Biotropil

Biotropil is a drug from the group of nootropics and psychostimulants. Its active ingredient is piracetam (a cyclic derivative of the GABA component).

Piracetam has nootropic properties, has an effect on the brain - improves its cognitive activity (memory, intellectual activity, attention and learning ability). [ 1 ]

The drug is used in monotherapy or combination therapy in cases of cortical myoclonus – to reduce the intensity of the provoking factor, which is vestibular neuronitis.

Indications Biotropil

It is used to eliminate the symptoms of diseases characterized by cognitive impairment and memory loss (excluding diagnosed dementia).

It can be used in cases of myoclonus of a cortical nature - as a monotherapy or as part of a combination regimen.

Release form

The medicinal element is released in tablets (volume 0.8 or 1.2 g) - 10 pieces inside a blister pack. Inside the box - 1, 3 or 6 such packs.

Pharmacodynamics

Among the mechanisms of therapeutic action in relation to the central nervous system:

• change in the speed of movement of excitation impulses within the brain;
• potentiation of metabolic processes within neuronal cells;
• improvement of microcirculation processes, which occurs due to the effect of drugs on rheological blood parameters (while no vasodilating effect develops).

Helps improve communication between the cerebral hemispheres, as well as conductivity within the synapses of neocortical structures. The effect of piracetam inhibits platelet aggregation, weakens erythrocyte adhesion and restores the elasticity of the erythrocyte wall. [ 2 ]

Piracetam demonstrates restorative and at the same time protective activity in case of cerebral dysfunction associated with poisoning, hypoxia and electroshock treatment. The drug weakens the intensity and reduces the duration of vestibular nystagmus.

Pharmacokinetics

When administered orally, complete absorption of the substance in the gastrointestinal tract is observed at high speed. Bioavailability values are about 100%.

The substance reaches plasma Cmax values (when using 2000 mg of the drug) after half an hour (in the cerebrospinal fluid – in 2-8 hours), amounting to 40-60 mcg/ml.

The distribution volume of the drug is about 0.6 l/kg. It is not subject to metabolic processes inside the body and is not synthesized with blood protein. Piracetam can cross the placenta, the BBB, and the walls used during hemodialysis.

The intraplasmic half-life is 4-5 hours (or 6-8 hours from the cerebrospinal fluid). This period may be prolonged in individuals with renal insufficiency. The substance is excreted by the kidneys by 80-100% with the help of CF (unchanged form). The level of intrarenal clearance of the drug in volunteers was 86 ml per minute.

Dosing and administration

The medicine is taken orally, the tablets are washed down with plain water. The selection of a personal dose and the duration of the therapeutic cycle is carried out taking into account the effectiveness of the therapy and the severity of the pathological process.

Adults.

Therapy for conditions associated with cognitive impairment or memory loss.

At first, you need to take 4800 mg of the drug per day (the first 7 days of the cycle). Often, this dosage is divided into 2-3 doses. The size of the maintenance dose is 2400 mg, with the dose divided into 2-3 doses. Then the dosage can be (if necessary) gradually reduced by 1200 mg per day.

Therapy for cortical myoclonus.

During the first 3 days, it is necessary to consume 24 g of the substance. If the desired result is not achieved, the medicine is continued to be administered in the specified portion (24 g per day) for a maximum of 1 week. If there is no medicinal effect by the 7th day of the cycle, the therapy is discontinued.

Once the medicinal effect has been achieved, starting from the day when a stable improvement was noted, it is necessary to reduce the dose by 1200 mg at 2-day intervals until the symptoms of the disease reappear (this will allow determining the average effective dose). The daily dosage should be divided into 2-3 uses.

Therapy using other antimyoclonic agents is continued in previously selected doses.

The treatment course should be continued until the signs of pathology disappear. You cannot abruptly stop taking Biotropil, as this will lead to a deterioration in the patient's condition - to prevent this process, you should reduce the dose gradually, by 1200 mg at 2-3-day intervals.

It is necessary to carry out repeated treatment courses every six months, while changing the dosage taking into account the patient’s condition, until the symptoms of the pathology weaken or disappear.

Elderly people.

The dosage of the drug should be adjusted in elderly patients with suspected or established renal dysfunction. Long-term therapy requires constant monitoring of CC indicators so that the dosage change is adequate.

Use in individuals with renal dysfunction.

Because the drug is excreted from the body through the kidneys, it should be used with extreme caution in people with renal insufficiency.

The prolongation of the half-life is directly caused by the weakening of renal function and the decrease in the values of CC. The interval between drug administrations should be changed based on the degree of intensity of renal dysfunction.

Schemes of the performed adjustments of the dosage portion:

• healthy kidney function (CC values >80 ml per minute) – the standard portion is divided into 2 or 4 doses;
• CC indicators in the range of 50-79 ml per minute - 2/3 of the standard dosage is taken in 2-3 doses;
• the level of CC is within 30-49 ml per minute – 1/3 of the standard portion is administered in 2 doses;
• CC values <30 ml per minute – 1/6 of the standard dosage is used once;
• The medication is not used in the terminal phase of the disease.

Application for children

Not used in pediatrics.

Use Biotropil during pregnancy

It is prohibited to prescribe Biotropil to breastfeeding or pregnant women.

Contraindications

Main contraindications:

• severe intolerance caused by piracetam, pyrrolidone derivatives or other elements of the drug;
• active stage of dysfunction of intracerebral blood flow (hemorrhagic stroke);
• terminal renal failure;
• Huntington's syndrome.

Side effects Biotropil

Side effects include:

• lesions associated with the functioning of the nervous system: drowsiness, headaches, tremors, hyperkinesia, balance disorder, insomnia, ataxia and an increase in the frequency of epileptic seizures;
• metabolic and nutritional disorders: weight gain;
• mental disorders: depression, hallucinations, anxiety and nervousness, as well as a feeling of confusion and severe excitability;
• blood lesions: hemorrhagic disorders;
• immune-related symptoms: anaphylactoid symptoms and intolerance;
• auditory disturbances: vertigo;
• problems with digestion: pain in the abdominal area (or its upper part), vomiting, diarrhea or nausea;
• lesions of the epidermis and subcutaneous layer: dermatitis, itching, Quincke's edema, urticaria and rashes;
• reproductive disorders: increased sexual activity;
• systemic symptoms: asthenia.

Overdose

Among the manifestations of developed overdose: potentiation of symptoms of negative reactions of the drug. Similar violations were noted in case of oral administration of a dosage of 75 g.

Symptomatic actions are performed: gastric lavage and induction of vomiting. The drug has no antidote. The hemodialysis procedure will allow excretion of 50-60% of the piracetam portion.

Interactions with other drugs

Thyroid hormones.

Administration together with T3+T4 elements may lead to the development of sleep disorders, increased irritability, and disorientation.

Acenocoumarol.

Clinical tests have shown that in people with severe recurrent thrombosis, administration of large doses of piracetam (9.6 g per day) did not affect the dose of acenocoumarol to obtain an INR of 2.5-3.5. In this case, a significant decrease in the degree of platelet aggregation, blood and plasma viscosity, von Willebrand factors (VIII: vW: Ag; VIII: C; VIII: vW: Rco values) and fibrinogen values was observed.

Storage conditions

Biotropil should be stored in a place closed to small children. Temperature values should not exceed 25°C.

Shelf life

Biotropil is permitted to be used for a period of 4 years from the date of release of the therapeutic product.

Analogues

The analogs of the drug are Nootropil with Lucetam and Piracetam.