Manufacturer: Arterium (Arterium) Ukraine

ATC code: N06BX53

Pharm group:

Release form: Solid dosage forms. Tablets.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Important! Check out the treatment

Method of administration and dosage:

Application features:

Side effects:

Interaction with other medicinal products:

Contraindications:

Overdose:

Storage conditions:

Best before date. 2 years. Store in its original packaging at a temperature not exceeding 25 ° C. Store out of the reach of children.

Vacation conditions:

On prescription

Package:

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

Release form and composition

Dosage forms of release of Thiocetam:

• solution for intravenous and intramuscular administration: clear, colorless or slightly yellowish liquid (5 and 10 ml in colorless transparent glass ampoules, 10 ampoules in a box or 5 ampoules in blisters, 2 packages in a cardboard box. ampoules without a point or break ring, an ampoule scarifier is inserted into the box);
• film-coated tablets: round, biconvex, yellow, a white or almost white core can be seen in cross-section (10 pcs. in blisters, 3 or 6 packs in a cardboard box).

Composition of 1 ml solution for injection:

• active ingredients: piracetam - 100 mg, morpholinium-methyl-triazolyl-thioacetate (thiotriazoline) - 25 mg;
• additional component: water for injection - up to 1 ml.

Composition of 1 tablet:

• active substances: piracetam - 200 mg, morpholinium-methyl-triazolyl-thioacetate (thiotriazoline) - 50 mg;
• auxiliary components: calcium stearate, sucrose (powdered sugar), low molecular weight povidone (low molecular weight medical polyvinylpyrrolidone 12 600 ± 2700), potato starch, microcrystalline cellulose;
• film casing: opadry II yellow, including titanium dioxide, macrogol, lactose monohydrate, hypromellose, triacetin, aluminum varnish based on sunset yellow dye, aluminum varnish based on indigo carmine dye, aluminum varnish based on quinoline yellow dye, iron dye oxide yellow.

Pharmacological properties

Pharmacodynamics

Thiocetam is a cerebroactive agent that exhibits antioxidant, nootropic and anti-ischemic activity. The pharmacological properties of the drug are due to the mutual enhancement of the action of its active substances - piracetam and thiotriazoline.

Piracetam is a nootropic agent that is a cyclic derivative of gamma-aminobutyric acid (GABA), which acts directly on the brain, thereby improving consciousness, attention, memory and learning ability. It does not have a psychostimulating and sedative effect. At the neural level, the remedy relieves different types synaptic transmission, with a predominant effect on the activity and density of postsynaptic receptors. Piracetam has a hemorheological effect, which is associated with its effect on the walls of blood vessels, erythrocytes and platelets. Thus, piracetam increases the indicators of short-term and long-term memory, eliminates amnesia, promotes the learning process, and improves cognitive and integrative brain activity.

Thiotriazoline is a drug that reacts with lipid radicals and reactive oxygen species due to the pronounced reducing properties of the thiol group, and also prevents the emergence of reactive oxygen species due to the reactivation of antiradical enzymes such as catalase, glutathione peroxidase and superoxide dismutase.

Pharmacokinetics

The pharmacokinetic parameters of Thiocetam have not been studied.

Indications for use

• chronic cerebral ischemia;
• diabetic encephalopathy;
• the recovery period of ischemic stroke (including cases of the presence of non-demented cognitive impairment).

Contraindications

• acute violation of cerebral circulation (hemorrhagic stroke);
• chorea of ​​Huntington;
• psychomotor agitation at the time of prescribing the drug;
• severe chronic renal failure (creatinine clearance< 20 мл/мин);
• age under 18;
• pregnancy and lactation;
• hypersensitivity to any active or auxiliary component of the drug.

In tablets, Thiocetam is also contraindicated in glucose-galactose malabsorption, fructose intolerance, hereditary lactose intolerance, sucrase / isomaltase or lactase deficiency.

The drug should be used with caution in the following cases:

• chronic renal failure (creatinine clearance 20–80 ml / min);
• hemostasis disorders, severe bleeding or surgery;
• old age (in the presence of cardiovascular pathologies).

Instructions for the use of Thiocetam: method and dosage

Injection

In the form of a solution, Thiocetam is administered intramuscularly or intravenously, and only if there is no possibility of oral administration of the drug.

In other cases (chronic disorders of cerebral circulation and the recovery period after ischemic stroke), depending on the clinical situation, intravenous infusion is prescribed once a day, 20-30 ml of solution diluted in 100-150 ml of 0.9% sodium chloride solution. The duration of therapy is 2 weeks, then the patient is transferred to Tiocetam tablets.

Film-coated tablets

Thiocetam tablets should be taken orally half an hour before meals. To avoid sleep disturbances, the last (evening) dose should be taken no later than 5 pm.

• chronic disorders of cerebral circulation and the recovery period after ischemic stroke: 2 tab. 3 times a day for a course of 25-30 days, if necessary, therapy is extended to 3-4 months;
• diabetic encephalopathy: 2 tab. 3 times a day for 45 days.

Side effects

• nervous system: tinnitus, drowsiness, insomnia, irritability, headache, imbalance, dizziness, confusion, anxiety, depression, mental agitation, hallucinations, asthenia, motor disinhibition, exacerbation of epilepsy, ataxia;
• gastrointestinal tract: abdominal pain (including gastralgia), dry mouth, diarrhea, bloating, nausea, vomiting;
• cardiovascular system: pain in the region of the heart, increased blood pressure, arrhythmia, tachycardia; in the elderly - exacerbation of coronary insufficiency;
• metabolism: weight gain;
• respiratory organs: attacks of suffocation, shortness of breath;
• hearing organs: vertigo;
• allergic reactions: fever, urticaria, itching, dermatitis, angioedema, anaphylaxis, hypersensitivity reactions;
• local reactions with intravenous and intramuscular injection: pain at the injection site.

Overdose

In case of an overdose, the occurrence or increase in the severity of the existing dose-dependent side effects is possible. In this case, the drug is canceled and, if required, symptomatic therapy is carried out in order to eliminate the developed disorders.

special instructions

Elderly patients with long-term treatment are shown regular monitoring of renal function. Based on creatinine clearance, adjust the dose if necessary.

Influence on the ability to drive vehicles and complex mechanisms

According to the instructions, Thiocetam can cause side effects such as dizziness, confusion, drowsiness, imbalance, and motor disinhibition. In this regard, during treatment, it is worth refraining from activities that require increased concentration of attention and speed of reactions, including driving a car and working with complex mechanisms.

Application during pregnancy and lactation

During these periods, Thiocetam is not prescribed due to the lack of experience with the drug.

Childhood use

The drug is contraindicated in patients under 18 years of age due to lack of experience with its use.

With impaired renal function

Severe chronic renal failure with creatinine clearance (CC)< 20 мл/мин – противопоказание к применению Тиоцетама. Если КК 20−80 мл/мин, требуется соблюдать особую осторожность в период терапии.

Use in the elderly

Elderly people with concomitant pathologies of the cardiovascular system Thiocetam should be used with caution due to the high likelihood of side effects.

Drug interactions

Thiocetam should not be used in combination with products that have an acidic pH.

Piracetam enhances the effect of antianginal drugs and antidepressants.

While taking hormones thyroid gland side effects such as sleep disturbances, irritability and confusion may occur.

The concomitant use of alcohol does not affect the serum concentration of piracetam. The ethanol concentration also does not change if piracetam is used at a dose of up to 1600 mg.

The drug does not inhibit cytochrome P450 isozymes. Interacting with others medicines unlikely.

The analogues of Thiocetam are: Glycine, Cavinton, Gopantam, Nootropil, Cerakson, Lucetam, Omaron, Encephabol, Cerebrolysin, Phezam, etc.

Terms and conditions of storage

Store out of the reach of children, protected from light, solution - at temperatures up to 25 ° С, tablets - at a temperature of 15–25 ° С.

The shelf life of the solution is 3 years, of the tablets - 2 years.

Conditions of dispensing from pharmacies

Dispensed by prescription.

Reviews of Thiocetam

Patients undergoing therapy with this nootropic drug leave different reviews about Thiocetam. For many, the remedy has helped a lot, so they consider it one of the most effective. However, some note the ineffectiveness of the treatment or complain about the side effects that have arisen. Thus, we can conclude that Thiocetam is an effective drug, but it should be prescribed individually and in a timely manner, and therapy should be carried out carefully, under close medical supervision.

The price of Thiocetam in pharmacies

The price of Thiocetam tablets is 500-570 rubles per pack of 60 tablets. The cost of the solution for injection is 410-615 rubles for 10 ampoules of 5 ml.

Do you know why doctors prescribe a drug like Thiocetam? Instructions for the use of this tool, as well as its form of release, composition and indications will be presented in this article. We will tell you about the pharmacological characteristics of the medication, whether it has contraindications and side effects.

Form of release of the drug and its composition

Currently, there are two available in pharmacies different shapes medication "Thiocetam". The instructions for use state that such a remedy is available in the form of a solution and tablets (for intravenous and intramuscular administration, as well as for oral administration, respectively).

The active substance of the solution is thiotriazoline and piracetam. This form of the drug is sold in ampoules (10 and 5 ml each), which are placed in cell contour packages and cardboard boxes.

As for the pills, then their active ingredients also are thiotriazoline and piracetam. They go on sale in a cardboard box of 60 pieces.

Pharmacological characteristics

What are the properties of the drug "Thiocetam"? The instructions for use inform that this agent belongs to the group of cerebroactive. It is capable of exhibiting antioxidant, anti-ischemic and nootropic properties.

Therapeutic effect the medication is due to the mutually potentiating effect of piracetam and thiotriazoline. The first element is a cyclic derivative of GABA. This substance belongs to nootropic drugs. It acts directly on the brain, improving attention and consciousness, learning and memory. At the same time, the drug does not have any psychostimulating and sedative effects.

At the neuronal level, a substance such as piracetam greatly facilitates synaptic transmission. It affects the activity and density of postsynaptic receptors. It should be especially noted that the hemorheological properties of piracetam are directly related to its effect on platelets, erythrocytes and vascular walls.

As for thiotriazoline, it is capable of reacting with lipid radicals and reactive oxygen species. This process occurs due to the pronounced reducing properties of the thiol group.

It should also be said that thiotriazoline prevents the formation of reactive oxygen species. This process is carried out by reactivating antiradical enzymes such as catalase, superoxide dismutase and glutathione peroxidase.

From all of the above, we can safely conclude that the drug "Thiocetam" (injections and pills) improves cognitive as well as integrative brain activity, promotes learning and eliminates amnesia. In addition, the drug increases the indicators of both long-term and short-term memory.

Indications

Why is Thiocetam needed? The instructions for use contain the following indications:

• cerebral ischemia (chronic);
• ischemic stroke (recovery period);
• non-demented cognitive impairment;
• diabetic encephalopathy.

Contraindications

Does a medication such as "Thiocetam" have contraindications? The instruction says that this drug cannot be used with:

• hypersensitivity to thiotriazoline or piracetam, as well as to other substances of the medicine;
• chorea of ​​Huntington;
• heavy renal failure chronic in nature;
• acute disorders of cerebral circulation (that is, hemorrhagic stroke);
• psychomotor agitation;
• pregnancy and lactation;
• hereditary lactose intolerance, lactase deficiency;
• deficiency of sucrase and fructose intolerance;
• glucose-galactose malabsorption;
• in childhood.

Reception with care

In the presence of any deviations, a medication such as "Thiocetam" is prescribed with extreme caution? The instruction says that this drug is able to affect platelet aggregation. In this regard, it should be used with caution in patients with surgical interventions, as well as with impaired hemostasis and severe bleeding.

Also, the use of the medication in question should be monitored by a doctor for chronic renal failure, in old age, with cardiovascular pathologies (in such a group of patients, adverse reactions are most often observed).

The drug "Thiocetam": instructions for use (injections)

If it is impossible to take the medication inside, it is administered intramuscularly or intravenously.

In case of ischemic stroke (during the recovery period), as well as chronic circulatory disorders in the brain, the drug is prescribed at 20-30 ml. It is preliminarily diluted in a 0.9% solution (100-150 ml) of sodium chloride, and then injected intravenously (drip) once a day.

The course of this treatment should be at least 15 days. After that, they switch to the tablet form of the drug.

How should Thiocetam solution be used in diabetic encephalopathy? Instructions for use (injections should be prescribed only by the attending physician) states that in this case the drug must be used in a volume of 5 ml (intramuscularly) once a day for 10 days. After such a course, you can safely switch to the tablet form.

Medication "Thiocetam": instructions for use (tablets)

The tablets should be taken orally half an hour before meals.

With ischemic stroke (during the recovery period), as well as with chronic circulatory disorders of the brain, the patient is given 2 tablets three times a day. Such treatment is carried out for 25-30 days. If necessary, the course can be extended up to 4 months.

For the treatment of diabetic encephalopathy, the patient is also prescribed 2 tablets three times a day. However, in this case, the treatment is carried out for 45 days.

The last dose of the drug must be taken no later than 5 pm. This will prevent sleep disturbances.

Overdose

What symptoms occur when the drug "Thiocetam" is taken incorrectly (the price of the medication is indicated below)? If the doctor's instructions are not followed, then the patient may have increased dose-dependent side effects. As a treatment, you should cancel the medicine, induce vomiting, flush the stomach (when taking pills) and use symptomatic therapy.

Side effects

There are many undesirable effects that can occur after using a medication such as Thiocetam. Instructions for use (the price of this drug is quite high) contains the following list of adverse reactions:

• Nervous system: motor disinhibition, anxiety, irritability, hallucinations, drowsiness, tinnitus, depression, insomnia, headaches, ataxia, dizziness, exacerbation of epilepsy, mental agitation, confusion, asthenia and imbalance.
• Digestive tract: dry mouth, nausea, bloating, vomiting, abdominal pain and diarrhea.
• Heart and blood vessels: hypertension, tachycardia, pain in the region of the heart, arrhythmia, coronary insufficiency (in the elderly).
• Allergies: angioedema, hypersensitivity, dermatitis, anaphylactic reactions, pruritus, fever, urticaria.
• Respiratory organs: attacks of suffocation and shortness of breath.
• Hearing organs: vertigo.
• Metabolism: weight gain.

Drug interactions

It is forbidden to prescribe injections and tablets "Thiocetam" with products that have an acidic pH value.

Due to the presence of piracetam in the preparation, the effect of antianginal agents and antidepressants is enhanced.

When used simultaneously with thyroid hormones, there is a possibility of confusion, sleep disturbance and irritability.

Metabolic interactions with other drugs are unlikely.

Taking the drug together with alcohol does not in any way affect the level of concentration of piracetam in the blood.

special instructions

During the period of therapy with the drug "Thiocetam", one should refrain from driving a car, as well as from practicing dangerous species works that require speed of psychomotor reactions and increased concentration of attention.

Storage conditions

The agent in question must be stored in a place protected from light (sunlight) and out of the reach of children. The storage temperature of the drug is 15-24 ° C. Its shelf life is two years.

The cost of the medication

How much does Thiocetam cost? The price of this product may be different, depending on the markup of the pharmacy chain, as well as on the form of release of the drug. The average cost of this medication is 460 Russian rubles.

Many patients who have been prescribed this drug feel that this is an overpriced price. Considering that the medication should be taken throughout long period(from several weeks to several months), the treatment is quite expensive.

Today the Galichpharm company produces Thiocetam in three dosage forms.

Solution for injection containing 0.1 g piracetam and 0.025 g thiotriazoline in 1 ml.

Thiocetam tablets containing 50 mg thiotriazoline and 200 mg piracetam in 1 tablet. Additional ingredients are povidone, potato starch, powdered sugar, calcium stearate, microcrystalline cellulose.

Thiocetam Forte tablets containing 400 mg piracetam and 100 mg thiotriazoline in 1 tablet. Additional ingredients are: potato starch, powdered sugar, povidone, magnesium stearate, microcrystalline cellulose, mannitol.

Release form

The solution for injection is packaged in ampoules of 5 ml or 10 ml - 10 per pack.

Film-coated tablets, 30 tablets or 60 tablets per pack.

Forte tablets, film-coated, 30 tablets or 60 tablets per pack.

pharmachologic effect

Nootropic, anti-ischemic, antioxidant and membrane stabilizing.

Pharmacodynamics and pharmacokinetics

The drug Thiocetam improves the cognitive and integrative activity of the brain, increases the efficiency of the learning process, promotes elimination symptoms of amnesia, and also increases indicators of long-term and short-term memory.

The mechanism of action is mutually potentiating action active substances. The drug accelerates the processes of glucose oxidation in the reactions of anaerobic and aerobic oxidation, increases the concentration of ATP, helps to normalize bioenergetic processes and stabilize metabolic processes in brain tissues.

It slows down the pathways of the formation of reactive oxygen species, inhibits the antioxidant enzymatic system, especially superoxide dismutase, reactivates the course of free radical processes in the brain tissues during ischemia, reduces and stabilizes the zones, respectively ischemia and necrosis, improves the rheological qualities of blood due to the activation of the fibrinolytic system.

When taken orally, it is well absorbed and penetrates into various tissues and organs, including brain tissue.

Has the ability to penetrate placental barrier.

The active ingredients are metabolized separately.

Piracetam metabolized in very small quantities and excreted in the kidneys.

The half-life is 4-8 hours.

Thiotriazoline amenable to metabolism in the liver and also excreted by the kidneys.

Indications for use

Chronic and incoming circulatory disorders of the brain, due to cerebral atherosclerosis, as well as those associated with previously diagnosed disorders of his blood circulation.

Thiocetam also used for pathological disorders of cerebral metabolic processes as a result of the obtained traumatic brain injury, diabetic encephalopathy, intoxications, as well as during the rehabilitation period hemorrhagic and ischemic strokes.

Contraindications

• chorea of ​​Huntington;
• patient hypersensitivity to thiotriazoline and / or piracetam or to other components of the drug;
• renal failure in the terminal stage;
• hemorrhagic stroke in the acute period;
• age under 18;
• period pregnancy;
• period breastfeeding.

Side effects

In general, the drug Thiocetam, both tablets and injections, is well tolerated. Side effects were observed only in rare cases and are associated with the active components of the drug.

Nervous system:

• general weakness;
• hyperexcitability;
• headache;
• anxiety;
• increased libido;
• hallucinations;
• confusion of consciousness;
• tremor;
• imbalance;
• hyperkinesia;
• drowsiness or insomnia;
• increased frequency of epileptic seizures;
• ataxia;
• asthenia;
• depression;
• noise in ears;
• dizziness.

Gastrointestinal tract:

• dry mouth;
• nausea or vomit;
• bloating;
• diarrhea;
• abdominal pain.

Skin integuments:

• itching;
• hyperemia of the skin;
• rash;
• hives;
• dermatitis;
• angioedema.

The immune system:

• reactions hypersensitivity, including anaphylaxis.

The cardiovascular system:

• tachycardia;
• arterial hypertension.

Respiratory system:

• suffocation;
• dyspnea.

• weight gain;
• fever;
• hyperthermia.

Instructions for use (Method and dosage)

For the solution for injection of the drug Thiocetam, the instructions for use recommend the following doses:

During therapy ischemic stroke dissolve ampoules of Thiocetam - 20-30 ml in saline- 100-150 ml, and is administered as an infusion once a day. The course of therapy is 14 days.

To eliminate the consequences withdrawal symptoms caused by alcohol intoxication as well as for treatment encephalopathy appoint intramuscular injections in a dose of 5 ml, administered once a day for 10-15 days.

Therapy diabetic encephalopathy involves intramuscular administration of the drug in a dose of 5 ml every day. The injections are carried out for 10 days. In the future, it is recommended to continue treatment with the use of tablets - 2 tablets three times a day (30 minutes before meals), for 45 days.

For tablets, the following treatment regimens are provided:

At chronic and incoming circulatory disorders of the brain and also after hemorrhagic and ischemic stroke during the rehabilitation period, 2 tablets are prescribed with a three-fold daily intake. The therapy is carried out for 25-30 days.

For therapy diabetic encephalopathy recommend taking 2 tablets of the drug 3 times a day, for 45 days.

Thiocetam tablets are taken 30 minutes before meals.

Instructions for use Thiocetam Forte assumes an individual duration of treatment, determined by the doctor in each individual case, depending on the severity and course of the disease.

Usually the recommended daily dose tablets Thiocetam Forte, with chronic and incoming circulatory disorders of the brain, as well as during the rehabilitation period after hemorrhagic and ischemic stroke, is 3 tablets taken 3 times a day, for 25-30 days.

For therapy diabetic encephalopathy, as a rule, 3 tablets are prescribed per day in 3 divided doses, for 45 days.

Thiocetam Forte tablets are taken 30 minutes before meals.

The course of therapy can range from 14 days to 3-4 months.

Overdose

When carrying out treatment in therapeutic doses, an overdose is impossible. In the case of taking doses of Tiocetam in excess of the recommended ones, side effects may appear or they may increase.

Interaction

The drug in the form of tablets should not be administered with drugs that have an acidic pH.

Thiocetam enhances the effect antianginal drugs and antidepressants.

Combined reception with thyroid hormones(T3 + T4) can cause irritability, sleep disturbances and disorientation.

Simultaneous use with Captopress and Enalapril increases the risk of developing unwanted side effects from the cardiovascular system.

Terms of sale

On prescription.

Storage conditions

At a temperature not higher than 25 ° C.

Best before date

For ampoules and tablets - 2 years.

For Forte tablets - 3 years.

special instructions

Patients with chronic renal failure Thiocetam is prescribed with caution.

The drug has an effect on platelet regeneration, in this connection, requires caution when used during surgical operations and in case of violations hemostasis.

Also, caution is necessary when prescribing Thiocetam to elderly patients who suffer from cardiovascular pathologies, due to the frequent occurrence of adverse reactions.

The drug can be prescribed when cerebrovascular insufficiency with impaired speech, attention, memory, decreased intellectual activity of the brain and disorders in the emotional sphere.

Analogs Matching ATX level 4 code:

Thiocetam analogs are represented by a fairly large number of drugs:

• Glycine;
• Gopantam;
• Cavinton;
• Lucetam;
• Nootropil;
• Omaron;
• Ceraxon;
• Cerebrolysin;
• Encephabol;
• Phezam and many others.

Experience of using the drug Thiocetam for the treatment of patients childhood, No.

With alcohol

Alcohol intake does not affect the serum concentration of Piracetam.

During pregnancy and lactation

Thiocetam is a combined nootropic agent. It can be prescribed for adults. The drug is contraindicated in women in position and breastfeeding. It is used for diseases of the brain.

Dosage form

Thiocetam is available in tablets and solution for intramuscular and intravenous administration.

Description and composition

Pills covered yellow shell, a white or almost white core can be seen in cross section.

Solution for injection is a clear, colorless or slightly yellowish liquid.

As active ingredients the drug contains and.

In addition to them, the tablets contain the following auxiliary components:

• potato starch;
• povidone;
• sucrose;
• calcium stearate.

The shell of the tablets is formed by opadry II yellow.

The solution contains water for injection as an active substance.

Pharmacological group

Thiocetam belongs to the group of cerebroactive drugs, which has a nootropic, anti-ischemic and antioxidant effect.

The therapeutic effect of the medication is explained by and.

Refers to cyclic derivatives of GABA, nootropic drugs. It acts on the brain, improves memory, and facilitates learning. The active substance does not possess sedative and psychostimulating properties. It acts on postsynaptic recipes and facilitates synaptic transmission.

Has an effect on red blood cells, platelets and walls blood vessels, this explains the hemorheological effects of the medication.

Reacts with active oxygen and lipid radicals, restores thiol groups and prevents the appearance of reactive oxygen species as a result of reactivation of antiradical enzymes: superoxide dismutase, catalase and glutathione peroxidase.

Thiocetam facilitates learning processes, improves integrative and cognitive activity of the brain, short-term and long-term memory, and eliminates amnesia.

Indications for use

for adults

The medication is prescribed for the following pathologies:

• chronic cerebral ischemia;
• the period of rehabilitation after ischemic stroke, including in people with non-dementia cognitive impairment;
• encephalopathy of diabetic genesis.

for kids

The drug is contraindicated in patients under 18 years of age, since there is insufficient experience in the treatment of this category of patients.

During gestation and breastfeeding, the medication cannot be taken, since there is no experience in treating these categories of patients.

Contraindications

Regardless of the form of release, the medication is contraindicated in the following pathologies:

• Huntington's disease;
• severe chronic renal failure, in which the glomerular filtration rate is less than 20 ml per minute;
• psychomotor agitation at the time of taking the medication;
• acute disorder of cerebral circulation (hemorrhagic stroke);
• individual intolerance to the composition of the medication.

The tablets should not be drunk if the patient has:

• impaired absorption of glucose and galactose;
• hereditary lactose intolerance, lack of lactase;
• lack of sucrase and isomaltase, fruit sugar intolerance.

Applications and doses

for adults

The tablets should be taken half an hour before meals.

In case of chronic disorders of cerebral circulation and the recovery period after ischemic stroke, the drug prescribes 2 tablets 3 times a day for 25-30 days. The duration of therapy can be extended up to 3-4 months.

In diabetic encephalopathy, the drug should be taken 2 tablets 3 times a day for 45 days.

To prevent sleep disorders, the last dosage should be taken no later than 5 pm.

Intramuscularly or intravenously, the drug should be administered only if the drug cannot be taken orally.

In case of chronic disturbance of cerebral circulation, as well as during the period of rehabilitation after an ischemic stroke, the drug is prescribed in 20-30 ml, previously diluted in 100-150 saline. The medication is administered once a day by intravenous drip for 2 weeks, then the drug must be taken in tablets.

In diabetic encephalopathy, the drug is prescribed in 5 ml intramuscularly 1 time per day for 10 days, then it is taken in tablets.

for kids

In pediatric practice, the medicine is not used.

for pregnant women and during lactation

After transferring the baby to the mixture during lactation, the drug is prescribed as usual.

Side effects

During therapy, the following undesirable reactions may occur:

• dizziness;
• weight gain;
• dyspnea, attacks of suffocation;
• nausea, loose stools, abdominal pain, gastralgia, bloating, dry mouth;
• increased heart rate, increased blood pressure, cardialgia, arrhythmia, in patients of the older age group, coronary insufficiency may worsen;
• hypersensitivity, anaphylactic reactions, including dermatitis, pruritus, urticaria, Quincke's edema, fever;
• motor disinhibition, drowsiness, irritability, depression, impotence, headaches, tinnitus, insomnia, disturbances of consciousness, exacerbation of epilepsy, ataxia, imbalance, mental agitation, anxiety, hallucination.

Thiocetam injections can cause pain at the injection site.

Interaction with other medicinal products

Thiocetam should not be prescribed in combination with medications that have an acidic pH. included in the drug enhance the effect of antidepressants and antianginal drugs.

When prescribing a medication in combination with hormones, confusion, sleep disorders and irritability can be observed.

There is no data on the pharmaceutical incompatibility of the drug Thiocetam with other solutions for injection.

special instructions

The medication should be prescribed with caution in patients with chronic renal failure with a glomerular filtration rate of 20-80 ml per minute.

The drug affects the adhesion of platelets, so it must be prescribed with caution to patients with impaired hemostasis, with severe bleeding, after surgery.

With caution, the medication should be prescribed to persons of the older age group with diseases of the cardiovascular system, since they often have undesirable reactions.

With prolonged treatment in elderly patients, renal function should be checked periodically, if necessary, the dosage should be adjusted depending on creatinine clearance.

During therapy, one should refrain from driving.

Overdose

It is necessary to cancel therapy, call, rinse the stomach, prescribe symptomatic treatment.

Storage conditions

The drug should be stored in a dark place out of the reach of children. In tablets, the medication must be stored at a temperature of 15-25 degrees; in injections, the medicine is also stored at a temperature not exceeding 25 degrees.

The shelf life of the tablets is 2 years, the injections are 3 years. Buy a medication regardless of dosage form can be prescribed by a doctor, so self-medication is unacceptable to them.

Analogs

You can replace Thiocetam following drugs:

1. is a partial analogue of the drug Thiocetam. It is produced in capsules that can be used in patients over 5 years old, including women in position. Breastfeeding should be interrupted during therapy.
2. refers to nootropic drugs. The therapeutic effect of the medication is explained by the German drug, which is a substitute for Thiocetam in the clinical and pharmacological group. A nootropic agent is produced in the form of a suspension and tablets for oral administration. The drug can be used in children older than 3 days of life, pregnant and lactating patients.

It is permissible to use an analogue instead of Thiocetam only after consultation with the attending physician, since each medication has a number of features.

Price

The cost of Thiocetam is on average 506 rubles. Prices range from 492 to 725 rubles.

A drug Thiocetam- a psychostimulating, nootropic drug.

Pharmacological properties

Thiocetam belongs to the group of cerebroactive agents, has nootropic, anti-ischemic, antioxidant and membrane stabilizing properties.

Thiocetam accelerates the utilization of glucose in the reactions of aerobic and anaerobic oxidation, normalizes bioenergetic processes, stabilizes metabolism in brain tissues and increases the body's resistance to hypoxia.

The drug inhibits the pathways of the formation of reactive oxygen species, reactivates the enzymatic antioxidant system, especially superoxide dismutase, inhibits free radical processes in the brain tissues during ischemia, improves the rheological properties of blood by activating the fibrinolytic system, stabilizes and reduces, respectively, the zones of necrosis and ischemia.

Thiocetam increases the intensity of the metabolic GABA shunt and the concentration of GABA in ischemic tissues.

Thiocetam improves the integrative and cognitive activity of the brain, promotes the learning process, eliminates amnesia, increases indicators of short-term and long-term memory.

Thiocetam eliminates the effects of stress (feelings of anxiety, phobia, depression, sleep disturbances), reduces the lag in the physical and mental development of premature babies.

Indications for use

The drug Thiocetam is used in the treatment of ischemic stroke and its consequences, such as speech disorders, mental and somatic disorders, decreased activity, disturbances in the emotional sphere; treatment (in the recovery period) of vascular, toxic and traumatic encephalopathy; elimination of withdrawal symptoms with alcohol intoxication, diabetic encephalopathy.

Mode of application

In case of ischemic stroke and for the treatment of its consequences, 20-30 ml of the drug Tiocetam should be prescribed, previously diluted in 100-150 ml of 0.9% sodium chloride solution, and administered intravenously by drop infusion once a day. The course of treatment is 2 weeks.

For the treatment of encephalopathy and the elimination of withdrawal symptoms with alcohol intoxication, prescribe intramuscularly 5 ml of the drug once a day for 10-15 days.

In diabetic encephalopathy, 5 ml intramuscularly 1 time per day for 10 days, followed by the appointment of 2 tablets of Tiocetam 3 times a day for 45 days 30 minutes before meals.

Side effects

With the clinical use of the drug Thiocetam, solution for injection, there may be cases of adverse reactions:

from the central and peripheral nervous system: headache, general weakness,

from the digestive tract: nausea, vomiting

from the side immune system: allergic reactions including rash, pruritus, urticaria, angioedema, anaphylactic shock

on the part of the cardiovascular system: lowering blood pressure

on the part of the vestibular system: dizziness;

general disorders and disorders at the injection site: skin hyperemia and itching at the injection site.

Patients may develop adverse reactions due to individual components of the drug:

Piracetam:

on the part of the blood and lymph: hemorrhagic disorders;

from the immune system: hypersensitivity, anaphylactoid reactions;

mental disorders: irritability, depression, hyperexcitability, anxiety, confusion, hallucinations

from the nervous system: hyperkinesia, drowsiness, ataxia, imbalance, increased frequency of epileptic seizures, headache, insomnia, tremors;

from the organs of hearing and labyrinth: dizziness

from the side digestive system: abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting

On the part of the skin and subcutaneous tissues: angioedema, dermatitis, rash, urticaria, itching

On the part of the reproductive system and breastfeeding, increasing sexual activity;

vascular disorders: hypotension, thrombophlebitis;

general disorders and disorders at the injection site: asthenia, pain at the injection site, fever, weight gain.

Ttiazotny koslot:

in patients, mainly elderly, in particular, while taking other drugs, cases have been described:

allergic reactions: skin flushing, fever

from the central and peripheral nervous system: dizziness, tinnitus

on the part of the cardiovascular system: tachycardia, increased blood pressure;

from the gastrointestinal tract: dry mouth, bloating,

from the respiratory system: shortness of breath, attacks of suffocation.

Contraindications

Contraindications to the use of the drug Thiocetam are: hypersensitivity to piracetam or thiazoic acid; end stage renal failure; chorea of ​​Huntington; acute cerebrovascular accident of the hemorrhagic type.

Pregnancy

Use the drug during pregnancy Thiocetam it does not follow.

Interaction with other medicinal products

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

Due to the presence of piracetam in the composition, the following interactions are possible:

Thyroid hormones. When combined with thyroid hormones, irritability, disorientation and sleep disturbance are possible.

Acenocoumarol. In patients with heavy course recurrent thrombosis, the use of piracetam in high doses (9.6 g / day) did not affect the dosage of acenocoumarol to achieve a PT value of 2.5-3.5, but with simultaneous use there was a significant decrease in the level of platelet aggregation, the level of fibrinogen, von Willebrand factors (coagulation activity (VIII: C) co-factor ristocetin (VIII: vW: Rco) and plasma protein (VIII: vW: Ag)), blood and plasma viscosity.

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

In in vitro experiments, piracetam does not inhibit cytochrome P450 isoforms 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, there was a slight inhibition of CYP2A6 (21%) and 3A4 / 5 (11%). However, the level of K and two CYP isomers is sufficient when exceeding 1422 μg / ml. Therefore, metabolic interaction with drugs that are biotransformed by these enzymes is unlikely.

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

Alcohol. Coadministration with alcohol did not affect the serum concentration of piracetam, and serum alcohol concentration did not change when 1.6 g of piracetam was taken.

Overdose

Symptoms of a drug overdose Thiocetam: increased manifestations of side effects of the drug.

Additionally

Prescribe with caution to patients with chronic renal failure.

The drug should be used with caution in elderly people with cardiovascular pathology due to the fact that the above adverse reactions in this group of patients are more common.

Allergic reactions are more common in allergy-prone individuals.

Due to the fact that piracetam reduces platelet aggregation, it is necessary to prescribe with caution to patients with impaired hemostasis, conditions that may be accompanied by bleeding (ulcers of the gastrointestinal tract), during major surgical operations (including dental interventions), patients with symptoms of severe bleeding or patients with a history of hemorrhagic stroke patients who use anticoagulants, platelet antiplatelet agents, including low doses of acetylsalicylic acid.

With prolonged therapy in elderly patients, regular monitoring of renal function indicators is recommended.

Main settings

Injection transparent, colorless or slightly yellowish.

* thiotriazoline (thiazolic acid morpholine salt).

Excipients: water d / i.

5 ml - ampoules (5) - blisters made of polyvinyl chloride film (2) - cardboard packs.
10 ml - ampoules (5) - blisters made of polyvinyl chloride film (2) - cardboard packs.

Description medicinal product THIOCETAM N based on the officially approved instructions for use of the drug and made in 2015. Updated date: 07.11.2016

pharmachologic effect

Pharmacotherapeutic group: Other psychostimulants and nootropics.

Combined drug. It has antioxidant, membrane stabilizing and nootropic properties. It improves the integrative and cognitive activity of the brain, helps to eliminate the symptoms of amnesia, and increases the indicators of short-term and long-term memory.

The pharmacological effect of the drug Thiocetam N is due to the mutually potentiating effect of thiotriazoline and piracetam.

The drug is able to accelerate the oxidation of glucose in the reactions of aerobic and anaerobic oxidation, affect bioenergetic processes, and increase the level of ATP.

Thiocetam H inhibits the pathways of the formation of reactive oxygen species, reactivates the antioxidant system of enzymes, especially superoxide dismutase, inhibits free radical processes in brain tissues during ischemia, improves the rheological properties of blood by activating the fibrinolytic system.

Pharmacokinetics

Piracetam is well absorbed when used internally, penetrates into various organs and tissues, including the brain tissue. The maximum concentration in blood plasma is reached after 1.5 hours, bioavailability is close to 100 %. The volume of distribution of piracetam is 0.7 l / kg, the half-life is 5 hours.

The drug crosses the placental barrier. Piracetam is practically not metabolized in the body and is excreted in the urine.

Thiotriazoline - after oral administration, the drug is rapidly absorbed, its absolute bioavailability is 53%. The maximum concentration in blood plasma is reached 1.6 hours after a single dose of 200 mg. The half-life is almost 8 hours.

Indications for use

Symptomatic treatment of memory and intellectual disorders in the absence of a diagnosis of dementia (symptomatic treatment of chronic psychoorganic syndrome) in patients:

• With chronic disorders cerebral circulation (discirculatory encephalopathy);
• with diabetic encephalopathy;
• with the consequences of an ischemic stroke;
• with the consequences of traumatic brain injury.

Dosage regimen

At treatment of the consequences of ischemic stroke appoint 20-30 ml of the drug, previously diluted in 100-150 ml of 0.9% sodium chloride solution, and injected intravenously drip 1 time / day. The course of treatment is 2 weeks.

For encephalopathy treatment appoint 5 ml of the drug in / m 1 time / day for 10-15 days.

At diabetic encephalopathy- 5 ml / m 1 time / day for 10 days with further prescription of the tablet form of the drug for 45 days 30 minutes before meals.

Patients with renal impairment dose adjustment of the drug Thiocetam N is required in accordance with the following scheme:

Have elderly patients the dose is adjusted in the presence of renal failure; long-term therapy requires control functional state kidneys.

Patients with impaired liver function dose adjustment is not required.

Patients with impaired renal and liver function the doses are adjusted depending on the QC indicators.

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

Side effects

From the nervous system: general weakness, headache, increased excitability, anxiety, hallucinations, increased sexual desire, confusion, imbalance, insomnia or drowsiness, tremors, increased frequency of epileptic seizures, hyperkinesia, ataxia, depression, asthenia, dizziness, tinnitus.

From the digestive system: nausea, vomiting, dry mouth, bloating, abdominal pain, diarrhea.

On the part of the skin and subcutaneous fat: flushing of the skin, itching, rash, dermatitis.

Allergic reactions: urticaria, angioedema.

From the immune system: hypersensitivity reactions, including anaphylaxis.

On the part of the cardiovascular system: tachycardia, arterial hypertension.

From the respiratory system, organs chest and mediastinum: shortness of breath, choking.

On the part of the blood system: blood clotting disorders.

General disorders: weight gain, hyperthermia, fever.

In case of adverse reactions, incl. not specified in this instruction, you should stop taking the drug and consult a doctor.

Application during pregnancy and lactation

The safety of using the drug Thiocetam N during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and during breastfeeding contraindicated.

Piracetam crosses the placental barrier. The concentration of piracetam in newborns reaches 70-90% of its concentration in the blood of the mother.

Piracetam is excreted in breast milk.

special instructions

The drug is prescribed with caution to patients with chronic renal failure.

Thiocetam N affects platelet aggregation, so it should be used with caution in patients with impaired hemostasis, during surgery.

The drug should be used with caution in elderly patients with cardiovascular pathology due to the fact that the adverse reactions described above in this group of patients are more common.

Allergic reactions are more common in allergy-prone individuals.

Due to the effect of piracetam on platelet aggregation, care should be taken when prescribing the drug to patients with risk factors for bleeding:

• exacerbation peptic ulcer stomach and duodenum previously carried over intracerebral hemorrhage, recent surgery (including dental), taking anticoagulants or antiplatelet agents, incl. low-dose aspirin.

Use in pediatrics

The experience of using the drug in children is insufficient. The drug is contraindicated for use in children and adolescents under the age of 18 due to lack of sufficient data.

Impact on driving ability Vehicle and management of mechanisms

Overdose

Treatment: discontinuation of the drug, symptomatic therapy.

Drug interactions

Thiocetam H should not be administered with drugs that have an acidic pH.

Piracetam in high doses (9.6 g / day) increases the effectiveness of acenocoumarol in patients with venous thrombosis, however, when using the drug Thiocetam N in therapeutic doses, this effect is not observed.

There was no interaction of piracetam with clonazepam, phenobarbital, phenytoin, sodium valproate.

The simultaneous use of piracetam and thyroid hormones (T3 + T4) can cause irritation, disorientation, and sleep disturbances.

The interaction of piracetam with drugs that can be biotransformed by enzymes of the P450 complex is unlikely.

Simultaneous reception with enalapril, captopres increases the risk of adverse reactions from the cardiovascular system.

Co-administration with alcohol does not affect the serum concentration of piracetam.

Contacts for inquiries

Corporation ARTERIUM, representative office, (Ukraine)

Representative office in the Republic of Belarus