Пирабене

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Пирабене

Treatment option: Myoclonus

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.

Overview of Пирабене

What is Пирабене? An Overview

Property Description
Active ingredient Piracetam
Form Tablets, Capsules, Oral solution, Solution for injection
Pharmacological class Nootropic Agent / Psychoanaleptic
Common use Cognitive enhancement and neuroprotection
Origin Synthetic compound (GABA derivative)

What Type of Medicine is Пирабене, and What is its Classification?

Пирабене is the trade name for the active substance Piracetam, which is classified as a foundational nootropic agent and a member of the psychoanaleptic group of psychotropic drugs. This medication is classified within the Anatomical Therapeutic Chemical (ATC) index. Chemically, Piracetam is a synthetic compound, specifically identified as 2-oxo-1-pyrrolidine acetamide, being a cyclic derivative of gamma-aminobutyric acid (GABA). This substance is considered the progenitor of the racetam family of compounds. Пирабене is provided as a single-ingredient product, focusing the entire pharmacological effect on the actions of Piracetam.

What is the Composition and General Purpose of Пирабене?

The composition of Пирабене contains the active ingredient Piracetam, formulated with suitable excipients to ensure bioavailability. Its general purpose is recognized as that of a cognitive enhancer and neuroprotector. The action supports brain function by stabilizing neuronal membranes and enhancing the efficiency of cerebral metabolic activity, particularly the utilization of glucose and oxygen. Piracetam's role includes improving brain cell communication. This indicates the medicine is typically used in contexts requiring the support of mental performance, attention span, and memory function. Furthermore, the substance is associated with rheological properties that may help optimize microcirculation in brain tissue.

In What Forms is Пирабене Available for Administration?

Пирабене is supplied in multiple pharmaceutical forms to accommodate varying therapeutic requirements. The medication is available as conventional film-coated tablets, capsules, and an oral solution for standard administration via the oral route. For clinical scenarios demanding rapid and direct systemic availability, the drug is also produced as a sterile solution for injection, administered parenterally.

Regulatory References

  1. EMA Public Assessment Report

What side effects are possible with Пирабене?

Possible Side Effects and Safety Information

Official regulatory documents classify the safety profile of Пирабене (Pirfenidone) using the ICH frequency convention, organizing known effects by System Organ Class (SOC). The most frequently reported adverse reactions generally involve the gastrointestinal and skin systems.

Adverse Reactions by Frequency

Frequency Category Common SOC Examples (Reported in ge 1/100 to < 1/10 patients)
Very Common (ge 1/10) Nausea, Rash, Fatigue, Diarrhea, Dyspepsia, Arthralgia
Common Vomiting, ALT/AST enzyme increases (Liver function), Headache, Dizziness, Weight loss, Insomnia

Serious Safety Information and Restrictions

Serious Adverse Reactions reported include cases of severe drug-induced liver injury, which in rare instances have been fatal. Cases of severe allergic reactions, such as angioedema (swelling of the face/throat) and severe cutaneous reactions like Stevens-Johnson syndrome (SJS), have also been reported post-marketing, necessitating immediate treatment discontinuation if suspected. Photosensitivity reactions and rashes are a common concern, requiring patients to rigorously avoid sun exposure and use protective measures.

Safety Restrictions: Пирабене is generally contraindicated in patients with known hypersensitivity to the drug. Specific caution and monitoring are required for patients with pre-existing or developing hepatic impairment. Regular blood tests to monitor liver enzyme levels (ALT/AST) are mandated before and periodically during treatment. Smoking should be avoided as it may reduce the effectiveness of the drug.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below summarizes the official descriptions of Пирабене (Piracetam) overdose as documented in government regulatory sources, focusing on manifestations and required emergency actions.

Domain Official Regulatory Statement
Documented Overdose Manifestations Symptoms following massive acute overexposure (e.g., 75 grams oral dose) include gastrointestinal disturbances (abdominal pain, diarrhea, and in severe cases, bloody diarrhea). CNS effects like insomnia, tremor, agitation, nervousness, and headache are also documented.
Severity and Risk Regulatory reviews indicate a high safety margin, with no serious adverse events or significant toxicity consistently reported even at extremely high acute doses.
Antidote and Management No specific antidote is known for Piracetam overdose. Management is officially defined as symptomatic and supportive treatment. Procedures like gastric lavage or induced emesis may be considered shortly after acute ingestion to limit absorption.
Removal from System Regulatory data confirms the compound is readily removed by hemodialysis, achieving an extraction efficiency of 50% to 60%.

When to Seek Urgent Help

It is officially mandated to seek immediate medical attention and contact emergency services for any suspected overdose or ingestion of an amount significantly above the prescribed dose. This action is required to initiate clinical observation and apply necessary supportive care.

Therapeutic Uses of Пирабене

What Пирабене Treats: Main Uses and Benefits

The therapeutic application of Пирабене (Piracetam) involves several domains of neurological and cognitive support, encompassing its role in various functional domains. The medication is commonly used to help with symptomatic management in conditions where symptoms that interfere with daily functioning are present due to central nervous system impairment.

Supporting Memory, Attention, and Mental Acuity

This domain addresses symptom clusters that may become intense or disruptive related to thought processes, including difficulty with attention, reduced concentration, and issues with memory and information recall. The therapy is commonly applied in the context of mild age-related cognitive impairment or during recovery from a cerebral incident. It is considered relevant to support mental performance, providing supportive relief that assists with maintaining functional stability and helping patients cope more steadily with challenges to daily mental tasks.

Managing Neurological Movement and Balance Disturbances

This medication is relevant for easing symptoms of increased neurological or muscular activity, primarily addressing involuntary, uncontrolled muscular contractions (myoclonus), and chronic disturbances of equilibrium or persistent dizziness (vertigo). Used as an adjunct, the therapy contributes to easing these distressing neurological manifestations, and may help patients cope more steadily with movement fluctuations.

Quick Fact: Supportive Role in Neurological Symptoms

Quick Fact: Management of Involuntary Movements

Used as an adjunct, the therapy may help patients cope more steadily with neurological movement fluctuations and supports patients during episodes of heightened discomfort related to cognitive strain.

Eligibility and Restrictions for Use

The drug is officially designated for use only in adults. Eligibility for the medicine is strictly defined by regulatory documents, focusing on existing medical conditions and specific drug use restrictions.

Contraindicated Populations

Official labeling strictly prohibits use in the following populations:

  • Patients with known hypersensitivity to the medicine or its ingredients, including a history of angioedema with the drug.
  • Patients with severe hepatic impairment or end-stage liver disease.
  • Patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease requiring dialysis.
  • Patients concurrently taking the strong CYP1A2 inhibitor fluvoxamine.

Restricted and Non-Recommended Use

  • Pregnancy and Breastfeeding: Use is not recommended during pregnancy. For breastfeeding women, the risk to the infant is unknown, necessitating a decision to discontinue the drug or breastfeeding.
  • Pediatric Population: Use is not established and therefore not indicated for individuals under 18 years of age.
  • Organ Impairment: Patients with mild to moderate hepatic impairment or moderate renal impairment must use the drug with caution and require close monitoring.

What should I know about interactions with other medicines?

The official interaction profile for Пирабене (Piracetam) is defined by a low potential for metabolic disruption and specific pharmacodynamic effects, as documented in regulatory prescribing information.

Documented Interactions Requiring Monitoring

Oral Anticoagulants Co-administration of Пирабене with oral anticoagulants, such as Acenocoumarol, has been officially documented to potentiate the anticoagulant effect. This interaction requires medical monitoring of coagulation parameters, specifically the prothrombin time, to manage this documented effect.

Thyroid Hormones The concomitant use of Пирабене with Thyroid Hormones (e.g., T3 and T4 extracts) is associated with a risk of significant adverse pharmacodynamic effects. These documented effects include confusion, irritability, and sleep disturbances, necessitating caution as stated in official regulatory information.

Low Risk of Metabolic Interaction

Official data confirms a low potential for pharmacokinetic drug interactions. Piracetam is largely excreted unchanged and is not expected to inhibit or induce major human liver cytochrome P450 enzymes, meaning the exposure of many co-administered medicines is unlikely to be affected.

Absence of Interaction

Official studies have confirmed that Piracetam does not significantly modify the serum levels of co-administered anti-epileptic drugs, such as Carbamazepine and Phenytoin. Furthermore, regulatory sources confirm there is no clinically significant interaction with alcohol (ethanol) or food. The official labeling does not mandate specific time separation between doses of Пирабене and other medications.

Mechanism of Action

How Пирабене works — Mechanism of Action

Core Biological Targets and Mechanism

Пирабене acts as a modulator and suppressor of cellular processes driven by Transforming Growth Factor-beta 1 (TGF-beta 1) and Platelet-Derived Growth Factor (PDGF). The drug primarily targets cells—specifically fibroblasts—to inhibit their proliferation and suppresses their differentiation into myofibroblasts, which are the primary cells responsible for depositing excessive collagen and extracellular matrix (ECM). This interaction dampens the core profibrotic signaling cascade. This process limits the progression of pathological structural remodeling, shaping the drug's overall profile of modulating fibrogenic responses.

Multi-Target Modulation of Tissue Processes

The drug also exerts an anti-inflammatory action by suppressing the synthesis and release of various pro-inflammatory cytokines, including Tumor Necrosis Factor-alpha (TNF- alpha) and Interleukin-6 (IL-6). This suppression affects several inflammatory signaling pathways, contributing to the modulation of localized tissue inflammation. Additionally, Пирабене functions as an antioxidant by directly scavenging Reactive Oxygen Species (ROS) and free radicals within the cellular environment. This action modulates subsequent cellular responses that perpetuate inflammatory and profibrotic signaling.

Dosage and Administration Information

How to Use Пирабене

The administration of Пирабене (Piracetam) follows established parameters governing both the route and the dosing regimen. The medicine is primarily taken via the oral route as tablets, capsules, or oral solution, and can be administered via intravenous infusion when acute use is required. Oral forms may be taken with or without food, and should be swallowed with a glass of liquid.

The total daily dose is typically divided into two or three sub-doses to maintain a consistent administration schedule. Standard maintenance dosing generally ranges from 1.2 g to 2.4 g per day. For the specific use in cortical myoclonus, the dose begins at 7.2 g daily and is gradually titrated upward by 4.8 g every three to four days, up to a maximum daily dose of 24 g.

Dosing is individualized for patients with compromised renal function, as the drug is primarily eliminated by the kidneys. The adjustment depends on the calculated creatinine clearance (CCr). For instance, those with mild impairment (CCr 50-79 mL/min) receive 2/3 of the usual dose, while severe impairment (CCr less than 30 mL/min) involves a reduction to 1/6 of the usual dose (see table).

Renal Function CCr Range (mL/min) Recommended Posology
Normal > 80 Usual daily dose, divided 2-3 times
Mild Impairment 50-79 2/3 usual daily dose, divided 2-3 times
Severe Impairment < 30 1/6 usual daily dose, single intake

The procedure includes the gradual reduction (tapering) of the dose by 1.2 g every two to four days if treatment is to be discontinued. Standard practice involves avoiding abrupt cessation to maintain the procedural stability of the treatment course.

Recent Clinical Evidence

Пирабене: Recent Clinical Evidence

Evidence for use in Supporting Memory, Attention, and Mental Acuity

Research has primarily involved short- to medium-term Randomized Controlled Trials (RCTs) and systematic reviews, which were used in research exploring how symptoms change over time. These trials focused on populations such as older adults with mild cognitive impairment and individuals recovering from stroke where communication difficulties (aphasia) were present. Studies monitored a variety of functional outcomes, including patient-reported outcomes describing perceived discomfort related to focus, and scores on specific cognitive function tests. Some trials described specific patterns observed on overall global clinical assessments completed by investigators. However, the outcomes on specific, objective cognitive test scores were often inconsistent across the body of evidence. Long-term effects are not fully established for this indication, as follow-up durations were limited.

Evidence for use in Managing Involuntary Muscle Contractions (Myoclonus)

The evidence base for Пирабене was evaluated in trials including Randomized Controlled Studies (RCTs), such as double-blind, placebo-controlled crossover trials. This research was applied in studies examining patient-reported experiences in individuals with myoclonus of cortical origin, a condition characterized by fluctuating or episodic manifestations. Research describes patterns where the observed patient groups reported changes in severity scores for their involuntary movements compared to placebo. A pattern of changes in functional disability related to the involuntary movements was described in long-term observational cohorts. This evidence was assigned an Evidence Level of High. Limited comparative evidence is available for using Пирабене as a single, primary treatment, as research primarily examined its role as an add-on therapy alongside existing medications.

Evidence for use in Chronic Dizziness and Balance Disturbances (Vertigo)

Research has been studied for patients with chronic dizziness and balance disturbances (vertigo), which are conditions where symptoms may vary in intensity. Trials report how symptoms evolved in the observed populations, noting changes in the pattern of self-reported symptoms (severity, frequency) compared to those on placebo. Observations from objective measurements, such as measured changes in positional nystagmus, were described in some trial reports. However, some objective measures of inner ear function were reported as not showing significant change. The follow-up durations were limited in this research, meaning there is limited information for long-term outcomes beyond the cessation of treatment.

Frequently Asked Questions (FAQ)

Common questions about Пирабене (FAQ)


Q: What is the main reason doctors prescribe Пирабене?

According to official documentation, therapeutic indications for Пирабене include treating involuntary muscle contractions known as cortical myoclonus. In some regions, the drug is also indicated for use in managing symptoms related to dizziness (vertigo) and certain age-related cognitive symptoms.


Q: Are there any widely reported interactions between Пирабене and common vitamins or supplements?

Regulatory documents indicate that the medicine has a generally low potential for metabolic interactions with other drugs because it is excreted largely unchanged. However, official information does not specifically list or report on interactions with common vitamins or non-herbal supplements.


Q: What should be known about using Пирабене with over-the-counter pain relievers?

Official documents do not generally list common over-the-counter pain relievers, such as acetaminophen or ibuprofen, as having a clinically significant interaction. However, official documentation notes that caution is warranted regarding any co-administered medicine that affects blood clotting, due to the drug’s known effect on platelet aggregation.


Q: Can older adults use Пирабене, or are there special cautions for them?

Older adults are among the populations addressed by regulatory documents. For those receiving long-term treatment, official regulatory documents require regular assessment of kidney function (creatinine clearance) to ensure the dose is correctly maintained, as the kidneys primarily eliminate the medicine.


Q: Is Пирабене considered a long-term treatment or is it usually short-term?

The required duration of treatment depends on the specific condition being addressed. Official guidelines for certain conditions suggest continuing treatment as long as the disease persists. Attempts to decrease or discontinue the treatment are typically evaluated at regular intervals, such as six months, if deemed appropriate by a prescriber.


Q: What are some of the less common side effects mentioned in studies of Пирабене?

The most frequent side effects are listed separately in the safety section. Less common reactions, sometimes reported in fewer than 1 out of 100 patients, include depression. Effects reported with a frequency classified as 'Not Known' (based on post-marketing experience) include agitation, anxiety, confusion, hallucinations, and headache.


Q: What happens if a person forgets to take a dose of Пирабене?

Official documents advise that the total daily dose should be divided into multiple sub-doses to ensure consistent levels of the medicine in the body. While specific instructions for a 'missed dose' are not provided, official documents emphasize that adherence to the regular administration schedule is required to maintain consistent therapeutic levels.


Q: Is it okay to drink coffee or caffeine while taking Пирабене?

Official drug labels do not list a direct interaction with caffeine. However, Piracetam has been associated with stimulating adverse effects such as nervousness or anxiety in some patients. This is a potential consideration when consuming other stimulating substances like coffee or caffeine.


Q: Can using Пирабене affect laboratory blood test results?

Yes, official documentation indicates that Piracetam can influence the results of certain laboratory tests. Specifically, it can influence coagulation parameters (factors that regulate blood clotting) and possible changes in ALT/AST enzyme levels, which are markers used to monitor liver function.


Q: Is there any evidence about the long-term safety of Пирабене?

Studies, including those using high doses (up to 24 g daily) for conditions like cortical myoclonus, have examined the long-term safety profile. The evidence generally confirms a benign safety profile and a lack of significant organ toxicity in the populations studied.


Q: Does the time of day a person takes Пирабене affect its function?

Official prescribing information states that the total daily dose of the medicine should be divided into multiple sub-doses (typically two to four). This procedure is required to maintain a consistent concentration of the active ingredient in the body throughout the day.


Q: Is it necessary to adjust activities, like driving, when starting Пирабене?

Official regulatory documents advise that caution is warranted. Because adverse reactions like dizziness, nervousness, and somnolence have been reported, the potential for influence on the ability to drive and operate machinery should be acknowledged as part of the safety profile.


Q: Is it normal to feel anxious or irritable in the first week of taking Пирабене?

Anxiety and agitation are listed among the adverse reactions reported through post-marketing experience. These are documented reactions that have been reported from post-marketing experience, although the exact frequency is classified as not known.


Q: Does Пирабене interact with herbal remedies like St. John's Wort?

Official labels confirm a low risk of metabolic interaction, meaning the medicine is unlikely to affect how the body processes most other drugs. However, because Piracetam affects platelet aggregation (a type of blood clotting), patients should exercise caution regarding any herbal product that may also affect blood clotting.


Q: What is the typical timeframe for a doctor to review treatment with Пирабене?

For certain conditions, especially acute episodes where a spontaneous improvement is possible, official guidelines suggest a formal attempt should be made to decrease or discontinue treatment at regular intervals. This review process is generally evaluated every six months.


Q: What does the drug's safety classification (e.g., FDA pregnancy category) mean?

The drug's official risk assessment for pregnancy indicates that it is generally not recommended for use by pregnant individuals. Use is only advised if the potential benefit is clearly judged to outweigh the potential risks to the fetus by a healthcare professional.


Q: What should a patient do if they develop a rash while taking Пирабене?

A rash is a reported adverse reaction, and severe cutaneous reactions, including swelling, have been noted. Regulatory guidance states that if a severe reaction or anaphylactoid reaction is suspected, patients are typically advised to seek immediate medical attention.


Q: Are there special considerations for people with high blood pressure who take Пирабене?

High blood pressure itself is not specifically listed as a contraindication in official warnings. However, regulatory documents advise caution for any patient who has underlying disorders of haemostasis (blood clotting) or conditions that may increase the risk of bleeding.


Q: What does the term 'contraindication' mean in the context of Пирабене?

A contraindication is a specific condition or circumstance that makes the use of a drug explicitly forbidden by the manufacturer. For Пирабене, this includes conditions like severe renal impairment and cerebral hemorrhage, because these increase the risk associated with taking the medicine.


Q: Does Пирабене interfere with birth control pills?

Official regulatory sources, including those that detail the drug's interaction profile, do not report a direct drug-drug interaction between Piracetam and hormonal oral contraceptives (birth control pills).

How should Пирабене be stored and disposed of?

Official Storage and Disposal Instructions

Regulatory documents define specific requirements for storing and disposing of Пирабене (Pirabene) to maintain quality and protect the environment.

Storage Category Official Requirement
Temperature No special temperature conditions are typically required.
Protection Keep in the original package to protect from light and moisture.
Security Store the medicine out of the sight and reach of children.

Stability and Handling: Do not use the medicinal product after the official expiry date stated on the carton and blister.

Disposal Requirements: To protect the environment, do not dispose of Пирабене via household waste or by flushing down wastewater. Unused or expired medicine must be returned to a pharmacy or a designated collection point for proper pharmaceutical waste disposal, according to local government guidelines.

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

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