Maxotropil^® (Tablets) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

ATC Code

N06BX03 (Piracetam)

Active Substance

Piracetam (Rec.INN registered by WHO)

Dosage Form

Maxotropil®

Effervescent tablets 600 mg: 10, 15, 20, 25, 30, 40, 45, or 60 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets white or almost white with inclusions, round, flat-cylindrical in shape, with a double-sided bevel, with a characteristic lemon odor; roughness of the tablet surface is allowed.

Excipients: sorbitol, sodium bicarbonate, anhydrous sodium carbonate, tartaric acid, aspartame, povidone K-25, lemon flavor, macrogol 6000, glyceryl dibehenate.

3 pcs. – non-cell contour packs (5) – cardboard packs.
3 pcs. – non-cell contour packs (10) – cardboard packs.
3 pcs. – non-cell contour packs (15) – cardboard packs.
3 pcs. – non-cell contour packs (20) – cardboard packs.
4 pcs. – non-cell contour packs (10) – cardboard packs.
10 pcs. – plastic tubes (1) – cardboard packs.
15 pcs. – plastic tubes (1) – cardboard packs.
20 pcs. – plastic tubes (1) – cardboard packs.
25 pcs. – plastic tubes (1) – cardboard packs.
30 pcs. – plastic tubes (1) – cardboard packs.
10 pcs. – polyethylene jars (1) – cardboard packs.
15 pcs. – polyethylene jars (1) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.
25 pcs. – polyethylene jars (1) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

Pharmacological Action

Nootropic agent. It has a positive effect on metabolic processes and cerebral circulation.

It increases glucose utilization, improves the course of metabolic processes, improves microcirculation in ischemic areas, and inhibits the aggregation of activated platelets.

It has a protective effect in brain damage caused by hypoxia, intoxication, and electric shock. It improves the integrative activity of the brain. It does not have a sedative or psychostimulant effect.

It reduces the duration of provoked vestibular neuronitis. It inhibits increased aggregation of activated platelets and, in the case of pathological erythrocyte rigidity, improves their deformability and filtration ability.

Pharmacokinetics

When taken orally, it is rapidly and almost completely absorbed from the gastrointestinal tract. The bioavailability is about 100%. C_max in plasma is reached in approximately 30 minutes, in cerebrospinal fluid – in 2-8 hours. The apparent V_d is 0.6 l/kg. It does not bind to plasma proteins.

It is distributed in all organs and tissues, penetrates the blood-brain barrier and the placental barrier. It selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal, and occipital lobes, in the cerebellum and basal ganglia.

T_1/2 from plasma is 4-5 hours, from cerebrospinal fluid – 6-8 hours. It is excreted by the kidneys unchanged. In renal failure, T_1/2 increases.

Indications

Memory disorders, dizziness, decreased concentration, emotional lability, dementia due to cerebrovascular accidents (ischemic stroke), head injuries, in Alzheimer’s disease, in old age, intellectual-mnestic disorders, cortical myoclonus; coma of vascular, traumatic or toxic origin; treatment of withdrawal and psychoorganic syndrome in chronic alcoholism; learning disabilities in children not associated with inadequate learning or family environment (as part of combination therapy); sickle cell anemia (as part of combination therapy).

ICD codes

Dosage Regimen

It is used orally, intramuscularly or intravenously. The dose, method and scheme of application, duration of therapy are determined individually, depending on the indications, clinical situation, patient’s age and the dosage form used.

Parenteral administration of piracetam is prescribed when oral forms are not possible (unconsciousness, difficulty swallowing). Intravenous administration is preferred.

Adverse Reactions

From the blood coagulation system: frequency unknown – bleeding.

From the immune system: frequency unknown – anaphylactoid reactions, hypersensitivity reactions.

From the psyche: often – nervousness; infrequently – depression; frequency unknown – agitation, anxiety, confusion, hallucinations.

From the nervous system: often – hyperactivity; infrequently – drowsiness; frequency unknown – ataxia, balance disorders, exacerbation of epilepsy, headache, insomnia, tremor.

From the hearing organ and labyrinth: frequency unknown – vertigo.

From the cardiovascular system: rarely – thrombophlebitis; with parenteral administration – arterial hypotension.

From the digestive system: frequency unknown – abdominal pain, diarrhea, nausea, vomiting.

From the skin and subcutaneous tissues: frequency unknown – angioedema, dermatitis, itching, urticaria.

Local reactions: rarely – pain at the injection site.

Others: often – weight gain; infrequently – asthenia, fever (only with parenteral administration); frequency unknown – increased sexual desire.

Contraindications

Hypersensitivity to piracetam; Huntington’s chorea, acute cerebrovascular accident (hemorrhagic stroke), end-stage chronic renal failure; children’s age – depending on the dosage form.

Use in Pregnancy and Lactation

During pregnancy, it should be used only as prescribed by a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of stopping breastfeeding should be decided.

Use in Hepatic Impairment

No dose adjustment is required for patients with impaired liver function.

Use in Renal Impairment

Contraindicated in severe renal failure. Use with caution in patients with renal failure; during the use of piracetam, monitoring of creatinine clearance is necessary. Dose adjustment is recommended in accordance with creatinine clearance values.

Pediatric Use

It can be used in children of the appropriate age categories strictly according to indications, in recommended doses, regimens and dosage forms. It is necessary to strictly follow the instructions in the piracetam drug instructions regarding contraindications for the use of specific piracetam dosage forms in children of different ages.

Geriatric Use

With long-term treatment of elderly patients, regular monitoring of creatinine clearance is necessary; dose adjustment may be required.

Special Precautions

Due to the antiplatelet effect of piracetam, it should be prescribed with caution to patients with severe hemorrhagic disorders, risk of bleeding (for example, with gastric ulcer), hemostasis disorders, in patients with surgical interventions, including dental interventions, in patients taking anticoagulants and antiplatelet agents, including low doses of acetylsalicylic acid.

Since Piracetam is excreted by the kidneys, caution should be exercised when prescribing it to patients with renal failure.

With long-term treatment of elderly patients, regular monitoring of creatinine clearance is necessary; dose adjustment may be required.

Piracetam penetrates through the filtering membranes of hemodialysis machines.

When treating cortical myoclonus, abrupt interruption of treatment should be avoided, as this may cause the seizures to resume.

If sleep disturbances occur, it is recommended to cancel the evening dose of piracetam, adding this dose to the daytime dose.

Effect on the ability to drive vehicles and mechanisms

During the use of piracetam, patients should be careful when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of piracetam and thyroid extract (triiodothyronine + thyroxine), confusion, irritability and sleep disturbance were noted.

With simultaneous use with thyroid hormone drugs, the development of central effects is possible – tremor, anxiety, irritability, sleep disorders, confusion.

With simultaneous use with CNS stimulants, an increase in the psychostimulant effect is possible.

With simultaneous use with antipsychotics, an increase in extrapyramidal disorders is observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.