Tiotsetam of a tablet
Producer: Arterium (Arterium) Ukraine
Code of automatic telephone exchange: N06BX53
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredients:
1 tablet contains a tiotriazolin, in terms of 100% substance - 50 mg, piracetam, in terms of 100% substance - 200 mg;
excipients: potato starch, povidone, sugar-powder, cellulose microcrystallic, calcium stearate, mix for a covering of "Opadry II Yellow" 33G22623 (FCF containing a yellow decline (Е 110)).
Pharmacological properties:
Pharmacodynamics. Drug concerns to group of tserebroaktivny means, has antiischemic, antioxidant, membrane stabilizing and nootropic properties. Drug improves integrative and cognitive activity of a brain, increases efficiency of process of training, promotes elimination of symptoms of amnesia, raises indicators of a short-term and long-term memory. The pharmacological effect of drug is caused by mutually exponential action of a tiotriazolin and piracetam. Drug is capable to accelerate oxidation of glucose in reactions of aerobic and anaerobic oxidation, to normalizovyvat biopower processes, to increase the ATP level, to stabilize metabolism in brain tissues. Drug brakes ways of formation of active forms of oxygen, reactivates antioxidant system of enzymes, especially a superoxide scavenger, slows down free radical processes in brain tissues at ischemia, improves rheological properties of blood due to activation of fibrinolitic system, stabilizes and reduces according to a zone of a necrosis and ischemia.
Pharmacokinetics. It is well soaked up at internal use, gets into different bodies and fabrics, including into brain tissues. Drug gets through a placental barrier. Each component of drug is metabolized separately. Piracetam is practically not metabolized in an organism and removed with urine. The elimination half-life – 4 – 8 h Tiotriazolin is metabolized in a liver and removed with urine.
Pharmaceutical characteristics. Main physical and chemical properties. Tablets, coated yellow color, a round form, with a biconvex surface, on a break the kernel of white color is visible.
Indications to use:
The transistor and chronic disturbances of cerebral circulation caused by atherosclerosis of vessels of a brain and disturbances of cerebral circulation in the past. Drug is also shown at disturbances of cerebral circulation, disturbances of the exchange processes of a brain caused by craniocereberal injuries, intoxications, diabetic encephalopathy and also during the rehabilitation period of ischemic and hemorrhagic strokes.
Route of administration and doses:
At transistor and chronic disturbances of blood circulation of a brain and during the rehabilitation period after an ischemic and hemorrhagic stroke on 2 tablets 3 times a day within 25 - 30 days.
Tablets Tiotsetam are appointed in 30 min. prior to food. The course of treatment makes from 2 - 3 weeks to 3 – 4 months. For treatment of diabetic encephalopathy appoint 2 tablets 3 times a day for 45 days.
Features of use:
Drug can be appointed at cerebrovascular insufficiency with the advent of disturbance of the speech, memory, attention, decrease in intellectual function of a brain and disturbance of the emotional sphere for increase in an opportunity to study at the cephalalgias including caused by neurocirculatory dystonia. Tiotsetam it is possible to use for treatment of above-mentioned diseases against the background of the available heart pathology (an angina of exertion, a myocardial infarction), a liver (hepatitis, cirrhosis) and viral infections.
With care appoint the patient with a chronic renal failure.
With care it is necessary to use drug at the elderly people having cardiovascular pathology since the side reactions described above at this group of patients are noted more often.
Allergic reactions meet at the persons inclined to an allergy more often. Ability to influence speed of reaction when driving by motor transport or work with other mechanisms. Use of drug during the driving of motor transport and work with the mechanisms requiring special attention in connection with risk of development of possible undesirable reactions from a nervous system is not recommended.
Side effects:
Results of post-marketing observation allowed to reveal that at a clinical use of tablets of Tiotsetam isolated cases collateral реакций:со the parties of the central and peripheral nervous system were observed: general weakness, headache;
from digestive tract: nausea, vomiting;
from skin: itch, rash, urticaria; very seldom - a Quincke's disease.
At some patients development of the side reactions caused is seldom possible:
- piracetam: from the central and peripheral nervous system - excitement, uneasiness, hallucinations, confusion of consciousness, balance disturbance, insomnia or drowsiness, a tremor, increase in frequency of attacks of epilepsy, a hyperkinesia, an ataxy, a depression, an adynamy; others - increase in body weight, an abdominal pain, diarrhea, dermatitis, a hyperthermia, an acute anaphylaxis;
- tiotriazoliny: allergic reactions - a dermahemia, fever, a Quincke's edema;
from cardiovascular system – arterial hypertension, pain in heart, tachycardia, disturbance of a sinoatrial rate; from the central and peripheral nervous system - dizziness, a sonitus; from a gastro intestinal path – dryness in a mouth, abdominal distention; from a respiratory organs – an asthma, it is very rare - suffocation attacks.
Interaction with other medicines:
Tiotsetam it is impossible to appoint with the drugs having acid рН. Due to availability of piracetam the effect of antidepressants and anti-anginal drugs amplifies. In high doses (9,6 g/days) piracetam increases efficiency of an atsenokumarol at patients with venous thrombosis, however at use of therapeutic
Tiotsetam's doses such effect is not observed. Interaction of piracetam with clonazepam, phenobarbital, Phenytoinum, sodium Valproatum was not observed. Simultaneous use of piracetam and thyroid hormones (T3+T4) can cause irritability, a disorientation, sleep disorders. Interaction of piracetam with drugs which give in to biotransformation P450 complex enzymes,
it is improbable. The concomitant use with enalapril, kaptopresy increases risk of development of side reactions from cardiovascular system. Joint reception with alcohol does not influence the level of concentration of piracetam in blood serum.
Contraindications:
- hypersensitivity to piracetam and/or a tiotriazolin, and also to other components of drug;
- end-stage renal failure;
- acute period of a hemorrhagic stroke;
- Huntington chorea;
- pregnancy, feeding period breast.
Overdose:
At use of therapeutic doses the overdose is impossible. However at non-compliance with the doses appointed by the doctor emergence and strengthening of side effects of drug (excitement, a sleep disorder, the dispeptic phenomena) is possible. In these cases reduce a dose of drug and appoint a symptomatic treatment. Use during pregnancy or feeding by a breast. Experience of use of drug during pregnancy or feeding by a breast is absent therefore this category of women should not appoint drug. Children. There is no experience of use of drug for treatment of children therefore препаратпротивопоказан for use for children.
Storage conditions:
Period of validity. 2 years. Store in original packaging, at a temperature not above 25 °C. Store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
On 10 tablets in the blister, 3 or 6 blisters to a pack.