Instructions for Neuro-norm capsules No. 60
Composition
active ingredient: 1 capsule contains: piracetam 400 mg, cinnarizine 25 mg;
excipients: lactose monohydrate, colloidal anhydrous silicon dioxide, magnesium stearate;
hard gelatin capsules: gelatin, titanium dioxide (E 171).
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsules with a white cap and body, containing white powder.
Pharmacotherapeutic group
Psychostimulants and nootropics. ATX code N06B X.
Pharmacological properties
Pharmacodynamics.
Neuro-norm is a combination drug. The active components of the drug are piracetam, a cyclic derivative of γ-aminobutyric acid, and cinnarizine, a selective calcium channel antagonist.
Piracetam is a nootropic that acts on the brain, improving cognitive functions such as learning ability, memory, attention, and mental performance. There are probably several mechanisms of action of the drug on the central nervous system: changing the speed of propagation of excitation in the brain; enhancing metabolic processes in nerve cells; improving microcirculation by influencing the rheological characteristics of the blood, without causing a vasodilator effect. Improves connections between the cerebral hemispheres and synaptic conduction in neocortical structures. After prolonged use of the drug, patients with decreased brain function show improvement in cognitive functions and improved attention.
Cinnarizine inhibits the contraction of vascular smooth muscle cells by blocking calcium channels. In addition to direct calcium antagonism, cinnarizine reduces the contractile effect of vasoactive substances such as norepinephrine and serotonin by blocking the calcium channel receptors controlled by them. The blockade of calcium entry into cells depends on the type of tissue, resulting in an antivasoconstrictor effect without affecting blood pressure and heart rate. Cinnarizine can further improve insufficient microcirculation by increasing the elasticity of the erythrocyte membrane and reducing blood viscosity. Cellular resistance to hypoxia increases. Cinnarizine inhibits stimulation of the vestibular system, which results in the suppression of nystagmus and other autonomic disorders. Cinnarizine prevents the occurrence of acute attacks of dizziness.
Pharmacokinetics.
The combined drug is rapidly and completely absorbed in the gastrointestinal tract.
The therapeutic effect appears after 1-6 hours.
The maximum level of piracetam in the blood plasma is noted after 2-6 hours. The distribution of piracetam to all important organs occurs quickly. Piracetam does not bind to plasma proteins and is not metabolized in the body, it penetrates well into tissues, through the blood-brain barrier and the placenta. Piracetam is excreted in the urine unchanged in about 30 hours.
The maximum level of cinnarizine after 1-4 hours is noted not only in the blood, but also in the liver, kidneys, heart, lungs, spleen and brain. It is 91% bound to blood plasma proteins. Cinnarizine is actively metabolized in the liver. Approximately 30% of metabolites are excreted in the urine, the rest - through the intestines. The half-life is about 4 hours.
Indication
Cerebrovascular disorders
Supportive treatment for symptoms of cerebrovascular origin, which include impaired memory and thinking functions, decreased concentration, and mood disorders (irritability).
Migraine prevention.
Disequilibrium
Supportive treatment for symptoms of labyrinth disorders, which include dizziness, tinnitus, nystagmus, nausea, vomiting.
Motion sickness
Prevention of motion sickness.
Contraindication
Hypersensitivity to piracetam, cinnarizine or any auxiliary component of the drug; individual sensitivity to pyrrolidone derivatives.
End-stage renal failure, acute cerebrovascular accident (hemorrhagic stroke), Huntington's chorea, parkinsonism, increased intraocular pressure, psychomotor agitation.
Interaction with other medicinal products and other types of interactions
Piracetam.
Thyroid hormones.
When used together with thyroid hormones, increased irritability, disorientation, and sleep disturbances are possible.
Acenocoumarol.
Clinical studies have shown that in patients with severe recurrent thrombosis, the use of piracetam in high doses (9.6 g/day) did not affect the dosage of acenocoumarol to achieve a prothrombin time (INR) of 2.5-3.5, but with its simultaneous use, a significant decrease in the level of platelet aggregation, fibrinogen levels, von Willebrand factors (VIII: C; VIII: vW: Ag; VIII: vW: Rco), blood viscosity and blood plasma was observed.
Pharmacokinetic interactions.
The likelihood of changes in the pharmacodynamics of piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged in the urine.
At a concentration of 1422 μg/ml, a slight inhibition of CYP2A6 (21%) and ZA4/5 (11%) was observed. However, the Ki level of these two CYP isomers is sufficient above 1422 μg/ml. Therefore, metabolic interactions with drugs that are biotransformed by these enzymes are unlikely.
Antiepileptic drugs.
The use of piracetam at a dose of 20 mg/day for 4 weeks or more did not change the concentration-level curve and maximum concentration (Cmax) of antiepileptic drugs in serum (carbamazepine, phenytoin, phenobarbital, sodium valproate) in patients with epilepsy.
Alcohol.
Co-administration with alcohol did not affect the serum concentration of piracetam, and serum alcohol concentration did not change when 1.6 g of piracetam was taken.
Cinnarizine.
Alcohol/CNS depressants/tricyclic antidepressants: Concomitant use may enhance the sedative effect of any of these drugs or cinnarizine.
Diagnostic procedures.
Due to its antihistamine effect, cinnarizine can mask positive reactions to skin reactivity factors during skin testing, so the use of the drug should be discontinued 4 days before the test.
Application features
Neuro-norm may cause stomach irritation; taking it after meals may reduce the effects of stomach irritation.
You should refrain from taking alcohol or antidepressants at the same time, as the drug may cause drowsiness, especially at the very beginning of treatment.
The use of the drug should be avoided in porphyria.
Regarding piracetam: due to the fact that piracetam reduces platelet aggregation, the drug should be prescribed with caution to patients with impaired hemostasis, conditions that may be accompanied by bleeding (gastrointestinal ulcer), during major surgical operations (including dental interventions), patients with symptoms of severe bleeding or patients with a history of hemorrhagic stroke; patients using anticoagulants, platelet antiaggregants, including low doses of acetylsalicylic acid.
The drug is excreted by the kidneys, so special attention should be paid to patients with renal insufficiency. With long-term therapy in elderly patients, regular monitoring of renal function is recommended, and if necessary, the dose should be adjusted depending on the results of the creatinine clearance study.
The drug should be used with caution in patients with hepatic insufficiency.
Regarding cinnarizine: patients with Parkinson's disease should only be prescribed the drug if the benefits of treatment outweigh the possible risk of worsening the course of this disease.
The drug contains lactose. Therefore, patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use during pregnancy or breastfeeding
Do not use the drug during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Due to the possibility of adverse reactions from the central nervous system, caution should be exercised when driving or operating other mechanisms.
Method of administration and doses
Neuro-norm capsules should be taken orally after meals, without chewing, with water.
Cerebrovascular disorders: 1 capsule 3 times a day.
Imbalance: 1 capsule 3 times a day.
Motion sickness: 1 capsule half an hour before a walk, repeating every 6 hours.
Children
Do not apply.
Overdose
Symptoms: increased side effects of the drug. In isolated cases of acute overdose, dyspeptic phenomena (diarrhea with blood, abdominal pain), changes in consciousness from drowsiness to stupor and coma, vomiting, extrapyramidal symptoms, arterial hypotension were observed.
Treatment. There is no specific antidote. Within the first hour after ingestion, gastric lavage should be performed. If justified, activated charcoal can be administered. Symptomatic therapy should be carried out. Hemodialysis may be used.
Adverse reactions
From the nervous system: confusion, nervousness, dizziness, hyperkinesia, ataxia, headache, insomnia, possible risk of worsening of the course and increase in the frequency of epileptic seizures, vestibular disorders, balance disorders, tremor, hypersomnia, lethargy, dyskinesia, parkinsonism, fatigue. Long-term use in elderly patients may lead to the development of extrapyramidal phenomena.
Immune system disorders: hypersensitivity, including anaphylaxis.
On the part of the digestive tract: dry mouth, dyspepsia, abdominal pain, upper abdominal pain, stomach discomfort, diarrhea, obstructive jaundice, increased salivation, nausea, vomiting.
From the vestibular system: vertigo.
Mental disorders: increased excitability, drowsiness, depression, anxiety, confusion, hallucinations.
Musculoskeletal system: muscle rigidity.
From the blood and lymphatic system: hemorrhagic disorders.
Others: asthenia, arterial hypertension, thrombophlebitis, hyperthermia, increased sexual activity.
With a long course of treatment, in rare cases, weight gain may occur.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a contour blister pack; 2 or 6 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
