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Пиралгин

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Пиралгин

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Treatment option:

Medically reviewed

Laura Arias

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 Пиралгин

Property Description
Active Ingredients Metamizole Sodium, Codeine, Naproxen Sodium, Phenobarbital, Caffeine
Form Tablet (Oral)
Pharmacological Class Combined Analgesic-Antipyretic
General Purpose Potent pain relief and fever reduction
Origin Synthetic

Пиралгин: A Multi-Component Analgesic-Antipyretic

Пиралгин is a synthetic, fixed-dose pharmaceutical preparation classified as a Combined Analgesic-Antipyretic drug used for the potent, multi-modal management of pain and the reduction of elevated body temperature. This preparation is consistently supplied in the oral tablet dosage form. The formulation is clinically recognized for its broad-spectrum action, supporting its utility in cases where discomfort is significant or prolonged. The combination of Metamizole with other agents is designed to address severe pain by leveraging multiple pharmacological mechanisms.

What Active Ingredients Compose Пиралгин?

The complex composition of Пиралгин is its defining characteristic, containing five distinct active pharmaceutical ingredients: Metamizole Sodium, Codeine Phosphate, Naproxen Sodium, Phenobarbital, and Caffeine. This high component count distinguishes it from most conventional pain relievers. The formulation includes Codeine, an opioid analgesic, and Phenobarbital, a barbiturate sedative, which places the medicine in the category of prescription-only medication in numerous jurisdictions. The blend of peripheral agents, such as Naproxen Sodium (an NSAID), with central-acting agents is a key design feature for maximizing therapeutic reach.

Why is Пиралгин a Combination Product?

Пиралгин is formulated as a combination product to achieve a pronounced synergistic effect, where the coordinated action of the five ingredients is greater than the sum of their individual effects. This combination strategy is intended to provide enhanced efficacy over single-agent treatments, particularly for moderate to severe symptoms. The benefit of this integrated approach is the comprehensive mitigation of discomfort, ensuring simultaneous central pain modulation, anti-inflammatory action, and modification of central nervous system activity.

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What side effects are possible with Пиралгин?

Possible Side Effects and Safety Information

The official safety profile for the multi-component drug Пиралгин is structured around the documented risks of its five active ingredients, as defined by governmental regulatory authorities.

Frequency and System-Organ Classifications

Adverse reactions are classified by frequency and by the affected system. Common effects, often linked to the Codeine and Phenobarbital components, include drowsiness, nausea, vomiting, and constipation, representing effects on the Nervous System and Gastrointestinal System. Less frequent, but officially documented, effects include gastrointestinal discomfort and mild peripheral oedema.

Serious Adverse Reactions and Safety Constraints

Regulatory documents list several serious adverse reactions, which are typically classified as Rare or Very Rare. These include potentially fatal Agranulocytosis, a blood disorder associated with Metamizole; Life-Threatening Respiratory Depression and the risk of abuse and dependence due to the opioid (Codeine) and barbiturate (Phenobarbital) components; and serious Gastrointestinal Bleeding and Perforation linked to the Naproxen component.

The regulatory profile also specifies population-specific constraints. Codeine is officially contraindicated in children younger than 12 years of age. The risk of serious or fatal respiratory depression is documented as greatest upon treatment initiation or following a dose increase. Additionally, the risk of serious gastrointestinal reactions is noted to increase with the duration of use.

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Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information

The official regulatory documentation for Пиралгин addresses overdose primarily by detailing the severe risks associated with its central nervous system depressants, Codeine and Phenobarbital. The overdose scenario is classified as potentially severe and life-threatening due to the risk of respiratory and cardiovascular compromise.


Manifestations and Key Risks Regulator-Mandated Action
Documented Presentations: Severe CNS effects, including somnolence, confusion, and progression to coma. Cardiovascular instability presenting as hypotension and cardiac arrhythmias. Specific signs may include miosis (pinpoint pupils), seizures, and acute renal failure. Seek immediate medical attention upon known or suspected overdose. Contact emergency services immediately if symptoms such as loss of consciousness, profound sedation, or difficulty breathing (respiratory depression) are observed.
Antidote and Management: The specific antidote Naloxone is listed for managing respiratory depression caused by the Codeine component. No specific antidote is known for the other components. Management is symptomatic and supportive, requiring continuous cardiac and respiratory monitoring. Supportive measures such as Gastric Lavage or Activated Charcoal and enhanced elimination techniques (e.g., Hemodialysis) are detailed procedures in the official overdose section.
Population Notes: Increased severity and risk of respiratory depression are documented for pediatric patients. Worsened outcomes are noted for individuals with existing renal or hepatic impairment. Hospital monitoring is required for assessment and management of all severe or complex overdose presentations.

Resulting Overdose Structure

The official overdose profile is determined by the combined high risk of Respiratory Arrest and Cardiovascular Collapse from the Phenobarbital and Codeine components. This high-risk classification directly mandates that patients seek immediate medical attention. Management procedures are defined as symptomatic and supportive treatment, requiring strict continuous observation and monitoring of key physiological functions, as explicitly detailed in the official prescribing information.

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Therapeutic Uses of Пиралгин

What Пиралгин treats: Main Uses and Benefits

The primary role of Пиралгин is to provide multi-component symptomatic relief across key therapeutic domains, offering enhanced support during acute episodes marked by heightened discomfort. The primary therapeutic domains align with the established use of its main components for addressing symptoms related to physical discomfort and systemic imbalance. The formulation includes components specifically utilized for the management of moderate to severe pain and fever. The medication is relevant in clinical settings where symptoms are disruptive and temporary assistance in symptom stabilization is appropriate.

The medication is commonly used across conditions characterized by periods of heightened symptoms, including symptoms related to headache, dental pain, neuralgia, myalgia, arthralgia, and algomenorrhea. It helps address symptom clusters that may appear suddenly or intensify over time, generally contributing to improved day-to-day comfort during difficult episodes. This dual action contributes to easing the overall symptom load during phases when symptoms become more noticeable, and may assist with maintaining a sense of stability during such periods.


Quick Fact: Relief for Heightened Symptoms

Symptom Type Example Conditions Patient Benefit
Pain & Fever Acute febrile states, muscle aches Supports general well-being
Episodic Pain Headache, menstrual discomfort Supports general well-being

Regulatory References

  1. review by the European Medicines Agency
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Eligibility and Restrictions for Use

The eligibility for Пиралгин is strictly defined by the regulatory profile of its five active components (Metamizole, Codeine, Naproxen, Phenobarbital, Caffeine), resulting in numerous absolute contraindications and restrictions.

Absolute Contraindications (Must Not Use)

Official labeling prohibits the use of this medicine in several high-risk populations:

  • Pediatric Use: Children younger than 12 years of age. Use is also restricted in adolescents under 18 following tonsillectomy or adenoidectomy.
  • Hypersensitivity: Patients with known allergy to Pyrazolone derivatives (Metamizole) or any other component.
  • Hematological Disorders: Individuals with a history of agranulocytosis, bone marrow depression, or acute porphyria.
  • Organ Function: Patients with severe hepatic impairment (liver failure) or severe renal impairment (kidney failure).
  • Gastrointestinal Conditions: Individuals with active peptic ulcers or gastrointestinal bleeding.
  • Reproductive Status: Women who are pregnant (especially in the third trimester) and women who are breastfeeding.

Restricted and Conditional Use

The medicine is generally allowed for use in non-pregnant, non-lactating adults 18 years of age and older who have none of the absolute contraindications. However, use is restricted and requires caution in specific groups:

  • Older Adults (Geriatric): Use requires caution due to an increased risk of adverse reactions, often necessitating close monitoring.
  • High-Risk Patients: Individuals with pre-existing conditions that affect breathing, or those with mild-to-moderate renal or hepatic disease.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information highlights several clinically significant interactions for products containing Metamizole, the primary active component in Пиралгин.

Pharmacokinetic and Pharmacodynamic Interactions

Metamizole is documented as a moderate to strong inducer of CYP3A4, CYP2B6, and CYP2C19, and a moderate inhibitor of CYP1A2 in the liver. This enzyme activity can significantly lower the plasma concentrations of certain co-administered medicines that are substrates for these enzymes. Practical constraints include the potential for reduced efficacy of the immunosuppressant Ciclosporin, necessitating close monitoring of its serum levels during concurrent use.

Specific Interacting Medicinal Products

Interacting Product Category Practical Regulatory Constraint
Aspirin (Acetylsalicylic Acid) for vascular protection Metamizole inhibits its anti-platelet effect; a timing delay in administration is recommended to avoid this clinically severe interaction.
Chlorpromazine (Phenothiazine) May result in additive hypothermia when co-administered.
Anticoagulants (Oral) & Lithium Use with caution due to the risk of altered blood levels or effects.
Medicines that cause Agranulocytosis Concomitant use requires caution due to the increased risk of blood disorders.

Interaction-Related Restrictions

Official documents advise caution regarding the concomitant use of Metamizole with certain diuretics (e.g., Triamterene) and antihypertensives (e.g., ACE inhibitors like Captopril). The necessity for close monitoring or alternative therapy is based on documented risk of altered drug effects.

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Mechanism of Action

The pharmacodynamic profile of Пиралгин results from a multi-modal modulation of central and peripheral signaling pathways, utilizing five distinct mechanisms.

Dual Mechanism for Central and Peripheral Nociceptive Modulation

The components utilize peripheral and central enzyme inhibition along with opioidergic agonism to modulate nociceptive transmission. mathbfNaproxen and mathbfMetamizole inhibit COX enzymes, thereby suppressing the synthesis of mathbfPGE2 that sensitizes peripheral nociceptors and influences the hypothalamic thermoregulatory set point. This peripheral action is complemented by mathbfCodeine which, via its active metabolite, activates the boldsymbolmu-Opioid Receptors ( MOR) in the spinal cord and brain, inducing neuronal hyperpolarization to dampen the transmission of nociceptive impulses through the CNS.

Mechanistic Modulation of CNS Excitability

mathbfPhenobarbital and mathbfCaffeine engage in a counter-modulatory mechanism to adjust CNS arousal. Phenobarbital acts as a positive allosteric modulator of the inhibitory mathbfGABA-A receptor, prolonging chloride ion flow to enhance inhibitory signaling and decrease neuronal excitability. mathbfCaffeine partially offsets central depression by acting as an antagonist to Adenosine Receptors ( A1/ A2A), thus preventing inhibitory signals that promote central depression.

Mechanism Constraints and Functional Specificity

The central MOR mechanism is subject to constraints, including the CYP2D6 enzyme polymorphism, which can constrain the mathbfCodeine component's central mechanism of action due to variable metabolite formation. Furthermore, mathbfMetamizole provides functional specificity by exerting a direct mathbfCa^2+-dependent spasmolytic action on visceral smooth muscle, which induces localized smooth muscle relaxation.

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Dosage and Administration Information

How to Use the Medicine: Administration Guidelines

This section describes the instructions for using the medicine. It does not cover what the medicine treats or its effects.

Administration Scope Requirement
Route of Administration Oral (Taken by mouth)
Standard Dosing Typically 1 tablet per dose
Frequency 1 to 3 times per day (as needed)
Timing Relative to Meals Usually advised to take after food (postprandially)
Maximum Daily Limit Should not exceed 4 tablets in a 24-hour period

Procedural and Population-Specific Rules

Specific constraints exist regarding the duration of treatment and dose adjustments for certain patient groups. These rules define the usage protocol.

  1. Duration Limit: The medicine is for short-term use. Continuous administration is limited to no more than 3 to 5 days unless the patient is under specific, physician-directed guidance.
  2. Dose Adjustment for Age: A reduced dose (e.g., half the adult dose) is required for children over 7 years of age (or over 12 years of age, depending on the specific label) and for elderly patients.
  3. Special Populations: The standard dose is lowered for patients diagnosed with impaired liver or kidney function to avoid exceeding acceptable body exposure levels.

Connection to the Overall Use Protocol

The administration guidelines establish a clear, structured sequence for taking the medicine, defining the oral route and the required timing after meals. These instructions set the daily maximum dose and limit the continuous duration of use, creating boundaries that govern how the drug may be procedurally administered. This procedural structure includes dose adjustments for defined sub-populations, such as pediatric and organ-impaired patients, to standardize its usage profile.

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Recent Clinical Evidence

Research evidence / Overview of studies for Пиралгин

Evidence for General Symptomatic Relief (Pain and Fever)

The research landscape for this combination medicine consists primarily of Systematic Reviews and Meta-analyses focused on the overall strategy of combining different classes of pain relievers. These studies often examine if the combined approach provides outcomes related to physical discomfort; research has explored how these outcomes differ from using single-ingredient medicines. Observational studies are also used to describe the practical application of key components, such as Metamizole, in conditions like headache, joint pain, and fever. The evidence level for the specific pill is broadly labeled as Moderate.

Evidence in Acute Pain Following Procedures

Research examining temporary physiological imbalance often focuses on standardized pain models, such as pain following surgical procedures, to explore short-term symptom changes. This evidence includes Randomized Controlled Trials (RCTs) which compared combinations of components against placebo. These trials monitored outcomes reflecting daily functioning, such as total perceived discomfort. The certainty for this specific combination is broadly labeled as Moderate.

What is Still Uncertain about the Combination

The existing evidence highlights what is known—and what is still uncertain—about this multi-component drug. The primary limitation is the documented research gap for direct comparison of the exact five-component fixed-dose formulation against simpler analgesic regimens. The evidence base incorporates a large amount of component-specific research, meaning the direct applicability of those findings to the full five-agent fixed-dose formulation is not yet fully clear. Furthermore, follow-up durations were generally limited, meaning long-term effects are not fully established.

Evidence in Special Populations and Subgroups

Studies monitoring physiological strain or stress have focused largely on Adult patients. Data for certain groups, such as children, pregnant individuals, or patients with multiple specific, comorbid conditions, remain insufficient. Subgroup findings are uncertain, meaning findings are primarily relevant to the populations studied.

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Frequently Asked Questions (FAQ)

Common questions about Пиралгин (FAQ)


Q: What is the main difference between Пиралгин and standard painkillers?

A: The main difference, according to official product information, lies in its composition. Пиралгин is a multi-component medicine containing five active ingredients, including the restricted substances Codeine (an opioid analgesic) and Phenobarbital (a barbiturate). This distinguishes it from most standard single-agent painkillers, such as those containing only Ibuprofen or Paracetamol.


Q: Is Пиралгин described as a strong pain reliever?

A: Official regulatory documents classify the medicine as a preparation intended for Potent pain relief and the reduction of fever. This classification is used to describe its intended therapeutic strength.


Q: What are the most commonly reported side effects of Пиралгин?

A: Official safety profiles list drowsiness, nausea, vomiting, and constipation as the most common effects. These side effects are related to the drug's action on the nervous system and the gastrointestinal tract, primarily due to the Codeine and Phenobarbital components.


Q: What food or drinks are described as interacting with Пиралгин?

A: Regulatory documents for medicines containing central nervous system depressants, such as Codeine and Phenobarbital, commonly specify that the concurrent use of alcohol may increase the risk of side effects. This can include increased drowsiness or difficulty breathing.


Q: Are there any common supplements that interact with Пиралгин?

A: Official labels state that caution is warranted when combining this type of medicine with any other supplements or herbal remedies. This warning is based on the general lack of sufficient testing for all possible interactions, as some active ingredients are known to affect how the body processes other substances.


Q: Does Пиралгин interact with blood thinners like Warfarin?

A: Regulatory documents advise that caution should be exercised when this medicine is used alongside oral anticoagulants, which include drugs like Warfarin. This is due to a documented risk of altered blood levels or changes in the effect of the anticoagulant.


Q: Can a person with known liver problems use Пиралгин?

A: Official regulatory guidance states that severe liver impairment is an absolute contraindication for use. For individuals with mild-to-moderate liver impairment, official documents indicate that a reduced dose is necessary, and use typically involves caution and close monitoring.


Q: Is Пиралгин safe to use if a person has kidney issues?

A: Severe kidney impairment is listed as an absolute contraindication in official documents. For individuals with mild-to-moderate kidney impairment, regulatory requirements describe that a reduced dose is required, and use typically involves caution and close monitoring.


Q: Is long-term use of Пиралгин known to cause any specific health issues?

A: Regulatory documents define a short period for continuous administration of the medicine, typically no more than a few days. The risk of serious side effects, including dependence and severe gastrointestinal reactions, is noted to increase with the duration of use.


Q: What official warning labels are attached to Пиралгин?

A: Official warnings attached to this medicine highlight the risks of several severe adverse reactions. These include potentially fatal Agranulocytosis (a severe blood disorder), Life-Threatening Respiratory Depression (breathing difficulty), and the potential for abuse and dependence associated with its controlled components.


Q: Why is consultation with a healthcare professional mentioned in relation to Пиралгин?

A: The requirement for professional consultation is based on the drug’s complex composition, which includes controlled substances. Official documents stipulate that a healthcare provider should evaluate the risk of severe, documented side effects and potential interactions before the medicine is used.


Q: What is the recommended period of time for using Пиралгин?

A: Official documents define a duration limit for continuous administration of no more than 3 to 5 days. This strict limitation is in place to mitigate the increased risk of severe adverse reactions, such as dependence and serious gastrointestinal issues, associated with extended use.


Q: What happens if someone accidentally takes too much Пиралгин?

A: Overdosing may lead to symptoms associated with the Codeine and Phenobarbital components, including severe drowsiness, slowed or shallow breathing, and low blood pressure. Regulatory documents state that immediate professional assistance is necessary if the maximum daily limit is exceeded.


Q: How should Пиралгин be stored according to official recommendations?

A: Official instructions describe that the medicine should be stored in its original packaging, away from light and moisture, at a temperature not exceeding 25 °C, and kept out of the reach and sight of children.


Q: Does Пиралгин show up on standard drug screening tests?

A: Because this medicine contains the active ingredients Codeine (an opioid) and Phenobarbital (a barbiturate), these components and their metabolites may be detectable in standard drug screening panels. This is consistent with regulatory guidelines for the testing of these controlled substances.


Q: Is it necessary to take Пиралгин with food?

A: Official administration guidelines advise taking the medicine after food. This procedural constraint is in place to help minimize the risk of gastrointestinal discomfort associated with certain ingredients, such as Naproxen, and to support the intended usage protocol.


Q: What is the difference between the active ingredients in Пиралгин and common over-the-counter drugs?

A: The key difference is the inclusion of the restricted ingredients Codeine (an opioid) and Phenobarbital (a barbiturate). These substances require a prescription and are not typically found in common over-the-counter pain relievers.


Q: Are there any documented cases of interactions between Пиралгин and herbal remedies?

A: Official regulatory information focuses on documented interactions with other medicines. Documents commonly advise caution when combining this type of medicine with any herbal remedies due to the lack of sufficient testing for all possible interactions with the five components.


Q: What does the patient information leaflet say about stopping Пиралгин?

A: Official patient information notes that abrupt discontinuation of the medicine, especially after prolonged use, is generally not recommended because withdrawal symptoms may occur due to the Codeine and Phenobarbital components. Official guidelines describe that a gradual dose reduction is often utilized to manage the discontinuation process.


Q: What research evidence exists comparing Пиралгин to placebo?

A: The evidence base includes Randomized Controlled Trials (RCTs) which have examined combinations of the drug’s components. These studies compared the component combinations against placebo, primarily focusing on outcomes for short-term symptom changes in standardized acute pain models.


Q: Why is Пиралгин restricted or unavailable in some countries?

A: The high level of regulatory restriction and regional unavailability is due to the medicine's complex composition. This includes the presence of the controlled substances Codeine (an opioid) and Phenobarbital (a barbiturate), which are subject to strict international controls.

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How should Пиралгин be stored and disposed of?

How to Store and Dispose of Piralgin

The storage and disposal of Piralgin must strictly follow the official regulatory requirements to ensure product stability and safety.

Storage Conditions

Requirement Official Instruction
Temperature Not exceeding 25 °C.
Protection Protect from light; store in a dry place.
Packaging Must be stored in the original packaging.
Child Safety Keep out of the reach and sight of children.

Disposal

Disposal of any unused or expired Piralgin tablets must be carried out in accordance with local requirements for pharmaceutical waste handling. This is a mandatory instruction to prevent environmental contamination and misuse, particularly given the product’s composition.

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

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