Thiocetam® (Tablets, Solution) Instructions for Use
ATC Code
N06BX (Other psychostimulants and nootropic drugs)
Active Substances
Piracetam (Rec.INN registered by WHO)
Thiotriazoline (BP British Pharmacopoeia)
Clinical-Pharmacological Group
A drug that improves brain metabolism
Pharmacotherapeutic Group
Nootropic agent
Pharmacological Action
Thiocetam® belongs to the group of cerebroactive agents and exhibits nootropic, anti-ischemic, and antioxidant properties.
The pharmacological effect of the drug is due to the mutually potentiating action of thiotriazoline and piracetam.
Piracetam is a cyclic derivative of GABA, a nootropic agent; it acts directly on the brain, improving functions such as learning, memory, attention, and consciousness, without having a sedative or psychostimulant effect.
At the neuronal level, Piracetam facilitates various types of synaptic transmission, exerting a predominant effect on the density and activity of postsynaptic receptors.
The hemorheological effects of piracetam are associated with its influence on erythrocytes, platelets, and the vascular wall.
Thiotriazoline reacts with reactive oxygen species and lipid radicals due to the pronounced reducing properties of the thiol group and prevents the occurrence of reactive oxygen species by reactivating antiradical enzymes: superoxide dismutase, catalase, and glutathione peroxidase.
Thiocetam® improves the integrative and cognitive activity of the brain, promotes the learning process, eliminates amnesia, and increases the rates of short-term and long-term memory.
Indications
- Chronic cerebral ischemia;
- Recovery period of ischemic stroke (including in patients with non-demented cognitive impairment);
- Diabetic encephalopathy.
ICD codes
| ICD-10 code | Indication |
| F07 | Personality and behavioral disorders due to disease, damage or dysfunction of the brain |
| G93.4 | Unspecified encephalopathy |
| I63 | Cerebral infarction |
| I69 | Sequelae of cerebrovascular diseases |
| ICD-11 code | Indication |
| 6E68 | Secondary emotionally labile personality disorder |
| 6E6Z | Unspecified secondary mental or behavioral syndromes |
| 8B11 | Cerebral ischemic stroke |
| 8B25.Z | Sequelae of cerebrovascular disease, unspecified |
| 8E47 | Encephalopathy, not elsewhere classified |
| 8E4A.0 | Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord |
| 8E63 | Post-cardiopulmonary bypass encephalopathy |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
The drug is administered intravenously, intramuscularly only when oral administration is not possible.
For chronic cerebrovascular disorders and in the recovery period after ischemic stroke, 20-30 ml of the drug is prescribed, pre-diluted in 100-150 ml of 0.9% sodium chloride solution, and administered intravenously by drip once a day.
The course of treatment is 2 weeks, after which they switch to the tablet form.
For diabetic encephalopathy, 5 ml is prescribed intramuscularly once a day for 10 days, followed by the appointment of the tablet form.
Tablets
Orally, 30 minutes before meals.
For chronic cerebrovascular disorders and in the recovery period after ischemic stroke, 2 tablets 3 times a day for 25-30 days.
The course of treatment can be extended to 3-4 months.
For the treatment of diabetic encephalopathy, 2 tablets are prescribed 3 times a day for 45 days.
The last dose should be taken no later than 5 p.m. (to prevent sleep disturbance).
Adverse Reactions
From the nervous system motor disinhibition, irritability, drowsiness, depression, asthenia, headache, dizziness, tinnitus, insomnia, mental agitation, imbalance, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.
From the gastrointestinal tract nausea, vomiting, diarrhea, abdominal pain (including gastralgia) and bloating, dry mouth.
From the cardiovascular system tachycardia, increased blood pressure, pain in the heart area, arrhythmias, in elderly persons exacerbation of coronary insufficiency is possible.
Allergic reactions hypersensitivity, anaphylactic reactions, including dermatitis, itching, urticaria and angioedema, fever.
From the respiratory system shortness of breath, asthma attacks.
From metabolism weight gain.
From the hearing organs vertigo.
Contraindications
- Hypersensitivity to piracetam or thiotriazoline, as well as to other components of the drug;
- Huntington’s chorea;
- Acute cerebrovascular accident (hemorrhagic stroke);
- Severe chronic renal failure (creatinine clearance less than 20 ml/min);
- Psychomotor agitation at the time of prescribing the drug;
- Childhood;
- Pregnancy and lactation period;
- Hereditary lactose intolerance, lactase deficiency;
- Sucrase/isomaltase deficiency, fructose intolerance;
- Glucose-galactose malabsorption.
Use in Pregnancy and Lactation
There is no experience with the use of the drug during pregnancy or breastfeeding, so the drug should not be prescribed to this category of women.
Use in Renal Impairment
Contraindicated in severe chronic renal failure (creatinine clearance less than 20 ml/min).
The drug should be prescribed with caution to patients with chronic renal failure (creatinine clearance 20-80 ml/min).
Thiocetam® affects platelet aggregation, so it must be used with caution in patients with impaired hemostasis, during surgical interventions, and with severe bleeding.
Pediatric Use
There is no experience with the use of the drug for the treatment of children, so the drug is contraindicated for the treatment of children under 18 years of age.
Geriatric Use
The drug should be used with caution in elderly persons with cardiovascular pathology because this group of patients more often experiences adverse reactions.
During long-term therapy in elderly patients, regular monitoring of renal function is recommended; if necessary, dose adjustment is carried out depending on creatinine clearance.
Special Precautions
The drug should be prescribed with caution to patients with chronic renal failure (creatinine clearance 20-80 ml/min).
Thiocetam® affects platelet aggregation, so it must be used with caution in patients with impaired hemostasis, during surgical interventions, and with severe bleeding.
The drug should be used with caution in elderly persons with cardiovascular pathology because this group of patients more often experiences adverse reactions.
There is no experience with the use of the drug for the treatment of children, so the drug is contraindicated for the treatment of children under 18 years of age.
During long-term therapy in elderly patients, regular monitoring of renal function is recommended; if necessary, dose adjustment is carried out depending on creatinine clearance.
Influence on the ability to drive vehicles and operate machinery
During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving a car, etc.).
Overdose
Symptoms occurrence or intensification of severity – dose-dependent adverse effects of the drug.
Treatment drug withdrawal, induction of vomiting, gastric lavage, symptomatic therapy.
Drug Interactions
Thiocetam® cannot be prescribed simultaneously with drugs that have an acidic pH value.
Due to the presence of piracetam, the effect of antidepressants and antianginal drugs is enhanced.
When prescribed simultaneously with thyroid hormones, confusion, irritability, and sleep disturbance are possible.
Piracetam does not inhibit cytochrome P450 isoenzymes.
Metabolic interaction with other drugs is unlikely.
Concomitant administration with alcohol did not affect the concentration level of piracetam in the serum; the serum ethanol concentration did not change when taking 1.6 g of piracetam.
Storage Conditions
Store the drug out of the reach of children, in a light-protected place at a temperature of 15 to 25°C (77°F).
Shelf Life
Shelf life – 2 years. Do not use the drug after the expiration date printed on the package.
Dispensing Status
The drug is dispensed by prescription.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for intravenous and intramuscular administration 25 mg+100 mg/ml: amp. 5 ml or 10 ml 10 pcs.
Marketing Authorization Holder
Art-Pharm, LLC (Russia)
Manufactured By
Halychpharm, JSC (Ukraine)
Dosage Form
 |
Thiocetam® | Solution for intravenous and intramuscular administration 25 mg+100 mg/ml: amp. 5 ml or 10 ml 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular administration transparent, colorless or with a slight yellowish tint.
| 1 ml | |
| Piracetam | 100 mg |
| Thiotriazoline (morpholinium-methyl-triazolyl-thioacetate) | 25 mg |
Excipients : water for injections – up to 1 ml.
5 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
Film-coated tablets 50 mg+200 mg: 60, 90, 100, or 120 pcs.
Marketing Authorization Holder
Art-Pharm, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Thiocetam® | Film-coated tablets 50 mg+200 mg: 60, 90, 100, or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow, round, biconvex; on the cross-section, a white or almost white core is visible.
| 1 tab. | |
| Thiotriazoline* | 50 mg |
| Piracetam* | 200 mg |
* calculated as 100% substance.
Excipients : potato starch – 23.47 mg, low molecular weight povidone – 3.5 mg, sucrose (powdered sugar) – 3.5 mg, microcrystalline cellulose – 66.03 mg, calcium stearate – 3.5 mg; film coating: opadry II yellow (aluminum lacquer based on dye indigo carmine – 0.0012 mg, aluminum lacquer based on dye sunset yellow FCF – 0.0045 mg, hypromellose – 2.4 mg, lactose monohydrate – 1.32 mg, macrogol – 0.48 mg, aluminum lacquer based on dye quinoline yellow – 0.21 mg, titanium dioxide – 1.22 mg, triacetin – 0.36 mg, dye iron oxide yellow – 0.0025 mg) – 6 mg.
10 pcs. – contour cell packs (6) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
90 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
120 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – dark glass bottles (1) – cardboard packs.
90 pcs. – dark glass bottles (1) – cardboard packs.
100 pcs. – dark glass bottles (1) – cardboard packs.
120 pcs. – dark glass bottles (1) – cardboard packs.
Solution for intravenous and intramuscular administration 25 mg+100 mg/ml: amp. 5 ml or 10 ml 10 pcs.
Marketing Authorization Holder
Art-Pharm, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Thiocetam® | Solution for intravenous and intramuscular administration 25 mg+100 mg/ml: amp. 5 ml or 10 ml 10 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intravenous and intramuscular administration | 1 tab. |
| Thiotriazoline | 25 mg |
| Piracetam | 100 mg |
5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
5 ml – ampoules (10) – cardboard packs.
10 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules (10) – cardboard packs.
![Thiocetam® [Tablets, Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Thiocetam® [Tablets, Solution] 2")