Piracetam Reneval, 800 mg 30 pcs

In adults:

– Symptomatic treatment of psychorganic syndrome, particularly in elderly patients, accompanied by decreased memory, dizziness, decreased concentration and activity, mood changes, conduct disorder, and gait disturbances (these symptoms may be early signs of age-related diseases such as Alzheimer’s disease and senile Alzheimer-type dementia);

– Treatment of vertigo and related balance disorders, except for vascular and psychogenic vertigo;

– Comprehensive therapy and monotherapy of cortical myoclonias;

– Comprehensive therapy of sickle cell anemia (for prevention of sickle cell vaso-occlusive crisis).

In children:

– Treatment of dyslexia (in combination with other methods);

– Complex therapy of sickle cell anemia (for prevention of sickle cell vaso-occlusive crisis).

Active ingredient

Piracetam

Composition

Per tablet:

Active ingredient:

piracetam – 800.0 mg.

Excipients (core):

croscarmellose sodium – 12.0 mg,

Pregelatinized starch – 12.0 mg,

povidone (polyvinylpyrrolidone) – 20.0 mg,

magnesium stearate – 8.0 mg.

Auxiliary substances (coating):

Hypromellose – 15.2 mg,

macrogol-4000 – 4.0 mg,

titanium dioxide – 8.8 mg.

How to take, the dosage

Oral.

With meals or on an empty stomach with fluids.

Symptomatic treatment of psychoorganic syndrome: 2.4 – 4.8 g/day in 2-3 doses.

The treatment of dizziness and related balance disorder: 2.4 to 4.8 g/day in 2-3 doses.

The treatment of cortical myoclonias: it starts 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 in 2 to 3 doses. Treatment is continued throughout the entire period of the disease. Every 6 months, attempts should be made to reduce the dose or to cancel the drug, gradually reducing the dose by 1.2 g/day every 2 days.

The treatment of sickle cell anemia: The daily prophylactic dose is 160 mg/kg body weight divided into 4 equal doses.

The treatment of dyslexia in children (in combination with other treatments): the recommended daily dose for children from 8 years and adolescents is 3.2 g divided into 2 doses.

Dosing in patients with impaired renal function: the dose should be adjusted according to creatinine clearance (CK) values:
Creatinine clearance for men can be calculated based on serum creatinine concentration using the following formula:

The creatinine clearance for women can be calculated by multiplying the resulting value by a factor

Elderly patients have the dose adjusted in the presence of renal insufficiency, with prolonged therapy, monitoring of renal function is necessary.

Dosage to patients with impaired liver function:
Patients with impaired liver function do not require dose adjustment. Patients with impaired both renal and liver function, dosing is according to the scheme.

Interaction

The possibility of changes in the pharmacokinetics of piracetam under the influence of other drugs is low, because 90% of piracetam is excreted unchanged by the kidneys.

When concomitant use with thyroid hormones, there have been reports of confusion, irritability and sleep disturbance.

According to the published study in patients with recurrent venous thrombosis the dose of piracetam 9.6 g/day improves the effectiveness of indirect anticoagulants (more significant decreases of platelet aggregation, fibrinogen, Willebrand factors, blood viscosity and plasma level were noted in comparison with application of indirect anticoagulants only).

In vitro, piracetam does not inhibit cytochrome P450 isoenzymes such as CYP1A2, 2B6, 2C8, 2C9, 2C19, 2B6, 2E1 and 4A9/11 at 142, 426 and 1422 µg/mL. A slight inhibition of CYP2A6 (21%) and ZA4/5 (11%) was observed at the concentration of 1422 µg/ml, but Ki levels of these two isoenzymes are sufficient above 1422 µg/ml, in connection with which a metabolic interaction with other drugs is unlikely.

The administration of piracetam at a dose of 20 g/day for 4 weeks did not alter the maximum serum concentration and area under the concentration-time curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproic acid).

Co-administration with alcohol had no effect on serum concentrations of piracetam; serum ethanol concentrations were not altered when 1.6 g of piracetam was taken.

Special Instructions

In the treatment of cortical myoclonias, abrupt interruption of treatment should be avoided as it may cause a recurrence of seizures.

In the treatment of sickle cell anemia, a dose of less than 160 mg/kg or irregular administration of the drug may cause exacerbation of the disease.

Permeasures through the filter membranes of hemodialysis machines.

Influence on driving and operating machinery During treatment, caution should be exercised when driving motor transport and engaging in other potentially dangerous activities that require increased concentration and rapid psychomotor reactions.

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 impairment of cerebral circulation (hemorrhagic stroke);

– End-stage renal failure (with creatinine clearance less than 20 ml/min);

– Children under 3 years.

With caution: impaired hemostasis; extensive surgical interventions; severe bleeding; chronic renal failure (with creatinine clearance 20-80 ml/min).

Side effects

Nervous system disorders: motor disinhibition, irritability, somnolence, depression, asthenia, headache, insomnia, agitation, balance disorder, ataxia, worsening of epilepsy, anxiety, hallucinations, confusion.

Digestive system disorders: nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

Metabolic disorders: weight gain.

Hearing disorders: vertigo.

Skin disorders: dermatitis, itching, urticaria.

Allergic reactions: angioedema, hypersensitivity, anaphylactic reactions.

Overdose

Symptoms: diarrhea with a mixture of blood, pain in the abdominal area.

Treatment: in case of significant overdose, gastric lavage or vomiting should be induced. Symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote. The effectiveness of hemodialysis for piracetam is 50-60%.

Pregnancy use

No controlled studies on the use of the drug during pregnancy have been conducted.

Piracetam penetrates through the placental barrier and into the breast milk.

The drug concentration in infants reaches 70-90% of its concentration in the blood of the mother.

Piracetam should not be administered during pregnancy.

During lactation the decision to stop breastfeeding should be made.

Similarities

Nootropil, Piracetam, Piracetam bufus, Notrocetam