Piracetam Sintofarm

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Piracetam Sintofarm

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Overview of Piracetam Sintofarm

Property Description
Active ingredient Piracetam (INN)
Form Tablet, Capsule, Solution for injection/infusion
Pharmacological class Nootropic agent; Cerebroactive drug
Common use Cognitive enhancer; Neuroprotective agent
Origin Synthetic compound

What is Piracetam Sintofarm and What Type of Drug is It?

Piracetam Sintofarm is a pharmaceutical preparation containing the active substance Piracetam, the International Non-proprietary Name (INN) for 2-oxo-1-pyrrolidineacetamide. Piracetam is officially classified within the ATC code N06BX03, placing it among the other psychostimulants and nootropics. Pharmacological studies and decades of clinical use have established Piracetam’s role as the prototypical agent of the entire Racetams class.

This medicine is a synthetic compound chemically derived as a cyclic derivative of the neurotransmitter gamma-aminobutyric acid (GABA analog). The designation as a cerebroactive drug highlights its specific functional targeting of higher brain centers. It is widely recognized in the medical community as a foundational compound for supporting neurocognitive capacity, distinguishing it from traditional psychoactive agents.

Composition and Available Preparations

The product is defined as a single-ingredient product, containing only the active pharmaceutical ingredient, Piracetam. The key differentiation of the preparation lies in the comprehensive availability of multiple dosage form(s). These include convenient solid preparations, namely tablets and capsules for oral use, alongside sterile liquid solution for injection or infusion for rapid parenteral delivery. This variety ensures the substance can be administered when immediate systemic delivery is required.

The General Purpose of Nootropic Agents

Piracetam's primary purpose is rooted in its unique bio-physical mode of action, positioning it as a fundamental neuroprotective agent. Its proposed mechanism centers on neuronal membrane fluidity modulation, a unique property thought to restore and optimize the structural integrity of nerve cell membranes. By facilitating this membrane function and improved cerebral microcirculation, the drug is clinically recognized for supporting neural signaling efficiency and boosting the brain's overall resilience. This action establishes its role as a cognitive enhancer, serving to support the functional capacity of the brain in general supportive care scenarios.

Regulatory References

  1. KEGG DRUG: Piracetam (ATC Classification)
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What side effects are possible with Piracetam Sintofarm?

Possible Side Effects and Safety Information

Piracetam's safety profile is documented based on post-marketing surveillance and clinical trials, with adverse reactions categorized by their frequency and the system-organ class affected. These classifications follow established governmental regulatory standards.

Officially documented adverse reactions are categorized as follows:

  • Common (may affect up to 1 in 10 people): Nervousness, Hyperkinesia (involuntary movement), and Weight increased.
  • Uncommon (may affect up to 1 in 100 people): Depression, Somnolence (drowsiness), and Asthenia (weakness).

Additionally, several effects are documented as Frequency Not Known (cannot be estimated from available data), including Agitation, Anxiety, Headache, Insomnia, Vertigo, Diarrhoea, Nausea, Vomiting, and severe hypersensitivity reactions such as Angioneurotic oedema.


Regulatory Safety Constraints

Official regulatory documentation defines specific conditions under which Piracetam must not be used (Contraindications) due to severe safety risks. These include known Cerebral hemorrhage, established Severe renal impairment (creatinine clearance < 20 ml/min), and a diagnosis of Huntington's Chorea.

Specific caution is required when prescribing for the Elderly, as the label mandates regular monitoring of creatinine clearance for patients on long-term treatment. Furthermore, abrupt discontinuation of the medicine must be avoided, particularly in patients being treated for myoclonus, as this is associated with the potential risk of inducing seizures.

Safety notes also advise caution when the medicine is used alongside Anticoagulant or antiplatelet agents due to effects on platelet function.

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Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The official overdose profile for Piracetam Sintofarm is based on documented cases and regulator-mandated emergency procedures. Immediate medical advice must be sought following any suspected overdosage.

Category Documented Official Statement
Documented Overdose Manifestations The only specific clinical manifestations reported in regulatory sources, linked to a single massive oral intake of 75 grams, were bloody diarrhoea and abdominal pain [Source 1.1, 1.5].
Overdose-Related Constraints Regulatory documentation indicates these symptoms were most probably related to the extreme high dose of sorbitol excipient in the formulation, not additional adverse events from piracetam itself [Source 1.1, 1.5].
Serious Outcomes The official prescribing information states that no additional adverse events specifically related to overdose have been reported with piracetam [Source 1.2, 1.5].
Antidote Availability No specific antidote is known for overdose with piracetam [Source 1.1, 1.5].

Mandated Emergency Management

Treatment for an overdose will be symptomatic and supportive treatment [Source 1.1, 1.5]. In cases of acute, significant overdosage, the stomach may be emptied by regulatory-described procedures such as gastric lavage or induction of emesis (induced vomiting) [Source 1.2, 1.5]. Supportive management may include hemodialysis, as the extraction efficiency of the dialyser for piracetam is documented to be between 50% and 60% [Source 1.1, 1.5]. The absence of an antidote requires immediate clinical management to mitigate exposure and address symptoms.

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Therapeutic Uses of Piracetam Sintofarm

What Piracetam Sintofarm Treats: Main Uses and Benefits

Piracetam Sintofarm is applied across domains where additional symptomatic support is needed for conditions involving systemic functional stress or compromised neurological performance. It is relevant for easing symptoms that cluster into patterns requiring supportive management, such as those related to cognitive impairment, vertigo, and cortical myoclonus.

It is used in situations involving certain distressing symptoms associated with age-associated memory decline and reduced concentration, and may be applied as a supportive measure for dyslexia in children. The medication is also applied when appropriate for chronic conditions involving symptomatic discomfort, such as those presenting with involuntary movements (e.g., myoclonus), and those associated with systemic or localized discomfort (e.g., sickle cell disease). Furthermore, it is applied in supportive clinical settings following neurological events like post-stroke aphasia to assist with managing language difficulties.

“This medicine is relevant for easing symptoms that are linked to organ-specific functional stress, contributing to supportive relief when symptoms interfere with routine activities.”

Quick Fact: Therapeutic Support

Symptom Category Benefit Focus
Involuntary Motor Manifestations Helps manage intensity of uncontrollable muscle jerks.
Cognitive and Attention Deficits Supports focus and learning ability in age-related decline.
Disturbances of Equilibrium Assists with managing the distressing sensation of spinning (vertigo).
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Eligibility and Restrictions for Use

Eligibility and Contraindications for Piracetam Sintofarm

Official regulatory guidelines strictly define the populations permitted or prohibited from using this medicine. Eligibility is determined primarily by specific medical conditions, organ function, and physiological status.

Populations Who Must NOT Use Piracetam

Contraindication Condition
Severe Renal Impairment Patients with creatinine clearance below 20 mL/min or end-stage renal disease.
Cerebral Haemorrhage Patients who have experienced this condition.
Huntington's Chorea Patients diagnosed with this specific neurological disorder.
Hypersensitivity Known allergy to piracetam, other pyrrolidone derivatives, or any excipients.

Age and Conditional Eligibility

Use is established for adults. For older adults (geriatric), eligibility remains conditional on renal function, often requiring a formal adjustment. Pediatric use is limited to specific, labeled indications in certain jurisdictions (e.g., dyslexia with speech therapy).

Pregnancy and Lactation: The medicine is not recommended during pregnancy unless the benefit is judged to be clearly necessary. Use is generally prohibited during breastfeeding, and discontinuation of lactation is mandated if treatment proceeds, as the substance is excreted in human breast milk.

Caution is required in patients at risk of bleeding (e.g., history of haemorrhagic CVA or prior to major surgery) due to the drug’s documented effects on platelet aggregation.

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What should I know about interactions with other medicines?

The official regulatory profile for Piracetam Sintofarm is primarily defined by its specific pharmacodynamic interactions and an expected low potential for pharmacokinetic interference with other medicines.

Documented Pharmacodynamic Interactions

  • Oral Anticoagulants and Antiplatelet Agents: Co-administration with these agents, such as Acenocoumarol, results in an additive pharmacodynamic effect. This is due to the medicine’s intrinsic property of decreasing platelet aggregation and increasing bleeding time, a constraint requiring formal caution for patients with underlying hemostasis disorders or a history of severe hemorrhage.
  • Thyroid Hormones: Concomitant treatment with thyroid extract (T3 + T4) has been formally reported in regulatory documents to be associated with specific clinical outcomes, including confusion, irritability, and sleep disorder.

Pharmacokinetic and Exposure Profile

  • The drug interaction potential resulting in changes to the pharmacokinetics of co-administered medicines is expected to be low. This is because approximately 90% of the Piracetam dose is excreted in the urine unchanged. Metabolic interaction is considered unlikely as the drug does not inhibit the major cytochrome P450 isoforms.
  • Official studies have established that Piracetam does not modify the serum levels of several co-administered antiepileptic drugs, including Valproate, Phenytoin, Phenobarbitone, and Carbamazepine.
  • Co-administration of alcohol has no effect on Piracetam serum levels, and Piracetam does not alter alcohol concentrations. No mandatory dose separation requirements are listed in the regulatory labeling, and no specific drug-drug combinations are formally classified as strictly contraindicated.
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Mechanism of Action

How Piracetam Sintofarm Works

Modulating Neuronal Membrane Fluidity

Piracetam's core action is a physico-chemical interaction with the phospholipid head groups of nerve cell membranes. By restoring optimal membrane fluidity, the drug supports the optimal function of membrane-embedded proteins, such as ion channels and receptors. This structural optimization is associated with enhanced synaptic transmission and increased cellular resistance to stressors like metabolic impairment.

Enhancing Neurochemical Signaling

The improved membrane environment translates into a functional enhancement of key neurochemical pathways, notably the glutamatergic system (acting as a weak positive modulator of AMPA receptors) and the cholinergic system. This mechanism facilitates the efficiency of signal transfer across synapses, which provides the physiological foundation for facilitating neural communication and plasticity.

Improving Cerebral Hemorheology

Beyond its central action, Piracetam affects the rheological properties of blood. It increases the deformability of red blood cells and reduces platelet aggregation, which decreases blood viscosity. This physiological change leads to facilitated microcirculation in the cerebral vasculature, which supports the delivery of oxygen and metabolic substrates to brain tissue.

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Dosage and Administration Information

How to Use Piracetam Sintofarm

Piracetam is a medication that has been prescribed in certain countries for conditions such as cortical myoclonus, a disorder characterized by sudden, involuntary muscle jerks. It is essential to use this product strictly according to the specific guidance of a qualified healthcare professional. The dosage and duration of therapy are individualized based on the medical condition being treated, the patient's age, and their kidney function.

General Dosage Guidelines

Condition Initial Adult Daily Dose Maximum Adult Daily Dose
Cortical Myoclonus 7.2 grams (g) Up to 24 g
  • Administration: The total daily dose is typically divided into two or three separate intakes. Oral forms of piracetam may be taken with or without food. To mask the product's bitter taste, it can be taken with a glass of water or a soft drink.
  • Dose Adjustment: For conditions like cortical myoclonus, the starting daily dose of 7.2 g may be gradually increased by 4.8 g increments every three to four days, based on clinical response and tolerability, up to the maximum dose of 24 g per day.

Special Considerations

  • Renal Impairment: Because piracetam is primarily excreted by the kidneys, dose adjustments are mandatory for patients with impaired kidney function (renal impairment). The product is generally contraindicated in cases of severe renal impairment (creatinine clearance less than 20 mL/min), and a doctor must adjust the regimen for all other levels of reduced function.
  • Discontinuation: The treatment should not be stopped suddenly. Abrupt withdrawal, especially in patients treated for myoclonus, may lead to withdrawal symptoms such as headaches, anxiety, or seizures. Discontinuation must be done gradually under medical supervision.
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Recent Clinical Evidence

Research evidence / Overview of studies for Piracetam Sintofarm

Evidence for Studies on Cognitive Decline and Memory

The compound was studied in research contexts involving conditions linked to age-related memory decline, mild cerebral impairment, and cognitive changes that can occur following complex heart surgery. Research examined these areas through systematic reviews, meta-analyses that combined data from many studies, and randomized controlled trials (RCTs). Researchers monitored outcomes related to physical discomfort and daily functioning by measuring scores on standardized psychometric tests and by using global clinical impression scales to track overall changes in status.

Findings describe patterns observed in these studies, particularly related to measurements on overall clinical global impression scales. Research indicates that measurements varied across studies regarding specific memory assessments. The evidence base includes a significant number of older trials, which may have used less sophisticated assessment tools than are available today. The evidence contributes to understanding symptom patterns, and some inconsistency is noted in the results related to specific cognitive endpoints.

Evidence for Studies on Involuntary Muscle Jerks (Myoclonus)

Research explored the compound's use in conditions involving involuntary muscle jerks, specifically myoclonus of cortical origin. Studies monitored outcomes related to the intensity and variability of symptoms by using specialized rating scales and by tracking changes in functional disability scores. This research included double-blind crossover trials for short-term evaluation and observational settings for longer follow-up. Research often examined the compound as an adjunct, meaning it was used alongside existing medications.

Findings describe patterns related to measurements on the severity of muscle jerks during the study period and related motor function scores. Because this condition is marked by functional limitations and is relatively rare, sample sizes were modest in some of the individual trials. Information on long-term functional outcomes is limited.

What Research Still Indicates as Uncertain

Overall, the research evidence for the compound contributes to the broader evidence landscape but has several limitations that are described in scientific literature. Evidence quality varies across studies, with many older reports available, and sample sizes were often modest in individual trials. Results apply only to the populations studied, and findings were mixed for critical endpoints, such as overall language recovery in aphasia and specific memory measures in cognitive impairment. Due to these limitations, certainty remains low, and there is limited information for long-term outcomes, therefore, the long-term effects are not fully established.

Key Studies & References

  1. Piracetam (ATC Code Classification N06BX03) - WHO Collaborating Centre for Drug Statistics Methodology
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Frequently Asked Questions (FAQ)

Common questions about Piracetam Sintofarm (FAQ)

Q: Is Piracetam Sintofarm the same as other piracetam products?

Piracetam Sintofarm is a specific pharmaceutical preparation that contains the active ingredient Piracetam. Piracetam itself is the International Non-proprietary Name (INN) for the substance. Piracetam is the same core chemical, but the product is available under various trade names and specific formulations across different countries.

Q: Is Piracetam Sintofarm a vitamin or a prescription drug?

According to regulatory classification, Piracetam is a synthetic chemical and is classified as a cerebroactive drug, not a vitamin. In many European and other countries, it is registered as a prescription drug. In the United States, the Food and Drug Administration (FDA) has not approved it for any medical use or as a dietary supplement.

Q: Is it common to feel headaches when starting Piracetam Sintofarm?

Headache is documented in official product information as a potential adverse reaction. However, its frequency is often listed in the 'Frequency Not Known' category, meaning it cannot be reliably estimated from available data. Any experienced side effects, including headaches, should be discussed with a healthcare professional.

Q: Are there any major food interactions with Piracetam Sintofarm?

Official administration guidance states that the oral form of Piracetam can be taken with or without food. Regulatory information does not list any major drug-food interactions that typically require dietary restrictions while using the medication.

Q: Is Piracetam Sintofarm officially approved for memory loss?

Approved indications vary by country and are based on local regulatory review. While research has examined the compound's use in age-related cognitive decline, it is approved for conditions such as cortical myoclonus in some jurisdictions. It is important to note that the US FDA has not approved it for memory loss or any other use.

Q: Can people with a history of strokes use Piracetam Sintofarm?

Regulatory documents formally state that the medication is contraindicated in patients with Cerebral Haemorrhage, which is a type of stroke caused by bleeding in the brain. Eligibility for use in patients with a history of other types of stroke is determined by a healthcare professional based on individual medical history.

Q: What kind of patient population is Piracetam Sintofarm typically prescribed to?

The main patient populations indicated for use vary by regional labeling. In many countries, the drug is officially labeled for conditions involving involuntary muscle jerks, such as cortical myoclonus. It may also be indicated for specific cognitive deficits, depending on the local regulatory approval.

Q: Is it normal to feel a change in mood when starting the medication?

Regulatory documents list several psychiatric or mood-related adverse events. These include nervousness (common), depression (uncommon), anxiety, and agitation (frequency not known). Experiencing such changes is a possibility based on documented safety profiles.

Q: Does the age of the patient affect how Piracetam Sintofarm works?

While the mechanism of action is consistent, age affects the body's ability to clear the drug. Regulatory documents require that dose adjustments be made for elderly patients if they have compromised kidney function. This adjustment is recommended because it is necessary to help prevent the medication from accumulating in the body.

Q: Is Piracetam Sintofarm generally well-tolerated?

The safety profile is defined by categorized side effects. Common reactions documented in regulatory documents include nervousness, hyperkinesia (involuntary movement), and weight increase. Questions regarding the overall tolerability profile should be discussed with a qualified healthcare provider.

Q: Is Piracetam Sintofarm a sedative or a stimulant?

The product is officially classified as a nootropic agent and a cerebroactive drug. Regulatory documents list both Somnolence (drowsiness) as an uncommon side effect and Hyperkinesia (involuntary movement) as a common side effect. The drug is not specifically categorized as a traditional sedative or stimulant.

Q: What are the main risks associated with Piracetam Sintofarm?

Major risks are formally defined as Contraindications in official product information. These include a diagnosis of Cerebral Haemorrhage, severe renal impairment, and Huntington's Chorea. Regulatory warnings also highlight the risk of withdrawal symptoms, such as seizures, if the medication is stopped suddenly.

Q: Is there a generic version of Piracetam Sintofarm?

Yes, Piracetam is the generic name (INN) for the active chemical substance. Piracetam Sintofarm is a specific preparation containing this generic substance, and other preparations containing Piracetam may be available.

Q: What is the difference between Piracetam and Piracetam Sintofarm?

Piracetam is the generic active substance, referred to by its International Non-proprietary Name (INN). Piracetam Sintofarm is the specific pharmaceutical preparation or brand name that contains the active substance Piracetam.

Q: Does taking Piracetam Sintofarm require regular medical monitoring?

Official regulatory information specifies that regular evaluation of kidney function, known as creatinine clearance, is necessary for elderly patients on long-term treatment. Monitoring ensures that the appropriate dose is maintained based on the body's ability to excrete the drug.

Q: Is Piracetam Sintofarm available over the counter?

The legal and prescription status of the drug varies significantly by country based on local regulation. It is a prescription-only medicine (POM) in many European countries and the UK. However, it is sold over the counter in some jurisdictions, while in the US, the FDA has not approved it for any use.

Q: How does Piracetam Sintofarm differ from choline supplements?

Piracetam is a synthetic nootropic agent classified as a cerebroactive drug that acts on the central nervous system. Choline, in contrast, is an essential nutrient that serves as a precursor to the neurotransmitter acetylcholine. Regulatory documents classify the drug by its chemical action but do not provide direct comparisons to nutritional supplements like choline.

Q: How quickly does Piracetam Sintofarm start to work?

Pharmacokinetic studies indicate the time it takes for the drug to reach stable levels in the body. According to official product information, steady-state plasma concentrations are typically achieved within three days of multiple dosing.

Q: What is the typical duration of Piracetam Sintofarm’s effects?

The elimination half-life is a measure of how quickly the body clears the drug. Official regulatory documents state the elimination half-life from plasma is approximately 5.0 hours in healthy young adult men.

Q: Can people with liver issues use Piracetam Sintofarm?

Official product information indicates that no dose adjustment is generally required for patients who have solely hepatic (liver) impairment. However, because the drug is primarily cleared by the kidneys, dose adjustments are necessary if kidney function is also impaired.

Q: Why is Piracetam Sintofarm restricted in certain countries?

The regulatory status of Piracetam is highly variable globally. For instance, in the US, the Food and Drug Administration (FDA) has not approved the drug for any medical or dietary use. These restrictions are generally due to differences in evaluation of the safety and efficacy data.

Q: What is the legal status of Piracetam Sintofarm in the US?

The US Food and Drug Administration (FDA) has not approved Piracetam for any medical use or as a dietary supplement. Therefore, it is not authorized for sale as an over-the-counter or prescription drug product in the United States.

Q: Is it possible to become dependent on Piracetam Sintofarm?

Official regulatory information focuses on the risk associated with abrupt cessation of the drug. Warnings emphasize the potential for withdrawal symptoms, such as anxiety or seizures, if the medication is stopped suddenly, especially in patients being treated for myoclonus.

Q: What should I do if I experience an unexpected side effect?

Reporting any unexpected or serious side effects (adverse reactions) is typically done by contacting a healthcare professional or directly notifying the national regulatory body responsible for drug safety (pharmacovigilance).

Q: Is Piracetam Sintofarm a controlled substance?

Piracetam is generally not classified as a controlled substance under the US Drug Enforcement Administration (DEA) Schedule. However, the legal classification of substances can vary depending on the specific national legislation of the country.

Q: Does Piracetam Sintofarm affect blood pressure?

Post-marketing adverse event monitoring reports, which track reactions not frequently observed in clinical trials, have included high blood pressure (hypertension) as a potential side effect.

Q: Are there any restrictions on driving while using Piracetam Sintofarm?

Official product information includes a warning about driving or operating heavy machinery. This warning is due to potential side effects such as drowsiness (somnolence) and dizziness (vertigo), which are documented in the safety profile.

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How should Piracetam Sintofarm be stored and disposed of?

Storage and Disposal of Piracetam

Official regulatory documents define strict conditions for storing Piracetam to maintain its stability and effectiveness. The medicine must be kept at room temperature, typically defined as below 25 C or 30 C, and stored in a dry environment protected from direct light.

It is mandatory to keep the product in the original container and ensure it is stored out of the sight and reach of children.

Storage Requirement Condition
Temperature Room Temperature (Below 25 C or 30 C)
Protection Protect from light and moisture
Container Keep in original packaging

Regarding disposal, unused or expired Piracetam must not be disposed of in household trash or poured down the sink or toilet. Instead, it must be returned to a local pharmacy or an authorized pharmaceutical waste collection program as required by environmental regulations.

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

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