PHESCETAM CAPSULES

Pharmacotherapeutic group: 

A drug that improves blood circulation and brain metabolism.

Pharmachologic effect:

Pharmacodynamics:
Piracetam activates metabolic processes in the brain by increasing energy and protein metabolism, accelerating the utilization of glucose by cells and increasing their resistance to hypoxia; improves interneuronal transmission in the central nervous system, improves the transmission of information inside and between the hemispheres of the brain, providing an anti-ischemic effect due to its effect on metabolism and hemorheology.

Cinnarizine is a selective blocker of slow Calcium channels, inhibits the entry of calcium ions into cells and reduces their content in the plasmolemma depot, reduces the smooth muscle tone of arterioles, reduces their response to biogenic vasoconstrictor substances (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin). It has a vasodilating effect (especially in relation to the vessels of the brain, enhancing the antihypoxic effect of piracetam), without having a significant effect on blood pressure. It shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, lowers the tone of the sympathetic nervous system. Increases the elasticity of erythrocyte membranes, their ability to deform, reduces blood viscosity.

Combined drug with a pronounced antihypoxic, nootropic and vasodilator effect. The combination of both components of the drug leads to mutual enhancement of their pharmacological action, expressed in the reduction of cerebral vascular resistance. The combination also contributes to a significant increase in brain blood flow.

Pharmacokinetics:

Piracetam - After ingestion, it is quickly and completely absorbed from the gastrointestinal tract. Smara piracetam is achieved in 2-6 hours. The bioavailability of piracetam is 95-100%

Cinnarizine - After oral administration, Cinnarizine is absorbed from the gastrointestinal tract quickly and exceeds 80-85%. Smac cinnarizine is achieved in 1-4 hours.

Distribution: 

Piracetam - Piracetam does not bind to plasma proteins.The volume of its distribution (Vd) is 0.6 l / kg. It penetrates the hematoencephalic (BBB) ​​and placental barrier. Accumulates in the brain tissue 1-4 hours after ingestion. From the cerebrospinal fluid is derived much slower than from other tissues.

Cinnarizine - Smacin of cinnarizine in 1-4 hours is noted not only in the blood, but also in the liver, kidneys, heart, lungs, spleen and in the brain. Plasma protein binding - 91%.

Metabolism and excretion: 

Piracetam is practically not metabolized and is excreted mainly by the kidneys in unchanged form (more than 95% of the dose taken in 30 hours). T1 / 2 of the brain - an average of 7.7 hours. With renal failure, T1 / 2 increases.

Cinnarizine is completely metabolized in the liver (by dealkylation). T1 / 2 cinnarizine is 4 hours. It is displayed in the form of metabolites (1/3 - by the kidneys with urine, 2/3 - through the intestine with feces).

Pharmacokinetics in special groups of patients.
Impaired renal function slows down the metabolism of the drug and in patients with renal insufficiency the dose of the drug should be reduced.

Indications for use:

- Insufficiency of cerebral blood circulation (atherosclerosis of cerebral vessels, the recovery period of ischemic and hemorrhagic strokes, head injuries, encephalopathy of various genesis);

- intoxication;

- diseases of the central nervous system, accompanied by a decrease in intellectual-mental functions (impaired memory, attention, mood);

- psychoorganic syndrome with a predominance of signs of asthenia and adynamia;

- asthenic syndrome;

- labyrinthopathy (dizziness, tinnitus, nystagmus, nausea, vomiting);

- Meniere's syndrome;

- the lag of intellectual development in children;

- Prevention of migraine and kinetoz.

Contraindications:

Individual intolerance, severe violations of the liver and / or kidneys, parkinsonism, pregnancy, lactation, children under 5 years.
With care: Parkinson's disease.
Use during pregnancy and lactation:
Contraindicated for use in pregnancy and lactation.

Dosage and administration:

Inside, regardless of the meal.
Adults - the average daily dose is -1-2 capsules three times a day for 1-3 months, depending on the severity of the disease. The course of treatment is 2-3 times a year.

Children (older than 5 years) - 1-2 capsules 1-2 times a day. Do not use for more than 3 months.

In case of renal failure, mild and moderate severity (CC less than 60 ml / min, therapeutic dose or increase the interval between doses of the drug.

Side effect:

Side effects in frequency of occurrence are distributed as follows:
very often (> 10%), often (> 1% and> 10%), infrequently (> 0.1% and <1%), rarely {> 0.01% and <0.1%), very rarely, including individual posts (<0.01%).
From the digestive system. Rarely - dyspepsia, epigastric pain, dry mouth.
From the side of the central nervous system. Rarely irritability, anxiety, sleep disturbance, headache.
Allergic reactions. Very rarely - skin rash.

Overdose:

To date, cases of overdose of the drug Phescetam have not been reported.

Interaction with other drugs:

With simultaneous use with Phescetam, it is possible to enhance the effects of nootropic, adaptogenic, antihypertensive drugs, as well as agents that inhibit the activity of the central nervous system (including ethanol).

With simultaneous use of vasodilators enhance the effect of the drug. Phescetam improves the tolerability of antipsychotic drugs (neuroleptics) and tricyclic antidepressants.
When combined, Phescetam reduces the effect of antihypertensive drugs.

Special instructions:

The drug should be prescribed with caution to persons with diseases of the liver and / or kidneys. In cases of mild and moderate renal failure (especially if creatinine clearance is less than 60 ml / min), reduce the therapeutic dose or increase the intervals between doses. In persons with impaired liver function, it is necessary to control the content of liver enzymes. Alcohol should be avoided during treatment.

The drug should be carefully prescribed for Parkinson's disease. This drug should not be taken by patients who rarely suffer from hereditary intolerance - galactose, Lapp deficiency of lactase or glucose-galactose malabsorption syndrome.

Influence on ability to drive motor transport and control mechanisms. In it is necessary to be careful when driving a car and to refrain from potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form:

Capsules (400 mg + 25 mg), 10 capsules in a PVC / AI blister. On 6 blisters with the application instruction in a cardboard box.

Storage conditions:

Store in a dark, dry place at a temperature not exceeding 25 ° C.
Keep out of the reach of children!

Shelf life: 

Do not use after the expiration date printed on the package.
Pharmacy sales terms: Prescription.