Спазматон

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Спазматон

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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 Спазматон

Property Description
Active Ingredients Sodium Metamizole, Pitofenone, Fenpiverinium Bromide
Form Tablet, Solution for injection (ampoule)
Pharmacological Class Analgesic and Antispasmodic Agent
Common Type Triple-component (Combination Drug)
Origin Synthetic derivative compound

What Type of Combination Drug is Спазматон?

Спазматон is classified as a combined medicinal product, structurally engineered to act as both an Analgesic and an Antispasmodic Agent simultaneously. This formulation's comprehensive approach is clinically recognized for providing relief in visceral pain states, distinguishing it from single-agent analgesics. The medication is sourced entirely from synthetic derivative compounds and is typically available for oral use as a tablet or for parenteral use as a solution for injection. Its pharmacological identity includes the use of Metamizole as a pain reliever.

The Triple-Component Composition of Спазматон

The medication is composed of three distinct active ingredients [INN]: the pain-relieving Sodium Metamizole, and two complementary spasmolytic agents, Pitofenone and Fenpiverinium Bromide. The core analgesic function is provided by Sodium Metamizole, which acts by modulating pain pathways. The two spasmolytics address muscular tension: Pitofenone provides a direct relaxation effect (myotropic spasmolytic action), while Fenpiverinium Bromide enhances this effect by modulating nerve signals (anticholinergic action). This synergistic combination is specifically formulated to manage pain where smooth muscle spasm is a known contributing factor.

General Purpose: Why Combine Pain Relief and Spasm Relaxation?

The general purpose of Спазматон is to provide relief in scenarios where discomfort arises from, or is complicated by, involuntary smooth muscle spasms, typical of visceral pain syndromes, such as those experienced during episodes of renal or biliary colic. By combining these active ingredients, the drug is able to target the underlying physical tension through relaxation while concurrently reducing the perception of pain. This dual therapeutic strategy ensures the medication addresses both the spasm and the pain symptom simultaneously, which is the foundational principle behind its design as a combined agent for antispasmodic and analgesic combinations.

Regulatory References

  1. National Institutes of Health

What side effects are possible with Спазматон?

Possible side effects and safety information

The safety profile of Спазматон (Sodium Metamizole, Pitofenone, Fenpiverinium Bromide) is formally defined by the adverse reactions and constraints documented in official regulatory labeling, primarily due to the Sodium Metamizole component.

Serious Adverse Reactions and Frequency

Certain reactions are classified as Rare or Very Rare in regulatory documents, but are considered clinically significant. These include the severe blood disorder Agranulocytosis (a sharp decrease in white blood cells), generalized allergic reactions such as Anaphylactic Shock, and severe skin reactions like Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The risk of Agranulocytosis is documented as not being dose-dependent and capable of occurring at any point during treatment.

System-Organ Class Effects

Adverse effects are formally grouped into affected physiological systems, known as System-Organ Classes (SOCs):

System-Organ Class (SOC) Examples of Officially Documented Effects
Blood and Lymphatic Agranulocytosis, Leukopenia, Thrombocytopenia
Immune System Hypersensitivity reactions, Anaphylactic Shock
Renal and Urinary Chromaturia (red urine coloration), Acute Renal Failure
Gastrointestinal Dry mouth, Nausea, Vomiting
Cardiac Tachycardia, Hypotension (more likely with injection)

Regulatory Safety Constraints

The medicine is strictly contraindicated by regulatory authorities in individuals with a known hypersensitivity to its active ingredients or other pyrazolone derivatives. Use is also constrained in patients with severe hepatic or renal impairment and those with pre-existing bone marrow depression. Specific caution is required for patients with conditions sensitive to anticholinergic effects, such as glaucoma or prostatic hypertrophy.

Overdose and Emergency Response

Documented overdose presentations of this combination typically involve severe effects from the Metamizole component, including Nausea, Vomiting, and CNS Depression leading to Sedation or Convulsions. Anticholinergic toxicity from the spasmolytic agents may also manifest as Mydriasis (dilated pupils) and Dryness of mucous membranes.

Physiological systems affected include the Cardiovascular system (Hypotension, Tachycardia, Circulatory Collapse), the Central Nervous System (potential Coma or Respiratory Paralysis), and the Hematopoietic system (Agranulocytosis risk). A dose-related factor for risk is the rapid intravenous administration, which is associated with an increased potential for hypotensive reactions. Overdose is further complicated in patients with impaired renal or hepatic function due to slower drug clearance.

Overdose situations are classified in regulatory documents as having the potential for Severe and Life-threatening outcomes, specifically Circulatory Collapse and Agranulocytosis. Emergency-response statements strictly mandate to seek immediate medical attention and discontinue treatment if symptoms such as fever, chills, sore throat, or painful mucosal changes arise, as these signal a potential blood dyscrasia. Contacting emergency services immediately is required for acute life-threatening signs.

Management is Symptomatic and Supportive, as no specific antidote is known for the primary Metamizole component, requiring intensive Hospital Monitoring of vital signs.

Therapeutic Uses of Спазматон

The core component is used for the symptomatic management of severe pain and fever that is not adequately addressed by other therapeutic measures, supporting its relevance in challenging symptomatic phases where such a therapeutic profile is required.

This medication is primarily relevant in clinical settings marked by the sudden onset of intense, cramping pain known as colic, particularly related to symptoms linked to organ-specific functional stress. It is commonly used across conditions characterized by episodic or fluctuating symptom patterns, such as renal colic, biliary colic, and severe, disruptive cramping associated with dysmenorrhea. The key therapeutic benefit provides supportive relief that helps patients cope more steadily with difficult, acute episodes and the symptoms related to physical discomfort. It is also applied in contexts where additional support for managing spastic discomfort is needed, especially when symptoms create noticeable interference with daily stability, and assists in addressing symptom clusters that may become intense or disruptive.

Quick Fact: Relief for Symptoms Related to Physical Discomfort

This combination plays a role in managing symptoms related to physical discomfort and heightened physiological activity, and is relevant when short-term symptomatic assistance is needed.

Eligibility and Restrictions for Use

Eligibility and Contraindications for Спазматон

The eligibility for using Спазматон (Metamizole, Pitofenone, Fenpiverinium Bromide) is strictly defined by official regulatory labeling, focusing on specific health conditions, age, and physiological states.


Absolute Contraindications (Must Not Use)

Population/Condition Restriction Basis
Hypersensitivity/Allergy To any active component, excipients, or pyrazolone derivatives.
Hematological Disorders Impaired bone marrow function or a history of metamizole-induced agranulocytosis.
Infants and Children Contraindicated for infants under 3 months and generally not recommended for children under 15 years in fixed-dose forms.
Pregnancy Contraindicated during the third trimester.
Gastrointestinal Intestinal obstruction, megacolon, or acute hepatic porphyria.

Restricted and Conditional Use

Use is subject to caution and medical oversight in certain groups:

  • Organ Impairment: Patients with mild to moderate renal or hepatic impairment may require dose reduction due to altered drug clearance.
  • Older Adults: Dose adjustment may be necessary due to age-related changes in organ function.
  • Pregnancy/Lactation: Use is generally advised against during the first six months of pregnancy and is not recommended while breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products — Official Regulatory Information for Спазматон

This interaction profile is based on the documented effects of the active components, primarily Metamizole, as described in governmental regulatory sources.

Classification Interacting Agents / Rules
Pharmacokinetic Interactions Ciclosporin, Tacrolimus: Metamizole is documented as an inducer of Cytochrome P450 (CYP) enzymes, including CYP3A4, CYP2B6, CYP2C8, and CYP2C9. Co-administration results in a decrease in the plasma concentrations and reduced systemic exposure of these substrate medicines.
Pharmacodynamic Interactions Methotrexate: Co-administration carries an official additive risk for haematologic toxicity. Chlorpromazine: Documented risk of additive hypothermia. Other Anticholinergic Agents: Increased risk of additive anticholinergic adverse effects due to Pitofenone and Fenpiverinium Bromide. Nephrotoxic Agents: Increased risk or severity of nephrotoxicity when co-administered with Metamizole.
Timing-Based Rules Acetylsalicylic acid (Aspirin) (for platelet aggregation inhibition): Metamizole co-administration reduces the anti-platelet effect. Regulatory guidance advises delaying Metamizole intake after Aspirin to preserve the anti-platelet effect.

Connection to the overall interaction profile:

The regulatory documents define the product's interaction structure primarily through Metamizole's activity as a CYP enzyme inducer and its pharmacodynamic interference with platelet aggregation. This structure establishes constraints for co-administered drugs by formally stating the outcomes of decreased systemic exposure for specific substrates and the existence of additive toxicity risks with other pharmacologic classes.

Mechanism of Action

The mechanism of action for Спазматон (which often contains metamizole) involves two primary, distinct pathways that modulate physiological contraction and pain signaling.

First, metamizole functions as a pro-drug, which is metabolized into active pyrazolone compounds. These compounds exhibit a spasmolytic effect in smooth muscle tissue, particularly in the gastrointestinal and urogenital tracts. This action is mediated by inhibiting the release of intracellular Ca^2+ from the sarcoplasmic reticulum. The precise molecular event for this is linked to the reduction in the synthesis of inositol phosphates, which are essential second messengers in the calcium-release cascade. This reduction leads to diminished Ca^2+-dependent contractile force within the smooth muscle cells.

Concurrently, its analgesic activity is centrally mediated. The active metabolites inhibit specific isoforms of cyclooxygenase (potentially COX-3) in the central nervous system, reducing the synthesis of inflammatory prostanoids. Additionally, the compound engages in an interaction with both the opioidergic and cannabinoid systems, which contributes to the modulation of nociception.

Dosage and Administration Information

How to Use Спазматон: Administration Guidelines

This section outlines the administration and dosing instructions for the combination drug Спазматон (Metamizole/Pitofenone/Fenpiverinium Bromide), as defined by standard guidelines. These instructions determine the appropriate routes, dosage, and duration for the use of this medicine.


Administration Scope

Instruction Detail
Route of Administration Approved for both Oral (tablet) and Intramuscular (IM) injection (solution) use.
Dosing Schedule Oral: The standard adult dose is 1 to 2 tablets per intake. The maximum daily dose must not exceed 6 tablets (equivalent to 3000 mg Metamizole Sodium).
Frequency and Timing Tablets are typically administered 2 to 3 times per day. Injections may be repeated after 6 to 8 hours if needed, but the maximum daily limit must be observed.
Timing in Relation to Meals Tablets should be taken by mouth with water after eating.
Age-Group Rules The oral form is approved for use in children over 9 years. The injection is typically reserved for adolescents over 15 years of age (> 53 kg). Lower doses (e.g., one-half the adult dose) are recommended for patients with mild to moderate renal or hepatic impairment.
Special Procedural Conditions The solution for injection is strictly for intramuscular administration and should be administered deeply into the muscle. Due to the nature of the components, parenteral use is intended to be carried out under medical control.

Use Protocol Structure

The protocol defines this medication for short-term treatment only, establishing that the overall course of treatment must generally not exceed 3 days. This constraint structures its use for acute, episodic pain management. The administration is conditional: the oral form is timed after meals, while the parenteral route mandates medical supervision for proper and controlled use.

Recent Clinical Evidence

Спазматон: Recent Clinical Evidence

Overview of Key Studies

Clinical research has explored whether Спазматон (often associated with the compound Metamizole) was associated with changes in various types of pain and symptoms involving smooth muscle spasms. Studies have frequently examined its use in the management of pain and fever. The available research generally focuses on outcomes such as pain intensity reduction and analgesic effects in acute conditions like postoperative pain, cancer pain, and colic.

A number of randomized, placebo-controlled trials have been conducted to understand the potential role of the drug. These investigations often involve comparisons to other common pain relievers, such as ibuprofen or acetaminophen, to assess relative analgesic effects.

Efficacy Endpoints and Findings

Studies primarily measure outcomes like the overall percentage of participants who report pain relief and changes in specific pain scores, often over short-term observation periods. Key findings indicated associations with pain reduction in various adult populations.

Outcome Measured Research Focus Evidence Summary
Analgesic Effect Acute and severe pain (e.g., colic) Single-dose Спазматон was observed to have comparable analgesic effects to single doses of certain other commonly used analgesics in moderate to severe pain.
Spasmolytic Effect Smooth muscle spasms Studies noted a distinctive action on smooth muscle tissue, which may contribute to its use in pain conditions linked to spasm, such as colic.

Safety and Global Availability

Safety is a critical area of ongoing research. While Спазматон is widely used in some regions for its analgesic, antipyretic (fever-reducing), and spasmolytic effects, it has been withdrawn from the market in other countries due to concerns related to rare, but serious, adverse events, primarily agranulocytosis. Regulatory bodies in different countries have reached varying conclusions regarding the benefit-risk profile based on local epidemiology data, leading to differing availability and indication restrictions globally.

Key Studies & References

  1. Metamizole [Dipyrone] - LiverTox - NIH
  2. Efficacy of metamizole versus ibuprofen and a short educational intervention versus standard care in acute and subacute low back (RCT)

Frequently Asked Questions (FAQ)

Common questions about Спазматон (FAQ)

Q: How does the drug classification of Спазматон compare to similar treatments?

Official classification defines Спазматон as a combination medicine that provides both pain relief (analgesic) and smooth muscle relaxation (antispasmodic). This dual action distinguishes it from single-component painkillers. Regulatory reviews have noted differences in its side effect profile, which regulatory reviews suggest may include distinct gastrointestinal and renal tolerability compared to traditional non-steroidal anti-inflammatory drugs (NSAIDs).

Q: What are the most commonly reported side effects listed in regulatory documents for Спазматон?

Official documents describe adverse events by system. Among the frequently reported effects associated with the main active component are digestive issues like nausea and vomiting, as well as headache and general feelings of weakness. It is noted that serious adverse events, such as the severe blood disorder agranulocytosis, are classified as rare or very rare in regulatory texts.

Q: Does taking Спазматон typically cause issues like drowsiness or dizziness?

Yes, regulatory information states that the medicine can potentially cause dizziness, fatigue, or feelings of lightheadedness, which may be related to changes in blood pressure. Official regulatory warnings indicate that the drug's effects may require caution regarding activities that demand full mental alertness, such as driving or operating machinery.

Q: Are there any specific lifestyle factors, such as diet, that may affect Спазматон's action?

Official patient guidelines for the tablet form of the medicine specify that it should be taken orally with water after eating. Official information describes the timing of use with meals. In general, maintaining a balanced diet and adequate hydration is a standard recommendation during any course of medication.

Q: Is it necessary to avoid alcohol completely when using Спазматон?

The official interaction profile does not explicitly state that the complete avoidance of alcohol is required for everyone using the medication. Due to the lack of explicit guidance in some official summaries, patients typically seek clarification from a healthcare professional regarding its consumption during treatment.

Q: What are the known interactions between Спазматон and common over-the-counter pain relievers?

Official documents specifically describe an interaction with acetylsalicylic acid (Aspirin), noting that the combination may reduce Aspirin's anti-platelet effect (its ability to prevent blood clots). Regulatory texts describe the potential for interference, indicating that the combination of this medicine with any other analgesic may warrant clarification.

Q: Does the official documentation for Спазматон list interactions with high blood pressure medicines?

Official documentation details pharmacokinetic interactions, noting that the main component acts as an enzyme inducer, which can decrease the levels of certain other medicines in the body. Official documents note that some combinations of this medicine with other drugs may require careful medical monitoring, especially with medications used for chronic conditions.

Q: How quickly is the described effect of Спазматон expected to begin after use?

According to regulatory pharmacokinetics data, the onset of a noticeable effect varies depending on the route of administration. For oral tablets, the described effect typically begins approximately 30 to 60 minutes after use. For the parenteral (injection) form, the onset is generally noted to be slightly faster, usually within about 30 minutes.

Q: What is the typical duration of the effects of one use of Спазматон?

The official dosing schedule for the medicine provides the clearest indication of its typical duration of action. Regulatory instructions define that repeat doses, where necessary, should be spaced at intervals of 6 to 8 hours to maintain the therapeutic effect.

Q: Do studies suggest that the effectiveness of Спазматон can change with prolonged use?

The regulatory protocol strictly defines the medication for short-term use only, with treatment typically not recommended to exceed 3 days. Since the drug is defined for a brief period, regulatory protocols and standard research primarily address its effectiveness and safety during this short-term duration.

Q: Is there any public research available that discusses the long-term use of Спазматон?

Although the medication is intended for brief use, regulatory agencies continuously monitor its safety profile through post-market surveillance. This ongoing review process tracks rare or long-term adverse events, which may become apparent after extended periods of monitoring by safety bodies.

Q: What organizations have reviewed and approved Спазматон for public use?

Every country where the drug is available requires approval from its specific governmental regulatory authority, such as the European Medicines Agency (EMA). These regulatory bodies conduct independent assessments of the medication's benefit-risk profile based on the available clinical data to determine its approval status for local public use.

Q: Why do some people confuse Спазматон with anti-inflammatory drugs?

This common confusion often stems from the medicine’s mechanism of action. The main component relieves pain partly by inhibiting cyclooxygenase ( COX), which is the same pathway targeted by non-steroidal anti-inflammatory drugs (NSAIDs). Due to this shared action and its common inclusion in comparative studies, people may mistakenly classify it as a traditional anti-inflammatory medicine.

Q: What is the difference between the active ingredient and the excipients in Спазматон?

The active ingredients are the core medicinal components responsible for providing the drug's intended effects, such as pain relief and smooth muscle relaxation. Excipients are the non-medicinal substances, like fillers or stabilizers, that are used to formulate the product (e.g., the tablet or solution). Official labeling is required to list both, as excipients can sometimes be the source of a hypersensitivity reaction.

Q: What are the potential general risks for people who use Спазматон without reading the full official leaflet?

Official regulatory guidance requires patients to be fully informed of specific, rare, but serious risks associated with the drug. The official leaflet contains crucial warnings, such as the symptoms of agranulocytosis (like fever or sore throat). The awareness of these details is important as such symptoms warrant prompt medical review.

Q: Does using Спазматон typically require any follow-up tests or check-ups?

Routine follow-up tests are not universally required for the short-term use of the medication. However, regulatory documents indicate that if a user develops symptoms suggestive of severe side effects (e.g., potential signs of agranulocytosis), the drug is typically discontinued, and medical monitoring, including a complete blood count, is warranted.

Q: Is the onset time for Спазматон the same regardless of how it is used (if multiple forms exist)?

No, the timing of the described effects differs between the available forms. Official pharmacokinetic information indicates that the oral tablet form is typically expected to begin showing its effect between 30 to 60 minutes after consumption. The parenteral (injection) form, which is administered under medical supervision, generally has a faster onset time, typically around 30 minutes.

Q: Do any official documents describe potential interactions with herbal or natural supplements?

Official interaction profiles primarily focus on co-administration with other prescription and non-prescription medicines. Regulatory documents do not consistently list specific interactions with herbal or natural supplements. Patients who consider combining this medication with any herbal remedies or supplements may be advised to seek clarification from a healthcare provider due to the limited data in standard regulatory summaries.

Q: What are the documented effects of Спазматон on driving or operating machinery?

Regulatory information specifically warns that the drug may impair concentration, and potential side effects include drowsiness, lightheadedness, and dizziness. Official guidance indicates that individuals should take caution and avoid driving or operating machinery if they experience drowsiness or impaired concentration, as these effects have been documented.

Q: Do government health agencies have a system for monitoring the safety of Спазматон after it is released?

Yes, regulatory agencies, such as the European Medicines Agency, employ sophisticated systems to monitor the safety of the drug after it is released to the market. This ongoing process, known as pharmacovigilance, allows regulatory committees to continuously assess and update the drug's official information based on real-world safety data.

Q: Does Спазматон impact laboratory results for common medical tests?

Official research indicates that the active components of the medication can interfere with the results of certain laboratory diagnostic tests. Specifically, the drug may lead to falsely decreased measurements for several analytes, including creatinine, triglycerides, and HDL cholesterol.

How should Спазматон be stored and disposed of?

How to Store and Dispose of Спазматон?

Storage Requirements

To ensure the stability and quality of Спазматон (tablets and injection solution), follow these official storage guidelines:

  • Temperature: Store at a temperature not exceeding 25^circC.
  • Protection: Keep the product in its original packaging (carton) to protect it from light. Tablets should also be stored in a dry place.
  • Access: The product must be stored in a location inaccessible to children.
  • Handling: Do not use the medication after the expiration date printed on the package.

Disposal Instructions

Proper disposal is required to protect the environment:

  • Do not dispose of the medicinal product in the sewerage system or in household waste.
  • Consult a pharmacist for guidance on how to safely dispose of any unused or expired medication.

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

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