Colifoam

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Colifoam

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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 Colifoam

Colifoam: Classification and Core Identity

Property Description
Active Ingredient Hydrocortisone acetate
Form Medicated aerosol foam (Rectal foam)
Pharmacological Class Corticosteroid / Glucocorticoid
General Purpose Localized anti-inflammation and swelling reduction
Origin Synthetic adrenocortical steroid

Colifoam is a specialized, prescription-only pharmaceutical product classified as a medicated aerosol foam intended for the localized administration of its active component. This unique dosage form is specifically designed for intrarectal use, distinguishing it from oral medications or simple liquid enema preparations. The foam is delivered via a pressurized canister and is engineered to adhere to the mucosal lining, ensuring focused therapeutic contact in the lower gastrointestinal tract. This targeted delivery mechanism is widely clinically recognized for optimizing contact time between the medication and the affected area, a critical factor for localized therapies.


The Active Ingredient: Hydrocortisone and the Glucocorticoid Class

The core therapeutic component in Colifoam is Hydrocortisone acetate, a synthetic derivative of the naturally occurring cortisol hormone. This compound is classified pharmacologically as a potent Glucocorticoid, which is a type of Corticosteroid. This classification indicates its role in inflammation and immune response regulation. As a single-active ingredient product, it leverages this compound's pharmacological properties to suppress inflammation. Hydrocortisone rectal foam is a specific preparation within the steroid group, differentiated by its specialized foam vehicle developed to treat inflammatory conditions primarily affecting the rectum and sigmoid colon.


General Therapeutic Purpose of the Localized Foam

The primary general purpose of Colifoam is to deliver anti-inflammatory and immunosuppressive effects directly to the irritated tissues. The specialized foam formulation is central to this purpose; the high viscosity of the rectal foam helps improve drug retention and distribution, optimizing the efficacy of the intrarectal therapy. This localized action is intended to reduce the physical symptoms of inflammation, such as swelling, irritation, and edema, at the site of disease activity. The use of foam ensures consistent coating of the inflamed internal mucosa.

What side effects are possible with Colifoam?

Possible Side Effects and Safety Information for Colifoam

Colifoam (hydrocortisone acetate rectal foam) may cause both local and systemic adverse reactions, as it is a corticosteroid that can be absorbed into the bloodstream. The risk of systemic effects, such as hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome, increases with prolonged or high-dose use, requiring cautious and monitored discontinuation to prevent adrenal insufficiency.

Serious and Clinically Significant Adverse Reactions

Systemic absorption may lead to several serious risks, including:

  • Increased susceptibility to infection, including serious or fatal infections like chickenpox and measles.
  • Cardio-renal effects such as elevated blood pressure, fluid retention, and hypokalemia (potassium loss).
  • Ocular disorders including the formation of posterior subcapsular cataracts and glaucoma (increased intraocular pressure).
  • Psychiatric disturbances, which may range from mood swings, insomnia, and euphoria to severe depression and psychotic manifestations.
  • Musculoskeletal effects, including bone formation inhibition in children, osteoporosis, and acute myopathy.

Safety Restrictions and Contraindications

This medication is strictly contraindicated in patients with known hypersensitivity to the drug, as well as in the presence of local conditions such as obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulae, or untreated viral, fungal, tuberculous, or bacterial infections.

Use requires caution and monitoring in patients with conditions like hypertension, congestive heart failure, diabetes mellitus, active or latent peptic ulcers, diverticulitis, and severe ulcerative colitis due to an increased risk of perforation. The contents of the aerosol container are flammable; patients must avoid fire, flame, and smoking during and immediately following administration.

Overdose and Emergency Response

The official regulatory profile for hydrocortisone acetate rectal foam (Colifoam) is defined by the risk of systemic overdosage resulting from drug absorption, especially with prolonged or excessive use over large surface areas. This exposure may produce signs and symptoms of Hypercorticism or Cushing’s syndrome, reflecting effects on the endocrine system. Documented manifestations include hypertension, salt and water retention, and metabolic changes such as hyperglycemia and glucosuria. Continued systemic absorption can lead to Hypothalamic-Pituitary-Adrenal (HPA) axis suppression.

When any manifestation of systemic overdosage occurs, the mandated action is to discontinue use of the rectal foam immediately. Official guidance states that immediate medical attention must be sought, and patients are instructed to contact emergency services or go to a hospital even if there are no initial signs of poisoning. There is no specific antidote documented for this type of overdosage.

Management focuses on treating symptoms and, if HPA axis suppression is confirmed through laboratory evaluation, involves the gradual withdrawal or substitution of the corticosteroid. Pediatric patients are officially noted to be more susceptible to systemic toxicity, with risks including linear growth retardation and delayed weight gain.

Therapeutic Uses of Colifoam

What Colifoam Treats: Main Uses and Benefits

The medication is relevant for use in conditions involving inflammatory or irritative processes in the lower bowel. It is applicable in conditions characterized by periods of heightened symptoms, such as ulcerative colitis, proctosigmoiditis, and granular proctitis. It is used in situations involving localized discomfort.

It is commonly used to help with symptom clusters that interfere with daily functioning, including physical discomfort such as rectal pain, persistent urgency, and frequent bowel movements. It provides support that helps ease the overall symptom burden and contributes to improved day-to-day comfort during symptomatic periods.

“This medication is applied across domains where additional symptomatic support is needed.”

It is considered relevant for use in clinical settings that involve acute or unstable symptom patterns, often used during phases when symptoms become more noticeable. This provides supportive relief when symptoms interfere with routine activities and managing the overall symptom load during episodic or fluctuating manifestations.

Quick Fact: Relief for Inflammation-Driven Discomfort

Regulatory References

  1. Medsafe Data Sheet

Eligibility and Restrictions for Use

Colifoam (hydrocortisone acetate rectal foam) is officially intended for use in the adult population and its eligibility is strictly defined by regulatory contraindications and required cautions.

Eligibility Scope

Classification Restricted Population/Condition Regulatory Status (Example)
Contraindicated Patients with known hypersensitivity to any component. Absolute Prohibition [Source 1.2]
Patients with local structural pathology (e.g., abscess, perforation, obstruction, fresh anastomoses) or active infections (e.g., systemic fungal, viral) [Source 1.2, 2.6].
Conditional Use Patients with impaired hepatic or renal function or diabetes mellitus [Source 1.6, 2.4]. Requires Caution and Monitoring
Elderly patients are more susceptible to adverse reactions [Source 1.6].
Age Restriction Young children [Source 2.2]. Potential for growth retardation
Maternal Status Pregnancy is classified as Category C by the FDA, meaning use is permitted only if the benefit justifies the risk to the fetus. Some labels list pregnancy as a contraindication [Source 1.1, 2.6]. Restriction/Contraindication
Lactation/Breastfeeding [Source 1.2, 2.3]. Discontinue nursing or the drug

What should I know about interactions with other medicines?

The official regulatory profile for hydrocortisone acetate rectal foam (Colifoam) details interactions primarily based on pharmacokinetic changes and additive pharmacodynamic effects, requiring specific constraints on co-administration.

Interaction Category Documented Interaction Statement
Metabolic (Exposure Alteration) Co-treatment with CYP3A4 inhibitors (e.g., Ketoconazole) may increase the risk of systemic effects due to decreased corticosteroid clearance. Conversely, hepatic enzyme inducers (e.g., Rifampin, Phenytoin) may enhance metabolic clearance, potentially resulting in decreased exposure.
Prohibited Combination A Contraindication exists for co-administration with live or live, attenuated vaccines, as the corticosteroid may diminish the immune response. Vaccine administration should be deferred.
Pharmacodynamic Risk Concurrent use with potassium-depleting agents (e.g., diuretics) increases the risk of hypokalemia. The combination with NSAIDs or Salicylates increases the documented risk of gastrointestinal bleeding.
Timing Requirement Anticholinesterase Agents must be withdrawn at least 24 hours before initiating corticosteroid therapy due to the documented risk of severe weakness.

For antidiabetic agents, the interaction involves the corticosteroid increasing blood glucose, potentially requiring a dosage adjustment of the antidiabetic medicine. These interaction domains define constraints necessary when co-administering enzyme modulators or agents that affect electrolyte balance, as stated in official government labeling.

Mechanism of Action

Colifoam (hydrocortisone acetate) is a corticosteroid that interacts with specific components of inflammatory signaling pathways. The active ingredient functions as an agonist by binding to intracellular glucocorticoid receptors (GRs) located within target cells of the rectal mucosa. This binding event initiates a sequence of molecular steps: the drug-receptor complex translocates into the nucleus, where it influences gene expression.

This nuclear action primarily acts to repress the activity of key pro-inflammatory transcription factors such as Nuclear Factor-kappa B (NF-κB). By blocking the transcription of inflammatory genes, the mechanism results in the suppressed synthesis of multiple pro-inflammatory mediators, including various cytokines and chemokines. The drug's influence on gene expression also modulates the activity of molecules required for white blood cell movement. This directly alters the local microvascular dynamics, influencing capillary permeability and limiting the extravasation and migration of immune cells into the affected tissue, thereby modulating the local physiological response.

Dosage and Administration Information

How Colifoam is Used: Official Administration Guidelines

Colifoam (hydrocortisone acetate rectal foam) is a prescription-only medication administered exclusively through the intrarectal route, utilizing a specialized applicator. The standardized usage protocol is based on the prescribed dose, frequency, and specific handling techniques detailed in the product information.


Official Dosing and Schedule

Administration Scope Detail
Dose and Strength One applicatorful, delivering 90 mg of hydrocortisone acetate.
Acute Dosing Applied once or twice daily (e.g., morning and night) during the initial treatment phase.
Timing Context Application is typically recommended after a bowel movement to promote optimal foam retention.
Duration The course of treatment is generally short-term, usually lasting two to three weeks.

Procedural and Course Instructions

Before application, the aerosol canister must be shaken vigorously for 5 to 10 seconds to ensure the correct formulation is dispensed. The patient is instructed to use the applicator while lying on their side or standing with one foot elevated, and must attempt to retain the foam for at least one hour to maximize localized therapeutic contact.

If a dose is missed, it should be used as soon as remembered, unless the next dose is due shortly; in that case, the missed dose is skipped, and the schedule resumes. Doses must not be doubled. Once symptoms subside, the frequency is gradually reduced (tapered) to the lowest effective dose, such as every second day, before discontinuation, rather than stopping abruptly. The medication's safety and effectiveness have not been established in children under 12 years of age.

Recent Clinical Evidence

Colifoam: Recent Clinical Evidence

The following overview describes the structure of the research studies conducted on hydrocortisone acetate rectal foam, focusing only on what the research explored and what outcomes were measured. All information is drawn from authorized regulatory and peer-reviewed scientific sources.


Evidence for Localized Inflammatory Conditions

Research includes Randomized Controlled Trials (RCTs) and comparative studies generally assessing short-term outcomes. These study designs were used in research exploring outcomes related to inflammatory states in the lower bowel, which are conditions characterized by fluctuating or episodic manifestations. These trials focused on adult patients with localized inflammation, such as ulcerative proctitis and proctosigmoiditis. Studies also explored use in inflammation related to radiation exposure, which relied on smaller clinical studies and observational reports. Researchers monitored both objective findings (like visual changes in the tissue) and patient-reported outcomes describing perceived discomfort.


The Role of the Foam Formulation

Studies explored the foam’s unique properties, examining the way it spreads and adheres to the rectal lining. Comparative research investigated whether findings differed based on the preparation used. Findings indicate that the specialized foam preparation was studied for its ability to provide localized coverage and retention within the rectum compared to liquid preparations. This research helps contextualize how the specialized vehicle may influence the localized therapeutic setting.


Current Research Gaps and Uncertainty

The research highlights areas where more data is needed. Long-term effects are not fully established beyond the typical two to three-week acute treatment period observed in the studies. Data for certain groups remain insufficient, particularly for pediatric populations and specific groups of older adults. Research indicates that sample sizes were modest in several key comparative studies. Furthermore, the evidence is limited regarding whether the preparation was observed in studies to reach or address inflammation situated higher up in the colon, as it is primarily restricted to the rectum and sigmoid colon. The findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Colifoam (FAQ)


Q: How quickly should I expect to see an improvement in my symptoms after starting Colifoam?

Official product information indicates that symptomatic improvement is often observed within five to seven days after beginning treatment. If a satisfactory response is not achieved within two to three weeks, a healthcare provider may determine that the drug should be discontinued.


Q: What are the most common side effects people report when using Colifoam?

Common effects reported in clinical use include local reactions at the application site, such as pain, burning, irritation, or dryness. Regulatory documents state that other reported common effects may include stomach pain, bloating, or changes in the menstrual period in women. Official warnings focus on serious, but less common, systemic side effects.


Q: What should I avoid doing right after I use Colifoam?

To optimize the medication's therapeutic contact, patients are generally advised to retain the foam for a specific period after application, as instructed by the prescribing information. If the foam is passed immediately, the product information indicates the dose's benefit may be lost, as optimal retention is critical for efficacy.


Q: Can I travel with Colifoam, and how should I pack it?

Colifoam is packaged in a pressurized aerosol canister that contains flammable contents. Official warnings state the container must be protected from heat and direct sunlight and should not be exposed to temperatures above 50 C (120 F). These storage rules must be followed to maintain the safety and stability of the product, particularly when handling the pressurized canister.


Q: How does the local application of Colifoam compare to systemic (whole-body) steroid use?

Colifoam is designed for local action, delivering the corticosteroid directly to the affected rectal tissue. However, official information notes that some systemic absorption may occur, especially with high doses or prolonged use, or when the lining of the bowel is severely inflamed. This absorption may increase the potential for systemic side effects, such as hypothalamic-pituitary-adrenal (HPA) axis suppression, which involves the body's natural steroid production.


Q: Will Colifoam affect my ability to drive or operate machinery?

Corticosteroids, when absorbed systemically, have been associated with central nervous system effects, including psychiatric disturbances like mood changes and insomnia. Due to the potential for central nervous system effects, including mood changes or insomnia, patients should be aware of how the medication affects them before driving or using machinery.


Q: What research shows Colifoam's benefit specifically in the lower colon?

Research findings have indicated that the specialized foam preparation provides topical administration, often reaching and coating the rectal lining up to approximately 10 centimeters from the anal verge. This localized coverage is noted in the clinical context of the drug's use.


Q: Why is proper cleaning of the applicator so important?

The manufacturer’s instructions strongly emphasize the importance of cleaning the applicator thoroughly after each use. This step is required by the manufacturer's instructions to maintain the proper function of the device and ensure hygienic administration for subsequent uses.


Q: Does using Colifoam mean I can stop taking my other colitis medications?

Regulatory information indicates that Colifoam is typically used as an adjunctive (additional) therapy, rather than a replacement for all other treatments. It is important that a patient’s health care provider is aware of all medications being taken.


Q: What is the main difference between Colifoam and a suppository for ulcerative colitis?

The key difference lies in the formulation and delivery vehicle. Colifoam is a medicated aerosol foam, which is designed to expand and adhere to the rectal lining. The foam vehicle is specifically designed to adhere to the mucosal lining, which can be advantageous in achieving targeted drug retention and distribution compared to solid suppositories.


Q: Is it normal to feel an urge to go to the bathroom right after using Colifoam?

Optimal drug effectiveness depends on retaining the medication in the rectum after application, as noted in the product instructions. The dosing schedule advises using the medication after a bowel movement to optimize retention.


Q: Can Colifoam cause weight gain or changes in appetite?

As a type of corticosteroid, this medication can be associated with side effects like increased appetite and weight gain, particularly with high-dose or prolonged use. Sometimes, weight gain can also be an observation associated with the underlying condition improving.


Q: Will I need to change my diet while I am using Colifoam?

Corticosteroids can affect the balance of fluid and electrolytes in the body. Since corticosteroids can affect the body’s balance of fluid and electrolytes, regulatory information notes that dietary salt restriction or potassium supplementation may be considered, particularly with higher or prolonged doses.


Q: Are there any long-term risks associated with the use of Colifoam?

Regulatory documents caution that this medication is intended for short-term, acute use. Official warnings advise against continuous, long-term use because this increases the risk of developing serious systemic side effects, including the suppression of the adrenal gland function, cataracts, glaucoma, and osteoporosis.


Q: What should I do if the applicator seems difficult or uncomfortable to insert?

Official instructions specify that the applicator must be inserted gently. If necessary, a neutral lubricant such as petrolatum can be used on the tip of the applicator to assist with the application.


Q: Do people experience mood changes or difficulty sleeping while on Colifoam?

Yes, official drug information lists psychiatric disturbances as potential adverse reactions associated with corticosteroids that are absorbed systemically. These effects can include insomnia, mood swings, anxiety, and other behavioral changes, which may require medical monitoring.


Q: What are the signs that Colifoam is starting to work?

Clinical observations indicate that a reduction in the visible signs of inflammation may be noted within five to seven days. However, clinical response is often judged by objective findings, such as those from a sigmoidoscopy, rather than symptomatic improvement alone.


Q: Can men and women use Colifoam the same way?

The official recommended dosage and administration instructions for Colifoam are standardized for all adult patients, regardless of gender. However, certain side effects, such as changes in the menstrual period, are specific to female patients.


Q: What are the side effects if I use Colifoam for longer than prescribed?

Using the product for a longer duration or at higher doses than prescribed significantly increases the risk of systemic absorption of the steroid. This elevates the likelihood of serious side effects, including the suppression of the body's natural corticosteroid production (HPA axis suppression).


Q: Does Colifoam have to be used at a specific time of day?

The prescribing information suggests establishing a consistent routine for administration. The instructions generally suggest applying the morning dose after a bowel movement and the evening dose right before going to bed to help with foam retention.


Q: How does Colifoam compare to other topical treatments for rectal inflammation?

Official information states that Colifoam is an adjunctive therapy intended for patients who may not tolerate or be able to retain liquid enema forms of corticosteroids. Its unique foam vehicle is designed to adhere to the mucosal lining, which provides localized coverage and retention, differentiating it from simple liquid preparations.


Q: Is Colifoam considered a high-risk medication?

As a glucocorticosteroid, Colifoam carries warnings about potentially serious adverse reactions from systemic absorption, such as HPA axis suppression and increased susceptibility to infection. Regulatory information specifies that its use requires careful monitoring due to the potential for systemic adverse effects.


Q: Does Colifoam help with symptoms like rectal bleeding and urgency?

Colifoam is used to treat localized ulcerative colitis and proctitis by reducing inflammation. As an anti-inflammatory agent for localized conditions, the medication is intended to address the underlying inflammation that contributes to symptoms like rectal bleeding and urgency.


Q: Can a person become dependent on Colifoam?

Long-term or high-dose use can lead to temporary dependence because the body may reduce its natural production of corticosteroids. For this reason, regulatory information warns that if the medication is stopped, the dose must be gradually reduced (tapered) according to medical guidance, as sudden cessation after long-term use can cause adverse effects.


Q: Can Colifoam cause a local burning or itching sensation?

Yes, local side effects are commonly reported. These application-site reactions include burning, itching, irritation, and rectal pain. If any persistent discomfort occurs, patients should consult their healthcare provider.


Q: What happens if some of the foam leaks out after application?

For the medication to be fully effective, retention in the rectum is necessary. If the foam is expelled immediately, the full benefit of the dose is considered lost, and patients are instructed to try and retain the foam for at least one hour.


Q: Is there a special technique for inserting the applicator to maximize effectiveness?

Official instructions detail specific administration positioning (e.g., lying on the side or standing with one foot elevated) and require that the canister is properly shaken and the applicator is filled only to the mark to ensure correct dispensing and retention. This is detailed in the full instructions for use.


Q: Can Colifoam affect fertility in men or women?

Long-term animal studies to evaluate the effect on fertility have not been performed for topical corticosteroids. Official documents note that safety for use in pregnancy and lactation has not been fully established. As with any medication, patients with fertility concerns may wish to discuss their use of corticosteroids with a qualified professional.


How should Colifoam be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory agencies mandate specific conditions for storing and disposing of the Colifoam pressurized aerosol container to maintain stability and ensure safety.

Storage Classification Requirement
Temperature Store below 25 C (77 F). Do not refrigerate or expose the canister to temperatures above 50 C (120 F).
Protection Keep in a cool, dry place. Protect from sunlight, excessive heat, and damp areas (e.g., bathrooms, near sinks).
Handling Keep the medicine out of reach of young children. Shake the aerosol can vigorously before each use.
Disposal Do not pierce, burn, or incinerate the container, even when empty. Return any expired or unused medicine to a pharmacist for proper disposal.

The product's shelf-life is determined by the expiry date printed on the packaging, and it must be stored in the original container until use.

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

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