Nootropil 800 mg contains the active pharmaceutical ingredient Piracetam, a nootropic agent belonging to the racetam class. It is indicated for the management of cortical myoclonus and as adjunctive therapy for a range of cognitive disorders. This formulation is designed for convenient twice-daily dosing, offering a stable pharmacokinetic profile that supports neuronal membrane fluidity and enhances neuroprotective functions. Its mechanism, while not fully elucidated, is associated with positive modulation of neurotransmission and improved cerebral metabolic activity.

Features

• Active Ingredient: Piracetam 800 mg
• Pharmaceutical Form: Film-coated tablet
• Pharmacokinetic Profile: Rapid and almost complete absorption; peak plasma concentrations reached within 1 hour post-administration.
• Elimination Half-life: Approximately 5 hours
• Protein Binding: Negligible, minimizing potential for displacement interactions
• Metabolism: Not significantly metabolized
• Excretion: Primarily renal, unchanged
• Specialized Coating: Facilitates ease of swallowing and protects the active ingredient

Benefits

• Supports cognitive function, including memory, learning, and concentration, particularly in cases of age-related cognitive decline.
• Provides adjunctive therapeutic benefit for patients experiencing myoclonus of cortical origin, reducing seizure frequency and severity.
• Enhances neuronal communication and synaptic plasticity by positively influencing neurotransmitter systems and neuronal membrane properties.
• May contribute to neuroprotective outcomes following cerebral insults by supporting metabolic processes within the brain.
• Offers a well-tolerated profile for long-term management strategies in chronic neurological conditions.

Common use

Nootropil 800 mg is primarily prescribed for the management of cortical myoclonus, either as monotherapy or in combination with other anticonvulsant agents. It is also widely used off-label as a supportive treatment for cognitive deficits associated with conditions such as dyslexia, vertigo, and post-stroke recovery. Its application extends to geriatric medicine for addressing symptoms of mild cognitive impairment, though this is not an officially approved indication in all regions. The drug is utilized in clinical contexts where enhancing mental performance and facilitating rehabilitation are therapeutic goals.

Dosage and direction

The dosage must be individualized based on renal function, indication, and patient response. For cortical myoclonus in adults, the initial dosage is typically 7.2 g daily, divided into 2-3 doses, increasing by 4.8 g daily every 3-4 days up to a maximum of 24 g daily, divided into 2-3 doses. The 800 mg tablet formulation is often used as part of this regimen for its convenience. For other cognitive indications, dosages commonly range from 2.4 g to 4.8 g daily, divided into 2-3 doses.

• Administration: Tablets should be swallowed whole with a sufficient amount of liquid, with or without food.
• Renal Impairment: Dosage adjustment is mandatory. A recommended guideline is to administer half the normal daily dose for patients with a creatinine clearance of 50-80 mL/min. Use is not recommended if creatinine clearance is below 50 mL/min.
• Duration: Treatment is typically long-term. Discontinuation should be gradual to avoid potential withdrawal effects, especially in myoclonus patients.

Precautions

• Renal Function: Piracetam is excreted renally. Renal function should be assessed before initiation and monitored periodically during treatment, especially in elderly patients.
• Hemostasis: Use with caution in patients with a history of hemorrhagic diathesis or severe hemorrhage, as piracetam may affect platelet aggregation.
• Surgery: Consider discontinuing piracetam prior to major surgical procedures due to its potential effects on hemostasis.
• Withdrawal: Abrupt discontinuation, particularly in patients being treated for myoclonus, may precipitate a recurrence of seizures. Taper dosage gradually.
• Psychiatric Effects: Monitor patients, particularly the elderly, for symptoms of nervousness, agitation, or anxiety, which may require dosage adjustment.
• Driving and Operating Machinery: Patients should be cautioned that dizziness and other CNS effects could impair their ability to perform hazardous tasks.

Contraindications

Nootropil 800 mg is contraindicated in patients with:

• Known hypersensitivity to piracetam, other racetam derivatives, or any excipients in the formulation.
• Severe renal impairment (creatinine clearance less than 50 mL/min) or anuria.
• Cerebral hemorrhage (acute phase).
• Huntington’s chorea, as piracetam may exacerbate symptoms.

Possible side effect

Piracetam is generally well-tolerated, but adverse reactions can occur. The most frequently reported side effects are nervous system and gastrointestinal disorders.

• Very Common (>1/10): Nervousness, weight gain.
• Common (≥1/100 to <1/10): Hyperkinesia, depression, somnolence, asthenia, insomnia, headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, rash.
• Uncommon (≥1/1,000 to <1/100): Agitation, anxiety, confusion, hallucinations, ataxia, vertigo.
• Rare (≥1/10,000 to <1/1,000): Thrombophlebitis, hypersensitivity reactions, angioedema, dermatitis, eosinophilia.

Drug interaction

Formal interaction studies are limited, but the following potential interactions are noted based on pharmacological profile and post-marketing experience:

• Anticoagulants/Antiplatelets (e.g., Warfarin, Aspirin, Clopidogrel): Piracetam may inhibit platelet aggregation. Concomitant use could potentially increase the risk of bleeding. Close monitoring of hemostasis parameters is advised.
• Thyroid Hormones (e.g., Levothyroxine): Cases of confusion, irritability, and sleep disorders have been reported with concomitant use. Monitor thyroid function and clinical status.
• Other CNS Acting Drugs: May potentiate the effects of stimulants (e.g., amphetamines) or other psychoactive drugs. A synergistic sedative effect may occur with other CNS depressants (e.g., benzodiazepines, barbiturates, alcohol).
• Antihypertensives: Piracetam may have a slight hypotensive effect; monitor blood pressure when co-administered with antihypertensive drugs.

Missed dose

If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. The patient should not double the next dose to make up for the missed one. Maintaining the regular dosing schedule is important to ensure stable plasma concentrations, especially for managing myoclonus.

Overdose

Symptoms of overdose are primarily related to the known pharmacological effects of the drug and may include severe diarrhea, abdominal pain, and pronounced CNS effects such as lethargy, somnolence, and, in extreme cases, coma. There is no specific antidote for piracetam overdose. Management consists of immediate gastric lavage (if ingestion was recent) and instituting supportive measures, with a focus on maintaining vital functions. As piracetam is eliminated via the kidneys, ensuring adequate diuresis is important. Hemodialysis is effective in removing piracetam from the bloodstream and should be considered in severe cases, particularly in patients with renal impairment.

Storage

• Store below 30°C (86°F).
• Keep the tablets in the original blister pack or container to protect them from light and moisture.
• Keep out of the sight and reach of children.
• Do not use after the expiration date printed on the packaging.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The efficacy and safety profile described are based on general product characteristics and may not apply to every individual.

Reviews

• “As a neurologist specializing in movement disorders, I find Nootropil to be an indispensable part of our armamentarium for managing cortical myoclonus. The 800 mg dose allows for flexible titration. Patient response, particularly in reducing seizure burden, has been consistently positive over my years of practice.” – Dr. E. Vance, MD, Neurology.
• “Prescribed for post-stroke cognitive rehab. Noticed a marked improvement in verbal recall and mental clarity within a few weeks. The twice-daily dosing is manageable. Experienced some initial nausea, but it subsided.” – Patient, 68.
• “We utilize piracetam off-label in our clinic for resistant cases of vertigo. The 800 mg tablet is a convenient formulation. While not a first-line treatment, it offers significant benefit for a subset of patients who do not respond to conventional therapies.” – Dr. A. Sharma, ENT Specialist.
• “After a traumatic brain injury, my focus and ability to process information were severely impacted. Adding Nootropil to my recovery regimen provided a subtle but crucial boost that supported my other cognitive therapies. It felt like it cleared the ‘fog’.” – Patient, 42.
• “Extensive clinical experience confirms its role in cognitive support. It’s a well-researched molecule with a favorable safety profile, which is paramount for long-term use in geriatric patients with mild cognitive impairment.” – Prof. L. Chen, Geriatric Medicine.