Tiocetam 10s 10 ml solution for injection in ampoules

The instruction for medical use


TIOTsETAM


the Trade name
Tiotsetam

Mezhdunarodnoye the unlicensed name
Is not present medicine

the Dosage form
Solution for injections

Structure
1 ml of solution contains
active agents: tiotriazolin - 25 g in terms of 100% substance,
piracetam - 100 g
excipient: water for injections up to 1 l.

The description
Transparent colourless or with hardly yellowish shade liquid

Pharmacotherapeutic group
Psychogogic and nootropic means
the Code of automatic telephone exchange N06BX

the Pharmacological

Pharmacokinetics Maximum Concentration properties of a tiotriazolin in blood plasma at intramuscular introduction - 0.84, at intravenous - 0.1 h linking with blood proteins does not exceed 10%. Tiotriazolin collects mainly in kidneys - 31%. In a significant amount it collects in a large intestine, heart, a spleen, least of all - in a small intestine and lungs (1 – 2%).
Piracetam at intake is quickly and almost completely soaked up from digestive tract. The maximum concentration in blood plasma is reached in 30 minutes, in liquor in 2-8 h. It is distributed in all bodies and fabrics, gets through a blood-brain and placental barrier. Selectively collects in tissues of a cerebral cortex, mainly in frontal, parietal and occipital lobes, in a cerebellum and basal gangliya. It is removed by kidneys in an invariable look.
A pharmacodynamics
Tiotsetam – the combined drug and pharmacological effect is caused antiischemic, by antioxidant, membrane stabilizing and immunomodulatory properties. Tiotriazolin strengthens compensatory activation of anaerobic glycolysis, reduces oppression of processes of oxidation in a tricarbonic acid cycle with preservation of the ATP intracellular fund. Drug activates an antioxidant system and slows down processes of oxidation of lipids in ischemic sites of a myocardium, reduces sensitivity of a myocardium to catecholamines, prevents progressive oppression of sokratitelny function of heart, stabilizes and reduces according to a zone of necrosis and ischemia of a myocardium. Improves rheological properties of blood (activation of a fibrinolytic system).
Piracetam increases glucose utilization, improves a course of metabolic processes, improves microcirculation in ischemic zones, inhibits aggregation of the activated thrombocytes. Improves integrative activity of a brain. Has protective action at the injuries of a brain caused by a hypoxia, intoxication, an electroshock.

Indications
- an ischemic stroke and its consequences (disturbance of the speech, mental and somatic disorders, decrease of the activity, disturbance of the emotional sphere)
- vascular, toxic and traumatic encephalopathy in the recovery period
- an abstinence syndrome in a drunkenness.

The route of administration and doses
In an ischemic stroke and for treatment of its consequences are appointed on 20 – 30 ml of the drug which is previously divorced in 100 – 150 ml of normal saline solution and entered intravenously by drop infusion 1 time a day. The course of treatment makes 2 weeks.
For treatment of encephalopathy and elimination of an abstinence syndrome in a drunkenness appoint intramusculary 5 ml of drug of 1 times a day within 10 – 15 days.

Side effects
allowed to establish Results of post-marketing observation that at clinical use of the drug Tiotsetam, solution for injections, isolated cases of side reactions were observed:
- the general weakness, a headache
- nausea, vomiting
- an itching, rashes, urticaria, an acute anaphylaxis, a Quincke's disease
At some patients the development of the side reactions caused is sometimes possible:
- piracetam:
- excitement, uneasiness, hallucinations, confusion of consciousness, balance disturbance, insomnia or drowsiness, tremor, increase in frequency of attacks of epilepsy, hyperkinesia, ataxy, depression, asthenia
others: increase in body weight, an abdominal pain, diarrhea, dermatitis, a hyperthermia,
- tiotriazoliny:
- a dermahemia, fever, a Quincke's edema
- arterial hypertension, pain in heart, tachycardia, disturbance of a sinoatrial rate
- dizziness, sonitus
- dryness in a mouth, an abdominal distension
- short wind
very seldom
- suffocation attacks.

Contraindications
- hypersensitivity to drug components
- an acute renal failure
- diabetes
- pregnancy and the period of a lactation
- acute disorders of cerebral circulation (hemorrhagic stroke).

Medicinal interactions
Drug enhances effect of antidepressants and anti-anginal drugs, exponentiates effect of indirect anticoagulants.

The special
instructions Use in pediatrics.
Medicine is not recommended to children and teenagers up to 18 years in view of lack of data on safety and efficiency.
With care drug is appointed the patient with chronic kidney disease. Tiotsetam influences aggregation of thrombocytes therefore it needs to be applied with care at patients with disturbance of a hemostasis, during surgical interventions and sick diabetes.


Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
do not influence

Overdose
Symptoms: excitement, sleep disorder, dispeptic phenomena.
Treatment: symptomatic treatment.

A form of release and packing
On 5 ml or 10 ml in ampoules of the corresponding capacity of vacuum or spray filling.
10 ampoules together with the instruction for medical use and the scarificator ampoule put in a box with the corrugated label parcel post.
5 ampoules on 5 ml or 10 ml in blister strip packaging from a film polyvinylchloride. Two blister strip packagings together with the instruction for medical use and the scarificator ampoule put in a pack.
When using ampoules with a break ring the insertion of scarificators is not provided.


To Store storage conditions the place protected from light at a temperature from 15 °C to 25 °C.
To store out of children's reach!


2 years
not to apply a period of storage after the expiration date specified on packing!

Prescription status
According to the prescription


the Arterium Corporation Producer, JSC Galichpharm,
Ukraine, 79024, Lviv, Opryshkovskaya St., 6/8