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Метамакс

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Метамакс

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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.

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Overview of Метамакс

What is Метамакс (Metamizole)?

Property Description
Active Ingredient Metamizole sodium (also known as Dipyrone)
Common Forms Tablets, injections, suppositories, drops
Pharmacological Class Pyrazolone derivative (Non-opioid analgesic)
Common Use Severe pain and high fever
Regulatory Status Restricted or banned in some countries, widely used in others

Метамакс is a pharmaceutical product containing the active substance metamizole sodium, primarily used to treat intense pain and fever. Chemically, metamizole is classified as a pyrazolone derivative, a group of non-opioid medicines. It has been used clinically since the early 20th century.

The medicine is valued for its triple action: pain relief (analgesic), fever reduction (antipyretic), and spasm relief (spasmolytic). As a prescription-only medicine, Метамакс often focuses on injectable solutions, positioning it for use in acute hospital settings or when immediate relief is required, such as managing pain following major surgery. This analgesic effect is recognized for providing relief in cases of acute, severe pain, including renal or biliary colic.

It is important to note that the regulatory status of metamizole varies significantly across the globe. While it is restricted or banned for human use in some countries due to concerns about the rare side effect agranulocytosis, it is considered a standard medication in many European, Asian, and South American countries. The medication is used in broad applications for managing pain and fever, particularly in cases where other standard treatments have failed.

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What side effects are possible with Метамакс?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety restrictions based on regulatory data for the pharmaceutical product related to Метамакс.

Adverse Reaction Scope

Category Frequency and Examples (by System/Class)
Very Common Restlessness, drowsiness, fatigue, and lethargy.
Common Insomnia, headache, dizziness, nausea, or bowel irregularities.
Serious Reactions Severe side effects include unusual changes in mood, muscle spasms or rigidity, allergic reactions, difficulty breathing, severe drowsiness, or a bluish discolouration of the skin (methaemoglobinaemia). These can also involve symptoms of Neuroleptic Malignant Syndrome (high blood pressure, stiff muscles) or Tardive Dyskinesia (uncontrolled, repeated movements).

Safety Considerations and Restrictions

  • Contraindications: This medication is contraindicated in patients with known hypersensitivity to paracetamol and/or metoclopramide, or any related ingredients. It is also restricted in patients with conditions such as porphyria, bleeding from the digestive tract, intestinal blockage, recent digestive tract surgery, phaeochromocytoma (a rare adrenal gland tumor), or epilepsy, as it may increase seizure frequency and severity.
  • Population/Condition Specific Warnings: Use in pregnancy or during lactation is not recommended due to insufficient safety data. Caution is required in patients with severe renal impairment, sepsis, malnutrition, or chronic alcoholism due to an increased risk of metabolic acidosis. The drug should not be administered to children under 18 years.
  • High-Level Monitoring: Patients should be monitored for signs of extrapyramidal reactions (involuntary muscle movements), especially if taking other drugs that may cause similar effects. Caution is necessary regarding activities requiring alertness, such as driving or operating machinery, due to the risk of drowsiness or dizziness. Avoid taking the medication with alcohol.
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Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The official regulatory documentation for Метамакс (Metamizole) provides clear instruction regarding the manifestations and required actions in cases of acute overdose. This information is derived from authoritative government health agencies, such as those overseeing the European Summary of Product Characteristics (SmPC).

Overdose Manifestations Severe Outcomes and Systemic Effects
Nausea, Vomiting, Abdominal Pain Circulatory Shock (life-threatening)
Somnolence, Vertigo, Convulsions Respiratory Paralysis
Renal Function Deterioration (Oliguria/Anuria) Severe Hypotension

Urgent Action Required

Immediate medical attention is required for any suspected overdose or the onset of severe symptoms. The regulatory information highlights that treatment is primarily supportive, as no specific antidote for Metamizole sodium is available.

Management procedures officially described include measures to limit absorption, such as administering Activated Charcoal if given early after ingestion. Techniques like Haemodialysis and Haemoperfusion are also specified as procedural steps that may be used to reduce the circulating concentration of the active metabolite in cases of severe intoxication.

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Therapeutic Uses of Метамакс

What Метамакс treats: Main Uses and Benefits

Метамакс (Metamizole) is commonly used to help with symptoms related to acute, severe pain, painful muscle spasms, and high fever. The medication is generally applied in clinical settings that involve acute or unstable symptom patterns, when short-term symptomatic assistance is needed.

It is relevant in contexts marked by increased discomfort or tension, such as during recovery following major surgery or for managing visceral distress associated with conditions like renal or biliary colic. This application contributes to improved comfort during periods of systemic imbalance.

The medication is used across conditions presenting with acute episodes where there is heightened discomfort.


Quick Fact: Support for Acute Symptomatic Discomfort

This medication is applied across domains where additional symptomatic support is needed to contribute to easing the overall symptom burden associated with physical discomfort and supports patients during episodes of heightened discomfort. It is used to assist with easing the painful manifestations of spasm and high temperature.

Regulatory References

  1. European Medicines Agency (EMA) therapeutic overview
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Eligibility and Restrictions for Use

The eligibility for using Metamizole sodium (Метамакс) is strictly defined by regulatory authorities and centers on age, history of specific health conditions, and reproductive status. Official labeling classifies populations into three core categories: contraindicated, restricted use, and approved.

Contraindicated Populations

Metamizole must not be used by individuals with a history of metamizole-induced agranulocytosis or other blood disorders, or those with impaired bone marrow function.

Absolute contraindications also include those with acute Intermittent Hepatic Porphyria or congenital G6PD deficiency, and individuals with known hypersensitivity to pyrazolones.

Age- and Condition-Based Rules

Population Group Eligibility Status (Regulatory Wording)
Infants Contraindicated for those below 3 months of age or below 5 kg body weight.
Children (3 months to 14 years) Use is permitted, but the dosage must be strictly weight-based.
Older Adults Use requires caution; a reduced dose may be necessary due to potential reduced organ clearance.

Pregnancy and Lactation

Use is contraindicated during the third trimester of pregnancy. In the first six months, use is highly restricted and only considered acceptable as a single dose if strictly necessary. For breastfeeding, repeated use should be avoided; following a single dose, breastmilk must be discarded for a 48-hour period.

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What should I know about interactions with other medicines?

Метамакс (Meldonium) Interactions with other medicines and products

It is essential to inform your healthcare provider about all medications, supplements, and herbal products you are taking before starting Метамакс (Meldonium) therapy. The concurrent use of Meldonium with certain drug classes may require dose adjustments or close medical supervision due to the potential for synergistic effects, particularly on blood pressure and heart function.

Key Potential Interactions

Drug Class Potential Effect Recommendation
Nitrates/Vasodilators Synergistic action, potentially leading to excessive lowering of blood pressure (hypotension). Use with caution; may require monitoring.
Certain Anticoagulants While not a primary interaction, close monitoring is generally advised with metabolic modulators, though specific major interactions are not well-established. Monitor clinical status.
Diuretics Generally considered compatible in complex therapy for heart conditions, but the overall treatment regimen requires physician review. Follow physician guidance.
Other Cardioprotective Agents The combination with other agents such as antiarrhythmic drugs, antiplatelets, or cardiac glycosides is often part of complex treatment but must be managed by a specialist. Requires specialist management.

Alcohol and Food

There are no established major interactions between Meldonium and food. However, it is generally recommended to avoid alcohol consumption with any treatment for cardiovascular conditions. Always adhere to your prescribing physician's directions regarding diet and concomitant substances.

This information does not list all possible interactions. Always consult a healthcare professional for personalized medical advice.

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Mechanism of Action

How Метамакс Works

Metamizole's physiological effect profile is achieved through three distinct mechanistic domains, primarily centered on central nervous system (CNS) modulation and smooth muscle control.


Central Modulation of Pain and Temperature

This domain acts on central targets, specifically through the inhibition of COX enzymes within the brain and spinal cord, which reduces the synthesis of the mediator PGE2. It also involves the agonism of CB1 receptors by its active metabolites, activating the descending inhibitory pain system. This combined molecular cascade modulates the transmission of nociceptive signals and adjusts the hypothalamic set point for body temperature control.


Functional Spasmolytic Action

The third key mechanism involves a direct action on smooth muscle fibers throughout the viscera, independent of its COX inhibition. This effect is achieved by interfering with intracellular calcium signaling necessary for muscle contraction, resulting in a functional relaxation of muscle tone. This physiological adjustment reduces the intensity and duration of spasmodic contractions in organs like the ureter or bile duct.


Mechanistic Constraint: Peripheral COX Activity

Metamizole exhibits a significant mechanistic constraint due to low inhibitory affinity for COX enzymes in peroxide-rich peripheral tissues. This low peripheral activity means the drug minimally modulates the molecular pathways responsible for localized inflammatory responses, directing its effect primarily toward central pain and temperature regulation.

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Dosage and Administration Information

Administration Protocol

Метамакс (Metamizole) is prescribed for use via several official routes, which include oral administration (tablets, drops, or solution), intravenous (IV) injection, intramuscular (IM) injection, and rectal administration via suppositories. The route is selected based on clinical requirements for onset and absorption.


Official Dosing and Scheduling

Administration is guided by strict schedules focused on time intervals and total quantity. For adults (ge 15 years), the standard single dose ranges from 500 mg to 1,000 mg. The core principle mandates starting with the lowest effective dose. Dosing is scheduled for up to four times per day, provided a minimum of 6 to 8 hours separates each dose.

Maximum total daily exposure is defined: the oral dose must not exceed 4,000 mg, and the injectable dose must not exceed 5,000 mg. The official instructions specify that the medicine is intended for short-term use only.


Procedural and Population-Specific Rules

Specific administration techniques are mandated by clinical parameters. Intravenous injection must be performed very slowly to comply with administration constraints. For the pediatric population (le 14 years), dosing is strictly weight-based (e.g., 8–16 mg/kg single dose), and in infants (le 1 year), only the IM route is documented for injection.

Population-specific adjustments are required: the dose is typically reduced for older adults and individuals with reduced renal or hepatic function. Clinical guidelines specify that these patients avoid multiple high doses to manage the rate of metabolite elimination. These parameters define the standard boundaries for the proper administration of the medicine.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Метамакс

The body of research for Метамакс (Metamizole) primarily consists of clinical trials and systematic reviews. These studies research contexts exploring how short-term, acute symptoms are measured. The evidence was evaluated in settings exploring how symptoms are measured and to understand the patterns observed when the medicine was studied for physical discomfort and fever.

Evidence for use in Severe Acute Pain After Surgery

Research focusing on this context has primarily involved randomized controlled trials (RCTs) and comprehensive meta-analyses. These studies were evaluated in adult patient groups experiencing phases of heightened symptom activity following surgical procedures. The outcomes research examined included how patients reported their pain intensity and the frequency of needing additional analgesic medication during the study period.

Findings describe patterns observed in these short-term studies. However, the evidence quality varies across studies, and many trials sample sizes were modest. The results apply only to the populations studied, and the research provides limited insight into long-term recovery.

Evidence for use in Acute, High Fever

This area was studied for its influence on outcomes related to systemic or functional imbalance, specifically high body temperature. The evidence is derived from systematic reviews and clinical trials applied in research contexts involving fluctuating or unstable symptoms in both adult and pediatric patients.

Research highlights changes measured during the study period, suggesting a consistent pattern related to measured changes in high body temperature in short-term scenarios. Because this application was studied for short-term or episodic symptom patterns, there is limited information for long-term outcomes or how the medicine performs over extended periods.

Research Gaps and Remaining Uncertainties

Methodological inconsistencies in existing clinical trials and the modest sample sizes of many studies contribute to uncertainty. Furthermore, comparative evidence is lacking for certain populations and specific contexts studied, limiting the capacity to fully contextualize the findings. The current body of evidence is characterized by short-term data, meaning the full understanding of outcomes related to long-term usage is not fully established. The research provides context but not individual predictions about how a patient may respond.

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Frequently Asked Questions (FAQ)

Common questions about Метамакс (FAQ)

Q: Why is Метамакс sometimes prescribed for different conditions?

Official documents state that the drug is described as having three main therapeutic actions: pain relief, fever reduction, and spasm relief. This triple action is the reason it is studied and used for a variety of conditions, including intense pain, high fever, and certain kinds of spasmodic discomfort.

Q: Are there any widely known lifestyle changes to consider while using Метамакс?

Official instructions note that alcohol consumption should be avoided while undergoing treatment. Furthermore, regulatory information indicates caution is necessary when operating heavy machinery or driving, as the medicine has the potential to cause dizziness or drowsiness.

Q: Are the side effects of Метамакс usually serious?

Official product information classifies adverse reactions into frequency groups, which include common, non-serious effects and separate, rare but serious reactions. Agranulocytosis, a severe blood disorder, is one such documented risk. Official product information states that these symptoms require immediate medical evaluation.

Q: Why does the packaging for Метамакс have a specific warning about a certain population?

According to regulatory documents, warnings and restrictions are put in place primarily to mitigate the risk of serious side effects, such as rare blood disorders. Restrictions also apply to certain populations, like those with impaired kidney or liver function and those in specific stages of pregnancy, to ensure the medicine is cleared from the body correctly.

Q: Is it common for doctors to adjust the dose of Метамакс over time?

Regulatory instructions state that dosage reduction is necessary for specific populations, including older adults and individuals with reduced kidney or liver function. This is necessary to manage how the body processes the medication. The core principle established by regulators is the use of the lowest effective dose for the patient's condition.

Q: Does the time of day I take Метамакс matter?

The primary requirement is that the interval between doses must be separated by a minimum of six to eight hours. Additionally, some official labels note that taking the medicine with or immediately after a meal may help reduce the potential for gastrointestinal discomfort.

Q: Do studies suggest that Метамакс is generally well-tolerated?

Studies and official information indicate that the drug's safety profile documents a wide range of potential adverse effects, classified by frequency from very common to rare. Regulatory guidance emphasizes that the medicine is intended for short-term use.

Q: How does the use of Метамакс relate to heart conditions, based on safety data?

Regulatory documents warn that rapid intravenous administration has been associated with a transient decrease in blood pressure (hypotension). Regulatory documents indicate that caution is necessary in patients with existing low blood pressure or circulatory issues.

Q: Are there specific symptoms that require immediate medical attention while on Метамакс?

Official warnings list specific symptoms that should be considered serious and require immediate medical evaluation. These include the sudden appearance of fever, chills, a sore throat, or any signs of unexpected bruising or bleeding. These symptoms are highlighted as they may be signs of a serious blood disorder.

Q: How quickly can someone expect to feel the initial effects of Метамакс?

According to official regulatory documents, the onset of pain relief action after oral administration is typically described as beginning within 30 to 60 minutes.

Q: Does Метамакс work right away or does it take time to build up in the system?

Regulatory data describes the medicine as a pro-drug, which means it is converted into active compounds inside the body. These active compounds reach their peak concentration typically one to two hours after administration, suggesting a fast onset followed by increasing effect.

Q: Can over-the-counter pain relievers be taken with Метамакс?

Regulatory documents note that the simultaneous use of Метамакс with other non-opioid pain relievers that inhibit COX enzymes should be avoided. This is noted to help prevent potential interactions and to minimize safety risks.

Q: What happens if a dose of Метамакс is missed?

Patient information from government sources describes the standard procedure: if a dose is missed, it is generally recommended to skip that dose and resume the usual schedule. It is noted that taking two doses at the same time should be avoided.

Q: Is there a risk of dependency or withdrawal with Метамакс?

The medicine is officially categorized as a non-opioid analgesic. Official documentation for this non-opioid analgesic does not list dependency or withdrawal symptoms among its classified adverse reactions.

Q: What is the typical duration of action for a single dose of Метамакс?

According to the official regulatory documents, the therapeutic effect of a single dose is generally described as lasting for a duration of approximately four to six hours after it has been administered.

Q: Is there a generic version of Метамакс available?

Regulatory listings confirm that the active substance, Metamizole, is generally available as an authorized generic equivalent. The generic versions are available in various authorized formulations, alongside the original brand name.

Q: Can I take Метамакс if I am also taking medication for anxiety?

Official documents list specific interactions with certain CNS depressants and psychotropic medicines, including those sometimes used for anxiety. Regulatory advice indicates that caution is necessary when combining the drug with any medicine that affects the central nervous system due to the risk of increased drowsiness.

Q: Is Метамакс used in other countries under a different name?

Regulatory and chemical databases confirm that the active ingredient, Metamizole, is utilized internationally under several different chemical and brand names. Examples of these alternate names include Dipyrone or Sulpyrine.

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How should Метамакс be stored and disposed of?

Storage and Handling Requirements

Official regulatory documents define strict rules for storing Metamizole to maintain its stability and quality. The product must be stored at room temperature, generally meaning storage below 25,mathrmC or 30,mathrmC, depending on the specific formulation. It is mandatory to protect the medicine from light by keeping it in the original outer packaging and to not freeze any solution forms.

All forms of the medicine must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Metamizole must be handled according to local pharmaceutical waste regulations. To prevent environmental contamination, the medicine must not be discarded via the wastewater system (sink or toilet). Consumers are typically directed to return unwanted medicine to a pharmacy or designated collection site, following the official guidelines for proper disposal.

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

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