Instructions Thiocetam solution for injection ampoule 10 ml No. 10
Composition
active substances: 1 ml of solution contains morpholinium salt of thiazide acid in terms of 100% substance - 25 mg, which is equivalent to 16.6 mg of thiazide acid; piracetam - 100 mg;
excipient: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Other psychostimulants and nootropics.
ATX code N06B X.
Pharmacological properties
Pharmacodynamics
Thiocetam® belongs to the group of cerebroactive agents and has nootropic, anti-ischemic, antioxidant, and membrane-stabilizing properties.
The pharmacological effect of the drug is due to the mutually potentiating effect of thiazide acid and piracetam.
Thiocetam® accelerates glucose utilization in aerobic and anaerobic oxidation reactions, normalizes bioenergetic processes, stabilizes metabolism in brain tissues, and increases the body's resistance to hypoxia.
The drug inhibits the pathways of formation of reactive oxygen species, reactivates the enzymatic antioxidant system, especially superoxide dismutase, inhibits free radical processes in brain tissues during ischemia, improves the rheological properties of blood by activating the fibrinolytic system, stabilizes and reduces areas of necrosis and ischemia, respectively.
Thiocetam® increases the intensity of the metabolic GABA shunt and the concentration of GABA in ischemic tissues.
Thiocetam® improves integrative and cognitive brain activity, promotes the learning process, eliminates amnesia, increases short-term and long-term memory. Thiocetam® eliminates the effects of stress (anxiety, phobias, depression, sleep disorders), reduces the lag in physical and mental development of premature children.
Pharmacokinetics
Not studied.
Indication
Treatment of ischemic stroke and its consequences, such as speech disorders, mental and somatic disorders, decreased activity, emotional disorders; treatment (in the recovery period) of vascular, toxic and traumatic encephalopathy; elimination of withdrawal syndrome in alcohol intoxication, diabetic encephalopathy.
Contraindication
Hypersensitivity to piracetam or thiazide acid; end-stage renal failure; Huntington's chorea; acute hemorrhagic stroke.
Interaction with other medicinal products and other types of interactions
Thiocetam® 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 combined with thyroid hormones, 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 of 2.5-3.5, but with its simultaneous use, a significant decrease in the level of platelet aggregation, fibrinogen levels, von Willebrand factors (coagulation activity (VIII: C); ristocetin cofactor (VIII: vW: Rco) and plasma protein (VIII: vW: Ag)), blood and plasma viscosity was noted.
Pharmacokinetic interactions. The possibility 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 in vitro experiments, piracetam did 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 when exceeding 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 for 4 weeks or more did not change the concentration-level curve and maximum serum concentration of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, sodium valproate) in patients with epilepsy.
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 taken.
Application features
The drug should be 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 above-mentioned adverse reactions are observed more often in this group of patients.
Allergic reactions are more common in people prone to allergies.
With long-term therapy in elderly patients, regular monitoring of renal function is recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are currently no such reports. However, caution should be exercised when using Thiocetam® in individuals who drive or operate dangerous machinery, given the possible adverse reactions from the nervous system.
Use during pregnancy or breastfeeding
Should not be used.
Method of administration and doses
In case of ischemic stroke and for the treatment of its consequences, 20-30 ml of the drug should be prescribed, previously diluted in 100-150 ml of 0.9% sodium chloride solution, and administered intravenously drip 1 time per day. The course of treatment is 2 weeks.
For the treatment of encephalopathy and elimination of withdrawal syndrome in alcohol intoxication, administer 5 ml of the drug intramuscularly once a day for 10-15 days.
For diabetic encephalopathy, 5 ml intramuscularly once a day for 10 days, followed by 1 tablet of Thiocetam® Forte or 2 tablets of Thiocetam® 3 times a day for 45 days, 30 minutes before meals.
Children
Not used.
Overdose
Symptoms: increased manifestations of side effects of the drug.
In these cases, the drug is discontinued and symptomatic treatment is prescribed.
Adverse reactions
During clinical use of 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 rash, itching, urticaria, angioedema, anaphylactic shock;
Cardiovascular system: decreased blood pressure;
From the vestibular system: dizziness;
General disorders and administration site conditions: skin hyperemia and itching at the injection site.
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;
Reproductive system and breastfeeding: increased sexual activity;
vascular disorders: hypotension, thrombophlebitis;
General disorders and administration site conditions: asthenia, injection site pain, fever, weight gain.
- thiazide acid:
In patients, mainly elderly, and in particular against the background of taking other drugs, cases have been described:
allergic reactions: skin hyperemia, fever;
from the central and peripheral nervous system: dizziness, tinnitus;
from the cardiovascular system: tachycardia, increased blood pressure;
Gastrointestinal: dry mouth, bloating;
Respiratory system: shortness of breath, suffocation attacks.
Expiration date
5 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility. Not installed.
Packaging
10 ml in an ampoule, 10 ampoules in a box.
Vacation category
According to the recipe.
Producer
PJSC "Galychpharm".
Location of the manufacturer and its business address
Ukraine, 79024, Lviv, Opryshkivska St., 6/8.
