Soker

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Soker

Method of action: Vasoprotective

Treatment option:

Medically reviewed

Rosario Oropesa

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 Soker

Soker: Core Definition and Quick Facts

Soker is a fixed-dose combination medicine engineered for topical anorectal application. It combines two active ingredients to achieve dual therapeutic action: immediate symptom relief and supportive tissue care.

Property Description
Active Ingredients Cinchocaine, Policresulen
Form Suppository, Ointment
Pharmacological Class Local Anesthetic and Hemostatic/Antiseptic Agent
Common Use (General) Relief from localized pain, itching, and minor bleeding
Origin Synthetic

Soker: Identity and Pharmacological Class

Soker belongs to the composite pharmacological class of a Local Anesthetic Agent combined with an Antiseptic and Hemostatic Agent. This combination approach is key to its therapeutic identity, allowing it to address both the sensory and structural components of local anorectal discomfort. Cinchocaine, the anesthetic component, is clinically recognized for its high potency and long duration of action, distinguishing it from shorter-acting topical anesthetics and ensuring sustained relief.

Composition, Form, and General Purpose

The preparation contains two distinct, synthetically derived active ingredients: Cinchocaine (specifically Cinchocaine Hydrochloride) and Policresulen. Policresulen, a synthetic polymer, is classified as an antiseptic and is utilized for its hemostatic action. Soker is available in two primary drug forms, the Suppository and the Ointment, both suitable for the topical anorectal route. The overall purpose is to provide simultaneous, effective relief from localized discomfort and actively support the natural repair process of the affected epithelium.

What side effects are possible with Soker?

Possible Side Effects and Safety Information

The safety profile of Soker, a fixed-dose combination of Cinchocaine and Policresulen, is based on official regulatory labeling, documenting potential adverse reactions and use restrictions. Side effects are primarily localized to the application site.


Officially Documented Adverse Reactions

The most frequently documented reactions are associated with the application site and are typically temporary. These effects are grouped according to the body system affected (System-Organ Class).

System-Organ Class Adverse Reaction Frequency Classification
General Disorders and Administration Site Conditions Local irritation, Discomfort (e.g., burning or itching) Occasional
Skin and Subcutaneous Tissue Disorders Temporary stinging, Skin rash Very Occasional

Allergic Contact Sensitivity is documented as a rare or isolated case serious adverse reaction. Manifestations may include inflammatory reddening of the skin (erythema) with the formation of vesicles (papules) and persistent itching (pruritus).


Safety-Related Restrictions and Special Populations

Official prescribing information includes specific limitations regarding the use of Soker, defining populations and conditions where the medicine is contraindicated or requires caution.

  • Contraindication: Do not use if there is a known hypersensitivity or allergy to Cinchocaine, Policresulen, or any other component of the preparation.
  • Pregnancy: Use is advised only when strictly indicated, following careful assessment of the potential risks to the mother and the child.
  • Pediatric Use: The medicine is not recommended for children below 12 years of age due to insufficient safety information, and its use is prohibited in children below 2 years of age.
  • Duration Pattern: Any local discomfort is noted to usually disappear after a short time, suggesting it may be more prominent at the start of treatment.

Overdose and Emergency Response

Overdose and when to seek help

Overdose scenarios for Soker are primarily defined by the documented risks associated with high systemic exposure to its potent local anesthetic component. All information is based strictly on government regulatory labeling regarding overdose presentation and mandated actions.

Documented Manifestations and Severe Outcomes Systemic toxicity is officially described through Central Nervous System (CNS) and Cardiovascular manifestations. CNS effects may include confusion, lightheadedness, tremors, and the potential for convulsions. Cardiovascular signs include hypotension and bradycardia, progressing to the severe outcomes of cardiovascular collapse and cardiac arrest. Life-threatening outcomes documented in regulatory sources include respiratory depression and respiratory arrest. If the product is accidentally swallowed, a local erosive effect on the mouth, throat, and esophagus is a documented risk.

Mandatory Emergency Actions Immediate medical attention is required for any severe systemic manifestation or in the event of accidental ingestion. Emergency services must be contacted immediately for any life-threatening symptoms such as respiratory or cardiac arrest. Management focuses on providing symptomatic and supportive treatment, often requiring continuous monitoring of cardiovascular and respiratory vital signs. Regulatory documents also note that elderly patients and those with hepatic impairment may be at heightened risk for systemic toxicity, necessitating special consideration.

Therapeutic Uses of Soker

What Soker treats: main uses and benefits

Soker is generally used in situations involving certain distressing symptoms and offers supportive therapeutic benefit across several key domains. It focuses on managing acute, disruptive manifestations rather than addressing the underlying cause of the condition. The primary therapeutic purpose of Soker is to assist with the management of pain and similar acute symptoms. This aligns with the overall therapeutic goal of addressing acute symptoms.


Symptomatic Relief During Acute Episodes

This domain covers situations involving symptoms associated with acute or episodic changes, or an acute phase where symptoms become difficult to tolerate. Soker is applied across domains where additional symptomatic support is needed, such as in clinical settings marked by increased discomfort or tension, and conditions presenting with systemic or localized discomfort. Soker helps address symptom clusters that may appear suddenly, providing support that helps ease the overall symptom burden and contributes to supporting day-to-day comfort during periods of heightened discomfort. It is often used when symptoms intensify and supportive relief is needed. The common indications include supporting symptom management in episodes characterized by symptoms related to physical discomfort and symptoms that create noticeable physiological strain.

“Symptomatic relief helps patients cope more steadily with difficult episodes.”

Management of Disruptive Manifestations

Soker is relevant in conditions characterized by periods of heightened symptoms, particularly when symptoms create noticeable functional strain. It is applied in settings where symptoms become temporarily overwhelming, offering symptomatic relief that helps patients cope more steadily with difficult episodes and assists with maintaining functional stability.


Quick Fact: Relevant for Symptom Management

Eligibility and Restrictions for Use

Who can and cannot use Soker?

Eligibility for Soker, a combination of Cinchocaine and Policresulen, is strictly defined by regulatory documents, which list absolute prohibitions and conditional-use groups.


Eligibility scope Official Regulatory Statement
Populations for whom use is allowed Adults aged 18 years and older who do not have any listed contraindications.
Populations for whom use is contraindicated Individuals with known hypersensitivity to Cinchocaine, Policresulen, or any excipient (e.g., soya/peanuts). Children below 2 years of age must not use this medicine.
Age-related eligibility rules Use is not recommended for children and adolescents under 18 years due to insufficient data.
Condition-specific eligibility rules Contraindicated in patients with severe liver impairment or an existing systemic infection. Prohibited for application at sites with anal fissures or open wounds.
Pregnancy and lactation eligibility status Not recommended for routine use during pregnancy and requires caution during lactation, with use conditional on a benefit-risk assessment.

Regulatory documents define eligibility through absolute prohibitions and restrictions. These include clear non-eligibility for infants and those with severe organ impairment or systemic infection. Use is conditional and restricted in pregnant and breastfeeding populations, requiring specific caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Soker is primarily structured around the class warnings associated with its local anesthetic component, Cinchocaine, as documented by government regulatory authorities. Interactions with the second active ingredient, Policresulen, are not explicitly documented in regulatory sources for this topical combination.


Official Interaction Statements

Regulatory documents highlight two main pharmacodynamic interaction risks that must be considered due to the potential for systemic absorption of Cinchocaine from the anorectal route:

  • Other Local Anesthetics: Co-administration with other products containing local anesthetics is documented to result in additive toxic effects. This interaction primarily affects the central nervous system and the cardiovascular system.
  • Methemoglobinemia-Inducing Agents: The concomitant use of Soker with known oxidizing agents (including certain nitrates, sulfonamides, and antineoplastic agents) is officially documented to increase the risk and potential severity of methemoglobinemia.

Population-Specific Interaction Notes

Official labeling notes a higher potential for adverse interaction effects in specific populations. In patients with hepatic or renal impairment, there is an increased potential for systemic exposure and toxicity from the Cinchocaine component. This is due to the drug's reliance on metabolism and clearance pathways that may be impaired, which must be considered against potential co-exposure.

Mechanism of Action

Soker's Pharmacological Mechanism

Soker's pharmacological effect is determined by two distinct and complementary mechanistic domains that modulate local physiological responses.


Reversible Blockade of Sensory Nerve Conduction

This domain covers the action of Cinchocaine, which targets Voltage-Gated Sodium Channels ( Nav channels) on peripheral sensory nerve fibers. By acting as a reversible inhibitor, Cinchocaine prevents the necessary influx of Na^+ ions, thereby impeding the propagation of nerve impulses. This mechanism directly results in the inhibition of sensory signal transmission from the application site to the central nervous system.


Chemically Induced Hemostasis and Tissue Structure Modulation

This domain relates to Policresulen, which initiates rapid, acid-catalyzed denaturation and coagulation of extracellular proteins in damaged tissue and on microbial surfaces. This chemical interaction forms a physiological coagulum, which mechanically seals minor vessels and physically facilitates the debridement of altered tissue. The resultant cascade contributes to local hemostasis and modulates the local environment, influencing the processes of epithelial proliferation and tissue remodeling.

Dosage and Administration Information

How to Use Soker: Official Administration Guidelines

Administration Scope

Soker is administered via the Topical (external) and Rectal (internal) routes. The two available forms—ointment and suppository—contain distinct amounts of active ingredients, with the suppository holding 100 mg Policresulen and 2.5 mg Cinchocaine Hydrochloride per unit. The standard initial regimen requires the preparation to be applied or inserted two to three times per day. A key procedural instruction is that rectal use (for both the ointment and the suppository) must be performed after emptying the bowel. For suppository use, the regimen may be reduced to once per day as acute symptoms improve.


Instruction Classifications (High-Level)

Classification Detail
Administration Method Type Topical (Ointment) and Rectal (Suppository)
Frequency Pattern Multiple times daily (2-3 times/day) for initial use
Use-Context Constraints Administration requires a prior preparatory step (bowel evacuation) and methodological requirement (applicator use for internal ointment)
Course Duration Rule Use is generally directed as a short-term course (e.g., up to seven days)

Resulting Procedural Structure

The official protocol dictates a structured application sequence: first, ensure the bowel is emptied. Next, apply the ointment or insert one suppository unit two to three times per day, confining use to the anorectal region. Internal application of the ointment explicitly requires the enclosed applicator/cannula. This administration framework defines the standardized approach to using the medicine.

Recent Clinical Evidence

Research evidence / Overview of studies for Soker

Evidence for Use in Hemorrhoidal Pathology

Research exploring the combination of Cinchocaine and Policresulen was studied in observational settings relevant to internal and external hemorrhoidal pathology. These investigations have primarily utilized multi-center observational studies and retrospective case series. Studies were conducted in adult populations with varying degrees of hemorrhoid severity, and research examined outcomes related to physical discomfort and patient-reported experiences.

Studies reported measurements of acute symptom changes over short treatment periods. Findings describe patterns observed in the studies related to measured changes in discomfort, itching, and minor bleeding. These documented outcomes were short-term, typically observing responses over defined time intervals like one to two weeks, and relied on patient-reported outcomes describing perceived discomfort by patients and physicians.

Evidence for Acute Anorectal Lesions and Symptoms

Research was studied for localized lesions and general symptomatic relief. For acute conditions like anal fissures and minor perianal lesions, the study structure includes multi-center observational studies and individual case reports. Research explored outcomes related to acute symptom severity, particularly pain, and changes linked to irritative states, such as signs of tissue regeneration.

Evidence for general anorectal symptom clusters (pain, itching, minor bleeding) is derived from broad regulatory acceptance and historical clinical experience, supported by findings from the aforementioned observational and prospective trials. Consistency in findings related to the acute symptomatic actions of its components has been documented.

Long-Term Research and Follow-up Gaps

The majority of research exploring short-term symptom changes for Soker was observed in studies concentrating on defined time intervals typically lasting less than two weeks. This means that follow-up durations were limited across the primary evidence base. Consequently, long-term effects are not fully established, and research provides context but not individual predictions regarding sustained symptom control. A key limitation is that comparative evidence is lacking from large-scale, head-to-head randomized controlled trials.

Key Studies & References

  1. Cinchocaine Hydrochloride+policresulen: Uses, Side Effects and Medicines (Regulatory/Product Information)
  2. Faktu Ointment: Product Monograph (Illustrative example of regulatory data for the combined product)

Frequently Asked Questions (FAQ)

Common questions about Soker (FAQ)


Q: Are there any particular foods or drinks that should be avoided while taking Soker?

A: Official drug documents focus primarily on interactions with other medicines. Formal warnings regarding interactions with specific foods or common drinks are generally not specified for this topical medicine. For specific guidance, the product's official information can be reviewed for any stated dietary precautions.


Q: What kind of drug-drug interactions are generally mentioned for Soker?

A: Official documentation describes a risk of additive toxic effects when combined with other local anesthetics. The drug label also indicates an increased risk of methemoglobinemia (a condition affecting blood oxygen levels) when used alongside certain oxidizing agents.


Q: Why does the packaging for Soker say to keep it in its original container?

A: Official storage guidelines indicate that using the original, tightly closed container helps to protect the product from environmental factors like moisture, light, or contamination that could potentially affect its quality and stability.


Q: What should I know about driving or operating machinery while on Soker?

A: According to the official product labeling, when this medicine is used as prescribed, it is generally not known to affect a person's ability to drive or operate heavy machinery.


Q: What is the difference between Soker and its main active ingredient?

A: Soker is defined in official documents as a fixed-dose combination medicine, meaning it contains two distinct active ingredients: Cinchocaine (a local anesthetic) and Policresulen (an antiseptic and hemostatic agent). Therefore, it is a combination product and not defined by a single main component.


Q: Why is there a Black Box Warning associated with Soker in the US?

A: Based on regulatory documentation, Soker is not associated with an FDA Boxed Warning. This warning is a serious cautionary statement highlighted in official U.S. labeling.


Q: Does Soker cause changes in weight (gain or loss)?

A: According to the official product information, weight changes (gain or loss) are not listed as documented or expected adverse reactions in the summary of side effects.


Q: Are there any known non-drug interactions mentioned in official documents for Soker?

A: Yes, official precautionary notes may reference non-drug interactions due to the local properties of one of the ingredients. These can include instructions to avoid using during menstruation or a note that the preparation may stain fabrics like cotton or leather.


Q: Is Soker known to cause sensitivity to sunlight?

A: Sensitivity to sunlight, known medically as photosensitivity or phototoxicity, is not listed as an officially documented adverse reaction in the drug's safety profile.


Q: Does Soker contain lactose or gluten, for people with sensitivities?

A: The official list of inactive ingredients, or excipients, for formulations like the suppository does not list lactose or gluten. Ingredients listed include substances like hard fat and soybean lecithin.


Q: Is Soker a controlled substance in all countries where it is sold?

A: The active ingredients in Soker, Cinchocaine and Policresulen, are generally not classified as controlled substances under major regulatory frameworks, such as the US Controlled Substances Act.


Q: What are the signs of a severe allergic reaction to Soker described in official materials?

A: Official documents describe signs of allergic contact sensitivity as including inflammatory reddening of the skin (erythema), the formation of small blisters or bumps (papules), and persistent itching (pruritus). These are listed as rare or isolated occurrences.


Q: What are the storage guidelines for Soker if I travel to a warm climate?

A: Official storage guidelines indicate that the medicine is kept at controlled room temperature (typically 20^circmathrmC to 25^circmathrmC). The product must be protected from excessive heat, which provides the general rule applicable to travel in warm climates.


Q: Is it normal for the color of the Soker tablet to vary slightly?

A: Official documents for forms like the suppository may state that slight spots or variations in color are natural characteristics of the base material. These minor variations do not affect the medicine's use or effectiveness.


Q: Can taking Soker interfere with sleep patterns?

A: Sleep pattern interference, such as insomnia, is not listed as an officially documented adverse reaction in the side effects profile for Soker.


Q: Is Soker known to affect fertility in men or women?

A: Non-clinical data from animal studies for the components showed no harm to the developing fetus. Specific human data on fertility effects are generally not established in the medicine’s regulatory labeling.


Q: What is the maximum duration of use discussed in the clinical studies for Soker?

A: The primary clinical studies concentrate on short treatment periods. Acute symptom changes were typically observed over defined time intervals that are generally less than two weeks or follow an initial course of up to seven days.


Q: How often do people usually need to take Soker?

A: The usage pattern described in official documents is administration two to three times per day initially. This frequency may be reduced to once per day as the acute symptoms improve.


Q: Why do official materials specify that Soker must be swallowed whole?

A: Official documents clarify that Soker is intended only for topical anorectal use as an ointment or suppository. It is not intended for swallowing or oral consumption, and should only be administered according to the labeled external or rectal directions.


Q: Are there specific instructions for what to do in case of an accidental overdose of Soker?

A: Yes, the official labeling includes a section that addresses incorrect use and overdosage. This information covers accidental ingestion or cases of excessive topical application.


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

A: Official documents do not include warnings regarding potential for dependence or abuse with Soker. Additionally, the drug's active ingredients are not classified as controlled substances under major regulatory frameworks.

How should Soker be stored and disposed of?

How to Store and Dispose of Soker?

To ensure product quality and safety, Soker must be stored according to its official drug labeling, which defines the specific temperature and handling conditions. Unless otherwise specified on the label, medications are often stored at controlled room temperature (20^circmathrmC to 25^circmathrmC or 68^circmathrmF to 77^circmathrmF), protected from excessive heat, freezing, and moisture. The original, tightly closed container must be used to protect the product, and any specific requirements for light protection should be followed.

All medicines must be kept out of sight and reach of children to prevent accidental ingestion or poisoning. After the labeled expiration date or after an in-use stability period (if applicable, such as after mixing or opening), the drug may no longer be fully effective or safe.

The proper disposal of unused or expired Soker is critical to protect public health and the environment. Most household medications can be safely discarded in the trash after mixing them with an undesirable substance (like coffee grounds) and sealing the mixture. Alternatively, use a drug take-back program or an authorized mail-back option. Do not flush Soker down the toilet or pour it down a drain unless it is specifically listed on the U.S. FDA's flush list for highly dangerous medications.

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

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