Piracetam, 400 mg capsules 60 pcs

Pharmacotherapeutic group:

Notropic agent.

ATX code

[N06BX03].

Pharmacological properties

Pharmacodynamics

Piracetam is a cyclic derivative of gamma-aminobutyric acid (GABA), is a nootropic agent that directly affects the brain, improves cognitive processes (learning ability, memory, attention, mental performance). It affects the central nervous system in different ways: it changes the speed of excitation distribution in the brain, improves metabolic processes in nerve cells, improves microcirculation, affecting blood rheological characteristics and does not cause vasodilation.

Piracetam inhibits platelet aggregation and restores the elasticity of the red blood cell membrane, reduces red blood cell adhesion. At a dose of 9.6 g, it reduces the level of fibrinogen and Willibrand factors, prolongs the bleeding time.

It improves interhemispheric connections in the brain and synaptic conduction in the neocortical structures.

Piracetam has a protective and restorative effect in cases of brain dysfunction due to hypoxia and intoxication.

Limits the severity and duration of vestibular nystagmus.

Pharmacokinetics

In oral administration the drug is quickly and almost completely absorbed, the peak concentration is reached 1 hour after administration. The bioavailability of the drug is approximately 100%. After a single dose of 2 g the maximum concentration is 40-60 mcg/ml, which is reached in blood after 30 minutes and after 5 hours in cerebrospinal fluid after intravenous injection. Estimated volume of distribution of piracetam is about 0.6 l/kg. Period of half-life of the drug from plasma is 4-5 hours and 8.5 hours from cerebrospinal fluid, which is prolonged in case of renal insufficiency. Pharmacokinetics of piracetam does not change in patients with hepatic insufficiency.

It penetrates through the blood-brain and placental barrier and membranes used in hemodialysis. In animal studies piracetam selectively accumulates in tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, cerebellum and basal ganglia. It does not bind with blood plasma proteins and is not metabolized in the body. 80-100% of piracetam is excreted unchanged by the kidneys through renal filtration. Renal clearance of piracetam in healthy volunteers is 86 ml/min.

Indications

Symptomatic treatment of psycho-organic syndrome, particularly in elderly patients with memory impairment, dizziness, decreased concentration and general activity, mood changes, behavior disorders, gait disturbances, and in patients with Alzheimer’s disease and senile dementia of the Alzheimer type.

The consequences of ischemic stroke are speech disorders, emotional disturbances, decreased motor and mental activity.

Chronic alcoholism – for the treatment of psychoorganic and withdrawal syndromes.

The period of recovery from trauma and intoxication of the brain.

Dizziness and related balance disorders, with the exception of vertigo of vasomotor and mental origin.

As part of the complex therapy of learning disability in children with psychorganic syndrome.

For the treatment of cortical myoclonias as mono- or complex therapy.

In the complex therapy of sickle cell anemia.

Active ingredient

Composition

One capsule contains:

The active substance: piracetam – 0,4 g .

Auxiliary substances: aerosil, microcrystalline cellulose.

How to take, the dosage

Over the mouth (with meals or on an empty stomach, with fluids); by IV or drip, IV/m (in case of difficulty in swallowing or when unconscious).

The last dose is taken no later than 5 p.m. (to prevent sleep disturbance).

The daily dose is divided into 2-4 doses.

The symptomatic treatment of psychoorganic syndrome: 4.8 g/day for the first week, then change to a maintenance dose of 1.2-2.4 g/day.

Treatment of vertigo and related balance disorders: 2.4-4.8 g/day.

Treatment of cortical myoclonias: it is begun with a dose of 7.2 g/day, every 3-4 days the dose is increased by 4.8 g/day until the maximum dose of 24 g/day. Treatment is continued throughout the entire period of the disease. Every 6 months it should be tried to reduce a dose or discontinue the drug, gradually reducing a dose by 1.2 g/day every 2 days. If there is little or no therapeutic effect, treatment should be discontinued.

In sickle cell vaso-occlusive crisis (in adults and children): prophylaxis – oral 160 mg/kg/day divided into 4 equal doses. A dose of less than 160 mg/kg/day or irregular administration may cause exacerbation of the disease; treatment by IV at 300 mg/kg/day, divided into 4 equal doses.

The treatment of dyslexia in children over 8 years of age (in combination with other treatments) is 3.2 g divided into 2 equal doses.

In mild CKD (IQ 50-79 ml/min), 2/3 dose divided into 2-3 doses; moderate (IQ 30-49 ml/min), 1/3 dose divided into 2 doses; severe (IQ 20-30 ml/min), 1/6 dose once.

Interaction

Concomitant use with iodine-containing thyroid hormones may cause confusion, irritability and sleep disturbance.

In high doses (9.6 g/day) in patients with venous thrombosis increases the anticoagulant effect of indirect anticoagulants (more pronounced reduction of platelet aggregation, fibrinogen, Willebrand factor, blood and plasma viscosity).

Pharmaceutically compatible with solutions of dextrose (5%, 10%, 20%), fructose (5%, 10%, 20%), 0.9% NaCl solution, Ringer’s solution, 20% mannitol solution, hydroxyethyl starch (6%, 10%).

Special Instructions

Patients with impaired hemostasis, prior to upcoming major surgical interventionsvb or in patients with symptoms of severe bleeding should be treated with caution.

In the treatment of cortical myoclonias, abrupt discontinuation of treatment should be avoided because it may cause recurrence of attacks.
In the treatment of veno-occlusive crises in sickle cell anemia, a dose less than 160 mg/kg or irregular administration of the drug may cause recurrence of the crisis.

In long-term therapy in elderly patients, regular monitoring of renal function is recommended; if necessary, dose adjustments are made depending on CK.

It penetrates through the filter membranes of hemodialysis machines.

At the time of treatment, care must be taken when driving a vehicle and engaging in other potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

Individual intolerance to piracetam or pyrrolidone derivatives or other components of the drug.

Acute impairment of cerebral circulation (hemorrhagic stroke).

End-stage renal failure (when creatinine clearance is less than 20 ml/min).

Children under 1 year of age.

Pregnancy and lactation.

Piracetam passes through the placental barrier and into the breast milk. The concentration of the drug in the infant reaches 70-90% of its concentration in the blood of the mother. Except in special circumstances, piracetam should not be prescribed during pregnancy. Breastfeeding should be refrained from while prescribing piracetam to a woman.

Side effects

CNS disorders: motor disinhibition, irritability, somnolence, depression, asthenia, headache, insomnia, mental agitation, impaired balance, ataxia, worsening of epilepsy, anxiety, hallucinations, confusion.

Digestive system disorders: nausea, vomiting, diarrhea, abdominal pain.

Metabolic disorders: weight gain.

Sensory system disorders: vertigo.

Skin disorders: dermatitis, itching, urticaria.

Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

Local reactions: pain at the injection site, thrombophlebitis

Other (when parenteral administration): fever, decreased BP.

Overdose

Symptoms: abdominal pain, diarrhea with blood.

Treatment: induction of vomiting, gastric lavage, symptomatic therapy, hemodialysis (effectiveness 50-60%). There is no specific antidote.

Similarities