Biotropil

Biotropil is a medicine from the group of nootropics and psychostimulants. Its active ingredient is the substance 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). [1]

The drug is used for monotherapy or combined treatment in the case of cortical myoclonus - to weaken the intensity of the action of the provoking factor, which is vestibular neuronitis.

Indications Biotropil

It is used to eliminate the symptoms of diseases in which there are cognitive impairments and memory loss (excluding diagnosed dementia).

It can be used in the case of cortical myoclonus - as a means of monotherapy or as part of a combined regimen.

Release form

The release of the drug element is made in tablets (volume 0.8 or 1.2 g) - 10 pieces inside the cell 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 inside the brain;
• potentiation of metabolic processes within neuronal cells;
• improvement of microcirculation processes, which occurs due to the effect of drugs in relation to rheological blood parameters (while a vasodilating effect does not develop).

Helps improve communication between the cerebral hemispheres, as well as conduction 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 the case of cerebral dysfunction associated with poisoning, hypoxia and electroshock treatment. The medicine weakens the intensity and reduces the duration of vestibular nystagmus.

Pharmacokinetics

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

Plasma indicators Cmax (when using 2000 mg of the drug), the substance reaches after half an hour (inside the cerebrospinal fluid - in 2-8 hours), amounting to 40-60 μg / ml.

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

The term intraplasmic half-life is 4-5 hours (or 6-8 hours from cerebrospinal fluid). This period can be prolonged in persons with impaired renal function. 80-100% of the substance is excreted through the kidneys using CF (unchanged form). The level of intrarenal drug clearance in the 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 portion 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 that are associated with cognitive impairment or memory impairment.

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

Therapy in case of cortical myoclonus.

In the period of the first 3 days, it is required to consume 24 g of the substance. In the absence of the required result, the drug is continued to be administered in the indicated portion (24 g per day) for a maximum of 1 week. If there is no drug effect by the 7th day of the cycle, therapy is canceled.

Once the drug effect is reached, starting from the day when sustained improvement was noted, it is necessary to reduce the serving by 1200 mg at 2-day intervals until symptoms of the disease reappear (this will determine the average effective serving rate). Divide the daily dosage into 2-3 uses.

The therapy with the use of other antimyoclonic substances is continued in pre-selected portions.

It is necessary to continue the treatment course until the signs of pathology disappear. It is impossible to abruptly cancel taking Biotropil, as this will lead to a deterioration in the patient's condition - in order to prevent this process, the portion should be reduced gradually, by 1200 mg at 2-3-day intervals.

It is required to conduct 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.

Aged people.

Correction of the dose of drugs is necessary in the elderly 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 must be used very carefully in people with kidney failure.

The prolongation of the half-life is directly caused by a weakening of renal activity and a decrease in CC values. The interval between drug injections needs to be changed based on the severity of renal dysfunction.

Schemes of the dosage portion adjustments performed:

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

Application for children

Not used in pediatrics.

Use Biotropil during pregnancy

It is forbidden to prescribe Biotropil to women who are breastfeeding or pregnant.

Contraindications

The main contraindications:

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

Side effects Biotropil

Among the side effects:

• lesions associated with the work of the NS: drowsiness, headaches, tremors, hyperkinesia, balance disorder, insomnia, ataxia and an increase in the incidence of epileptic seizures;
• metabolic and nutritional disorders: weight gain;
• mental disorders: depression, hallucinations, anxiety and nervousness, as well as a feeling of confusion and intense excitability;
• blood lesions: hemorrhagic disorders;
• signs associated with immunity: anaphylactoid symptoms and intolerance;
• hearing impairment: vertigo;
• digestive problems: 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 signs: asthenia.

Overdose

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

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

Interactions with other drugs

Thyroid hormones.

Administration together with T3 + T4 elements can 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. At the same time, in the case of such a combination, a significant decrease in the degree of platelet aggregation, blood and plasma viscosity, Willibrandt factors (values VIII: vW: Ag; VIII: C; VIII: vW: Rco) and fibrinogen parameters was observed.

Storage conditions

Biotropil should be stored in a place closed from the penetration of small children. Temperature values - no more than 25 ° C.

Shelf life

Biotropil is allowed to be used within a 4-year period from the date of the release of the therapeutic product.

Analogs

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