Thiocetam solution for injection (100mg/25mg)/ml in 10ml ampoules No. 5x2
Name
Thiocetam solution d/in. (100 mg/25 mg)/ml in amp. 10 ml in container pack No. 5x2
Description
Transparent, colorless or slightly yellowish liquid.
Main active ingredient
Piracetam
Release form
Injection.
Dosage
(100mg/25mg)/ml in 10ml amp in container pack No. 5x2
Pharmacodynamics
The drug has antioxidant, membrane-stabilizing and nootropic properties. The drug improves integrative and cognitive activity of the brain, helps eliminate 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. The drug can accelerate the oxidation of glucose in aerobic and anaerobic oxidation reactions, influence bioenergetic processes, and increase ATP levels. 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, and improves the rheological properties of blood by activating the fibrinolytic system.
Pharmacokinetics
The volume of distribution of piracetam is almost 0.6 l/kg. The half-life of piracetam from blood plasma is 4–5 hours and, accordingly, 6–8 hours from cerebrospinal fluid. This period may be prolonged with renal failure. Does not bind to blood plasma proteins and is not metabolized in the body. 80–100% of piracetam is excreted unchanged by the kidneys through glomerular filtration. The renal clearance of piracetam in healthy volunteers is 86 ml/min. The pharmacokinetics of piracetam does not change in patients with liver failure. Piracetam penetrates the blood-brain and placental barriers, membranes used in hemodialysis. In animal studies, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital zones, the cerebellum and basal ganglia. The maximum concentration of thiazotic acid in blood plasma is achieved with intramuscular administration - after 0.84 hours, with intravenous administration - after 0.1 hours. Binding to blood proteins does not exceed 1%.
Indications for use
Symptomatic treatment of memory disorders and intellectual impairments in the absence of a diagnosis of dementia (symptomatic treatment of chronic psychoorganic syndrome) in patients with chronic cerebrovascular accidents (dyscirculatory encephalopathy), diabetic encephalopathy, consequences of an ischemic stroke or traumatic brain injury.
Directions for use and doses
When treating the consequences of an ischemic stroke, 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, 5 ml of the drug is prescribed intramuscularly once a day for 10–15 days. For diabetic encephalopathy, 5 ml intramuscularly 1 time per day for 10 days, followed by administration of the tablet form of the drug for 45 days, 30 minutes before meals. Patients with renal failure require dose adjustment of the drug in accordance with the following scheme: Renal failure Creatinine clearance (ml/min) Dose and frequency of use Normal >80 Usual dose Mild 50–79 2/3 of the usual dose in 2–3 doses Moderate 30–49 1/3 of the usual dose in 2 divided doses Severe
Use during pregnancy and lactation
The safety of the drug during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is contraindicated. Piracetam penetrates the placental barrier. The concentration of piracetam in newborns reaches 70–90% of its concentration in the mother’s blood. Piracetam is excreted in breast milk.
Precautionary measures
The drug is prescribed 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 adverse reactions described above are more common in this group of patients. Due to the effect of piracetam on platelet aggregation, caution should be exercised when prescribing the drug to patients with hemostasis disorders, surgery (including dental), risk factors for bleeding (for example, gastric and duodenal ulcers), previous hemorrhagic stroke or intracerebral hemorrhage, patients taking anticoagulants or antiplatelet agents, including low doses of acetylsalicylic acid. When prescribing the drug to elderly patients, regular monitoring of kidney function indicators is recommended. Use in children. The drug is contraindicated for use in children under 18 years of age due to the lack of sufficient data.
Interaction with other drugs
Thiocetam should not be administered with drugs that have an acidic pH. Due to the presence of piracetam in the composition, the following types of interactions are possible: Thyroid hormones. When combined with thyroid hormones, 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 of 2.5–3.5, but with its simultaneous use there was a significant decrease in the level of platelet aggregation, fibrinogen levels, 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 changes in the pharmacokinetics of piracetam under the influence of other drugs is low, since 90% of the drug 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 concentrations 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 when exceeding 1422 μg/ml. Therefore, metabolic interaction with drugs that undergo biotransformation by these enzymes is unlikely. Antiepileptic drugs. Piracetam 20 g/day for 4 weeks in patients with epilepsy receiving stable doses of antiepileptic drugs did not change the maximum serum concentration and AUC (area under the curve) of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital and valproate). Co-administration with alcohol did not affect the serum concentration of piracetam, and the concentration of ethanol in the blood serum did not change when taking 1.6 g of piracetam orally.
Contraindications
– hypersensitivity to piracetam, thiazotic acid, as well as to pyrrolidone or thiazotic acid derivatives; – end-stage renal failure (creatinine clearance less than 20 ml/min); - Huntington's chorea; – acute cerebrovascular accident of hemorrhagic type; – psychomotor agitation at the time of drug prescription; – pregnancy period; – period of breastfeeding.
Compound
1 ml of solution contains morpholinium salt of thiazotic acid, in terms of 100% substance 25 mg, which is equivalent to 16.6 mg of thiazotic acid; piracetam 100 mg; excipient: water for injection.
Overdose
Symptoms: increased manifestations of side effects of the drug. In such cases, stop using the drug and prescribe symptomatic treatment.
Side effect
With the clinical use of the drug Thiocetam, solution for injection, cases of adverse reactions may be observed: from the central and peripheral nervous system: headache, general weakness; from the digestive tract: nausea, vomiting; from the immune system: allergic reactions, including rashes, itching, urticaria, angioedema, anaphylactic shock; from the cardiovascular system: decreased blood pressure; from 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 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 organs of hearing and labyrinth: dizziness; from the digestive system: abdominal pain, pain in the upper abdomen, diarrhea, nausea, vomiting; from the skin and subcutaneous tissues: angioedema, dermatitis, rash, urticaria, itching; from the reproductive system: increased sexual activity; vascular disorders: hypotension, thrombophlebitis; general disorders and disorders at the injection site: asthenia, pain at the injection site, fever, weight gain. – thiazotic acid: allergic reactions: skin hyperemia, fever; from the central and peripheral nervous system: dizziness, tinnitus; from the cardiovascular system: tachycardia, increased blood pressure; from the gastrointestinal tract: dry mouth, bloating; from the respiratory system: shortness of breath, attacks of suffocation. If adverse reactions occur, including those not indicated in the instructions for use, you must stop using the drug and consult a doctor.
Storage conditions
Store in original packaging at a temperature not exceeding 25°C. Keep out of the reach of children.
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.
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.
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.
Note!
Description of the drug Thiocetam solution d/in. amp. 5ml No. 10 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
