Аминтакс

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Аминтакс

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Аминтакс

Property Description
Active Ingredient Neomycin, Nystatin, Polymyxin B
Form Vaginal Capsule (or Ovule)
Pharmacological Class Local Anti-infective Combination
Common Use Combating local bacterial and fungal infections
Origin Primarily Synthetic or Semi-synthetic

What Type of Medicine is Аминтакс?

Аминтакс is a fixed-dose triple combination drug specifically formulated as a Local Anti-infective Combination, designed for vaginal administration. This product belongs to the broader pharmacological class of antibiotics and antifungals, intended to address pathogens directly at the site of application. The strategy of using this triple combination in gynecological care is recognized for managing infectious conditions where a broad-spectrum response is desired. Its classification as a triple combination distinguishes it from monotherapies by integrating multiple active components into one vaginal capsule (or ovule). This combination represents a specialized local therapy.

Composition: Neomycin, Nystatin, and Polymyxin B

The formulation contains three primary active ingredients: Neomycin, an aminoglycoside antibiotic, Polymyxin B, a polypeptide antibiotic, and Nystatin, a polyene macrolide antifungal. The two antibiotics are included to deliver antibacterial action, while Nystatin provides the necessary fungicidal action. This combination is delivered via a semi-synthetic triglyceride vehicle, a lipophilic base crucial for maintaining the integrity of the soft vaginal capsule and ensuring controlled, localized release of the active compounds. This particular form offers a distinct advantage in its localized effect compared to systemic treatments.

General Therapeutic Purpose of the Combination

The general therapeutic purpose of the Аминтакс combination is to provide broad-spectrum coverage against various microorganisms frequently involved in localized infectious conditions. By incorporating two distinct antibacterial agents and one antifungal agent, the product is intended to combat infections that may stem from bacteria, fungi, or a mixture of both, such as those often encountered in vulvovaginal health. This combination strategy is an approach for managing infections of mixed etiology. The purpose is to ensure a targeted and comprehensive approach against multiple types of pathogens within the area of need.

Regulatory References

  1. Polygynax (Neomycin/Polymyxin B/Nystatin) Patient Information Leaflet (Rwanda FDA)

What side effects are possible with Аминтакс?

Possible Side Effects and Safety Information

The safety profile for this triple combination product is primarily characterized by the risk of local reactions and potential concerns related to the systemic absorption of its antibiotic components, Neomycin and Polymyxin B.

Documented Adverse Reactions

Adverse reactions listed in regulatory documents are often classified by System Organ Class (SOC). Reactions affecting the Reproductive system and breast disorders include common local effects such as a burning sensation, irritation, pruritus (itching), and local oedema (swelling). Effects classified under Immune system disorders involve various forms of hypersensitivity, including rash and allergic contact dermatitis.

Regulatory reporting often classifies the frequency of these local and hypersensitivity reactions as Not known, as estimation cannot be reliably made from available spontaneous reporting data.

Systemic Risk and Special Safety Considerations

Although administered locally, there is a documented potential for systemic absorption, which is officially linked to serious risks, especially with prolonged use or in certain populations. These systemic risks, associated with the aminoglycoside component (Neomycin), involve potential ototoxicity (hearing damage) and nephrotoxicity (kidney damage).

Specific population and usage constraints are documented in official labeling:

  • Pregnancy and Lactation: Use is generally not recommended due to the potential ototoxic risk to the fetus associated with aminoglycoside absorption. Similarly, use during lactation is advised against.
  • Renal Insufficiency: Patients with impaired kidney function have an officially documented increased risk of systemic effects (auditory and renal) due to higher potential systemic exposure.
  • Prolonged Use: Regulatory documents state that prolonged use may increase the risk of hypersensitivity reactions, such as allergic eczema, and may heighten the risk of systemic effects.

Additionally, the excipient Soybean Oil is a documented risk for hypersensitivity reactions, and the product is formally restricted from being used with certain latex barrier contraceptives due to the risk of material degradation.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for this triple combination drug emphasizes that overdose concerns are primarily linked to the potential for systemic absorption of the active components, particularly following excessive and prolonged administration. Because this medicine is administered locally, systemic toxicity is primarily a risk under conditions of prolonged, non-standard use.

Documented Overdose Manifestations

Overdose manifestations are officially documented to affect specific physiological systems due to the potential systemic availability of the antibiotic components:

  • Auditory and Renal Effects: Documented systemic effects include potential injury to the auditory system (ototoxicity) and the renal system (nephrotoxicity).
  • Severe Outcomes: A further documented risk upon significant systemic absorption is neuromuscular blockade.
  • Local Effect: Prolonged use is also officially associated with an increased risk of allergic eczema.

Mandatory Emergency Actions

When overdose is suspected, official regulatory guidance mandates immediate action:

  1. Urgent Medical Care: It is required to seek immediate medical attention or go to the closest hospital emergency department.
  2. Required Procedure: The official instruction is to bring the medicine container, box, or label when seeking care.

Management of an overdose is described as symptomatic and supportive treatment; no specific antidote is officially documented in the prescribing information.

Population-Specific Risk

Regulatory documents identify patients with impaired renal function as a population at particularly elevated risk for developing severe systemic effects (auditory and renal toxicities) following excessive exposure.

Therapeutic Uses of Аминтакс

The primary therapeutic use of this local anti-infective combination is applied in the management of infectious conditions. It is typically used in clinical settings that involve acute or unstable symptom patterns where the cause may be mixed—involving both susceptible bacterial pathogens and fungal organisms—to support comprehensive initial treatment and contribute to the easing of symptoms.

It is relevant for conditions associated with polymicrobial presentations, including infectious vaginitis, vulvovaginitis, and non-specific infections.

“The broad-spectrum approach is relevant for easing symptom burden in conditions characterized by periods of heightened symptoms.”

This medication supports the management of symptom clusters that interfere with daily comfort, helping to ease vaginal pruritus (itching) and burning, assisting with local irritation, and managing abnormal discharge. Furthermore, it is applied for local prophylaxis to help prevent the development of infection before and after minor gynecological procedures. This provides supportive relief when symptoms interfere with routine activities.


Quick Fact: Relief for Acute Discomfort
This combination is relevant in clinical settings to help ease pronounced symptoms like inflammation, burning, and discharge, supporting the patient during episodes of heightened discomfort.

Regulatory References

  1. Official patient information from the Medicines Authority of Malta

Eligibility and Restrictions for Use

Population Eligibility Rules

The use of Аминтакс is strictly defined by regulatory documents, limiting the eligible patient population and establishing absolute contraindications.

Category Status/Rule (as stated in regulatory sources)
Populations for whom use is allowed Adult women only.
Populations for whom use is not recommended Pregnant women and Breastfeeding women.
Populations for whom use is contraindicated Patients with known hypersensitivity to Neomycin, Polymyxin B, Nystatin, or related drug classes.
Age-related eligibility rules Intended for adults only. Use is not established in children or adolescents.
Condition-specific eligibility rules Patients with renal insufficiency require caution due to the increased, though minimal, risk of systemic toxicity.
Eligibility-related restrictions Contraindicated with the use of diaphragms or latex/polyurethane condoms; generally not recommended with spermicidal products; not recommended for prolonged or excessive administration.

Eligibility Classifications

Classification Basis (as defined in official documents)
Eligibility severity classification Absolute Contraindication (Allergy, Device/Excipient), Not Recommended (Pregnancy/Lactation), Caution Required (Renal Insufficiency).

Official Eligibility Statements

  • The use is contraindicated in patients with a history of allergy to the active substances, related compounds (aminoglycosides/polypeptides), or the excipients, including known peanut or soya allergy.
  • The medicine is contraindicated with the use of certain barrier contraceptives (diaphragms/condoms) due to the risk of material rupture from the formulation base.
  • Use is not recommended during pregnancy or breastfeeding due to potential risks from systemic absorption of aminoglycosides like Neomycin.

Regulatory documentation defines who can and cannot use the medicine by classifying risks into mandatory contraindications and less severe restrictions. This structure ensures that eligibility is strictly limited to the adult female population and prohibits use in circumstances where allergy is a risk or physical incompatibility with contraceptives exists.

What should I know about interactions with other medicines?

Interactions with other medicines and products — official regulatory information for Аминтакс

Property Value
Medicinal product categories with documented interactions Local contraceptives (barrier methods and spermicides); Systemic medicines with known nephrotoxic or ototoxic potential.
Specific interacting medicines (if explicitly listed) Spermicides, Latex condoms, Latex diaphragms.
Mechanistic basis of interactions (only if stated in label) Excipient-Based Physical Incompatibility; Local Pharmacodynamic Antagonism; Additive Systemic Toxicity (conditional risk).
Population-specific interaction notes (if applicable) Risk of systemic toxicity is heightened in patients with Impaired Renal Function or with prolonged treatment.
Interaction-related restrictions Contraindicated co-administration with Latex barriers. Not Recommended co-administration with Spermicides.

Official interaction statements:

  • Co-administration with barrier contraceptives such as Latex Condoms and Latex Diaphragms is formally contraindicated, as the fatty excipients in the vaginal capsule are documented to weaken and compromise the integrity of the latex material.
  • Co-administration with Spermicides is not recommended because the local treatment components are likely to cause local pharmacodynamic antagonism that inactivates the spermicidal action, diminishing its contraceptive efficacy.
  • Due to the conditional risk of minimal systemic absorption, the co-administration with other systemic ototoxic or nephrotoxic medicines may increase the risk of systemic toxicity (nephrotoxicity/ototoxicity), a risk which is specifically increased in patients with Impaired Renal Function.

Regulatory documents define the product’s interaction structure primarily through two forms of local incompatibility: a physical contraindication stemming from the excipients reacting with latex barrier contraceptives, and a pharmacodynamic restriction that diminishes the efficacy of spermicides. The profile also formally documents a crucial, conditional systemic toxicity risk associated with the active components, which requires consideration only when co-administered with other systemically toxic agents or in the context of impaired renal function.

Mechanism of Action

Аминтакс, also known as Amantadine, exerts its effects through multiple, distinct biological targets in the central nervous system (CNS) and on the influenza A virus. In the CNS, the molecule functions as a weak antagonist at the N-methyl-D-aspartate (NMDA) type glutamate receptor. This interaction modulates excitatory glutamatergic neurotransmission.

Аминтакс also interacts with the sigma1 receptor, acting as an agonist. Activation of the sigma1 receptor enhances the activity of tyrosine hydroxylase and modulates dopamine release, which contributes to increased striatal dopamine levels. Furthermore, the drug is a negative allosteric modulator of certain nicotinic acetylcholine receptors, specifically the alpha4beta2 and alpha7 subtypes.

Separately, in the context of the influenza A virus, Аминтакс acts as a non-competitive inhibitor of the viral matrix protein 2 (M2) proton channel. This M2 ion channel inhibition prevents the necessary H^+ ion influx into the virion core, blocking a required step in the uncoating process and subsequent release of viral genetic material into the host cell cytoplasm.

Dosage and Administration Information

How to Use Аминтакс

Administration of Аминтакс, a triple combination of Neomycin, Nystatin, and Polymyxin B, follows a standardized regimen.

Standard Administration Guidelines

Entity Detail
Route of Administration Strictly Vaginal for local application.
Dosing Schedule One vaginal capsule (or ovule) per administration event.
Frequency Pattern Once daily, administered in the evening before bedtime.
Course Duration The standard duration for a full course of treatment is typically 12 consecutive days

Procedural Context and Constraints

The usage protocol specifies that the medicine must be inserted deeply into the vagina, preferably while the patient is in a lying down position. This procedure is intended to ensure adequate contact time and retention of the medicine at the site of application. The capsule is for local vaginal use only and must not be swallowed.

Administration of this medicine is generally restricted to adults. The treatment course is designed to be continuous and should not be discontinued during the menstrual period. The duration of use should be limited to the specified course to help mitigate the risk of developing resistant microorganisms.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Аминтакс

Evidence for Use in Infectious Vaginitis

The evidence for Аминтакс was studied for the condition of infectious vaginitis, which often presents with fluctuating or episodic manifestations involving both bacteria and fungi. Researchers primarily explored this application through short-term, comparative randomized controlled trials (RCTs) designed to examine the combination in adult women (ages 18 to 64). The study populations included cases identified as strictly bacterial, strictly fungal, or mixed.

Research examined clinical outcomes, was studied for measured changes in a patient's signs and symptoms. They also explored the microbiological outcomes, focusing on the measured change in specific pathogens present. These studies report how symptoms evolved in the observed populations; research describes short-term changes in patient-reported outcomes related to physical discomfort, such as vaginal discharge, burning, and itching.

Types of Clinical Trials and Their Focus

The research landscape includes comparative trials that studied the triple combination against specific comparative treatments. These studies were used in research exploring how symptoms change over time during the typical 12-day administration period. The trials focused on outcomes linked to inflammatory or irritative states. Additionally, in vitro (laboratory) studies were also evaluated in a lab setting to observe the active components interacting with bacterial and fungal isolates.

Long-Term Follow-up and Durability of Response

The follow-up durations for the key clinical trials were limited, with primary outcome assessments typically conducted at the end of the 12-day treatment period or shortly thereafter (e.g., up to 15–17 days). This means that the research focused on short-term symptom changes, but follow-up was limited to the study period. As a result, long-term effects are not fully established regarding the durability of the findings.

Research in Specific Groups and Populations

The majority of the research was observed in generally healthy adult women. However, certain studies research examined subgroups of pregnant and non-pregnant women to observe outcomes in these distinct groups. These findings describe group patterns, not personal outcomes. Data for certain groups remain insufficient in the broader research base.

Limitations and Research Gaps

A key limitation is that follow-up durations were limited, meaning the long-term effects are not fully established concerning the maintenance of clinical and microbiological observations. Additionally, evidence quality may vary across studies, partly because the combination was studied for an extended period, leading to differences in older and newer trial methodologies. Comparative evidence is lacking for certain pairings with all currently already marketed therapies used in practice.

Key Studies & References

  1. Official patient information from the Medicines Authority of Malta (Summary of Product Characteristics for the combination)
  2. Neomycin, Nystatin, and Polymyxin B Combination Drug Information (NIH/NLM Source)

Frequently Asked Questions (FAQ)

Common questions about Аминтакс (FAQ)

Q: Is Аминтакс the same type of medicine as [similar drug name]?

Аминтакс is classified as a fixed-dose triple combination drug and a Local Anti-infective Combination. This formulation contains three distinct active ingredients: two antibiotics and one antifungal. This combination is designed for broad-spectrum local application, which distinguishes it from single-agent medicines.


Q: How quickly do people typically start to feel a difference after taking Аминтакс?

Research studies primarily assessed patient outcomes, such as changes in discomfort, discharge, and itching, over the entire 12-day treatment course and shortly thereafter. Official documents do not typically specify a precise time when patients should expect to notice the first difference. Treatment progress is described in research over the full duration of the prescribed course.


Q: Is it true that Аминтакс can cause [minor, common side effect]?

Official documentation lists local reactions that affect the reproductive system, such as a burning sensation, irritation, itching (pruritus), and local swelling (oedema). The frequency of these local effects is often classified as Not known, as a reliable estimation cannot be made from available spontaneous reporting data.


Q: If I miss a dose of Аминтакс, what is the official guidance?

Regulatory information states that the full course must be completed as prescribed. Guidance for how to manage a missed dose typically involves consulting a prescribing healthcare professional.


Q: What kind of studies have been done on Аминтакс?

Research for this product primarily consists of short-term, comparative randomized controlled trials (RCTs) conducted in adult women examining clinical and microbiological outcomes for infectious vaginitis. In addition to human trials, in vitro (laboratory) studies were also performed to observe how the active components interact with pathogens.


Q: Is it normal to feel a change in [energy/sleep pattern] when first starting Аминтакс?

Official documentation for this local vaginal product does not explicitly list changes in energy or sleep patterns as documented side effects. Known systemic risks are primarily focused on potential ototoxicity (ear damage) and nephrotoxicity (kidney damage) if any systemic absorption were to occur.


Q: What happens if I stop taking Аминтакс suddenly?

Official documents indicate that the full treatment course is designed to be continuous and should be completed to help mitigate the risk of developing resistant microorganisms. Regulatory documents also specify that the course should not be discontinued during the menstrual period.


Q: Can I take Аминтакс with a common pain reliever like ibuprofen?

Caution is advised for co-administration with other systemic ototoxic or nephrotoxic medicines. This risk is associated with combining the product with other systemic ototoxic or nephrotoxic medicines. Ibuprofen is typically regulated as a medication that requires caution regarding kidney function.


Q: What is the typical timeframe for treatment with Аминтакс?

The standard duration of treatment stipulated in regulatory documents is typically 12 consecutive days of continuous administration. The course is designed for short-term, targeted use against the localized infection.


Q: Is it safe to use herbal supplements while taking Аминтакс?

There is limited official information regarding the interaction between this product and herbal supplements. Regulatory guidance for one of its components advises that complementary medicines are generally not tested for their effect on other prescription medicines. It is recommended to discuss the use of herbal supplements with a healthcare provider.


Q: What common medicines are specifically listed as having major interactions with Аминтакс?

Officially documented products that are contraindicated or not recommended for co-administration are Latex Condoms, Latex Diaphragms, and Spermicides. The label also lists a category of systemic ototoxic or nephrotoxic medicines for which caution is required.


Q: Do people usually take Аминтакс with or without food?

The administration of the medicine is for strictly vaginal use only. As a local treatment, the procedure is not related to or dependent upon food or drink consumption.


Q: Is there any research on the use of Аминтакс in pregnant or breastfeeding individuals?

Although studies were conducted in subgroups of pregnant and non-pregnant women, regulatory documents state that use is not recommended during pregnancy or lactation due to potential risks from systemic absorption of aminoglycosides.


Q: How does Аминтакс relate to [specific class of similar drugs, e.g., SSRIs/beta-blockers]?

Аминтакс is classified as a Local Anti-infective Combination drug, meaning it contains antibiotic and antifungal components intended for vaginal use. This places it distinctly apart from systemic drug classes like SSRIs (antidepressants) or Beta-blockers (heart medications).


Q: Does the research suggest Аминтакс is primarily for short-term or chronic use?

Official documents indicate the medicine is intended for short-term use, with a standard duration of 12 consecutive days. Regulatory documents warn that prolonged use may increase the risk of hypersensitivity reactions and the potential for systemic effects.


Q: Does Аминтакс have a black box warning?

Official regulatory documents for this specific combination drug do not typically feature the highest level of caution known as a Black Box Warning. The label does, however, formally document a conditional risk of ototoxicity (hearing damage) and nephrotoxicity (kidney damage) linked to systemic absorption.


Q: Is Аминтакс available over the counter?

The drug is generally regulated as a prescription-only medicine (POM) across major health jurisdictions. It is not widely available as an over-the-counter product.


Q: Why is Аминтакс used for more than one condition?

The drug is specifically formulated to provide broad-spectrum coverage against various microorganisms that cause infectious vaginitis, including both bacteria and fungi. The combination of three active ingredients is intended to address this mixed etiology.


Q: Can older adults typically use Аминтакс?

The product is generally intended for use in adult women. Official warnings note that elderly patients may have increased sensitivity to the effects of the Neomycin component, which is associated with a risk of systemic effects (ototoxicity and nephrotoxicity).


Q: Are there any specific laboratory tests required before or during treatment with Аминтакс?

No specific mandatory tests are explicitly detailed in general use instructions. However, official warnings about systemic risk emphasize that patients with impaired renal function have an increased risk of systemic toxicity, suggesting that monitoring of renal function may be conducted for at-risk patients.


Q: What is the purpose of the 'patient information leaflet' for Аминтакс?

The purpose of the patient information leaflet is to provide patients with official, detailed instructions on how to properly use the medicine. It also lists official warnings, documented side effects, and storage requirements as mandated by regulatory bodies.


Q: Does Аминтакс contain gluten or common allergens?

The official documentation states the product contains the excipient Soybean Oil, which is a documented risk for hypersensitivity reactions and requires caution for those with peanut or soya allergy. There is no explicit regulatory information concerning the presence or absence of gluten.


Q: How long does Аминтакс stay in the body after the last dose?

The active components are minimally absorbed systemically. For the small absorbed fraction of Neomycin, official documents describe it as being rapidly distributed and excreted by the kidney. Nystatin and Polymyxin B do not undergo significant systemic circulation.


Q: What are the most frequent reasons people discontinue Аминтакс?

Regulatory documents describe the most frequent side effects that might prompt a discussion about discontinuation as local reactions such as burning, itching, or signs of allergic hypersensitivity.

How should Аминтакс be stored and disposed of?

Official Storage Conditions

Regulatory documents stipulate that Аминтакс (Neomycin, Nystatin, Polymyxin B vaginal capsules) must not be stored above 25 C (77 F). To maintain the product's stability and integrity, it is necessary to avoid exposure to both extremely high and low temperatures. The medication must not be used past the expiry date shown on the outer carton.

Child Safety and Disposal Requirements

As a mandatory safety precaution, the medicine must be kept out of the sight and reach of children at all times. For the disposal of expired or unused capsules, regulatory instructions prohibit throwing the medicine away via wastewater or general household waste. Instead, individuals are instructed to consult a pharmacist for guidance on proper discarding procedures to ensure environmental protection.

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

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