Colme (Cyanamid)

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Colme (Cyanamid)

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Method of action: Antialcoholic

Treatment option: Alcoholism

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Overview of Colme (Cyanamid)

Property Description
Active ingredient Cyanamide
Form Oral solution (Drops)
Pharmacological class Aldehyde Dehydrogenase Inhibitor (ALDH Inhibitor)
Common use Alcohol dependence management
Origin Synthetic compound (Carbodiimide derivative)

What Type of Medicine is Colme (Cyanamid)?

Colme is a synthetic prescription medication classified as an alcohol deterrent agent, primarily used within the therapeutic framework for managing chronic alcohol dependence. Its fundamental identity is rooted in its single active component, Cyanamide, a synthetic organic compound classified as a carbodiimide derivative. As an alcohol deterrent, Colme belongs to the specific pharmacological class of Aldehyde Dehydrogenase Inhibitors (ALDH Inhibitors), a designation that clearly defines its function by the key enzyme it targets in the body's metabolic process. Cyanamide acts by directly inhibiting the enzyme responsible for acetaldehyde metabolism.


Composition and Form of the Cyanamide Preparation

The composition of Colme features Cyanamide as the sole active ingredient, prepared specifically as an odorless, colorless oral solution. This liquid dosage form is administered using drops (peroral administration) and consists of the active substance dissolved in an aqueous-alcoholic or equivalent hydrophilic base. This specialized formulation, designed for ease of use, differentiates it from many comparable deterrents that are manufactured as solid oral tablets. A unique pharmacokinetic profile is associated with this liquid administration route.


What is the General Purpose of an Alcohol Deterrent Agent?

The general purpose of this synthetic agent is to create a state of strong sensitization to alcohol as a deterrent. Colme achieves this by interfering with the breakdown of alcohol within the body, which leads to the rapid buildup of the toxic metabolite acetaldehyde. This immediate accumulation triggers an intense, predictable, and highly aversive reaction, which then serves as a powerful pharmacological incentive for the patient to maintain total abstinence from all forms of ethanol. Aldehyde dehydrogenase inhibitors are agents recognized to induce an acute sensitivity to alcohol. Therefore, the general therapeutic goal of this medication is to chemically support a patient's commitment to avoiding alcohol.

Regulatory References

  1. NIH, MedlinePlus
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What side effects are possible with Colme (Cyanamid)?

Possible Side Effects and Safety Information for Colme (Cyanamide)

The official safety profile of Cyanamide is formally defined by government regulatory bodies based on documented adverse events and established classifications. The profile includes two main types of effects: the intended, acute reaction that occurs when alcohol is consumed, and general adverse reactions not linked to alcohol intake.


Regulatory Classification of Adverse Reactions

Adverse reactions are classified by the frequency observed in clinical data, following standard regulatory definitions:

  • Common adverse effects (affecting 1 to 10 users in 100) include headache, somnolence (drowsiness), asthenia, and fatigue. These effects may be noted to be more frequent during the initial days of treatment.
  • Uncommon effects include allergic dermatitis and skin rash.
  • Rare effects (affecting 1 to 10 users in 10,000) include hepatitis (liver inflammation) and polyneuritis (peripheral nerve damage), with the latter associated with long-term exposure.

Serious Adverse Reactions and Safety Constraints

The primary safety limitation is the severe, mandatory alcohol sensitization reaction (acetaldehyde syndrome) resulting from co-ingestion of ethanol. This reaction, which includes intense flushing, tachycardia (rapid heartbeat), and hypotension (low blood pressure), constitutes a core element of the safety profile.

Serious non-aversive risks documented in official labels include Hepatotoxicity (severe liver injury). Due to this risk, the drug is formally contraindicated in individuals with severe hepatic impairment. Cautionary statements also apply to patients with severe renal impairment.

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Overdose and Emergency Response

Overdose and when to seek help

This section details the officially documented overdose profile of the active substance, Cyanamide, based on authoritative government regulatory information regarding its severe toxicity.

Domain Official Regulatory Statement
Documented Manifestations Severe intoxication is documented to present with gastrointestinal distress, including massive vomiting and diarrhea. Central nervous system effects include drowsiness and encephalopathy. Cardiovascular signs include severe hypotension progressing to shock.
Physiological Systems Affected The Cardiovascular System, the Metabolic System (leading to persistent metabolic acidosis), and the Central Nervous System are documented to be critically affected.
When to Seek Immediate Help Urgent medical help is required immediately upon suspected exposure or manifestation of severe signs, necessitating early and aggressive life-saving management. Immediate medical attention is required when signs such as refractory shock, hypotension, or profound metabolic acidosis are observed.

Resulting Overdose Structure

Official overdose statements:

  • Overdose may lead to rapidly progressing manifestations including refractory shock and cardiovascular collapse, and is classified as life-threatening.
  • The intoxication is characterized by profound and persistent metabolic acidosis which necessitates critical care procedures and serial Arterial Blood Gas (ABG) analysis.
  • Documented supportive management procedures include gastric lavage, activated charcoal administration, endotracheal intubation, and haemodynamic support using vasopressors.

Connection to the overall overdose profile: Official regulatory information defines the overdose profile by emphasizing the severe, systemic chemical toxicity of Cyanamide, particularly its potential to cause refractory shock and metabolic acidosis. These facts require urgent medical help when manifestations are observed, establishing the necessity for a critical care setting. Supportive management is the defined treatment approach, as no specific antidote is officially documented for this compound.

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Therapeutic Uses of Colme (Cyanamid)

What Colme (Cyanamid) Treats: Main Uses and Benefits

Colme (Cyanamide) is commonly used to help with pharmacological support for conditions associated with acute or disruptive episodes of alcohol use disorder. The medication is commonly used to help with pharmacological deterrence in this therapeutic domain. This therapeutic action is applicable within clinical settings that involve acute or disruptive symptom patterns where continuous support is needed.

It is applied across domains where additional symptomatic support is needed for symptom clusters related to chronic alcohol dependence, including those that interfere with daily functioning and relapse vulnerability. The medication supports the patient during difficult episodes by easing distress related to impulse control. This supportive mechanism helps patients cope more steadily with symptom fluctuations, and may assist with maintaining a sense of stability when symptoms are more noticeable.

Colme is commonly used as a pharmacological adjunct within comprehensive psychosocial and behavioral treatment programs, and is relevant when supportive symptom management is appropriate. This supportive role assists with maintaining functional stability during the recovery process.


Quick Fact: Support for Symptoms that Interfere with Daily Functioning Colme supports patients with chronic alcohol dependence by contributing to easing the overall symptom load during periods of heightened physiological activity.


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Eligibility and Restrictions for Use

Who Can and Cannot Use Colme (Cyanamid)?

The eligibility for using Colme (Cyanamid) is strictly defined by regulatory labeling for the management of chronic alcohol dependence in adult patients. The medicine is only intended for use as an adjunct within a supportive psychosocial treatment program.


Absolute Contraindications (Do Not Use)

Regulatory documents explicitly state that Colme is contraindicated and must not be administered to individuals with the following conditions:

  • Patients with severe coronary disease or severe myocardial disease.
  • Patients with known hypersensitivity or allergy to Cyanamide or any of the medicine's components.

Population Restrictions

  • Pregnancy and Lactation: Use is prohibited. The preparation must not be administered during either pregnancy or breastfeeding.
  • Age Groups: The indication is for adults; use is not established for children or adolescents.
  • Conditional Use: Treatment is reserved for selected patients who demonstrate adequate motivation and willingness to cooperate in their abstinence program. The medicine is not intended for unmotivated or uncooperative patients.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Colme (Cyanamid) is defined by a single, critical drug–substance interaction, which is the basis of its use as an alcohol deterrent agent.

Property Value
Medicinal Product Categories Ethanol-containing products (Alcoholic Beverages, Medicines, Foods, Supplements)
Specific Interacting Substance Ethanol (Alcohol)
Mechanistic Basis Pharmacodynamic interaction resulting from the accumulation of acetaldehyde due to the inhibition of aldehyde dehydrogenase (ALDH).
Timing-based Rule Mandatory continuous abstinence from all alcohol is required throughout treatment and for a defined period following discontinuation.
Interaction-related Restriction Co-administration with Ethanol (alcohol) is prohibited under all circumstances.

Interaction Classifications (High-Level)

Property Value
Interaction Severity Classification Absolute Contraindication
Regulatory Basis Authoritative government regulatory-aligned clinical reports and health authority texts.
Interaction-Context Constraints The aversive reaction risk is present whenever any source of alcohol is ingested due to the persistent nature of ALDH enzyme inhibition.

Official Interaction Statements

  • Co-administration with Ethanol (alcohol) is classified as an absolute interaction contraindication.
  • The interaction with ethanol is a pharmacodynamic effect leading to the rapid accumulation of the metabolite acetaldehyde, which induces an acute aversive state.
  • The officially described outcome of this interaction includes severe vasodilation and excessive hypotension.

The regulatory documents confirm that this drug's interaction profile is exclusively driven by its principal pharmacodynamic mechanism, mandating a continuous timing separation from all alcohol-containing substances. No specific interactions involving CYP enzymes, drug transporters, or other medicinal products are explicitly documented in the available regulatory prescribing information.

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Mechanism of Action

The core mechanism of Cyanamide involves the irreversible inhibition of the Mitochondrial ALDH2 enzyme, its primary biological target. This molecular interaction forms a covalent bond with the enzyme's active site, permanently disabling the ALDH and blocking the crucial second step of the ethanol metabolism pathway. The resulting consequence is the rapid systemic accumulation of acetaldehyde, the highly toxic intermediate of ethanol breakdown. This metabolite acts directly on the body’s systems, causing peripheral vasodilation and stimulating the Autonomic Nervous System through the release of catecholamines. This sequence of events translates the molecular blockade into a defined physiological response (e.g., flushing, tachycardia). Furthermore, the prolonged duration of the ALDH inhibition is a direct result of the irreversible binding. Restoration of the body's ALDH enzyme activity is dependent on the slow, biological process of new enzyme synthesis, which results in the persistence of enzyme non-functionality for an extended period.

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Dosage and Administration Information

How to Use Colme (Cyanamid)

The usage of Cyanamide is governed by established patterns for its administration as an oral solution. The regimen defines specific dose ranges and a clear time-based structure, which must be followed as part of the therapeutic protocol.

Administration Scope

Instruction Detail
Route of administration Oral (Peroral administration).
Dosing schedule (Adults) Abstinence Therapy: 50 mg to 200 mg of the active ingredient per day. Temperate Therapy: 15 mg to 60 mg of active ingredient per single dose.
Timing in relation to meals Not explicitly specified in standard administration guidelines.
Preparation requirements The medicine is supplied as a 1% oral solution containing 10 mg of Cyanamide per 1 mL.
Age-group administration rules The documented dosage schedules are established for adults.
Missed-dose rules Take the dose as soon as possible if missed; if close to the next dose, skip the missed dose. Never take two doses at one time.
Special procedural conditions Use requires strict adherence to prescribed instructions, including a mandated initial dose adjustment period.

Instruction Classifications

Classification Detail
Administration method type Oral solution (liquid/drops).
Frequency pattern Daily (administered in one or two divided doses), with a potential reduction to every other day in the temperate regimen.
Regulatory basis Established protocol for pharmacological administration.
Use-context constraints Defined as a continuous regimen that must not be interrupted or discontinued except by specialist instruction.

Resulting Procedural Structure

Official step sequence:

  • Administer the oral solution via the oral route in the prescribed dose.
  • Divide the total daily dose into one or two separate administrations per day.
  • Undergo a required initial dose adjustment period (approximately one week) to determine the maintenance dose.
  • Continue the administration without interruption unless otherwise instructed by the prescriber.

Connection to the overall use protocol: The instructions establish a structured, continuous oral regimen using a defined solution strength and frequency pattern. This protocol mandates an initial titration period to set the appropriate maintenance dose, distinguishing the early phase of use from the ongoing long-term administration. The instruction set is completed by providing an explicit rule for managing missed timing, ensuring procedural continuity throughout the course of use.

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Recent Clinical Evidence

Phase III Clinical Trials

Research has explored whether the novel combination therapy was studied for its potential effects for managing symptoms of Alcohol Use Disorder (AUD). This investigation typically involves double-blind, placebo-controlled trials focusing on outcomes such as cumulative abstinence duration.

  • Study Findings on Abstinence
    • One study comparing cyanamide to placebo in adolescents with alcohol dependence found that the mean cumulative abstinence duration was significantly greater in the cyanamide group.
    • The proportion of patients who remained continuously abstinent throughout the 90-day treatment period was also higher in the cyanamide group compared to the placebo group in the studied population.

Adverse Event Monitoring and Special Populations

Monitoring for adverse events is a primary component of the clinical development program, particularly given the known effects on alcohol metabolism.

  • Liver Function Monitoring

    • Studies comparing cyanamide to disulfiram reported that individuals taking cyanamide experienced significantly higher levels of the liver enzyme ALT at four and twelve weeks, suggesting a difference in effects on liver function.
    • The substance is an aldehyde dehydrogenase (ALDH) inhibitor, and research was designed to investigate this interaction in the context of reducing alcohol consumption.
  • Safety Profile Context

    • In the adolescent study, the rate of adverse events was examined, and apart from occasional diarrhea, no difference in side effects between groups was reported during the short-term trial period. However, clinicians recommend continuous observation due to reported hepatotoxic, hematological, and dermatological side effects. Further studies are required to fully assess the long-term safety and efficacy profile.
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Frequently Asked Questions (FAQ)

Common questions about Colme (Cyanamid) (FAQ)

Q: How quickly does Colme start working?

The medicine is designed to cause an aversive reaction if alcohol is consumed. Official product information indicates that the full aversive effect, such as flushing and rapid heartbeat, typically begins within 30 minutes to one hour after alcohol is consumed. This reaction serves as the deterrent effect of the medicine.


Q: What foods or non-alcoholic drinks should I avoid while on Colme?

The absolute contraindication is the co-administration of any product containing ethanol (alcohol). Regulatory documents state that all sources of alcohol should be strictly avoided, which includes not only alcoholic beverages but also certain foods, non-alcoholic drinks, or common medicines that may contain ethanol.


Q: Is it safe to use mouthwash while taking Colme?

Mouthwash and similar products may contain alcohol (ethanol). Because regulatory guidelines emphasize the necessity of continuous abstinence from all alcohol during treatment, products like mouthwash are generally advised against due to the risk of triggering the severe aversive reaction.


Q: Can Colme interact with common pain relievers like ibuprofen?

The drug’s official interaction profile is driven by the severe reaction it causes with alcohol. Regulatory prescribing information does not explicitly document specific interactions involving common drug classes such as general pain relievers or other non-alcohol medicinal products.


Q: Does Colme interact with anxiety or depression medication?

According to official regulatory prescribing information, no specific interactions involving common drug classes, such as medications for anxiety or depression, are explicitly documented in the official labeling.


Q: Is it true that Colme can be used to treat other conditions?

The medicine is officially indicated only for the management of chronic alcohol dependence in adults. The regulatory label is confined to the documented use as an adjunct within a supportive psychosocial treatment program.


Q: What is the difference in how Colme and disulfiram work?

Colme (Cyanamide) and Disulfiram (Antabuse) are both classified as alcohol deterrent agents that inhibit the ALDH enzyme. Regulatory documents describe Cyanamide as an irreversible inhibitor of the ALDH2 enzyme, which is the core mechanism of its action.


Q: Can I stop taking Colme suddenly?

Official instructions define the administration as a continuous regimen that should not be interrupted or discontinued. Any changes to the course of treatment, including discontinuation, must be decided based on the instruction of a medical specialist, as the regimen is defined as continuous.


Q: Is Colme the same kind of medicine as Antabuse?

Yes, Colme (Cyanamide) and Antabuse (Disulfiram) are considered the same kind of medicine. Both are classified in regulatory texts as alcohol deterrent agents that work by inhibiting the enzyme aldehyde dehydrogenase (ALDH) to create an aversive physical reaction to alcohol.


Q: Is Colme a cure for alcohol dependence?

No, official regulatory documents describe this medicine as an alcohol deterrent agent intended for use as an adjunct (a supportive addition) within a comprehensive psychosocial treatment program. It is not classified as a cure for alcohol dependence.


Q: Will Colme make me feel sick even if I haven't had alcohol?

The severe, aversive physical reaction (flushing, rapid heartbeat) is triggered only by the co-ingestion of alcohol. However, regulatory documents do classify other common effects, such as headache and fatigue, which may be felt independent of alcohol intake.


Q: Are there any long-term health concerns associated with Colme?

Regulatory documents list potential serious risks, including Hepatotoxicity (severe liver injury). The serious risk of Hepatotoxicity means that the drug is formally contraindicated in severe hepatic impairment, necessitating caution. They also note that rare effects associated with long-term exposure include peripheral nerve damage (polyneuritis).


Q: Does Colme prevent me from wanting alcohol?

The medicine’s therapeutic purpose is to create a strong, predictable aversive physical reaction to alcohol intake, which acts as a deterrent. Official regulatory documents focus on this physical deterrent mechanism, not on the reduction of craving or desire for alcohol.


Q: Are there any government warnings about Colme I should know about?

Key warnings documented in regulatory labels relate to the risk of a severe, acute reaction if alcohol is ingested. Other safety constraints include the risk of Hepatotoxicity (severe liver injury), which leads to contraindication in severe hepatic impairment.


Q: Can Colme cause problems with concentration?

Regulatory documents classify side effects such as somnolence (drowsiness) and fatigue as common adverse effects. These effects may potentially impair the patient’s ability to concentrate or pay attention, and patients should be aware of this possibility.


Q: Is Colme considered addictive?

The active ingredient is classified as an Aldehyde Dehydrogenase Inhibitor. The medicine is not classified as a controlled substance and does not fall into the pharmacological classes of medicines associated with abuse potential or addiction.


Q: Can Colme be taken with herbal supplements?

The official interaction profile is defined by alcohol, and the regulatory prescribing information does not explicitly document any interactions with herbal supplements. Due to the limited data available on supplement interactions in the regulatory labels, safety or lack of interaction with herbal supplements cannot be explicitly confirmed in official drug information.


Q: What should be done if an allergic reaction is suspected?

Official information states that hypersensitivity to the active substance or its components is an absolute contraindication to use. Official instructions advise that in the event of any severe, unexpected, or suspected allergic reactions, seeking immediate medical assistance is the appropriate course of action.


Q: Does taking Colme impact driving ability?

Common side effects listed in the product information include somnolence (drowsiness) and fatigue. Because these effects may impair alertness, they could potentially impact the ability to drive or operate machinery. Official documents caution that patients should be aware of how the medicine affects them before engaging in activities that require full attention.


Q: Are there specific tests needed before starting Colme?

Due to the documented serious risk of Hepatotoxicity (severe liver injury) and the absolute contraindication in severe hepatic impairment, regulatory guidance indicates that monitoring, such as liver function tests, is generally necessary before and during treatment.


Q: Can the effects of Colme be reversed quickly in an emergency?

The medicine works through the irreversible inhibition of a key enzyme in alcohol metabolism. Regulatory texts indicate that the restoration of the enzyme's activity is a slow, biological process dependent on the synthesis of new enzyme, which means the effects are not quickly reversed.


Q: Do official documents mention specific patient support programs related to Colme?

Regulatory documents emphasize that the medicine is intended to be used as an adjunct within a supportive psychosocial treatment program. The drug's efficacy is contingent on this supporting context, but specific program names are not listed.


Q: What is the official recommended duration of treatment with Colme?

The medicine is defined in official instructions as a continuous regimen intended for ongoing, long-term administration as part of a patient's overall management plan. The total duration is determined by the treating specialist.


Q: Will Colme change the way other medications affect me?

Regulatory documents state that the interaction profile is exclusively driven by its principal effect on alcohol metabolism. No specific interactions involving metabolic pathways, such as CYP enzymes or drug transporters, that would substantially change how most other non-alcohol medications affect you are explicitly documented.

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How should Colme (Cyanamid) be stored and disposed of?

The storage and disposal of Cyanamide (Colme) are governed by specific regulatory requirements to maintain product quality and ensure safety.

Storage & disposal scope Detail
Labeled storage temperature requirements: Store the aqueous solution under refrigerated conditions (between 2, C and 8, C). The product must not be stored above 30, C.
Light/moisture protection requirements: Must be protected from light and kept in a dry place, as the substance is moisture-sensitive.
Packaging-related storage rules: Keep the medicine in its original container and ensure the container is tightly closed.
Child-protection storage requirements: The medicine must be stored out of the sight and reach of children and in a location accessible only to authorized persons.
Disposal instructions: Unused or expired product must not be poured down the drain or disposed of in household trash. It must be taken to a hazardous or special waste collection point according to local regulations.

These official rules strictly define the storage environment, requiring cold temperatures and protection from light and moisture to maintain stability. Disposal is regulated to prevent environmental contamination, mandating specific procedures for pharmaceutical waste.

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

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