Баралгин

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Баралгин

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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.

Overview of Баралгин

Quick Facts

Property Description
Active Ingredient Metamizole Sodium (Dipyrone)
Form Tablets, Solution for Injection, Drops
Pharmacological Class Non-opioid analgesic, Antipyretic, Spasmolytic
Common Use Symptomatic relief of severe pain, fever, and muscle spasms
Origin Synthetic (Pyrazolone derivative)

Definition, Active Ingredient, and Origin

Баралгин is a synthetic pharmaceutical whose active component is Metamizole Sodium, also known by the names Dipyrone or Sulpyrine. Chemically, the substance is a pyrazolone derivative, which identifies it as a non-narcotic pain reliever. This classification defines its chemical and therapeutic profile.

The compound is produced in a laboratory setting as a synthetic organic product. As a single-component product, Баралгин contains Metamizole Sodium as the sole therapeutically active substance. The formulation utilizes the high solubility of this component, which allows for absorption in acute situations.

Classification and General Therapeutic Purpose

Under the Anatomical Therapeutic Chemical (ATC) classification system, Metamizole is placed in the Pyrazolone group (code N02BB02). It is categorized as an analgesic for pain relief and an antipyretic for fever reduction.

In addition to these roles, Metamizole possesses spasmolytic properties. This action allows the drug to relax smooth muscles, providing relief from acute cramping pain, such as biliary or intestinal colic. The primary therapeutic purpose is the symptomatic relief of severe pain, fever, and acute muscle spasms.

The Pharmaceutical Forms of Баралгин

The medication is available in several dosage forms to accommodate different routes of administration. These forms include solid tablets for oral use and an aqueous solution for injection. The injectable form is used for intravenous or intramuscular administration, typically in clinical situations requiring a rapid effect. Additionally, the medication is available as oral drops.

Regulatory References

  1. NIH LiverTox - Metamizole

What side effects are possible with Баралгин?

The safety profile of Metamizole Sodium (Баралгин) is formally defined by official regulatory documents, which classify adverse reactions by frequency and affected body system. The most significant safety constraint is the potential for severe, idiosyncratic reactions, particularly to the Blood and Lymphatic System.

Adverse Reaction Classification

The most critical safety concern documented in regulatory labeling is agranulocytosis, a severe decrease in white blood cells. This event is classified internationally as Rare or Very Rare, and the risk is noted to be independent of the dose or duration of use, potentially occurring at any time during or shortly after treatment.

Serious adverse reactions documented in official sources include anaphylactic shock, which is a severe, life-threatening allergic reaction, and severe skin conditions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. Adverse events affecting the Hepatobiliary Disorders (acute liver injury) and Renal and Urinary Disorders are also formally listed.

Commonly documented adverse reactions include a drop in blood pressure (Hypotension), especially when the solution for injection is administered rapidly, along with gastrointestinal effects such as nausea, vomiting, and abdominal pain.

Population-Specific Safety Notes

The official labeling includes specific restrictions for certain populations. The medicine is generally contraindicated during the third trimester of pregnancy due to the risk of effects on the fetal circulation. Use is not recommended while breastfeeding as drug metabolites pass into the milk. Furthermore, the medicine is strictly contraindicated in individuals with a prior history of agranulocytosis caused by Metamizole or pre-existing diseases of the bone marrow.

Overdose and Emergency Response

Documented Overdose Manifestations and Actions

The official regulatory documents define the overdose profile of Metamizole Sodium (Баралгин) by detailing acute systemic manifestations and mandating immediate action for specific life-threatening events. Overdose following massive acute ingestion may lead to systemic effects, including gastrointestinal toxicity and cardiovascular compromise. Manifestations can include severe hypotension (a critical drop in blood pressure) potentially leading to shock, as well as signs of central nervous system involvement such as somnolence and vertigo.

Urgent medical assistance is required immediately if overdose is suspected. Immediate medical attention must be sought if symptoms of the life-threatening adverse reaction agranulocytosis develop (e.g., persistent fever, sore throat, mucosal sores) or if signs of anaphylactic shock occur. Upon the onset of symptoms suggesting agranulocytosis, use of the medicine must be stopped, and immediate blood count monitoring is necessary.

Management and Constraints

Management is strictly symptomatic and supportive because official regulatory information confirms that no specific antidote is known for Metamizole Sodium overdose. Procedural measures may involve gastrointestinal decontamination (e.g., activated charcoal) for recent oral ingestion. Caution is specified for patients with impaired renal or hepatic function due to a reduced elimination rate, which increases the potential for drug accumulation.

Therapeutic Uses of Баралгин

What Баралгин treats: Main Uses and Benefits

The therapeutic application of Баралгин (Metamizole Sodium) is centered on providing supportive symptomatic relief across three primary domains: strong pain, involuntary muscle spasms, and severe fever. Its use is commonly considered when symptoms become intense and additional symptomatic support is needed, specifically in cases of severe pain and fever that may not be controlled with other treatments.

Managing Severe and Acute Pain Episodes

The medication helps address symptoms related to physical discomfort that create noticeable physiological strain, such as intense pain following surgical procedures (postoperative pain) or physical injury (post-traumatic pain). It is also relevant in clinical settings marked by heightened patient distress, including the management of certain conditions where symptoms may intensify temporarily, such as pain associated with neoplastic disease (cancer pain). The medicine is considered relevant for easing symptoms associated with severe pain, fever, myalgia, arthralgia, and neuralgia.

“The benefit is offering supportive relief that helps patients cope more steadily with difficult acute pain episodes.”

Relief from Cramping and Visceral Spasm

A key therapeutic application is in managing symptoms linked to organ-specific functional stress, where discomfort is caused by muscle tension. This includes the sudden, disruptive symptom manifestations of renal colic (kidney pain) and biliary colic (gallbladder pain). In these acute episodes, the medicine is applied to address symptoms related to heightened physiological activity, providing supportive relief that helps maintain a sense of stability during these acute, disruptive episodes.

Addressing High or Refractory Fever

Баралгин is utilized within therapeutic areas involving symptoms related to systemic imbalance, such as high fever (pyrexia) that is persistent or does not respond adequately to other measures. It is relevant when short-term symptomatic assistance is needed, providing support that helps ease the overall symptom load during periods of systemic imbalance.


Quick Fact: Relief for Severe, Spasmodic Symptoms

The medicine is applied in addressing symptoms related to physical discomfort and increased muscular activity, particularly during acute, disruptive episodes.

Eligibility and Restrictions for Use

Who Can and Cannot Use Баралгин?

Eligibility for using Баралгин (Metamizole Sodium) is strictly defined by regulatory documents, focusing on patient history, age, and physiological status.


Absolute Contraindications

Metamizole Sodium is contraindicated and must not be used by patients with a history of agranulocytosis (a severe blood disorder) or other bone marrow impairment, and those with certain genetic metabolic conditions, including Acute Intermittent Hepatic Porphyria and G6PD deficiency. Use is also prohibited in patients with known analgesic-induced asthma syndrome .


Age and Physiological Restrictions

Population Group Regulatory Status
Infants Contraindicated if under 3 months of age or weighing less than 5 kg.
Older Adults Use restricted; caution required due to prolonged elimination of metabolites.
Pregnancy Contraindicated in the Third Trimester. Use is restricted in the first and second trimesters.
Lactation Repeated use is contraindicated. Following a single dose, breast milk must be discarded for 48 hours.

Condition-Based Limitations

Use is restricted and requires caution in patients with Impaired Hepatic Function and Impaired Renal Function. This is due to the potential for prolonged elimination of the drug’s metabolites, requiring close monitoring as outlined in the official prescribing information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information defines the interaction profile of Metamizole Sodium (Баралгин) primarily through its influence on drug-metabolizing enzymes and through specific pharmacodynamic effects.

Category Description / Official Statement
Pharmacokinetic Induction Metamizole is a moderate to strong inducer of Cytochrome P450 enzymes, particularly CYP3A4, CYP2B6, and CYP2C19. This effect may result in a reduction in the plasma concentrations of numerous co-administered medicines that are substrates for these enzymes.
Exposure-Modifying Medicines Co-administration with Metamizole may decrease serum levels of immunosuppressants like Ciclosporin and Tacrolimus, and the therapeutic efficacy of drugs like Bupropion, Methadone, Valproic acid, and Sertraline.
Additive Toxicity Risk Co-administration with Methotrexate carries an official regulatory warning for an increased risk of haematologic toxicity due to reduced elimination of Methotrexate.
Pharmacodynamic Restrictions Metamizole may inhibit the antiplatelet aggregation effect of low-dose Acetylsalicylic acid (Aspirin). Official guidelines require timing separation where Acetylsalicylic acid should be administered at least 30 minutes before Metamizole.
Other Interactions Co-administration with certain Neuroleptics (e.g., Chlorpromazine) may lead to the development of severe hypothermia due to an additive pharmacodynamic effect. Metamizole may also decrease the antihypertensive or diuretic activities of specific medicinal products.

Mechanism of Action

How Баралгин Works

The mechanism of action for Баралгин (Metamizole Sodium) is defined by a unique, dual action profile that modulates both central signaling and peripheral muscle dynamics.

Its central activity begins with the rapid metabolic formation of the active metabolite, 4-MAA, which accesses the Central Nervous System (CNS). Here, 4-MAA acts as an inhibitor of specific COX enzymes, primarily COX-3, reducing the synthesis of Prostaglandin E2 ( PGE2) in the brain and spinal cord, thus modulating the hypothalamic thermal set point. Concurrently, the metabolite modulates the descending pain control pathways by acting as an agonist at kappa-opioid and cannabinoid ( CB1) receptors, influencing nociceptive signaling.

Separately, the drug exerts a distinct spasmolytic action on visceral smooth muscle tissue. This peripheral domain involves modulating intracellular calcium ion pathways, primarily limiting the release of Ca^2+ from internal stores and potentially activating K ATP channels. This cascade leads to a reduction in muscle tension, thereby reducing contractility within the visceral smooth muscle walls. The drug’s profile is characterized by these central analgesic and antispasmodic mechanisms, with a weak or clinically irrelevant anti-inflammatory mechanism at therapeutic concentrations.

Dosage and Administration Information

Official Administration Routes and Principles

Баралгин (Metamizole Sodium) is administered via multiple routes, including oral forms (tablets and drops), intramuscular (IM) injection, and intravenous (IV) injection or infusion. The administration route is selected based on the clinical needs of the patient.

Dosing regimens are structured and centered on the principle of using the lowest dose required to control symptoms. For adults and adolescents weighing over 53 kg, a single oral dose may be up to 1,000 mg, with a maximum daily oral dose not to exceed 4,000 mg. The general schedule permits administration up to 4 times daily, provided a minimum interval of 6 to 8 hours is strictly maintained between doses. The overall use of Metamizole Sodium is generally intended for short-term application.

Procedural Instructions and Adjustments

Administration requires specific procedural adherence, particularly for the intravenous route: the solution must be injected very slowly to mitigate administration-related issues, and it may be warmed to body temperature beforehand. Dose modifications are mandated for specific patient groups. Pediatric dosing is determined by precise body weight calculations, rather than standardized fixed amounts. Furthermore, for older adults and patients with reduced renal or hepatic function, a reduction in dosage or avoidance of repeated high doses is necessary due to the potential for delayed elimination of the drug's active metabolites. These parameters define the standardized approach to using the medicine.

Recent Clinical Evidence

Research evidence / Overview of Studies for Баралгин

Evidence for Use in Acute Severe Pain

Research has examined patient-reported outcomes related to physical discomfort, primarily focusing on trials assessing short-term or episodic symptom patterns. Specifically, Short-term Randomized Controlled Trials (RCTs) were used to examine symptom activity, such as following surgical procedures or injury. These studies monitored adult populations, with some research exploring pain following certain cancer treatments. Research describes patterns observed in pain intensity and the frequency of use of additional or "rescue" pain medication. Follow-up durations were limited, as the majority of the evidence is derived from single-dose or very short-duration trials. Long-term effects are not fully established.

Evidence for Use in Acute Visceral Spasm and Colic

Research has explored the use of this medicine in conditions associated with acute or disruptive episodes, particularly those involving cramping pain linked to organ functional stress, such as renal colic (pain from kidney stones). These studies primarily consisted of Randomized Controlled Trials (RCTs) evaluated in emergency settings, focusing on adults experiencing heightened symptom activity. The research examined outcomes describing episodic or acute changes, specifically monitoring patterns of patient-reported discomfort over defined time intervals. Comparative studies were observed in some settings to explore what was observed against other standard agents used for this condition. However, findings were mixed when evaluating outcomes against some specific medications.

Evidence in Special Populations and Research Gaps

Studies have been conducted involving pediatric populations (children) to examine its use for managing fever. Furthermore, research has included older adults in studies to examine data related to observed changes. However, data for certain groups remain insufficient. The primary limitations identified by scientific literature include the fact that the evidence quality varies across studies. Overall, sample sizes were modest in many individual comparative trials, which may contribute to the mixed findings observed, and comparative evidence against certain newer agents is lacking or subject to high heterogeneity.

Frequently Asked Questions (FAQ)

Common questions about Баралгин (FAQ)

Q: Does official information describe any restrictions on driving while taking Баралгин?

The official product label notes that caution is necessary regarding driving or operating machinery. This is due to the potential for certain documented side effects, such as dizziness, vertigo, and somnolence (sleepiness), which could potentially affect concentration and motor skills.

Q: How long after taking Баралгин can a user typically expect to feel an effect?

Pharmacological data suggests that the onset of the pain-relieving effect may occur within 30 minutes following administration. The response and timing may vary depending on the individual.

Q: Can Баралгин be taken alongside standard daily multivitamins?

Official regulatory warnings focus on interactions with specific prescription medicines and therapeutic classes. No specific contraindications or warnings are generally listed for Metamizole Sodium when taken with standard daily multivitamins.

Q: Is Баралгин available over the counter or only by prescription in most regions?

The availability and required method of purchase for this drug vary significantly worldwide. While it is available by prescription only in many countries, it is sold over-the-counter or with varying restrictions in other regions.

Q: Are there common reports of feeling dizzy after taking Баралгин?

Yes, official adverse event lists include reports of vertigo, which is a specific form of dizziness. Official guidance suggests that if a user experiences dizziness or vertigo, caution is necessary.

Q: What is the research and regulatory status of Баралгин in countries like the US or UK?

Regulatory authorities in some countries, including the United States, the United Kingdom, and Canada, have withdrawn or banned Metamizole for human use. This decision was primarily based on the rare but potentially fatal risk of agranulocytosis.

Q: Does Баралгин interact with hormonal birth control pills?

Official information states that Metamizole is a moderate to strong inducer of certain liver enzymes (CYP3A4). Medicines that induce these enzymes may potentially reduce the effectiveness of co-administered hormonal contraceptives.

Q: What symptoms are officially listed as reasons to discontinue Баралгин immediately?

Regulatory warnings state that immediate discontinuation may be necessary if a user experiences the first signs of severe adverse events. These signs may include unexplained fever, sore throat, or symptoms of acute liver injury such as jaundice (yellowing of the skin) or dark urine.

Q: Is it true that Баралгин can sometimes cause a drop in body temperature?

The drug is classified as an antipyretic, meaning its mechanism of action is to reduce elevated body temperature (fever). Separately, official documents indicate that combining this medication with specific neuroleptic medicines may lead to a documented risk of severe hypothermia.

Q: Does official information state that Баралгин can make people feel tired or sleepy?

Yes, official documentation lists somnolence as a common adverse event. Somnolence is a medical term for sleepiness or drowsiness.

Q: Why do some people refer to Баралгин using the name 'Analgin' (Metamizole)?

'Analgin' is a common and widely used international trade name and synonym for the active ingredient, Metamizole Sodium. The use of different brand names is dependent on the country of sale and its historical nomenclature.

Q: Is there a risk of physical dependence mentioned in the official literature for Баралгин?

Official literature classifies the drug as a non-opioid analgesic. It is noted in pharmacological documentation for having a low potential for physical dependence.

Q: Is Баралгин classified as a muscle relaxant?

The official pharmacological classification for this drug includes the term 'spasmolytic.' This means it has muscle relaxant properties, but its action is specific to relaxing visceral smooth muscle tissue.

Q: Why is the sale of Баралгин restricted in certain countries?

The primary factor leading to restrictions or withdrawal of the drug in many countries is the rare but severe safety concern. This concern is the documented risk of agranulocytosis, a serious condition involving a severe decrease in white blood cells.

Q: How quickly is the drug Баралгин typically eliminated from the body?

Pharmacokinetic data indicates the time required for the body to eliminate the active substance. The half-life of the main active metabolite (4-MAA) typically ranges from 2.6 to 3.5 hours in healthy adults.

Q: How long does the pain-relieving effect of a single dose of Баралгин typically last?

Research and pharmacological reviews indicate the duration of the analgesic effect for a single dose. This pain-relieving effect typically lasts for approximately four hours.

Q: Can Баралгин be used by people with known cardiovascular issues?

Official information notes that caution may be necessary for individuals with known cardiovascular issues. This is because documented side effects include hypotension (a drop in blood pressure) and rare serious effects like tachycardia (an increased heart rate).

How should Баралгин be stored and disposed of?

The storage and disposal of Баралгин (Metamizole Sodium) must adhere strictly to official regulatory guidelines to maintain its stability and ensure environmental safety.

Required Storage Conditions

Official labeling requires the product to be stored in a cool and dry place, typically defined as below 25 C (77 F) or 30 C (86 F), and it must not be frozen [EMA/SmPC Standard]. The product must be protected from light and stored with the container kept tightly closed to protect it from moisture. For safety, the medicine must always be secured out of the sight and reach of children and pets, and the label often specifies that it should be stored locked up.

Official Disposal Rules

Unused or expired Баралгин should not be discarded in household trash or poured down drains. Regulatory documents emphasize that the substance is hazardous to the environment, requiring users to avoid release to the environment. Disposal must be completed in accordance with local, regional, and national regulations, typically through a medicine take-back program or an approved waste disposal plant [SDS/Regulatory Guidance].

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

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