Escotropil (Solution) Instructions for Use

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

ATC Code

N06BX03 (Piracetam)

Active Substance

Piracetam (Rec.INN registered by WHO)

Dosage Forms

	Escotropil	Solution for infusion 20% (10 g/50 ml): bottle 1 or 28 pcs.
		Solution for infusion 20% (20 g/100 ml): bottle 1 or 28 pcs.
		Solution for infusion 20% (40 g/200 ml): bottle 1 or 28 pcs.
		Solution for infusion 200 mg/ml: 50 ml, 100 or 200 ml bottle 1 or 28 pcs.

Dosage Form, Packaging, and Composition

50 ml – blood substitute bottles (1) – cardboard packs.
50 ml – blood substitute bottles (28) – cardboard boxes.

100 ml – blood substitute bottles.
100 ml – blood substitute bottles (1) – cardboard packs.
100 ml – blood substitute bottles (1) – cardboard boxes.
100 ml – blood substitute bottles (28) – cardboard boxes.

200 ml – blood substitute bottles.
200 ml – blood substitute bottles (1) – cardboard packs.
200 ml – blood substitute bottles (28) – cardboard boxes.

50 ml – bottles (1) – cardboard packs.
50 ml – bottles (28) – cardboard boxes.
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (28) – cardboard boxes.
200 ml – bottles (1) – cardboard packs.
200 ml – bottles (28) – cardboard boxes.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

The active component is Piracetam – a cyclic derivative of gamma-aminobutyric acid.

Piracetam is a nootropic agent. It acts directly on the brain, improving cognitive processes such as learning ability, memory, attention, and mental performance. Piracetam affects the central nervous system (CNS) in various ways: by changing the rate of excitation propagation in the brain, improving metabolic processes in nerve cells, improving microcirculation, affecting the rheological properties of blood, and without causing a vasodilating effect.

The drug improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures, increases mental performance, and improves cerebral blood flow.

Piracetam inhibits platelet aggregation and restores the elasticity of the erythrocyte membrane, reducing erythrocyte adhesion. At a dose of 9.6 g, it reduces the level of fibrinogen and von Willebrand factors by 30-40% and prolongs bleeding time.

Piracetam reduces the severity and duration of vestibular nystagmus.

Pharmacokinetics

The half-life of the drug from blood plasma is 4-5 hours, from cerebrospinal fluid – 7.7 hours. In patients with renal failure, the half-life is prolonged. The pharmacokinetics of piracetam do not change in patients with hepatic impairment.

It penetrates the blood-brain and placental barriers. In animal studies, Piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal, and occipital lobes, in the cerebellum and basal ganglia. It does not bind to plasma proteins, is not metabolized in the body, and is excreted by the kidneys – 2/3 unchanged within 30 hours. The renal clearance of piracetam in healthy volunteers is 86 ml/min.

Indications

• Symptomatic treatment of psycho-organic syndrome, particularly in elderly patients, accompanied by memory loss, decreased concentration and general activity, mood changes, behavioral disorders, gait disturbance, as well as in patients with Alzheimer’s disease and Alzheimer’s type dementia;
• Treatment of the consequences of acute cerebrovascular accident (ischemic stroke), such as speech impairment, emotional disturbances, decreased motor and mental activity;
• Chronic alcoholism – for the treatment of psycho-organic and withdrawal syndromes;
• Comatose states (and during the recovery period), including after brain injuries and intoxications;
• Treatment of dizziness and associated balance disorders, excluding dizziness of vascular origin and psychogenic dizziness;
• Treatment of cortical myoclonus as mono- and complex therapy;
• As part of complex therapy for sickle-cell anemia;
• In pediatric practice: dyslexia in children over 8 years of age (as part of complex therapy)

ICD codes

Dosage Regimen

Administer slowly! Piracetam solutions are administered intravenously by drip at a rate of 30-40 drops per minute.

Bolus intravenous administration (for example, for relieving withdrawal syndrome in alcoholism, emergency treatment of sickle-cell anemia, etc.) is performed over at least 2 minutes, with the daily dose distributed over several administrations (2-4) at equal intervals so that the dose per administration does not exceed 3 g.

Parenteral administration of piracetam is prescribed when oral dosage forms of the drug (tablets, capsules, oral solution) cannot be used, for example, in case of difficulty swallowing or when the patient is in a coma.

When possible, switch to oral administration of piracetam.

The duration of treatment is determined by the doctor depending on the disease and taking into account the dynamics of symptoms.

For symptomatic treatment of chronic psycho-organic syndrome, depending on the severity of symptoms, 2.4-4.8 g/day is prescribed.

For the treatment of cerebrovascular disorders (stroke), 4.8-12 g/day is prescribed.

For the treatment of comatose states, as well as perceptual difficulties in individuals with brain injuries, the initial dose is 9-12 g/day, maintenance dose – 2 g/day. Treatment is continued for at least 3 weeks.

For alcohol withdrawal syndrome – 12 g/day. Maintenance dose 2.4 g/day.

Treatment of dizziness and associated balance disorders 2.4-4.8 g per day, course 10-15 days.

For cortical myoclonus, treatment is started with a dose of 7.2 g/day, every 3-4 days the dose is increased by 4.8 g/day until a maximum dose of 24 g/day is reached. Treatment is continued throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or discontinue the drug, gradually reducing the dose by 1.2 g/day every 2 days. In the absence of effect or insignificant therapeutic effect, treatment is discontinued.

For sickle-cell anemia, the daily prophylactic dose is 160 mg/kg of body weight, divided into four equal doses. During a crisis – 300 mg/kg.

Children. The only indication is dyslexia in children over 8 years of age (as part of complex therapy). Escotropil is prescribed at a dose of 30-50 mg/kg/day.

Dosing for patients with impaired renal function

Since Piracetam is excreted from the body by the kidneys, caution should be exercised when treating patients with renal failure according to the following dosing regimen.

For elderly patients, the dose is adjusted in the presence of renal failure. During long-term therapy, monitoring of renal functional status is necessary.

Dosing for patients with impaired hepatic function

Patients with impaired hepatic function do not require dose adjustment. In case of impaired renal and hepatic functions simultaneously, dosing is carried out according to the scheme above (see section “Dosing for patients with impaired renal function”).

Adverse Reactions

From the CNS and peripheral nervous system: motor disinhibition (1.72%), irritability (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%).

These side effects occur more often in elderly patients receiving the drug at a dose of more than 2.4 g/day. In most cases, it is possible to achieve regression of such symptoms by reducing the drug dose. In isolated cases – dizziness, headache, ataxia, exacerbation of epilepsy, extrapyramidal disorders, tremor, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased libido.

From the cardiovascular system: rarely – decrease or increase in blood pressure.

From the digestive system: in isolated cases – nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

From metabolism: weight gain (1.29%) – occurs more often in elderly patients receiving the drug at a dose of more than 2.4 g/day.

From the skin: dermatitis, itching, rash.

Allergic reactions: angioedema.

Contraindications

• Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug;
• Psychomotor agitation at the time of prescribing the drug;
• Huntington’s chorea;
• Acute cerebrovascular accident (hemorrhagic stroke);
• End-stage renal failure (with creatinine clearance less than 20 ml/min);
• Contraindicated in children, except for use in dyslexia in children over 8 years of age (as part of complex therapy).

With caution: hemostasis disorders, extensive surgical interventions, severe bleeding.

Use in Pregnancy and Lactation

Animal studies have not revealed a damaging effect of piracetam on the embryo and its development, including in the postnatal period. No changes in the course of pregnancy and childbirth were observed.

Studies in pregnant women have not been conducted. Piracetam penetrates the placental barrier and into breast milk. The concentration of the drug in newborns reaches 70-90% of its concentration in the mother’s blood. If it is necessary to prescribe the drug during pregnancy, the potential benefit to the mother and the risk to the fetus should be assessed. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Patients with impaired hepatic function do not require dose adjustment.

Use in Renal Impairment

It is prohibited to use the drug in end-stage renal failure (with creatinine clearance less than 20 ml/min). Caution should be exercised when treating patients with renal failure according to the dosing regimen.

Pediatric Use

Contraindicated in children, except for use in dyslexia in children over 8 years of age (as part of complex therapy).

Geriatric Use

During long-term therapy of elderly patients, regular monitoring of renal function parameters is recommended; if necessary, dose adjustment is carried out depending on the results of creatinine clearance testing.

Special Precautions

Due to the effect of piracetam on platelet aggregation, caution is recommended when prescribing the drug to patients with hemostasis disorders, during major surgical operations, or to patients with symptoms of severe bleeding. When treating patients with cortical myoclonus, abrupt interruption of treatment should be avoided, as this may cause recurrence of seizures.

During long-term therapy of elderly patients, regular monitoring of renal function parameters is recommended; if necessary, dose adjustment is carried out depending on the results of creatinine clearance testing.

During treatment, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Penetrates through the filtering membranes of the hemodialysis apparatus.

Overdose

In case of overdose, symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.

Drug Interactions

Increases the effectiveness of thyroid hormones and antipsychotic agents (neuroleptics). When prescribed concomitantly with neuroleptics, Piracetam reduces the risk of extrapyramidal disorders.

When used concomitantly with drugs that have a stimulating effect on the CNS, enhancement of CNS stimulation is possible.

No interaction was noted with clonazepam, phenytoin, phenobarbital, valproic acid.

High doses of piracetam (9.6 g/day) increase the effectiveness of indirect anticoagulants in patients with venous thrombosis (significant inhibition of platelet aggregation, concentrations of fibrinogen, von Willebrand factors, blood and plasma viscosity were noted compared to the use of only indirect anticoagulants).

The possibility of changing the pharmacodynamics of piracetam under the influence of other drugs is low, because 90% of piracetam is excreted unchanged in the urine.

Taking piracetam at a dose of 20 mg/day did not change the C_max and area under the concentration-time curve of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, valproic acid) in epileptic patients taking a constant dose.

Concomitant use with alcohol did not affect the concentration of piracetam in serum, and the concentration of alcohol in serum did not change when taking 1.6 g of piracetam.

Storage Conditions

List B.

The drug should be stored in a light-protected place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.