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Sucral CREAM

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Sucral CREAM

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Treatment option:

Medically reviewed

Marina Burgos

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.

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Overview of Sucral CREAM

What is Sucral CREAM? A Combination Cytoprotective Preparation

Property Description
Active ingredients Sucralfate, Lidocaine, Metronidazole
Form Cream (Topical/External preparation)
Pharmacological class Cytoprotective, Local Anesthetic, Anti-infective combination
Common use Relief and management of anorectal conditions
Origin Synthetic/Semi-synthetic derived compound preparation

Sucral CREAM: Identity and Classification

Sucral CREAM is defined as a fixed-dose combination medicine formulated as a cream specifically intended for rectal application. Pharmacologically, it is classified as a blend of a cytoprotective agent, a local anesthetic, and an anti-infective agent.

This particular preparation is a synthetic derived compound designed to provide comprehensive relief. It is typically available as a prescription-only medication, which reflects the necessity for professional guidance regarding its combination of active agents. Unlike simple single-action preparations, Sucral CREAM provides a distinct advantage by combining three mechanisms in one topical product, a combination used for providing multifaceted support in managing localized anorectal discomfort.


Composition and General Therapeutic Purpose

The medicine's formulation is centered on the precise combination of three active ingredients: Sucralfate, Lidocaine (Lignocaine), and Metronidazole. The preparation is housed within an emulsifying cream base, which ensures optimal application as an external preparation.

The primary purpose of combining these agents is to provide simultaneous symptomatic relief and support healing and repair of damaged tissues. The inclusion of Sucralfate is integral to promoting localized healing and creating a protective barrier in anorectal treatments. This means the medicine is specifically designed to help the affected area recover by shielding it from further irritation. The combination further supports tissue stability through the pain-relieving action of Lidocaine and the microbial modulation of Metronidazole, supporting an environment for recovery. The combined formulation is a specialized approach, differentiating it from over-the-counter single-component creams.

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What side effects are possible with Sucral CREAM?

Possible Side Effects and Safety Information

The medicine's safety profile, based on official regulatory documents, is characterized by local reactions at the application site and specific systemic cautions related to potential absorption of its active components (Sucralfate, Lidocaine, and Metronidazole).


Adverse Reactions and Frequencies

Adverse reactions are classified by frequency according to regulatory standards, with the most common events being localized to the area of application. The officially listed reactions primarily involve the Skin and Subcutaneous Tissue Disorders and the Gastrointestinal System.

Classification Representative Side Effect System-Organ Class
Very Common (ge 10%) Erythema (Redness) Administration Site
Common (1%-10%) Local Pruritus, Burning, Irritation, Constipation Skin/Gastrointestinal
Frequency Not Known Anaphylaxis, Peripheral Neuropathy Immune/Nervous System

Serious Safety Considerations

The official labeling documents rare but serious adverse reactions, which are typically associated with high systemic exposure. These include the risk of convulsive seizures and cardiac effects (e.g., hypotension, bradycardia), which are linked to the Lidocaine component. There is also a documented risk of Methemoglobinemia, a rare blood disorder, and Aluminum Accumulation and toxicity in patients with compromised renal function due to Sucralfate.

Safety Constraints for Special Populations

Specific caution is required in patients with severe hepatic impairment or chronic renal failure as these conditions can increase the risk of toxic plasma concentrations of the active components. Furthermore, the label notes that the safety and effectiveness of the components have generally not been established in the pediatric population.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation structures the overdose profile of Sucral CREAM around the risks of systemic toxicity, primarily due to the local anesthetic and anti-infective components (Lidocaine and Metronidazole). Overdose may occur from excessive topical use or accidental oral ingestion.

Documented Overdose Manifestations

System Affected Manifestations Listed in Regulatory Sources
Central Nervous System (CNS) Somnolence, confusion, dizziness, tremors, and potentially leading to seizures or coma.
Cardiovascular System Signs of bradycardia, hypotension, and the documented risk of cardiac arrest.

Required Emergency Actions

The label mandates that any suspected overdose requires immediately seeking urgent medical attention. If severe or life-threatening symptoms are observed, such as convulsions, profound bradycardia, or respiratory distress, the instruction is to contact emergency services immediately.

Treatment is symptomatic and supportive, focused on the maintenance of cardiorespiratory function. Continuous cardiac monitoring and close neurological observation are required. Regulatory information states that no specific antidote is known for the combination.

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Therapeutic Uses of Sucral CREAM

The primary therapeutic use of this combination cream is the focused management of symptoms and supportive care for several distressing anorectal conditions. The preparation is relevant for easing symptoms associated with localized conditions, helping to address pain and discomfort.

Managing Acute Discomfort and Supporting Recovery

This cream is commonly used in clinical settings that involve acute or disruptive symptom patterns, addressing symptom clusters that may become intense or disruptive, including severe pain, burning, and localized swelling. Conditions where it may be relevant include anal fissures, symptomatic hemorrhoids, and as part of postoperative anorectal care.

“This type of localized support helps in managing symptoms that create noticeable physiological strain and symptoms that interfere with daily functioning.”

Applied across domains where additional symptomatic support is needed, this combination is relevant for easing symptoms that arise from impaired tissue integrity and is often used during phases when symptoms become more noticeable. It is generally helpful in situations requiring assistance with maintaining functional stability and may be part of symptomatic management following various surgeries. The supportive application helps address symptoms that become more disruptive during flare-ups and contributes to easing the overall symptom load.

Quick Fact: Relevant for Easing Intense Discomfort

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Eligibility and Restrictions for Use

Official Population Eligibility for Sucral CREAM

The eligibility for using Sucral CREAM (Sucralfate, Lidocaine, Metronidazole) is strictly defined by regulatory documents, which establish specific populations who may use the medicine, who must not, and who requires special caution.

Population Category Eligibility Status Conditions
Absolute Contraindication Prohibited Patients with known hypersensitivity to Metronidazole, Lidocaine (or other amide-type local anesthetics), Sucralfate, or any excipients. Use is also contraindicated in the presence of deep wounds or puncture injuries at the site.
Age-Group Rules Not Recommended Use in children and adolescents (generally under 18 years) is not established or recommended due to a lack of safety and efficacy data. The cream is primarily intended for adults.
Physiological Status Not Recommended/Caution Use during pregnancy is not recommended unless clearly necessary. Women who are breastfeeding should be advised not to nurse during treatment.
Comorbidity-Linked Use with Caution Caution is required for patients with severe hepatic impairment (liver disease), renal impairment (kidney disease), a history of blood disorders, or specific inherited conditions like Porphyria.

The official eligibility profile classifies the medicine for use primarily in the adult population without these specific contraindications or conditions, requiring explicit caution and monitoring when used in patients with severe organ impairment.

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What should I know about interactions with other medicines?

The official interaction profile for Sucral CREAM is structured by the regulatory constraints associated with its three active components: Sucralfate, Lidocaine, and Metronidazole. These interactions are documented based on effects on pharmacokinetics and combination prohibitions.

Official Combination Constraints

Restriction Type Interacting Substances (Official Labeling)
Absolute Prohibition Disulfiram (prohibited due to the Metronidazole component); Alcohol (Ethanol) consumption (prohibited during and for at least 24 hours post-treatment).
Exposure Increase (PK) Warfarin and other coumarin anticoagulants; Cimetidine; Beta-blockers (e.g., Propranolol).
Timing Separation Required Oral Ciprofloxacin, Digoxin, Phenytoin, Levothyroxine, Theophylline, and other specified oral medicines.

Administration and Clearance Constraints

The most frequent regulatory constraint involves a timing separation rule. The Sucralfate component may physically reduce the oral absorption and subsequent systemic exposure of concurrently administered oral medications. To prevent this documented decrease, affected oral medicines must be administered at least two hours before or six hours after the Sucralfate component.

Separately, the Metronidazole component can increase the systemic exposure and effect of oral anticoagulants, such as Warfarin. Clearance of both Lidocaine and Metronidazole may be reduced by metabolic inhibitors or in populations with severe hepatic disease, increasing the risk of component accumulation. Furthermore, patients with renal dysfunction carry an increased risk of aluminum accumulation due to the Sucralfate component.

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Mechanism of Action

How Sucral CREAM Works — Mechanism of Action

️ Physical Shielding and Cytoprotection

This mechanism involves the physical binding of the active ingredient to exposed proteins on damaged epithelial tissues, forming an adherent, highly viscous polyanionic gel complex. This complex acts as a physical barrier that provides cytoprotection by shielding the underlying cells from mechanical friction, chemical irritants, and enzymatic degradation, which contributes to the maintenance of local tissue integrity.

Local Growth Factor Enhancement

Beyond physical protection, the sucralfate complex functions as a local modulator by binding and protecting key endogenous growth factors like Epidermal Growth Factor (EGF) and Fibroblast Growth Factor 2 (FGF2) from enzymatic breakdown. This indirect action increases the effective local concentration and signaling of these factors, influencing the proliferative phase of repair, which includes enhanced re-epithelialization and angiogenesis.

Modulation of the Wound Microenvironment

The drug's mechanism also contributes to modulating the local environment through its binding capacity for irritants (e.g., enzymes). This function, coupled with the creation of the physical barrier, influences the severity of the inflammatory response and limits the impact of dysregulated local mediator activity, which contributes to the local microenvironment conditions necessary for tissue regeneration.

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Dosage and Administration Information

Sucral CREAM is administered by topical application. The primary method of use is the external application of a thin film or a measured dose directly to the affected perianal area. For internal anorectal conditions, the medicine may be applied intra-anally or intrarectally using a specialized, lubricated disposable applicator.

Before each application, the area must be gently cleansed and dried to ensure proper adherence and absorption. For internal application, the applicator must not be inserted if it causes additional pain, a special procedural condition detailed in the official instructions.


Dosing and Duration

The standard labeled regimen for adults specifies that the cream is applied up to three to four times daily. Application timing is typically scheduled to coincide with specific periods of the day, such as in the morning, at night, or immediately following a bowel movement.

The overall course of treatment is strictly defined as short-term use. Continuous use is typically limited to a maximum of seven consecutive days; if the condition does not improve within this time, use must be discontinued. It is crucial to adhere to the officially prescribed amount, and the maximum recommended daily dosage must not be exceeded.

In terms of age-specific instructions, the use of Sucral CREAM in children under 12 years of age is restricted and requires consultation with a physician prior to administration.

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Recent Clinical Evidence

Recent Clinical Evidence

Research on this compound has explored whether it supports tissue repair and investigated its potential in individuals with chronic skin conditions and ulcers. Studies primarily examined its role in promoting tissue protection, reducing discomfort, and observing changes in inflammation and healing time.


Phase III Clinical Trials

Large-scale Phase III trials were conducted to evaluate its application in individuals with specific conditions, such as Diabetic Foot Ulcers (DFU) and post-operative wounds.

  • Study 1 (Healing in DFU): This pivotal trial assessed its effects on ulcer size reduction over a measured period, often compared to conventional dressings. Research evaluated whether its application was associated with the development of healthy granulation tissue and time to closure. The study protocol stipulated that the cream was typically applied with dressing changes.
  • Study 2 (Post-Operative Recovery): A separate study documented the impact of the cream on patients recovering from procedures such as hemorrhoidectomy. This investigation compared the time required for complete wound healing and the reporting of post-operative discomfort compared to other topical agents or placebo.

Combination Therapies and Specialized Use

Research has also explored the use of the topical agent in combination with other established treatments, such as in the management of chronic venous ulcers and certain types of burns. These investigations primarily focused on epithelialization rates and local infection markers.


Summary of Findings

Overall research has focused on the potential for short-term relief and support for wound closure, particularly in challenging wounds. Based on current research, evidence remains limited regarding long-term structural changes or definitive superiority across all dermatological conditions. Findings regarding specific biomarkers of inflammation showed variability across various study populations.

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Frequently Asked Questions (FAQ)

Common questions about Sucral CREAM (FAQ)

Q: How quickly does Sucral CREAM start to feel like it's working?

A: The cream contains Lidocaine, which acts as a local anesthetic. According to the properties of this ingredient, it is associated with a rapid onset of action, intended to provide temporary relief of discomfort.

Q: What are the most commonly reported temporary side effects of Sucral CREAM?

A: Official regulatory documents describe localized reactions as the most commonly reported events. These include Erythema (redness), listed as very common, and common reactions like local Pruritus (itching), Burning, and Irritation at the application site.

Q: Can men and women use the same tube of Sucral CREAM for different conditions?

A: The medicine is indicated for the management of specific anorectal conditions. Regulatory documents do not differentiate the recommended uses based on the patient’s sex, focusing instead on the affected condition and overall eligibility criteria.

Q: Can I use other skin products like sunscreen or moisturizer with Sucral CREAM?

A: Official product information focuses primarily on interactions with oral medicines. No specific regulatory information is available regarding the concurrent application of most other topical skin products, such as sunscreens or moisturizers, in the same area.

Q: What is the difference in purpose between Sucral CREAM and an antifungal cream?

A: Sucral CREAM is classified as a Cytoprotective, Local Anesthetic, and Anti-infective combination preparation for anorectal conditions. It includes the anti-infective agent Metronidazole. An antifungal cream is specifically approved for treating conditions caused by fungus.

Q: What is the general classification of Sucral CREAM (e.g., analgesic, anti-inflammatory)?

A: Sucral CREAM is officially classified as a Cytoprotective, Local Anesthetic, and Anti-infective combination preparation. These classifications describe the primary actions of its three active components working together.

Q: Is Sucral CREAM the same as other moisturizing creams?

A: No. Sucral CREAM is a fixed-dose combination prescription medicine containing three active pharmaceutical ingredients. It is classified as a cytoprotective, local anesthetic, and anti-infective product, which distinguishes it from general over-the-counter moisturizing creams.

Q: Can I use Sucral CREAM on my face?

A: The drug is specifically indicated and studied only for the management of anorectal conditions. Therefore, the official indication is limited to the anorectal area.

Q: Is it normal to feel a tingling sensation when I first apply Sucral CREAM?

A: The official product information lists reactions like Burning and Irritation at the application site as common adverse reactions. Some individuals may describe these sensations as a temporary tingling feeling after application.

Q: What should I do if I accidentally get Sucral CREAM in my eyes?

A: Sucral CREAM is for external/rectal use only, and contact with the eyes should be avoided. General guidance suggests seeking immediate direction from a healthcare professional after accidental exposure.

Q: Can I use Sucral CREAM on broken or irritated skin?

A: Official regulatory documents state that use of the medicine is contraindicated (prohibited) if there are deep wounds or puncture injuries present at the site where the cream would be applied.

Q: Is Sucral CREAM absorbed into the bloodstream?

A: Yes, regulatory documents related to the medicine’s pharmacokinetics indicate that the active components, including Lidocaine and Metronidazole, are absorbed into the systemic circulation following topical application.

Q: Does the color or smell of Sucral CREAM change over time?

A: Official storage instructions require the cream to be kept in its container, tightly closed, and stored away from excess heat and moisture. These conditions help to maintain the stability, integrity, and intended physical qualities of the product over its shelf life.

Q: Can I travel with Sucral CREAM in my carry-on luggage?

A: Official storage instructions require keeping the cream within a specific temperature range, typically 20 C to 25 C, and protecting it from freezing. Official guidance requires protecting the product during travel by ensuring storage conditions are maintained.

Q: Why does the official documentation list certain patient groups as 'cannot use'?

A: Patient groups are listed as 'cannot use' due to a contraindication, such as having a known hypersensitivity (allergy) to any component. Caution is also required for patients with pre-existing conditions, like severe liver or kidney impairment, due to the documented risk of active component accumulation.

Q: What is the purpose of the non-active ingredients in Sucral CREAM?

A: Non-active (or inactive) ingredients are officially included to form the necessary cream base. This base is essential for the medication’s correct consistency, stability, and optimal application as a topical external preparation.

Q: Is there a maximum time frame for how long Sucral CREAM can be used?

A: Yes, the officially prescribed regimen dictates that continuous use of the cream is defined as short-term. Treatment is typically limited to a maximum of seven consecutive days.

Q: Can I use Sucral CREAM with an over-the-counter hydrocortisone cream?

A: The official interaction profile does not specifically mention concurrent use with topical hydrocortisone. However, regulatory documents advise caution when combining Sucral CREAM with other topical products as their combined effect or interference with absorption has not always been established.

Q: Does Sucral CREAM have a generic version available?

A: While this specific three-component combination product is branded, the active components—Sucralfate, Lidocaine, and Metronidazole—are themselves widely available as generic single-ingredient preparations.

Q: Are there different storage requirements for Sucral CREAM in hot climates?

A: Official regulatory documents specify that the cream must be stored at Controlled Room Temperature (20 C to 25 C) and kept away from excess heat. This means necessary protection is required in high-temperature environments.

Q: Is it mandatory to wash my hands after using Sucral CREAM?

A: Official instructions for application suggest the need to prevent accidental transfer of the medicine, which generally involves cleansing the hands after use.

Q: Why is Sucral CREAM not approved for treating all types of skin irritation?

A: The medicine is approved by regulatory bodies based on the specific conditions and patient populations studied during clinical trials. It is specifically indicated only for the management of anorectal conditions, not for general, unrelated skin irritation.

Q: Is it possible to develop a resistance to the effects of Sucral CREAM over time?

A: Because the cream contains Metronidazole, which is an anti-infective agent, official documents include standard warnings about the potential for microbial resistance that is generally associated with this class of drug.

Q: Do pediatric warnings exist for Sucral CREAM?

A: Yes. The official labeling states that the safety and effectiveness have generally not been established in the pediatric population. The product is primarily intended for use in adults.

Q: What official bodies have approved the use of Sucral CREAM?

A: The medicine is approved and regulated by various governmental authorities for use within their specific jurisdictions. These bodies include the FDA in the United States and equivalent health regulatory agencies worldwide.

Q: How often do regulatory bodies review the safety of Sucral CREAM?

A: Regulatory bodies continually monitor the safety of approved medicines, including Sucral CREAM, through mandated post-marketing surveillance and review processes to ensure the safety information remains current and complete.

Q: What is the common reason why patients discontinue using Sucral CREAM?

A: Regulatory documents list common side effects at the application site, such as Pruritus (itching), Burning, and Irritation. These localized adverse reactions are often cited as potential reasons for patients to stop using a topical medication.

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How should Sucral CREAM be stored and disposed of?

How to Store and Dispose of Sucral CREAM: Official Requirements

Regulatory documents specify the precise conditions for storing and disposing of this product to maintain stability and safety.

Storage Conditions

Requirement Official Instruction
Temperature Store at Controlled Room Temperature, typically 20 C to 25 C.
Container Keep the cream in the container it came in and ensure it is tightly closed.
Protection Store away from excess heat and moisture; the product must not be frozen.
Child Safety Keep the medication out of the sight and reach of children.

Disposal Instructions

Unused or expired cream must be disposed of properly. Regulatory authorities prefer the use of an authorized drug take-back program. If a take-back program is unavailable, the product should be mixed with an unappealing substance (such as dirt or cat litter) in a sealed container and then thrown in the household trash. The cream must not be flushed down the toilet or poured into a sink.

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

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