Instructions for Thiocetam forte film-coated tablets No. 30
Composition
active ingredients: 1 tablet contains: piracetam in terms of 100% substance – 400 mg; morpholinium salt of thiazide acid in terms of 100% substance, which is equivalent to 66.5 mg of thiazide acid – 100 mg;
Excipients: potato starch; mannitol; powdered sugar; magnesium stearate; povidone; coating mixture **.
** - coating mixture contains: hypromellose; lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol/macrogol; triacetin.
Dosage form
Film-coated tablets.
Main physicochemical properties: white or almost white film-coated tablets, oval in shape, with a score on one side of the tablet.
Pharmacotherapeutic group
Psychostimulants and nootropics.
ATX code N06B X.
Pharmacological properties
Pharmacodynamics.
The drug belongs to the group of cerebroactive agents and has anti-ischemic, antioxidant, membrane-stabilizing, and nootropic properties.
The drug improves the integrative and cognitive activity of the brain, increases the efficiency of the learning process, helps eliminate symptoms of amnesia, and improves short-term and long-term memory.
The pharmacological effect of the drug is due to the mutually potentiating effect of thiazide acid and piracetam.
The drug is able to accelerate glucose oxidation in aerobic and anaerobic oxidation reactions, normalize bioenergetic processes, increase ATP levels, and stabilize metabolism in brain tissues.
The drug inhibits the pathways for the formation of reactive oxygen species, reactivates the antioxidant enzyme system, especially superoxide dismutase, inhibits free radical processes in brain tissues during ischemia, improves the rheological properties of blood by activating the fibrinolytic system, and stabilizes and reduces areas of necrosis and ischemia, respectively.
Pharmacokinetics.
It is well absorbed when administered orally, penetrates into various organs and tissues, including brain tissue. The drug penetrates 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. The half-life is 4-8 hours. Morpholinium salt of thiazide acid is rapidly absorbed after oral administration, 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.
Indication
Transient and chronic disorders of cerebral circulation caused by atherosclerosis of cerebral vessels and disorders of cerebral circulation in the past. The drug is also indicated for disorders of cerebral circulation, disorders of brain metabolism caused by craniocerebral injuries, intoxications, diabetic encephalopathy, as well as in the rehabilitation period of ischemic stroke.
Contraindication
Hypersensitivity to piracetam or pyrrolidone derivatives, and/or to thiazide acid, as well as to any other component of the drug.
Acute hemorrhagic stroke.
Acute renal failure. End-stage renal failure.
Huntington's cholera.
Interaction with other medicinal products and other types of interactions
Thiocetam® Forte should not be administered with drugs that have an acidic pH.
Due to the presence of piracetam, the following types of interactions are possible:
Thyroid hormones.
When used together with thyroid hormones (T3+T4), increased irritability, disorientation, and sleep disturbances 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 its simultaneous use, a significant decrease in the level of platelet aggregation, fibrinogen levels, von Willebrand factors (VIII: C; VIII: vW: Ag; VIII: vW: Rco), blood and plasma viscosity was observed.
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 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, a slight inhibition of CYP2A6 (21%) and 3A4/5 (11%) was observed. However, the Ki level of these two CYP isomers is sufficient above 1422 μg/ml. Therefore, metabolic interactions with drugs that are biotransformed by these enzymes are unlikely.
Antiepileptic drugs.
The use of piracetam at a dose of 20 mg/day daily for 4 weeks or more did not change the concentration-level curve and maximum concentration (Cmax) of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, sodium valproate) in patients with epilepsy.
Simultaneous administration with enalapril, captopril increases the risk of developing adverse reactions from the cardiovascular system.
Alcohol.
Co-administration with alcohol did not affect the serum concentration of piracetam, and serum alcohol concentration did not change when 1.6 g of piracetam was administered.
Application features
The drug should be taken with caution by elderly people suffering from cardiovascular disease, as adverse reactions are more common in this group of patients.
Allergic reactions are more common in people prone to allergies.
Effect on platelet aggregation.
Due to the fact that piracetam reduces platelet aggregation, the drug should be prescribed with caution to patients with impaired hemostasis, conditions that may be accompanied by bleeding (gastrointestinal ulcer), during major surgical operations (including dental interventions), patients with symptoms of severe bleeding or patients with a history of hemorrhagic stroke; patients taking anticoagulants, platelet antiaggregants, 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.
During long-term therapy in elderly patients, regular monitoring of renal function is recommended; if necessary, the dose should be adjusted depending on the results of the creatinine clearance test.
The drug contains lactose as an excipient, which should be taken into account in patients with galactose intolerance, lactase deficiency or glucose/galactose malabsorption.
1 tablet of Thiocetam® Forte contains 0.007 g of powdered sugar, which should be taken into account by patients with diabetes.
Use during pregnancy or breastfeeding
Should not be used.
Ability to influence reaction speed when driving vehicles or other mechanisms
The use of the drug is not recommended when driving vehicles and working with mechanisms that require increased attention due to the risk of developing possible adverse reactions from the nervous system.
Method of administration and doses
The dosage and duration of treatment are determined by the doctor in each individual case, depending on the nature and course of the disease.
For transient and chronic cerebral circulation disorders and during the rehabilitation period after ischemic stroke, 1 tablet 3 times a day for 25-30 days.
Thiocetam Forte tablets should be administered 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 apply.
Overdose
When using therapeutic doses, overdose is impossible.
If you deviate from the doses prescribed by your doctor, side effects of the drug may occur and intensify (excitement, sleep disturbances, dyspeptic symptoms). In these cases, the dose of the drug should be reduced and symptomatic treatment should be prescribed (inducing vomiting, gastric lavage).
In case of overdose, the concentration of sodium and potassium in the urine increases. In such cases, the drug must be discontinued.
Adverse reactions
During clinical use of the drug Thiocetam® Forte, cases of adverse reactions may be observed:
from the central and peripheral nervous system: headache, general weakness, insomnia, drowsiness, anxiety, internal tension;
Gastrointestinal: nausea, vomiting, dry mouth, diarrhea;
from the immune system, skin and subcutaneous tissue: allergic reactions, including rash, itching, urticaria, sweating;
From the vestibular system: dizziness.
Patients may develop adverse reactions caused by individual components of the drug:
– piracetam:
Blood and lymphatic system disorders: 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, balance disorders, increased frequency of epileptic seizures, headache, insomnia, tremor;
From the side of the organs of hearing and labyrinth: dizziness;
from the digestive system: abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting;
Skin and subcutaneous tissue disorders: angioedema, dermatitis, rash, urticaria, itching;
From the reproductive system and breastfeeding: increased sexual activity;
general disorders: asthenia, weight gain.
- thiazide acid:
Skin and subcutaneous tissue disorders: itching, skin hyperemia, 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;
Gastrointestinal: dyspepsia, including dry mouth, bloating, nausea, vomiting;
from the respiratory system: shortness of breath, wheezing;
general disorders: fever, general weakness.
Expiration date
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 in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyivmedpreparat".
Location of the manufacturer and its business address
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
