bloody stools, which are direct manifestations of an inflammatory state. The therapy helps ease the overall symptom burden by providing supportive relief when these symptoms interfere with daily functioning. This targeted support helps patients cope more steadily with difficult episodes and may contribute to improved day-to-day comfort when symptoms are more noticeable.


Quick Fact: Relief for Distal Inflammation Symptoms

Category Typical Symptom Relief
Conditions Ulcerative Proctitis, Proctosigmoiditis
Symptoms Rectal pain, Tenesmus, Bloody stools
Context Acute flare-ups in localized disease
Patient Benefit Supports easing overall symptom burden

Eligibility and Restrictions for Use

Who Can and Cannot Use Colofoam?

Eligibility for Colofoam (hydrocortisone acetate) is strictly defined by regulatory documents, focusing on patient status and pre-existing conditions. Official labeling establishes populations who must not use the medicine (contraindications) and those who require caution or special consideration.

Contraindicated Populations

Colofoam is contraindicated (must not be used) in patients with:

  • Hypersensitivity: A known allergy or documented hypersensitivity to hydrocortisone acetate or any other ingredient in the product formulation.
  • Local Rectal Conditions: Specific gastrointestinal/anorectal conditions that increase the risk of complication, including obstruction, abscess, peritonitis, perforation, fresh intestinal anastomoses, extensive fistulas, and sinus tracts.
  • Systemic Infections: Active or uncontrolled systemic fungal infections.

Restricted or Special-Consideration Use

Caution or special consideration is required for:

  • Infections: Use is generally not recommended in the presence of active or quiescent tuberculosis, untreated fungal, bacterial, systemic viral, or parasitic infections.
  • Pediatric Patients: Use in children requires special care due to a potential increased risk of side effects, including growth retardation.
  • Clinical Conditions: Use with caution is advised for patients with certain conditions like hypertension, heart failure, renal insufficiency, peptic ulcers, or diverticulitis.

What should I know about interactions with other medicines?

Colofoam Interactions with other medicines and products

Regulatory documentation outlines specific patterns where co-administration with other substances is documented to result in a formal interaction. The primary concerns involve pharmacokinetic interference with steroid metabolism and pharmacodynamic risks related to electrolyte balance.

Documented Interaction Patterns

Interaction Type Interacting Agent Category Official Outcome Description
Absolute Contraindication Live Vaccines Prohibited due to the risk of diminished immune response.
Pharmacokinetic CYP3A4 Inhibitors (e.g., Ketoconazole) May reduce hydrocortisone clearance, potentially increasing systemic exposure and the risk of corticosteroid effects.
Pharmacokinetic Enzyme Inducers (e.g., Rifampin) May induce metabolism, resulting in decreased systemic exposure to the corticosteroid.
Pharmacodynamic Potassium-Depleting Agents Concomitant use may lead to an additive risk of developing hypokalemia.
Pharmacodynamic Anticoagulants (e.g., Warfarin) May result in a modification of the anticoagulant effect; close observation is required.

Official prescribing information notes that co-administration with Aminoglutethimide may lead to a loss of the expected corticosteroid-induced adrenal suppression. These documented patterns define the necessary regulatory caution when combining this rectal foam with other medicinal products.

Mechanism of Action

Binding to the Glucocorticoid Receptor

Colofoam's active component, hydrocortisone, acts as an agonist for the intracellular Glucocorticoid Receptor (GR), a core biological target within immune and inflammatory cells of the rectal and distal colonic mucosa. This binding activates the receptor complex, which then translocates (moves) into the cell's nucleus, initiating the drug's effects on gene expression.


Dampening Inflammatory Signaling Pathways

Once inside the nucleus, the drug-receptor complex engages in transrepression by interfering with key pro-inflammatory transcription factors, such as Nuclear Factor Kappa B (NF-κB) and Activator Protein 1 (AP-1). This action prevents these factors from binding to DNA and activating the transcription of inflammatory genes. This mechanism also upregulates anti-inflammatory proteins, such as Annexin A1, which inhibits the enzyme phospholipase A2.


Modulating Local Vascular and Cellular Responses

The molecular actions lead to an anti-inflammatory physiological effect by reducing the synthesis of pro-inflammatory mediators (cytokines, prostaglandins). This process limits the infiltration of immune cells (e.g., neutrophils) and reduces capillary permeability, which collectively produces a decrease in local tissue edema and cellular accumulation in the intestinal wall.

Dosage and Administration Information

How to Use Colofoam

Colofoam is for rectal administration only using the enclosed applicator. Following the official instructions ensures the correct dosage and proper delivery of the foam into the rectum. The usual dosing schedule for adults is one full applicatorful once or twice daily for two to three weeks, and then potentially every second day thereafter, as directed by a healthcare provider.


Official Administration Protocol

Administration Scope Specification
Route of Administration Rectal
Dosing Schedule One applicatorful (measured dose) administered once or twice daily, for the prescribed duration.
Preparation Requirement The aerosol can must be shaken vigorously for at least 60 seconds (1 minute) immediately before each use.
Missed Dose Rule If a dose is missed, it should be administered as soon as possible. If it is almost time for the next dose, the missed dose should be skipped, and the regular schedule resumed. Do not administer a double dose to compensate for a missed one.

Procedural Steps for Use

  1. Preparation: Shake the aerosol can vigorously for one minute to ensure proper foam formation.
  2. Filling: Place the can upright on a level surface. Insert the nozzle into the tip of the applicator, ensuring the applicator plunger is withdrawn all the way out.
  3. Loading: Press down gently on the can's valve button until the foam fills the applicator barrel to the designated fill line. The can must be held upright during the entire filling process.
  4. Administration: Remove the applicator from the can. Gently insert the applicator tip into the rectum. Depress the plunger to expel the foam, then withdraw the applicator.
  5. Post-Use Care: The applicator parts must be thoroughly washed with warm water after use.

Recent Clinical Evidence

Colofoam: Recent Clinical Evidence


Evidence for Ulcerative Proctitis and Proctosigmoiditis

Colofoam was evaluated in research exploring active Ulcerative Proctitis and Proctosigmoiditis, conditions presenting with cycles of stability and flare-ups confined to the lower part of the bowel. The core evidence is derived from Randomized Controlled Trials (RCTs), where the medicine was evaluated in adult patient groups with active inflammation. These trials often involved comparisons with other topical treatments, such as different steroid enemas or mesalamine suppositories.

Studies monitored outcomes related to physical discomfort and irritative states, including the clinical status and the status of the bowel lining, which was monitored via visual assessment and tissue examination. Research highlights changes measured during the study period for specific patient-reported outcomes describing perceived discomfort, such as the evolution of rectal bleeding and urgency. These studies also monitored the level of systemic absorption as a secondary measure, showing patterns related to limited physiological absorption.


Durability of Observed Changes and Long-Term Follow-up

The majority of the available research has focused on the initial observation period during acute episodes. Consequently, the clinical trials typically had follow-up durations that were limited, rarely extending past eight weeks for the primary endpoints. Research has not extensively explored the observed short-term changes or the duration that an effect may last without further intervention. Data for long-term outcomes remains insufficient, and the durability of observed changes are not fully established in the existing published evidence landscape.


Evidence in Specific Patient Groups

Research efforts primarily focused on adult patients with localized inflammatory disease. As a result, the data for certain groups remain insufficient. For instance, evidence is limited for the use of the medicine in children or older adults. The results apply only to the populations studied in the clinical trials.


Study Limitations and Research Gaps

The evidence base, while relying on controlled trials, has key limitations that help contextualize its application. Evidence quality varies across studies was associated with the historical lack of a fully standardized set of primary outcomes for proctitis trials. The short follow-up durations mean the evidence primarily reflects patterns related to immediate symptom changes during the acute phase. Comparative evidence is not fully available against certain newer treatment options. Evidence highlights what is known, and what remains uncertain, regarding the evidence base for Colofoam.

Key Studies & References Efficacy, Safety and Tolerability of Rectal Therapies in Ulcerative Proctitis and Ulcerative Proctosigmoiditis

Frequently Asked Questions (FAQ)

Common questions about Colofoam (FAQ)


Q: Why is Colofoam prescribed for [condition name]?

According to official product labeling, Colofoam is indicated for the topical treatment of active ulcerative proctitis in the distal (lower) part of the rectum. It is designated as an adjunctive therapy, meaning it is used in addition to other main treatments for this inflammatory bowel condition.


Q: How long does the effect of Colofoam typically last after application?

The duration of use is typically for a limited period, and is guided by the official dosing schedule, which often lasts two to three weeks, sometimes followed by a step-down regimen. This reflects the period required to address the acute inflammation.


Q: What is the difference between Colofoam and a standard cream treatment?

Colofoam uses a unique aerosol foam formulation specifically designed for rectal use, whereas a standard cream is intended for external topical application. The foaming and expanding properties of the product are intended to allow for more extensive and consistent coating over the mucosal surfaces compared to external preparations.


Q: Is Colofoam safe to use long-term?

Official documents indicate that this medication is generally intended for short-term use. Because the product contains a corticosteroid, prolonged or excessive use increases the potential risk of serious systemic side effects. These risks include the potential for Hypothalamic-Pituitary-Adrenal (HPA) axis suppression and conditions like Cushing's syndrome.


Q: How does the FDA classify Colofoam?

Regulatory agencies classify Colofoam as a prescription-only medicine (Rx). Pharmacologically, its active ingredient is defined as a glucocorticoid, which is a type of corticosteroid known for its anti-inflammatory properties.


Q: Is it true that Colofoam is mainly used for short-term treatment?

Official product information describes the typical course of treatment as a limited period. This involves using the product once or twice daily for a set duration, often two to three weeks, supporting its use as a short-term treatment.


Q: What is the purpose of the non-medicinal ingredients in Colofoam?

The non-medicinal ingredients, which include propellants such as isobutane and propane, are essential components of the product's formulation. Their purpose is to create the specific aerosol foam necessary for proper delivery, ensuring the medication can be consistently administered to the rectal area.


Q: How quickly should I expect Colofoam to start working?

Patient information suggests that improvements in symptoms associated with the condition may begin to be observed within 5 to 7 days of starting treatment. The prescribed anti-inflammatory effect during the acute phase is linked to adherence to the full administration schedule as directed by the healthcare provider.


Q: Does Colofoam cause weight gain?

Weight gain is listed in official documentation among the possible, though often less common, side effects that can occur with corticosteroid use. This potential side effect is usually associated with the systemic absorption of the drug.


Q: Can Colofoam affect sleep?

Official adverse reaction reports for this class of medicine include the possibility of insomnia, which is difficulty falling or staying asleep. If experienced, this is typically related to the potential for some systemic absorption of the corticosteroid.


Q: Will Colofoam interact with vitamins or supplements like Vitamin D?

Regulatory labels advise that the rectal foam has the potential to interact not only with prescription and over-the-counter medicines but also with vitamins and herbal products. The potential for drug interactions extends beyond just prescription drugs.


Q: Does Colofoam have a strong smell?

The active ingredient in the product, hydrocortisone acetate, is chemically described in official sources as an odorless, white crystalline powder.


Q: Can I travel with Colofoam on an airplane?

The container is a pressurized aerosol. Official instructions state the container must not be burned or punctured. Travel with pressurized aerosols is governed by transportation regulations, and patients must comply with these guidelines.


Q: Do people typically stop using Colofoam once their symptoms improve?

Official administration instructions state that treatment is typically gradually discontinued once the prescribed course is complete or as symptoms warrant. This discontinuation process, which may involve moving to an every-other-day schedule, is always determined by a healthcare provider.


Q: What should I do if the side effects of Colofoam are bothersome?

Regulatory patient information states that any signs of adverse reactions or bothersome side effects are to be reported immediately to the prescribing physician or healthcare provider for professional guidance.


Q: Can Colofoam be used during pregnancy, based on regulatory information?

Regulatory information indicates the drug is in a category where its use during pregnancy is considered only when the potential benefit is determined to outweigh the potential risk to the developing fetus. Infants born to mothers who have received substantial doses should be closely observed for signs of hypoadrenalism.


Q: What happens if Colofoam gets into the eyes or mouth?

The official product information specifies that Colofoam is strictly for rectal use only. The product labeling explicitly includes a warning to avoid contact with the eyes during preparation and administration.


Q: Does Colofoam affect blood test results?

Since the medication is a corticosteroid, systemic absorption has the potential to affect certain metabolic processes. Official adverse reaction warnings note that corticosteroids can decrease carbohydrate tolerance (blood sugar), which indicates they may impact related blood tests.


Q: Is Colofoam a treatment or a cure for the condition it treats?

Regulatory indications define Colofoam as an adjunctive therapy for the condition it addresses. This means it is used as a treatment to help manage the disease's symptoms, not as a permanent cure.


Q: Is Colofoam known to cause headaches or dizziness?

Official adverse reaction documentation lists both headache and vertigo (dizziness or a spinning sensation) among the possible less common or rare side effects. These effects are associated with the potential systemic exposure to the corticosteroid component.


Q: Do official documents mention any potential for dependence on Colofoam?

Regulatory-based patient information explicitly notes that there is no evidence to suggest that this rectal foam is addictive.


Q: Is Colofoam typically used as a first-line treatment?

Official prescribing information indicates Colofoam is designated as an adjunctive therapy. This designation suggests it is intended to be used as an additional or secondary treatment to manage the condition, rather than a primary first-line treatment.


Q: Can I share my Colofoam prescription with a family member?

Official patient counseling information advises against using this medication for any disorder other than the specific condition for which it has been prescribed. Prescription medicine is intended for the exclusive use of the patient whose name is on the label.

How should Colofoam be stored and disposed of?

Colofoam (hydrocortisone acetate rectal foam) requires specific storage and handling due to its pressurized aerosol formulation, as defined by regulatory labeling.


Storage Conditions

The container must be stored upright at Controlled Room Temperature, specifically between 20° to 25°C (68° to 77°F), with permitted excursions between 15° to 30°C (59° to 86°F).

  • Do not refrigerate the product.
  • Do not store above 49°C (120°F).
  • The container is under pressure and must not be burned or punctured.
  • Keep this and all medicines out of the reach of children.

Disposal Instructions

Official labeling does not provide detailed instructions for discarding unused or expired Colofoam. Due to its pressurized nature, disposal must follow local pharmaceutical waste regulations for aerosol containers, adhering to the rule that the container must not be burned or punctured.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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