Thiocetam® [Piracetam, Thiotriazoline]

Thiocetam® FORTE, film-coated tablets

Instruction manual

For medical use of the drug

Structure:

Active ingredients: 1 tablet contains: piracetam in terms of 100% substance - 400 mg; morpholinium salt of thiazoic acid in terms of 100% substance, which is equivalent to 66.5 mg of thiazoic acid - 100 mg;

excipients: potato starch; mannitol; icing sugar; magnesium stearate; povidone; mixture for coating "Opadry II Yellow" 33G22623 **.

** - mixture for coating "Opadry II Yellow" 33G22623 contains: hypromellose; lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol (macrogol) 3000; triacetin; quinoline yellow (E 104); yellow sunset FCF (E 110); iron oxide yellow (E 172); indigo carmine (E 132).

Dosage form.

Film-coated tablets.

Basic physico-chemical properties: tablets, film-coated yellow, oval, with a risk on one side of the tablet. A white core is visible on the fault.

Pharmacotherapeutic group.

Psychostimulating and nootropic drugs. code atx n06 in x.

Pharmacological properties.

Pharmacodynamics

The drug belongs to the group of cerebroactive drugs, has anti-ischemic, antioxidant, membrane-stabilizing and nootropic properties.

The drug improves the integrative and cognitive activity of the brain, increases the effectiveness of the learning process, helps to eliminate the symptoms of amnesia, and increases indicators of short-term and long-term memory.

The pharmacological effect of the drug is due to the mutually potentiating effect of thiazoic acid and piracetam.

The drug is able to accelerate the oxidation of glucose in the reactions of aerobic and anaerobic oxidation, normalize bioenergy processes, increase ATP level, stabilize metabolism in brain tissues.

The drug inhibits the formation of reactive oxygen species, reactivates the antioxidant enzyme system, especially superoxide dismutase, inhibits free radical processes in the brain tissue during ischemia, improves blood rheological properties due to the activation of the fibrinolytic system, stabilizes and reduces, respectively, areas of necrosis and ischemia.

Pharmacokinetics

It is well absorbed by internal use, penetrates into various organs and tissues, including brain tissue. The drug crosses the placental barrier.

Each component of the drug is metabolized separately. Piracetam is practically not metabolized in the body and excreted in the urine. The elimination half-life is 4-8 hours. Morpholinium salt of thiazoic acid after oral administration is rapidly absorbed, its absolute bioavailability is 53%. The maximum concentration in the blood plasma is reached 1.6 hours after a single dose of 200 mg. The half-life is about 8 hours.

Clinical characteristics.

Indications.

Transient and chronic cerebrovascular disorders caused by atherosclerosis of cerebral vessels and cerebrovascular disorders in the past. the drug is also indicated for disorders of cerebral circulation, metabolic disorders of the brain caused by traumatic brain injuries, intoxications, diabetic encephalopathy, as well as in the rehabilitation period of ischemic stroke.

Contraindications

Hypersensitivity to piracetam or pyrolidone derivatives, and / or thiazoic acid, as well as to any other component of the drug.

Acute hemorrhagic cerebrovascular accident.

Acute renal failure.

The terminal stage of renal failure.

Huntington Chorea.

Interaction with other drugs and other types of interactions.

Thiocetam forte should not be prescribed with drugs that have an acidic pH.

Due to the presence of piracetam, the following types of interaction are possible:

Thyroid hormones.

When combined with thyroid hormones (T3 + T4), increased irritability, disorientation and sleep disturbance are possible.

Acenocoumarol.

In patients with severe recurrent thrombosis, the use of piracetam in high doses (9.6 g / day) did not affect the dosage of acenocoumarol to achieve a prothrombin time (INR) of 2.5-3.5, but with simultaneous use, a significant decrease in the level of aggregation was noted platelets, fibrinogen levels, Willibrandt factors (VIII: C; VIII: vW: Ag; VIII: vW: Rco), blood and plasma viscosity.

Pharmacokinetic interactions.

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

In vitro, piracetam does not inhibit the cytochrome P450 isoform of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9 / 11 at a concentration of 142, 426, 1422 μg / ml.

At a concentration of 1422 μg / ml, slight inhibition of CYP2A6 (21%) and 3A4 / 5 (11%) was noted. However, the Ki level of these two CYP isomers is sufficient if 1422 μg / ml is exceeded. Therefore, metabolic interaction with drugs that undergo biotransformation by these enzymes is not possible. Antiepileptic drugs.

The use of piracetam at a dose of 20 mg / day for 4 weeks or more did not change the concentration level curve and the maximum concentration (Cmax) of antiepileptic drugs in blood serum (carbamazepine, phenytoin, phenobarbital, sodium valproate) in patients with epilepsy.

Concomitant use with enalapril, captopril increases the risk of adverse reactions from the cardiovascular system.

Alcohol.

Concomitant use with alcohol did not affect the level of concentration of piracetam in blood serum and the concentration of alcohol in blood serum did not change with 1.6 g of piracetam.

Features of the application.

With caution, it is necessary to take the drug for elderly people who suffer from cardiovascular pathology, since adverse reactions in this group are noted more often.

Allergic reactions are more common in people prone to allergies.

Effect on platelet aggregation. Due to the fact that piracetam reduces platelet aggregation, it is necessary to prescribe the drug with caution to patients with impaired hemostasis, conditions that may be accompanied by hemorrhages (gastrointestinal ulcer), during significant surgeries (including dental interventions), and patients with severe symptoms bleeding or a patient with a history of hemorrhagic stroke; patients who use anticoagulants, platelet antiplatelet agents, including low doses of acetylsalicylic acid. The drug is excreted by the kidneys, so special attention should be paid to patients with renal failure.

Elderly patients. With prolonged therapy in elderly patients, regular monitoring of renal function indicators is recommended, if necessary, the dose should be adjusted depending on the results of a study of creatinine clearance.

The drug contains lactose as an excipient, which should be considered in patients with galactose intolerance, lactase deficiency or impaired glucose / galactose absorption.

1 tablet of Thiocetam Forte contains 0.007 g of powdered sugar, which should be considered in patients with diabetes mellitus.

Use during pregnancy or lactation.

Do not use.

The ability to influence the reaction rate when driving with other mechanisms.

It is not recommended to use the drug when driving vehicles and working with mechanisms that require increased attention, due to the risk of the development of possible adverse reactions from the nervous system.

Dosage and administration.

The dosage and duration of treatment is determined by the doctor in each individual case separately, depending on the nature and course of the disease.

In transient and chronic cerebrovascular disorders and in the rehabilitation period after ischemic stroke, 1 tablet 3 times a day for 25-30 days.

Prescribe Thiocetam Forte tablets 30 minutes before meals. The course of treatment is from 2-3 weeks to 3-4 months.

For the treatment of diabetic encephalopathy, prescribe 1 tablet 3 times a day for 45 days.

Children.

Do not use.

Overdose.

When used in therapeutic doses, an overdose is not possible.

If you deviate from the doses prescribed by the doctor, it is possible that side effects of the drug may arise and intensify (agitation, sleep disturbance, dyspeptic phenomena). In these cases, reduce the dose of the drug and prescribe symptomatic treatment (induce vomiting, rinse the stomach).

With an overdose in the urine, the concentration of sodium and potassium increases. In such cases, the drug must be discontinued.

Adverse Reactions

With the clinical use of the drug thiocetam forte, there may be cases of adverse reactions:

from the central and peripheral nervous system: headache, general weakness, insomnia, drowsiness, anxiety, internal stress;

from the gastrointestinal tract: nausea, vomiting, dry mouth, diarrhea;

from the immune system: allergic reactions, including rashes, itching, urticaria, sweating;

from the vestibular system: dizziness.

Patients may develop adverse reactions caused by individual components of the drug:

• piracetam:

from the blood and lymph: hemorrhagic disorders;

from the immune system: hypersensitivity, anaphylactoid reactions; mental disorders: nervousness, depression, increased excitability, anxiety, agitation, hallucinations;

from the nervous system: hyperkinesia, drowsiness, ataxia, imbalance, increased frequency of epilepsy attacks, headache, insomnia, tremor;

on the part of the organs of hearing and the labyrinth: dizziness;

from the digestive system: abdominal pain, pain in the upper abdomen, diarrhea, nausea, vomiting;

on the part of the skin and subcutaneous tissues: angioedema, dermatitis, rashes, urticaria, itching;

from the reproductive system and lactation: increased sexual activity;

general disorders: asthenia, weight gain.

• thiazole acid:

on the part of the skin and subcutaneous tissue: itching, flushing of the skin, rash, urticaria, angioedema;

from the immune system: anaphylactic shock;

from the central and peripheral nervous system: dizziness, tinnitus;

from the cardiovascular system: tachycardia, increased blood pressure;

from the gastrointestinal tract: dyspepsia, including dry mouth, bloating, nausea, vomiting;

from the respiratory system: shortness of breath, suffocation;

general disorders: fever, general weakness.

The product contains dye yellow sunset FCF (E 110), which can cause allergic reactions.

Shelf life.

3 years.

Storage conditions.

In the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging.

10 tablets in a blister, 3 or 6 blisters pack.

Vacation category.

On prescription.

Manufacturer.

Pao Kyivmedpreparat.

The location of the manufacturer and the address of the place of business.

Ukraine, 01032, Kiev, st. Saksaganskogo, 139.