Nootropil 200 mg/ml 5 ml, 12 pcs.

Name: Nootropil 200 mg/ml 5 ml, 12 pcs.
SKU: 20594
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EAN: 4603149000397 SKU: 20594 Categories: Brain Enhancements, Medicine, Neurology and Psychiatry

Description

Pharmacotherapeutic group:

Notropic agent.

ATC code: N06BX03.

Pharmacological properties

Pharmacodynamics.

The active ingredient is piracetam, a cyclic derivative of gamma-aminobutyric acid (GABA).

Piracetam is a nootropic which directly affects the brain, improving cognitive (learning) processes such as learning ability, memory, attention, and mental performance. Piracetam affects the central nervous system in different ways: by changing the rate of propagation of excitation in the brain, improving metabolic processes in nerve cells, improving microcirculation, affecting rheological characteristics of the blood and causing no vasodilator effect.

It improves connections between the cerebral hemispheres and synaptic conduction in the neocortical structures, increases mental performance, improves cerebral blood flow.

Piracetam inhibits platelet aggregation and restores the elasticity of the red blood cell membrane, reduces red blood cell adhesion. At a dose of 9.6 g, it reduces the level of fibrinogen and Willebrand factors, by 30-40% and prolongs the bleeding time.

Piracetam has a protective and restorative effect in disorders of brain function due to hypoxia and intoxication.

Piracetam reduces the severity and duration of vestibular nystagmus.

Pharmacokinetics.

The elimination half-life of the drug from plasma is 4-5 hours and 8.5 hours from cerebrospinal fluid, which is prolonged in renal insufficiency.

The pharmacokinetics of piracetam is not changed in patients with hepatic insufficiency.

It penetrates through the blood-brain and placental barriers and membranes used in hemodialysis. In animal studies piracetam selectively accumulates in cortical tissues, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia. It does not bind with blood plasma proteins, is not metabolized in the body and is excreted unchanged by the kidneys by renal filtration. Renal clearance of piracetam in healthy volunteers is 86 ml/min.

Indications

Tinnitus, Concussion and other craniocerebral injuriesSymptomatic treatment of psychorganic syndrome, particularly in elderly patients, accompanied by memory impairment, decreased concentration and general activity, mood changes, behavior disorders, gait disturbances, as well as in patients with Alzheimer’s disease and dementia of the Alzheimer type.

Treatment of consequences of acute impairment of cerebral circulation (ischemic stroke), such as speech disorders, emotional disturbances, decreased motor and mental activity.

Chronic alcoholism – for treatment of psycho-organic and withdrawal syndromes.

Comatose states (and in the recovery period) including those after brain injuries and intoxications.

Treatment of vertigo and associated balance disorders except for vertigo of vascular genesis and psychogenic vertigo.

For treatment of cortical myoclonias as mono- or complex therapy.

As a part of complex therapy of sickle cell anemia.

Treatment of dyslexia in children, in combination with other methods, including speech therapy.

Active ingredient

Piracetam

Composition

One ampoule contains:

the active substance: piracetam – 1 g/5 ml;

excipients: sodium acetate trihydrate, glacial acetic acid, water for injection.

How to take, the dosage

Parenteral administration of piracetam is indicated when oral forms of the drug (tablets, capsules, oral solution) cannot be used, for example, when swallowing is difficult or the patient is in a coma, and intravenous administration is preferable.

Intravenous infusion of the daily dose is performed through a catheter at a constant rate for 24 hours a day (e.g., in coma or in the initial treatment of severe myoclonias). The drug is pre-diluted in one of the compatible infusion solutions: dextrose 5%, 10%, or 20%, fructose 5%, 10%, or 20%, sodium chloride 0.9%, dextran 40 (10% in sodium chloride 0.9% solution), Ringer, mannitol 20%. The total volume of the solution to be administered is determined taking into account the clinical indications and the patient’s condition.
Bolus intravenous administration (e.g. in withdrawal syndrome in alcoholism, emergency treatment of sickle-cell anemia, etc.

Intramuscularly the drug is administered if the administration through the vein is difficult or the patient is overexcited. However, the amount of the drug that can be administered intramuscularly is limited, especially in children and patients with low body weight. In addition, intramuscular introduction of the drug may be painful due to the large volume of liquid.

The volume of the solution administered intramuscularly may not exceed 5 ml. The drug administration frequency is similar to that of intravenous or oral administration.
If possible the drug is administered orally (see Instructions for Use for respective pharmaceutical forms).

The duration of treatment is determined by the physician depending on the disease and taking into account the dynamics of symptoms.

Symptomatic treatment of chronic psychorganic syndrome. 2.4-4.8 g/day.

Treatment of cerebrovascular disorders (stroke). 4.8-12 g/day.

Treatment of coma-like states and perception difficulties in persons with brain injuries. The initial dose is 9-12 g/day and maintenance dose is 2 g/day. The treatment is continued for at least three weeks.

Alcohol withdrawal syndrome. 12 doses per day. The maintenance dose is 2.4 g/day.

Treatment of dizziness and related balance disorders – 2.4-4.8 g/day.

Cortical myoclonus. The treatment starts with a dose of 7.2 g/day. Every 3-4 days the dose is increased by 4.8 g/day until the maximum dose of 24 g/day is reached. Treatment is continued throughout the entire period of the disease. Every 6 months an attempt should be made to reduce a dose or cancel a drug, gradually reducing a dose by 1.2 g/day every 2 days. In case of absence of the effect or insignificant therapeutic effect the treatment is discontinued. The daily prophylactic dose is 160 mg/kg of body weight, divided into 4 equal doses. During the crisis – 300 mg/kg intravenously divided into 4 equal doses.

Dosing to patients with impaired renal function.

Since Nootropil® is excreted by the kidneys the patient should be treated with caution in patients with renal insufficiency and the dosage should be adjusted according to the given dosage scheme:

/td>

Renal insufficiency	CK (ml/min)		Dosing regimen
Norm	> 80	normal dose
Light	50-79	2/3 of the normal dose in 2-3 doses
Medium	30-49		1/3 of the usual dose in 2 doses
Severe	< 30	1/6 of the usual dose once
	End Stage	–	contraindicated

In elderly patients, the dose is corrected in the presence of renal insufficiency, and monitoring of renal function is necessary during long-term therapy.

Treatment of dyslexia in children (in combination with speech therapy). Recommended daily dose for children from 8 years and adolescents is 3.2 g divided into two injections.

Interaction

Piracetam increases the effectiveness of thyroid hormones and antipsychotic drugs (neuroleptics). When administered simultaneously with neuroleptics, piracetam reduces the risk of extrapyramidal disorders. When concomitant use with drugs which have stimulating effect on CNS, strengthening of the stimulating effect on CNS is possible.

No interaction with clonazepam, phenytoin, phenobarbital, valproic acid was noted.

High doses (9.6 g/day) of piracetam increase the efficacy of indirect anticoagulants in patients with venous thrombosis (there was a greater decrease of platelet aggregation, fibrinogen, von Willebrand factors, blood viscosity and plasma level compared to indirect anticoagulants alone).

The possibility of changes in pharmacodynamics of piracetam under the influence of other drugs is low because 90% of the drug is excreted unchanged in the urine.
In vitro piracetam does not inhibit cytochrome Р450 isoenzymes, such as CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at concentrations of 142, 426 and 1422 mkg/ml. A slight inhibition of CYP2A6 (21%) and 3A4/5 (11%) was observed at the concentration of 1422 µg/ml, but Ki levels of these two isoenzymes are sufficient above 1422 µg/ml, due to which metabolic interaction with other drugs is unlikely.

The administration of piracetam at a dose of 20 mg/day did not alter the peak and serum concentration curve of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproic acid) in epilepsy patients receiving a constant dose.

Co-administration with alcohol had no effect on serum concentrations of piracetam, and serum alcohol concentrations were not altered by 1.6 g of piracetam.

Special Instructions

Due to the effect of Piracetam on platelet aggregation, caution is recommended when prescribing the drug in patients with impaired hemostasis, during major surgery or in patients with symptoms of severe bleeding. When treating patients with cortical myoclonias, abrupt interruption of treatment should be avoided, which may cause recurrence of seizures.

In long-term therapy of elderly patients, regular monitoring of renal function parameters is recommended; if necessary, the dose should be adjusted depending on the results of creatinine clearance study.

Bearing in mind the possible side effects, caution should be exercised when operating machinery and driving a vehicle. It penetrates through the filter membranes of hemodialysis machines.

Contraindications

Hypersensitivity to piracetam or pyrrolidone derivatives or other drug components.

Psychomotor agitation at the time of prescribing the drug.

Gentington’s chorea.

Acute impairment of cerebral circulation (hemorrhagic stroke).

End-stage renal failure (with creatinine clearance less than 20 ml/min).

Children under 3 years of age.

With caution:

disorder of hemostasis;

extensive surgical interventions;

severe bleeding.

Side effects

CNS and peripheral nervous system disorders: motor disinhibition (1.72%), irritability (1.13%), somnolence (0.96%), depression (0.83%), asthenia (0.23%).

These side effects occur more frequently in elderly patients who received the drug in doses greater than 2.4 g/day. In most cases it is possible to achieve regression of such symptoms by reducing the dose of the drug. In single cases – dizziness, headache, ataxia, worsening of epilepsy course, extrapyramidal disorders, tremor, lack of balance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased libido.

Cardiovascular system disorders: rarely – decreased or increased blood pressure.

Digestive system disorders: in single cases – nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

Metabolism: weight gain (1.29%) – more often in elderly patients who received the drug in dose more than 2.4 g/day.

Skin disorders: dermatitis, itching, rash.

Allergic reactions: angioedema.

Overdose

Symptoms: A single case of dyspeptic phenomena in the form of diarrhea with blood and abdominal pain in a daily dose of 75 g was registered. It seems to be associated with the use of a large total dose of sorbitol contained in the drug. There were no other cases of drug overdose.

Treatment: In case of overdose it is recommended to apply symptomatic therapy that may include hemodialysis. There is no specific antidote. Efficiency of hemodialysis for piracetam is 50-60%.

Pregnancy use

No controlled studies have been conducted in pregnant women. Piracetam penetrates through the placental barrier and into breast milk. The concentration of the drug in the infant reaches 70-90 % of its concentration in the blood of the mother. Except in special circumstances, it should not be administered during pregnancy. Women should refrain from breastfeeding when prescribing piracetam.

Similarities

Nootropil, Piracetam, Piracetam bufus, Notrocetam

Additional information

Weight	0.132 kg
Shelf life	5 years
Conditions of storage	At a temperature not exceeding 30°C. Store the medicine out of the reach of children!
Manufacturer	Acica Pharmaceuticals S.r.l., Italy
Medication form	solution for injections and infusions
Brand	Acica Pharmaceuticals S.r.l.