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Thiocetam 10 ml No. 10 solution d/in.amp.

APPROVED by the Order of the Chairman of the Committee for Control of Medical and Pharmaceutical Activities of the Ministry of Health of the Republic of Kazakhstan dated "____"______________20__, No. ______________ Instructions for the medical use of the drug TIOCETAM Trade name Tiocetam International nonproprietary name No Dosage form Solution for injection Composition 1 ml of solution contains active substances: thiotriazoline - 25 g based on 100% substance, piracetam - 100 g excipient: water for injection up to 1 liter. Description Transparent, colorless or slightly yellowish liquid Pharmacotherapeutic group Psychostimulants and nootropic drugs ATC code N06BХ Pharmacological properties Pharmacokinetics The maximum concentration of thiotriazoline in blood plasma when administered intramuscularly is 0.84, when administered intravenously - 0.1 hour, binding to blood proteins does not exceed 10% . Thiotriazoline accumulates mainly in the kidneys - 31%. It accumulates in significant quantities in the colon, heart, spleen, and least of all in the small intestine and lungs (1 - 2%). When taken orally, Piracetam is quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 30 minutes, in the cerebrospinal fluid after 2-8 hours. It is distributed in all organs and tissues, penetrates the blood-brain and placental barrier. Selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. It is excreted unchanged by the kidneys. Pharmacodynamics Thiocetam is a combined drug and its pharmacological effect is due to anti-ischemic, antioxidant, membrane-stabilizing and immunomodulatory properties. Thiotriazolin enhances the compensatory activation of anaerobic glycolysis, reduces the inhibition of oxidation processes in the Krebs cycle while maintaining the intracellular ATP pool. The drug activates the antioxidant system and inhibits the processes of lipid oxidation in ischemic areas of the myocardium, reduces the sensitivity of the myocardium to catecholamines, prevents progressive inhibition of the contractile function of the heart, stabilizes and reduces, respectively, areas of necrosis and myocardial ischemia. Improves the rheological properties of blood (activation of the fibrinolytic system). Piracetam increases glucose utilization, improves metabolic processes, improves microcirculation in ischemic areas, and inhibits the aggregation of activated platelets. Improves integrative brain activity. It has a protective effect against brain damage caused by hypoxia, intoxication, and electric shock. Indications for use: ischemic stroke and its consequences (speech impairment, mental and somatic disorders, decreased activity, emotional disturbances); vascular, toxic and traumatic encephalopathy in the recovery period; withdrawal syndrome due to alcohol intoxication. Method of administration and dosage For ischemic stroke and for the treatment of its consequences, 20–30 ml of the drug is prescribed, previously diluted in 100–150 ml of saline, and administered intravenously once a day. The course of treatment is 2 weeks. To treat encephalopathy and eliminate withdrawal symptoms from alcohol intoxication, 5 ml of the drug is prescribed intramuscularly once a day for 10–15 days. Side effects The results of post-marketing surveillance allowed us to establish that during the clinical use of the drug Thiocetam, solution for injection, isolated cases of adverse reactions were observed: - general weakness, headache - nausea, vomiting - itching, rashes, urticaria, anaphylactic shock, angioedema In some patients sometimes it is possible to develop adverse reactions caused by: - piracetam: - agitation, anxiety, hallucinations, confusion, imbalance, insomnia or drowsiness, tremor, increased frequency of epileptic attacks, hyperkinesia, ataxia, depression, asthenia others: weight gain, pain in abdomen, diarrhea, dermatitis, hyperthermia; - thiotriazoline: - skin hyperemia, fever, Quincke's edema - arterial hypertension, pain in the heart, tachycardia, sinus rhythm disturbance - dizziness, tinnitus - dry mouth, bloating - shortness of breath very rarely - attacks of suffocation. Contraindications - hypersensitivity to the components of the drug - acute renal failure - diabetes mellitus - pregnancy and lactation - acute cerebrovascular accidents (hemorrhagic stroke). Drug interactions The drug enhances the effect of antidepressants and antianginal drugs, potentiates the effect of indirect anticoagulants. Special instructions Use in pediatrics. The drug is not recommended for children and adolescents under 18 years of age due to the lack of data on safety and effectiveness. The drug is prescribed with caution to patients with chronic renal failure. Thiocetam affects platelet aggregation, so it should be used with caution in patients with impaired hemostasis, during surgery and in patients with diabetes mellitus. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Do not affect Overdose Symptoms: agitation, sleep disturbance, dyspeptic symptoms. Treatment: symptomatic treatment. Release form and packaging 5 ml or 10 ml in ampoules of appropriate capacity for vacuum or syringe filling. 10 ampoules, along with instructions for medical use and an ampoule scarifier, are placed in a box with a corrugated label-parcel. 5 ampoules of 5 ml or 10 ml in a blister pack made of polyvinyl chloride film. Two contour blister packs, along with instructions for medical use and an ampoule scarifier, are placed in a pack. When using ampoules with a break ring, inserting scarifiers is not provided. Storage conditions Store in a place protected from light at a temperature of 15 °C to 25 °C. Keep out of the reach of children! Shelf life: 2 years Do not use after the expiration date indicated on the package! Conditions for dispensing from pharmacies By prescription, JSC "Galichfarm", Ukraine, 79024, Lvov, st. Opryshkovskaya, 6/8

Interactions

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

Due to the presence of piracetam in the composition of the drug, interaction with the following drugs is 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 require a change in the dose of acenocoumarol to achieve a prothrombin time (INR) value of 2.5–3.5, but with simultaneous use there was a significant decrease in the level of aggregation platelets, fibrinogen levels, von Willibrand factors (VIII: C; VIII: vW: Ag; VIII: vW: Rco), blood and plasma viscosity.

Pharmacokinetic interactions. The likelihood of changes in 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 cytochrome P450 isoforms CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at a concentration of 142; 426 and 1422 µg/ml.

At a concentration of 1422 μg/ml, slight inhibition of CYP 2A6 (21%) and 3A4/5 (11%) was noted. However, the Ki level of these two CYP isomers is sufficient when exceeding 1422 μg/ml. Therefore, metabolic interaction with drugs that undergo biotransformation by these enzymes is unlikely.

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

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

Alcohol. Concomitant use with alcohol did not affect the plasma concentration of piracetam, and the concentration of alcohol in the blood plasma did not change when using 1.6 g of piracetam.

special instructions

The drug can be prescribed for cerebrovascular insufficiency with symptoms of speech impairment, memory, attention, decreased intellectual function of the brain and disturbance of the emotional sphere to increase the ability to learn in cephalalgia, including those caused by neurocirculatory dystonia. Thiocetam can be used to treat the above diseases against the background of existing pathology of the heart (angina pectoris, myocardial infarction), liver (hepatitis, cirrhosis) and viral infections.

The drug should be used with caution in elderly people with cardiovascular pathology, since the above-described adverse reactions are observed more often in these patients.

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 with caution to patients with impaired hemostasis, conditions that may be accompanied by hemorrhages (gastrointestinal ulcers), during major surgical operations (including dental procedures), patients with symptoms of severe bleeding and patients having a history of hemorrhagic stroke; patients who use anticoagulants, platelet antiplatelet agents, including low dose acetylsalicylic acid. The drug is excreted by the kidneys, so special attention should be paid to patients with renal failure.

Elderly patients. During long-term therapy in elderly patients, it is recommended to regularly monitor renal function indicators and, if necessary, adjust the dose depending on creatinine clearance.

The drug in tablet form contains lactose as an excipient, which should be taken into account when used in patients with galactose intolerance, lactase deficiency or impaired absorption of glucose and galactose.

1 tablet of Thiocetam contains 3.5 mg of powdered sugar, which should be taken into account when prescribing to patients with diabetes.

Use during pregnancy and lactation. Should not be used.

Children. Not used.

The ability to influence reaction speed when driving vehicles or working with other mechanisms. The use of the drug when driving vehicles and working with mechanisms that require increased attention is not recommended due to the risk of developing possible adverse reactions from the nervous system.

Application

Thiocetam forte tablets. The duration of treatment is determined by the doctor in each individual case separately, depending on the course of the disease.

For transient and chronic cerebrovascular accidents and during the rehabilitation period after ischemic and hemorrhagic stroke, 2 tablets 3 times a day for 25–30 days.

Thiocetam Forte tablets are prescribed 30 minutes before meals.

The course of treatment ranges from 2–3 weeks to 3–4 months.

For the treatment of diabetic encephalopathy, 2 tablets are prescribed 3 times a day for 45 days.

Thiocetam solution for injection. For ischemic stroke and for the treatment of its consequences, 20–30 ml of the drug is prescribed, previously diluted in 100–150 ml of 0.9% sodium chloride solution, and administered intravenously once a day. The course of treatment is 2 weeks.

To treat encephalopathy and relieve withdrawal syndrome during alcohol intoxication, 5 ml of the drug is prescribed intramuscularly once a day for 10–15 days.

For diabetic encephalopathy, 5 ml IM once a day for 10 days, followed by 2 tablets of Thiocetam Forte 3 times a day for 45 days, 30 minutes before meals.

Side effects

During the clinical use of the drug thiocetam, adverse reactions may occur:

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

from the digestive tract: nausea, vomiting, diarrhea;

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

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, confusion, hallucinations;

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

from the organ of hearing and labyrinth: dizziness;

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

from the skin and subcutaneous tissues: angioedema, dermatitis, rashes, urticaria, itching;

from the reproductive system: increased sexual activity;

general disorders: asthenia, weight gain;

thinitric acid:

from the skin and subcutaneous tissue: itching, skin hyperemia, rashes, urticaria, angioedema;

from the immune system: anaphylactic shock;

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

from the cardiovascular system: tachycardia, increased blood pressure;

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

from the respiratory system: shortness of breath, suffocation;

general disorders: fever, general weakness, pain at the injection site.

The drug contains the dye sunset yellow FCF (E110), which may cause allergic reactions.

Indications

Tablets: transient and chronic cerebrovascular accidents caused by atherosclerosis of cerebral vessels and cerebrovascular accidents in the past. the drug is also indicated for disorders of cerebral circulation, metabolic processes in the brain caused by traumatic brain injury, intoxication, diabetic encephalopathy, as well as during the rehabilitation period after ischemic and hemorrhagic stroke.

Injection solution: treatment of ischemic stroke and its consequences such as speech impairment, mental and somatic disorders, decreased activity, emotional disturbances; treatment (during the recovery period) of vascular, toxic, traumatic encephalopathy; elimination of withdrawal syndrome due to alcohol intoxication, diabetic encephalopathy.

Pharmacological properties

Pharmacodynamics.
Thiocetam belongs to the group of cerebroactive drugs and has nootropic, anti-ischemic, antioxidant and membrane-stabilizing properties. the drug improves integrative and cognitive activity of the brain, increases the efficiency of the learning process, helps eliminate the symptoms of amnesia, and increases short-term and long-term memory. The pharmacological effect of the drug is due to the mutually potentiating effect of thiotriazoline and piracetam.

Thiocetam has the ability to accelerate the oxidation of glucose in aerobic and anaerobic oxidation reactions, normalizes bioenergetic processes, increases ATP levels, and stabilizes metabolism in brain tissue. The drug inhibits the formation of reactive oxygen species, reactivates the antioxidant enzyme system, especially superoxide dismutase, inhibits free radical processes in brain tissue during ischemia, improves the rheological properties of blood by activating the fibrinolytic system, stabilizes and reduces areas of necrosis and ischemia.

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

Thiocetam improves integrative and cognitive activity of the brain, promotes the learning process, eliminates amnesia, and increases short- 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 infants.

Pharmacodynamics. It is well absorbed when taken orally and penetrates various organs and tissues, including brain tissue. Penetrates through the placental barrier. Each component of the drug is metabolized separately. Piracetam is practically not metabolized in the body and is excreted in the urine. T½ - 4-8 hours. Thiotriazoline is rapidly absorbed after oral administration, its absolute bioavailability is 53%. Cmax in blood plasma is achieved 1.6 hours after a single dose of 200 mg. T½ is almost 8 hours.