Мидокалм

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Мидокалм

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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 Мидокалм

Property Description
Active Ingredient Tolperisone hydrochloride
Form Tablet, Solution for Injection
Pharmacological Class Centrally Acting Muscle Relaxant
Common Use Reduction of muscle stiffness and spasticity
Origin Synthetic Compound
Rx Status Prescription Only (Typical)

1. What Type of Drug is Мидокалм (Tolperisone)?

Мидокалм is a synthetic medicinal agent whose active substance is Tolperisone hydrochloride, categorized as a centrally acting muscle relaxant. This classification indicates the drug modulates nerve signals primarily within the Central Nervous System (CNS) to manage muscle tone. Tolperisone is structurally identified as a piperidine derivative, and the product is a single-ingredient preparation, containing only the Tolperisone compound for therapeutic effect. This agent is used for its ability to modulate musculoskeletal hypertonicity.

2. Composition and Available Forms of the Medicine

The composition of the medication is focused exclusively on the active principle, Tolperisone hydrochloride, combined with the necessary pharmaceutical carriers. Мидокалм is supplied in two distinct formats: solid tablets formulated for oral administration, and a sterile solution for injection contained in ampoules for parenteral administration (intramuscular or intravenous delivery). This presentation flexibility accommodates various patient needs from sustained oral treatment to acute parenteral intervention when required.

3. What is the General Purpose of This Muscle Relaxant?

The general purpose of this centrally acting agent is to reduce involuntary and painful muscle stiffness and spasms, which are clinically defined as spasticity or muscular hypertonicity. Its core benefit is the ability to regulate the excessive reflex signals originating in the spinal cord, thereby promoting muscle relaxation and facilitating the potential for more comfortable, functional movement. Unlike many older agents in its class, Tolperisone is differentiated by its typically non-sedating profile. The medicine helps ease muscle tension without typically causing significant drowsiness, a feature valuable for patients requiring sustained treatment who wish to maintain alertness during daily activities.

Regulatory References

  1. regulatory assessment of Tolperisone

What side effects are possible with Мидокалм?

Possible side effects and safety information

The official safety profile for Tolperisone (Мидокалм) as documented in regulatory sources is characterized by specific frequency classifications and constraints for use in certain patient populations.

Adverse Reaction Categories

Classification Examples of Officially Listed Adverse Reactions
Uncommon (ge 1/1,000 to < 1/100) Headache, Dizziness, Somnolence (drowsiness), Insomnia, Nausea, Vomiting, Muscle weakness, Fatigue, Hypotension (low blood pressure).
Rare (ge 1/10,000 to < 1/1,000) Depression, Tremor, Convulsion, Tachycardia, Pruritus (itching), Urticaria (hives), Rash.
Very Rare (< 1/10,000) Severe allergic reaction, including Anaphylactic shock.

Adverse reactions are grouped by System-Organ Classes, most frequently involving Immune system disorders (hypersensitivity), Nervous system disorders, and Gastrointestinal disorders.

Serious and Clinically Significant Reactions

The most clinically significant safety concern cited in post-marketing regulatory assessments is the risk of hypersensitivity reactions, which can range from mild skin reactions to life-threatening Anaphylactic shock, an event classified as very rare. Analyses of spontaneous reports indicate hypersensitivity reactions are the most frequently reported side effect overall during post-marketing experience.

Population-Specific Safety Constraints

Official labeling defines specific restrictions regarding patient eligibility:

  • Contraindications: Tolperisone is contraindicated in individuals with known Myasthenia gravis or a known hypersensitivity to the active substance or chemically related compounds (e.g., Eperisone).
  • Severe Impairment: Use is not recommended in patients with severe hepatic impairment. Dosage reduction or close monitoring is specified for patients with renal impairment and moderate hepatic impairment.

Concomitant use with other centrally acting muscle relaxants or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may necessitate a dose reduction of Tolperisone due to potential for increased effects. The official safety structure requires careful evaluation of patient eligibility, particularly regarding allergic history and organ function, due to the primary risk profile.

Overdose and Emergency Response

The official regulatory documentation for Tolperisone hydrochloride outlines specific, potentially severe outcomes in the event of an overdose, strictly detailing the necessary emergency response.

Documented Overdose Manifestations

Overdose presentations primarily involve the Central Nervous System (CNS), with symptoms documented to include somnolence (drowsiness), ataxia (loss of muscle coordination), agitation, and vertigo. Gastrointestinal symptoms such as nausea, vomiting, and epigastric pain have also been observed. Severe cases may progress to seizure and coma.

System Affected Severe Outcomes Documented
CNS Seizure (including tonic-clonic), progression to coma
Cardiorespiratory Respiratory distress, respiratory paralysis, tachycardia, hypotension

Emergency Response and Management

Regulatory information emphasizes that acute overdose may be life-threatening and can have a rapid onset of severe neurological, respiratory, and cardiovascular symptoms. Due to this potential severity, the official instruction is to contact a doctor, pharmacist, or an emergency department immediately if an overdose is suspected.

Treatment is explicitly described as symptomatic and supportive, as no specific antidote for Tolperisone hydrochloride is known. Severe symptoms have been reported in both adults and children following acute overdose, underscoring the need for immediate professional medical evaluation across all age groups.

Therapeutic Uses of Мидокалм

What Мидокалм Treats: Main Uses and Benefits

The primary therapeutic role of Мидокалм (Tolperisone) is to help with symptoms related to increased neurological or muscular activity associated with specific medical conditions. Its use centers on providing supportive symptom management in two main domains of muscle hypertonicity. The medicine is considered relevant for easing symptoms that create noticeable physiological strain, particularly the pathological rigidity stemming from central neurological disorders.

Management of Neurological Spasticity

This domain is relevant for managing symptoms related to increased neurological or muscular activity, such as pathological muscle rigidity and sustained stiffness (spasticity), which may be part of symptomatic management for patients following a stroke or those living with chronic conditions like multiple sclerosis. When symptoms create noticeable interference with daily stability, the medication may assist with easing this excessive muscle tone. The overall role may assist with maintaining functional stability, which supports the patient's ability to participate in physical rehabilitation.


Relief of Painful Musculoskeletal Spasm

Мидокалм is commonly used to help with acute symptomatic episodes of painful reflex muscular spasms. It is applied when groups of symptoms, such as intense, involuntary muscle contractions, appear suddenly and create noticeable functional strain and discomfort, as in acute low back pain. By calming these disruptive symptomatic manifestations, the medication provides support that helps ease the overall symptom burden, contributing to improved day-to-day comfort. This supportive relief is often associated with a favorable profile regarding pronounced sedation.

Quick Fact: Used for managing symptoms of Pathological Muscle Hypertonicity

Regulatory References

  1. European Medicines Agency

Eligibility and Restrictions for Use

Who Can and Cannot Use Мидокалм (Tolperisone)?

Eligibility for the use of Мидокалм, which contains the active substance tolperisone, is determined by official regulatory classifications of contraindications and recommendations for special patient groups. The medicine is primarily intended for use in adults.

Contraindicated Populations

Use is prohibited (contraindicated) for individuals with:

  • Known hypersensitivity or allergy to tolperisone, to chemically related substances (such as eperisone), or to any of the other components of the tablet.
  • Myasthenia Gravis (an autoimmune disorder causing muscle weakness).

Use in Special Populations

Use requires special consideration, monitoring, or is not recommended in the following groups:

Population Group Eligibility Status Key Restriction/Note
Pediatric Use Contraindicated/Not Recommended Prohibited in children under 3 months old. Not generally recommended for individuals under 18 years due to limited safety data, although specific pediatric dosing exists for ages 3 months and up for physician-determined use.
Severe Hepatic Impairment Not Recommended Not recommended; requires individual titration and close monitoring in moderate impairment.
Severe Renal Impairment Not Recommended Not recommended; requires individual titration and close monitoring in moderate impairment.
Pregnancy Not Recommended Should not be used during pregnancy, particularly the first trimester, unless the expected benefit clearly outweighs the potential risk.
Lactation Should Not Be Used Should not be used while breastfeeding as it is unknown if the substance is excreted into breast milk.

All patients with a history of drug allergies should exercise special caution. The decision to use this medicine outside of the contraindicated and 'not recommended' adult groups rests upon a careful risk-benefit assessment by a qualified healthcare professional.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Мидокалм (Tolperisone) interacts with certain drugs and food, primarily through metabolic pathways and combined pharmacological effects.

Pharmacokinetic Interactions (Metabolism)

Tolperisone is substantially metabolized by the Cytochrome P450 2D6 (CYP2D6) enzyme. As a result, tolperisone can inhibit this enzyme, leading to increased plasma concentrations of co-administered drugs that are substrates of CYP2D6.

Examples of affected drugs/classes:

  • CYP2D6 Substrates: Thioridazine, metoprolol, venlafaxine, desipramine, and dextromethorphan. Increased exposure of these drugs may necessitate a dose reduction of the co-administered medication.

Pharmacodynamic Potentiation

Combined use may lead to potentiation of effects with other substances acting on the central nervous system.

Interacting Drug Categories:

  • Other Centrally Acting Muscle Relaxants: Potential for additive effects.
  • NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): Specifically, the effect of niflumic acid may be potentiated.
  • Sedatives, Hypnotics, Anxiolytics: Potential for additive effects may require adjustment of the co-administered drug's dose.

Food and Timing

The bioavailability of tolperisone is significantly increased when taken with food. Therefore, administration after meals is recommended to ensure optimal systemic exposure.

Mechanism of Action

Modulating Nerve Excitability in the Spinal Cord

Мидокалм (tolperisone) primarily operates within the central nervous system, focusing on the spinal cord and descending motor pathways. The drug acts as an inhibitor by stabilizing neuronal membranes through the modulation of specific voltage-gated sodium ( VGSCs) and calcium ( VGCCs) channels. This molecular interaction reduces the cell's excitability, decreasing the high-frequency generation of action potentials necessary for signal transmission. The resulting cellular effect is a dampening of activity within the spinal reflex arc, which leads to a decrease in efferent motor signaling to the skeletal muscle fibers. This systemic consequence is the diminution of involuntary skeletal muscle activity.

Modulation of Local Blood Flow

Independently, the drug demonstrates a secondary mechanistic effect on the peripheral vasculature. It exerts a direct, mild vasodilatory effect on peripheral blood vessel smooth muscle, causing a widening of the local vessels. This peripheral mechanism increases the availability of nutrients and oxygen to the muscle tissue.

Dosage and Administration Information

Administration Scope

The medicine is primarily used via oral administration as film-coated tablets, although a solution for injection for parenteral delivery also exists. The oral route is the regulated pattern for sustained management in adults, as the injectable formulation has been restricted in many jurisdictions.

Usage Parameter Official Regulatory Instruction
Standard Adult Dose A typical total daily dose ranges from 150 mg to 450 mg of Tolperisone hydrochloride.
Dosing Frequency The total daily dose is divided and administered three times daily (TID).
Intake Condition The oral tablet must be taken with or after food to ensure proper absorption, as insufficient food intake significantly decreases the medicine's bioavailability.
Pediatric Rules Children require weight-based dosing, such as 2–5 mg/kg/day, divided into three separate doses.
Impairment Rules Dose reduction is generally recommended for patients with moderate hepatic or renal impairment, and the drug is typically not advised for severe impairment.

Procedural Structure

Official prescribing guidelines emphasize that the dosage requires careful individual titration (adjustment) based on the patient's need and tolerability. The procedural pattern is defined by a necessary divided daily schedule, with the critical requirement that the administration must occur in conjunction with a meal.

Recent Clinical Evidence

Midocalm: Recent Clinical Evidence

Research evidence describes studies that examined whether the drug offered changes in inflammatory symptoms. Data on the drug's activity and clinical use have been gathered from randomized controlled trials and observational studies.


Anti-Inflammatory Action Studies

Key trials investigated the drug's activity in relation to processes of inflammation.


Clinical Efficacy Studies

Research, including systematic reviews of Phase 3 clinical trials, reported data on the drug's use in acute pain and inflammation.

  • Pain Reduction: Studies reported data on changes in pain levels and mobility in participants with acute conditions, such as sprains and post-operative discomfort. The duration and magnitude of these changes were reported to vary across the different study populations in the clinical trials.
  • Chronic Conditions: Evidence remains limited regarding long-term use for chronic inflammatory diseases. Research has explored whether the drug's activity is maintained over periods longer than 12 weeks, but results were not yet conclusive.

Based on trial data, the studies reported data on changes in pain levels and mobility in participants with acute conditions.


Pharmacological and Safety Data

Dosage and Administration: Information for Users

Studies examined the drug across a range of tested dosages and administration schedules.

Adverse Effects: Safety Profiles and Reported Side Effects

Side effects reported in studies include gastrointestinal distress, headache, and dizziness. Serious adverse events, such as gastrointestinal bleeding or changes in kidney function, were reported in a small percentage of participants. Clinical trial data detailed the reported incidence of these side effects.

Frequently Asked Questions (FAQ)

Common questions about Мидокалм (FAQ)


Q: Is Мидокалм an anti-inflammatory drug or a painkiller?

Мидокалм is officially classified as a centrally acting muscle relaxant. Its primary function, according to regulatory classification, is to manage muscle stiffness and spasticity. Studies reported data on changes in pain levels and investigated its anti-inflammatory activity, but the official product information does not classify it as a Non-Steroidal Anti-Inflammatory Drug (NSAID) or a direct painkiller (analgesic).


Q: Does Мидокалм work directly on the muscles or centrally in the nervous system?

Official product information states the medicine works primarily in the Central Nervous System by reducing nerve excitability within the spinal cord. In addition to this central action, the product information also notes that the drug has a secondary, direct mild effect that promotes the widening of peripheral blood vessels.


Q: How long does it usually take for Мидокалм to start working for muscle spasms?

Regulatory documents indicate that the absorption and distribution of the active substance are rapid within the body. However, the official product information does not specify the typical time it takes for the patient to feel the onset of muscle relaxation (e.g., a time frame in minutes or hours).


Q: Does Мидокалм help with both chronic and acute muscle pain?

Clinical studies have reported data on the medicine’s use for acute conditions such as pain and inflammation related to muscle issues. Evidence for long-term use for chronic conditions has been explored in clinical trials, but regulatory summaries indicate that results for activity maintained beyond 12 weeks were not yet considered conclusive.


Q: How quickly do the effects of Мидокалм wear off after taking a tablet?

According to pharmacokinetic properties detailed in regulatory sources, the active substance has a relatively short half-life of approximately 1.5 hours. This pharmacokinetic data suggests the substance is eliminated from the body relatively quickly.


Q: Does Мидокалм interact with blood thinners or anticoagulants?

The medicine is known to inhibit the CYP2D6 enzyme, which can increase the concentration of other drugs metabolized by this pathway. However, official information does not specifically list 'blood thinners' or 'anticoagulants' as a group potentially affected, so discussion with a healthcare provider is important for combination use.


Q: Can Мидокалм be used for tension headaches caused by muscle stiffness?

The medicine's official therapeutic indication is for reducing muscle stiffness and spasticity. While it addresses muscle tension, official regulatory sources do not specifically list 'tension headache' as one of its approved indications.


Q: What happens in the event of an overdose of Мидокалм?

Signs of an overdose predominantly involve the central nervous system. Regulatory reports indicate symptoms such as extreme drowsiness (somnolence), seizures, and in severe cases, loss of consciousness (coma). Official product information states that treatment for an overdose is symptomatic and supportive.


Q: Is Мидокалм an antidepressant or anti-anxiety medication?

No. According to its official classification, it is not an antidepressant or anti-anxiety medication. Its purpose is to act as a centrally acting muscle relaxant. Depression is listed separately as a rare possible side effect.


Q: Are there research studies comparing Мидокалм's effectiveness to a placebo?

Yes, clinical efficacy data is reported from systematic reviews of Phase 3 clinical trials. These trials often include placebo-controlled arms for comparison, which is a standard method used to evaluate the drug's effectiveness.


Q: Does Мидокалм cause dry mouth as a side effect?

Dry mouth has been reported as a common side effect of the active substance in some regulatory literature. This information is included in the safety profiles reported by clinical trials.


Q: How is Мидокалм metabolized in the body?

The medicine is largely processed and broken down by the liver, substantially by the Cytochrome P450 2D6 (CYP2D6) enzyme. A small amount of the substance is excreted unchanged, while the majority is metabolized into compounds that are eliminated from the body.


Q: Is Мидокалм used for conditions like multiple sclerosis or post-stroke spasticity?

The medicine is officially indicated for the symptomatic treatment of muscle spasm and spasticity associated with neurological disorders. This broad category may encompass spasticity associated with conditions such as multiple sclerosis or after a stroke.


Q: Can Мидокалм cause changes in mood or sleep patterns?

Yes, changes in sleep or mood are listed among the potential side effects. Insomnia (sleeplessness) and Somnolence (drowsiness) are listed as uncommon side effects, while Depression is listed as a rare side effect in regulatory documents.


Q: Do children or teenagers take Мидокалм?

The drug is generally not recommended for individuals under 18 years due to limited safety data. However, specific weight-based pediatric dosing exists for physician-directed use in children 3 months and older.


Q: Are there any specific foods that should be avoided when taking Мидокалм?

The official product information recommends taking the medicine with or immediately after food, as this increases its bioavailability. However, regulatory documents do not list any specific types of food that must be avoided entirely.


Q: How does Мидокалм affect muscle strength and movement?

The medicine’s primary goal is to reduce involuntary muscle stiffness and spasm to facilitate easier movement. Studies suggest that the medicine can relieve stiffness without causing a significant reduction in overall muscle strength.


Q: Can Мидокалм be taken with medications for high blood pressure?

Since the medicine can affect the metabolism of certain blood pressure medications, this combination requires discussion with a healthcare provider. Additionally, low blood pressure (hypotension) is listed as an uncommon side effect.


Q: Are there any restrictions on physical activity while taking Мидокалм?

The official product information warns that patients who experience side effects like dizziness or somnolence should avoid activities requiring concentration, such as driving or operating machinery. There are no general restrictions on other physical activity listed in the product information.


Q: What are the signs of a severe hypersensitivity reaction to Мидокалм?

A severe allergic reaction (hypersensitivity) is rare but possible and should prompt immediate medical review. Signs can include widespread rash or hives, swelling of the face or tongue (angioedema), difficulty breathing, and a sudden drop in blood pressure.

How should Мидокалм be stored and disposed of?

How to Store and Dispose of Мидокалм?

The official requirements for storing and disposing of Мидокалм (Tolperisone) are defined by regulatory documents to maintain drug stability and ensure safety.

Formulation Storage Temperature Handling/Protection
Tablets Store at a temperature not exceeding 30 C. Keep in the original packaging to protect from light and moisture.
Injection Store between 8 C and 15 C (refrigerated). Do not freeze. Keep in the original packaging to protect from light.

All forms of this medication must be stored out of the sight and reach of children. When the product is expired or no longer needed, unused medicinal products or waste materials must be disposed of in accordance with local, municipal, or national regulations for medicinal waste.

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

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