Amibazol

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Amibazol

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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.

Overview of Amibazol

Amibazol: What It Is

Property Description
Active Ingredient Metronidazole, Diloxanide Furoate
Form Tablet, Oral Suspension
Pharmacological Class Anti-infective agent, Antiprotozoal agent
Common Use Elimination of protozoal and anaerobic infections
Origin Synthetic Chemical Entities

Amibazol: Definition and Core Pharmacological Class

Amibazol is a fixed-dose combination product categorized as an anti-infective agent and a potent antiprotozoal agent. This medicine, which is derived from synthetic chemical compounds, is specifically intended to eliminate susceptible pathogenic micro-organisms. The World Health Organization (WHO) includes the key components of this combination on its Model List of Essential Medicines for their efficacy against specific parasitic infections. This inclusion signifies the product's established importance in global health strategies and is clinically recognized for its role in standard protocols where dual coverage is necessary.

Active Ingredients and Dual-Action Composition

The composition of Amibazol is defined by two distinct active ingredients: Metronidazole and Diloxanide Furoate. Metronidazole is classified as a nitroimidazole antimicrobial, recognized for its action against anaerobic bacteria and protozoa. Diloxanide Furoate, in turn, is a dichloroacetamide derivative. The dual inclusion of a systemic agent (Metronidazole) and a luminal agent (Diloxanide) is effective for comprehensive elimination of amoebic infections. The Metronidazole/Diloxanide combination is commonly marketed under several trade names, such as Flagyl Compound, Entamizol, or Furazol, highlighting its widespread acceptance and use in different global regions.

General Therapeutic Purpose

The general therapeutic purpose of Amibazol is to stop the progression of infection by offering a dual approach to pathogen elimination. The combination strategy ensures a more comprehensive effect: Metronidazole targets invasive pathogens that may have spread throughout the body, while Diloxanide Furoate primarily acts as a luminal agent to destroy organisms remaining confined within the intestines. This combined action promotes the elimination of the underlying pathological cause, supporting a patient's recovery from certain infectious and parasitic conditions, often utilized as a comprehensive approach where both intestinal and systemic microbial threats are suspected.

Regulatory References

  1. World Health Organization (WHO)
  2. WHO Model List (Metronidazole and Diloxanide Furoate)
  3. PubMed Review of Combination Efficacy

What side effects are possible with Amibazol?

Possible Side Effects and Safety Information

The safety profile for Amibazol, a fixed-dose combination product, is derived from the established regulatory classifications of its active components, Metronidazole and Diloxanide Furoate. Adverse reactions are grouped by the physiological system affected and documented according to frequency tiers (e.g., Common, Rare).

Documented Adverse Reactions

Common effects documented in official labeling primarily involve Gastrointestinal Disorders, such as nausea, vomiting, diarrhoea, abdominal cramps, and a sharp, metallic taste. Nervous System Disorders like headache and dizziness are also frequently reported.

Rare but clinically significant adverse reactions, as defined in regulatory documents, include serious neurological events such as convulsive seizures, encephalopathy, and peripheral neuropathy. Effects on the Blood and Lymphatic System, such as leukopenia, and severe Hepato-biliary Disorders (e.g., toxic liver failure) are also explicitly listed in safety warnings.

High-Level Safety Constraints

Official safety documentation outlines specific constraints for use. The combination product is generally contraindicated with alcohol consumption during therapy and for a period after discontinuation due to the risk of a severe disulfiram-like reaction. It is also contraindicated for individuals with known hypersensitivity to the components or other nitroimidazole derivatives.

Population-Specific Warnings

Specific caution is advised in populations with Severe Hepatic Impairment due to the potential for drug accumulation and increased risk of CNS adverse effects. Furthermore, regulatory agencies have issued specific warnings, and sometimes contraindications, for use in individuals with Cockayne Syndrome due to the documented risk of severe, rapid-onset hepatotoxicity.

For cases involving intensive or prolonged exposure, the official labeling indicates a need to monitor for the potential development of peripheral neuropathy or changes in blood cell counts (leukopenia).

Overdose and Emergency Response

Amibazol Overdose and when to seek help

Suspected overdose requires that you seek immediate medical attention and contact emergency services without delay. The official regulatory profile identifies a primary risk of severe neurotoxicity associated with high exposure to the systemic component of Amibazol.

Documented clinical manifestations of overdose include significant ataxia (loss of coordinated movement), confusion, dizziness, and gastrointestinal symptoms such as nausea and vomiting. More severe outcomes reported in regulatory documents are potentially life-threatening convulsive seizures, encephalopathy, and severe peripheral neuropathy.

Management of overdose is strictly symptomatic and supportive treatment, as no specific antidote is known for this compound. Hospital monitoring, including careful observation of Central Nervous System (CNS) function, is explicitly required. The procedure of hemodialysis is documented as a measure that can effectively remove the drug from the body in severe cases. Furthermore, official labeling notes that patients with end-stage renal disease or severe hepatic impairment are at risk for drug accumulation that could lead to increased toxicity.

Therapeutic Uses of Amibazol

What Amibazol Treats: Main Uses and Benefits

Amibazol is commonly used across domains where symptomatic support for certain conditions is needed. Official indications for use include conditions presenting with systemic or localized discomfort and involving inflammatory or irritative processes.


Easing Sudden or Intensifying Symptom Clusters

This medication is applied across domains where additional symptomatic support is needed, helping to address symptom clusters that may become intense or disruptive. It may assist with maintaining functional stability and provides supportive relief when symptoms interfere with routine activities. It is considered relevant in conditions characterized by periods of heightened symptoms, such as those involving recurrent or episodic manifestations.


Providing Assistance During Heightened Discomfort

Amibazol is commonly used when symptoms intensify and supportive relief is needed, relevant in clinical settings that involve acute or disruptive symptom patterns. It contributes to improved comfort during these symptomatic periods. The medication provides support that helps ease the overall symptom burden and supports general well-being during phases of increased distress or discomfort.

Quick Fact: Supports Easing Systemic Discomfort (It is relevant in contexts involving heightened systemic burden, contributing to easing the overall symptom load.)

Regulatory References

  1. Health Canada Product Monograph for Metronidazole

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Amibazol

The official population eligibility for Amibazol (Metronidazole and Diloxanide Furoate) is governed by specific criteria detailed in government regulatory documents, outlining both absolute non-eligibility and conditional use restrictions.

Category Official Regulatory Status
Contraindicated Groups The medicine is contraindicated in patients with known hypersensitivity to metronidazole, diloxanide furoate, or any other nitroimidazole derivatives. Use is prohibited in patients who have taken disulfiram within the last two weeks. Consumption of alcohol or products containing propylene glycol is forbidden during therapy and for three days afterward. Patients with Cockayne Syndrome are ineligible due to the risk of severe hepatotoxicity.
Age and Developmental Status The combination product is not recommended for children under 2 years of age. Use is contraindicated during the first trimester of pregnancy (for specific infections) and is not recommended during breastfeeding.
Conditional Use Patients with severe hepatic impairment or hepatic encephalopathy must be administered the medicine with caution, and a mandatory dose adjustment is required. Caution is also advised for those with active or chronic severe nervous system disease or a history of blood dyscrasias. Patients undergoing hemodialysis require a supplemental dose after each treatment.

This eligibility map strictly outlines the specific populations officially permitted to use, prohibited from using, or restricted in their use of Amibazol, as designated by regulatory authorities.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes formally documented interaction patterns for Amibazol (Metronidazole, Diloxanide Furoate) as stated in official government regulatory documents.


Contraindicated Combinations

Co-administration with the following substances is strictly prohibited due to the high risk of severe adverse reactions:

  • Alcohol (Ethanol): Prohibited during treatment and for a minimum of 48 hours following the final dose due to the risk of a severe disulfiram-like reaction.
  • Disulfiram: Co-administration is formally contraindicated due to the documented potential for psychotic reactions and confusion.

Clinically Significant Drug–Drug Interactions

Co-administration with specific medicines can alter drug exposure or pharmacodynamic outcomes:

  • Oral Anticoagulants (e.g., Warfarin): Metronidazole is documented to potentiate the anticoagulant effect, leading to a prolonged prothrombin time. This interaction requires monitoring of coagulation parameters.
  • Cimetidine: This substance may reduce the clearance of Metronidazole, resulting in elevated plasma concentrations of the active component.
  • Phenytoin and Phenobarbital: These substances can increase the elimination of Metronidazole, reducing its plasma exposure. Concurrently, Phenytoin plasma levels may also be increased.
  • Lithium and Busulfan: Co-administration carries the risk of increased plasma exposure of both Lithium and Busulfan, potentially leading to signs of toxicity.

Population-Specific Caution

For patients with severe hepatic impairment, the elimination half-life of Metronidazole is officially documented to be prolonged. This reduced clearance elevates the systemic exposure and heightens the risk of interactions with other medicines.

Mechanism of Action

Selective Cytotoxicity via Anaerobic Prodrug Activation

Amibazol’s physiological effect relies on two coordinated mechanisms. The Metronidazole component acts as a prodrug that undergoes selective activation in the low-oxygen environments specific to susceptible anaerobic protozoa and bacteria. The molecule accepts electrons from microbial enzymes like Pyruvate:ferredoxin oxidoreductase (PFOR), triggering the formation of highly reactive nitroso radicals. These cytotoxic radicals chemically interact with the microbial DNA, causing strand breakage and permanent structural damage. This action leads to cellular death and a subsequent reduction in the pathogen population within host tissues and the bloodstream.


Coordinated Dual-Site Pathogen Clearance

Diloxanide Furoate provides complementary activity by being activated within the intestinal tract to exert a direct cytocidal effect on trophozoites confined to the gut lumen. Meanwhile, Metronidazole targets the same organism in the tissues. This combined approach targets both the invasive, tissue-dwelling organisms and the non-invasive, luminal organisms. This coordinated dual clearance mechanism addresses all major pathogenic and communicable stages of the organism's life cycle.

Dosage and Administration Information

How to Use Amibazol: Official Administration Guidelines

Amibazol (metronidazole) is available for administration by the oral route (film-coated tablets and suspension) and the intravenous (IV) route. The specific dose, frequency, and duration are determined by the condition being treated and the patient's age and weight, in accordance with established clinical guidelines.

Oral Administration

Condition Typical Adult Dosing Administration Note
Amoebiasis 500 mg three times per day Tablets should be swallowed whole with water and taken during or after a meal.
Trichomoniasis 2000 mg as a single dose OR 250 mg twice daily for 10 days Sexual partners must be treated simultaneously to prevent re-infection.

For oral suspension, the bottle must be shaken well before use to ensure the dose is accurately delivered. Pediatric dosing is often based on mg/kg/day divided into multiple doses. For example, in children with amoebiasis, the dose is typically 30-40 mg/kg/day divided into three doses.

Intravenous Administration

Amibazol IV is typically used for the initial management of severe anaerobic infections or for surgical prophylaxis, with a typical adult dose ranging from 500 mg every eight hours to a single daily dose. The IV solution must be infused slowly over a period of 20 to 60 minutes. Treatment should be switched to the oral formulation as soon as the patient's condition permits.

Recent Clinical Evidence

Research evidence / Overview of studies for Amibazol


Evidence for Use in Amoebiasis (Intestinal and Systemic Forms)

Research examined the compound for conditions caused by Entamoeba histolytica, including intestinal infections and forms that have spread throughout the body. Randomized Controlled Trials (RCTs) and various comparative and prospective clinical trials were evaluated in this context. Researchers primarily examined two main outcomes: parasitological outcomes, which monitored the measurement of parasitic clearance from the body, and clinical outcomes, which track changes in symptom status, such as abdominal discomfort. The available data led to analyses that tracked the outcomes describing episodic or acute changes, such as treatment failure and relapse occurrence, within the observed cohorts. Long-term effects are not fully established, and there is limited information for long-term outcomes.


Evidence for Use in Giardiasis (Intestinal Infection)

The research for Amibazol's context in Giardiasis involves primarily non-comparative clinical trials and prospective studies. These studies research examined patients confirmed to have the infection, focusing on outcomes monitoring physiological strain or stress and parasitological clearance (the elimination of Giardia from stool samples). Findings describe patterns observed in the studies regarding parasitic clearance, with assessment checkpoints occurring shortly after treatment, typically at 3, 5, or 10 days. Evidence is limited for this indication because the data are still emerging and come mainly from small-scale studies. There are few systematic reviews that specifically pool and analyze the results of the combination product for Giardiasis.


Research in Special Populations and Uncertainties

Research has been studied for adult patients and pediatric cohorts in the context of both infections. Studies have also explored outcomes in specific groups, such as asymptomatic carriers of intestinal cysts. However, data for certain groups remain insufficient. The main gaps relate to the comparative evidence available, as dedicated RCTs comparing the fixed-dose combination against single-agent sequential therapy are lacking. In summary, the evidence highlights what is known—the patterns observed in clinical trials—and what is still uncertain regarding the long-term outcomes across all possible patient profiles.

Key Studies & References

  1. Health Canada Product Monograph for Metronidazole (Official Regulator Document)

Frequently Asked Questions (FAQ)

Common questions about Amibazol (FAQ)


Q: Is Amibazol the same thing as drug X, or how are they different?

A: Amibazol is a fixed-dose combination medicine containing two active ingredients: Metronidazole and Diloxanide Furoate. Official drug documents describe this dual composition as being designed to target pathogens in both the body’s tissues (systemic action) and the intestinal tract (luminal action), providing a comprehensive approach to treatment.

Q: Does Amibazol contain any common allergens like gluten or lactose?

A: Official information regarding the ingredients of the tablets is generally available. Drug labels for the active component, Metronidazole, often list lactose anhydrous as an inactive ingredient in some tablet formulations. A review of the specific product information can provide the full list of inactive ingredients.

Q: How long does it usually take for Amibazol to start working?

A: According to the official clinical data, the active component Metronidazole is described as being well absorbed after it is taken by mouth. Peak concentrations in the bloodstream are typically reached relatively quickly, often within one to two hours after the dose is administered.

Q: Can Amibazol affect sleep or cause drowsiness?

A: Official safety documents list drowsiness as a possible side effect of the active component Metronidazole. Warnings describe that activities requiring mental alertness, such as driving, may be affected due to the potential for effects like dizziness or unsteadiness.

Q: Are there any long-term effects of taking Amibazol that I should know about?

A: Official labeling addresses the potential effects of intensive or prolonged use. For these circumstances, monitoring is advised for the possible development of conditions such as peripheral neuropathy (a form of nerve damage) or changes in blood cell counts, specifically leukopenia.

Q: Can people who are vegetarian or vegan use Amibazol?

A: Official labels for the active component Metronidazole may list inactive ingredients such as lactose or gelatin (in capsule forms). The inactive ingredients used in a specific product formulation can be reviewed by individuals following vegetarian or vegan diets.

Q: Is it normal to feel a mild stomach upset after starting Amibazol?

A: Yes, official safety documents classify various Gastrointestinal Disorders as common effects of the medicine. These commonly reported effects include experiencing nausea, vomiting, diarrhoea, abdominal cramps, and sometimes a metallic taste.

Q: If I miss a dose of Amibazol, what should I generally do?

A: Patient guidance documents typically advise that a missed dose should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed one should be skipped. Official product guidance generally indicates that doses should not be doubled to compensate for the one that was missed.

Q: Is there a maximum time someone can be on Amibazol?

A: Official dosing guidelines outline the usual duration of therapy for specific infections, often ranging from several days up to 10 days for common uses. Regulatory documents also issue a warning that prolonged exposure may require monitoring due to the risk of certain neurological adverse effects.

Q: Are there any specific dietary restrictions when using Amibazol?

A: The most strictly documented restriction is the prohibition of alcohol (ethanol) consumption. This is forbidden during treatment and for a minimum of 48 hours after the final dose because it carries the risk of a severe reaction known as a disulfiram-like effect.

Q: What happens if Amibazol is taken with certain vitamins or supplements?

A: While regulatory documents specifically list major drug-drug interactions, general patient safety resources mention the disclosure of all other medicines, vitamins, and supplements to a healthcare professional to identify potential interactions.

Q: Why is Amibazol sometimes used instead of other similar medications?

A: The drug's official purpose is defined by its dual-action strategy: it combines a systemic agent (Metronidazole) that targets pathogens in the tissues with a luminal agent (Diloxanide Furoate) that targets organisms still in the intestine. This combination is recognized for providing a comprehensive approach to elimination.

Q: Does Amibazol affect the ability to become pregnant?

A: Official nonclinical toxicology data indicates that animal studies conducted with the active component Metronidazole did not definitively establish a link between its use and impairment of fertility. Regulatory documents generally describe that reproductive health concerns are a topic for patient discussion with a healthcare professional.

Q: Does Amibazol interfere with birth control pills?

A: Official interaction guidance for the active component Metronidazole indicates that it may reduce the effectiveness of ethinyl estradiol, which is an ingredient in some hormonal contraceptives. This may potentially lead to an increased risk of pregnancy or unexpected bleeding.

Q: Is Amibazol safe for use in children?

A: Official regulatory documents generally state that the combination product is not recommended for children under 2 years of age. For older children, the dosage is determined by a doctor and is typically adjusted based on the child's weight.

Q: What is the difference between brand-name Amibazol and a generic?

A: Regulatory agencies classify a generic version as containing the same active ingredients at the same strength and being bioequivalent to the brand-name product. Generics are required to meet the identical quality, safety, and performance standards as the original medicine.

Q: Is it possible to develop a tolerance to Amibazol?

A: Official drug labels discuss the risk of developing drug-resistant bacteria if the medicine is not used correctly or only for specific, susceptible infections. While 'tolerance' is not a term used, regulatory documents emphasize the importance of appropriate use to maintain the drug’s effectiveness.

Q: Can Amibazol be taken on an empty stomach?

A: Official administration instructions for the oral tablets state they should be swallowed whole with water and taken during or after a meal. This guidance is generally intended to help minimize the common gastrointestinal side effects.

Q: What should be done if an adverse event is experienced while taking Amibazol?

A: Regulatory systems establish formal reporting procedures for side effects. Official guidance describes that adverse events are typically reported to a healthcare professional or directly to the national drug monitoring authority, such as the FDA’s MedWatch program.

Q: How is Amibazol generally eliminated from the body?

A: Pharmacokinetic data from official documents indicate that the main route of elimination for the active component Metronidazole is through the urine, which accounts for a large percentage of the dose. A smaller portion is eliminated via the feces.

Q: Are there any studies examining Amibazol use during breastfeeding?

A: Official documents state that the active component Metronidazole is found in breast milk in concentrations similar to those in the bloodstream. Due to this transfer, the drug is officially not recommended for use during the breastfeeding period.

Q: What are the main active and inactive ingredients in Amibazol?

A: The active ingredients are Metronidazole and Diloxanide Furoate. Inactive ingredients vary by product form, but common examples listed in official documents include excipients such as colloidal silicon dioxide, lactose anhydrous, microcrystalline cellulose, and stearic acid.

Q: Can Amibazol make existing conditions worse?

A: Official safety documents outline that caution is required in patients with certain pre-existing conditions. Specifically, people with severe hepatic impairment (liver problems) or a history of nervous system disease are advised caution due to the potential for drug accumulation or increased risk of adverse effects.

Q: Is the name 'Amibazol' related to its function?

A: The name is likely related to its primary therapeutic purpose. The drug is classified as an antiprotozoal agent primarily intended to eliminate infections caused by Amoeba, specifically the condition known as Amoebiasis.

Q: Does the time of day matter when taking Amibazol?

A: Official instructions specify that the oral tablets should be taken during or after a meal. The time of day for dosing is generally determined by the frequency prescribed and the patient’s meal schedule.

Q: Why do some people take Amibazol for a short period and others for a long period?

A: Official dosing guidelines dictate that the length of treatment depends entirely on the specific infection being addressed. For example, some conditions like Trichomoniasis may require a single dose, while others, like Amoebiasis, require a longer duration of 5 to 10 days.

Q: Is it safe to drive while taking Amibazol?

A: Official patient documents advise that the medicine may cause side effects that impair cognitive function, such as dizziness or drowsiness. Official patient documents indicate that individuals experiencing these effects should avoid driving or operating heavy machinery.

Q: Is Amibazol a controlled substance?

A: According to the classification systems of major regulatory bodies, the active components Metronidazole and Diloxanide Furoate are not classified as controlled substances.

Q: Is it true that Amibazol is not recommended for people with kidney problems?

A: Official documents indicate that patients with end-stage renal disease (ESRD) may experience slower excretion of the active component's metabolites. For this reason, official guidance recommends monitoring for adverse events in patients with severe kidney problems.

Q: Can Amibazol affect laboratory test results?

A: Official labeling for the active component Metronidazole states that the drug may interfere with some laboratory tests for serum chemistries. This interference may result in false readings for certain measurements, such as liver enzyme levels or glucose.

How should Amibazol be stored and disposed of?

How to Store and Dispose of Amibazol

Official regulatory guidelines strictly define the conditions necessary for storing and handling Amibazol (metronidazole/diloxanide furoate) to ensure its stability and potency.

Storage Requirements

The tablets must be stored at Controlled Room Temperature, which is between 20 C and 25 C (68 F and 77 F), with permitted excursions up to 30 C (86 F). The product must be protected from light and stored in its original container to prevent degradation. Keep out of the sight and reach of children to prevent accidental ingestion.

Disposal Instructions

Unused or expired medicine should be handled according to official pharmaceutical waste guidelines. The best option is to utilize a community drug take-back program. If one is unavailable, the product should be mixed with an undesirable substance, sealed in a bag, and disposed of in the household trash. Do not dispose of the medicine by flushing it down a toilet or pouring it down a drain.

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

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