Sermion pills coated 5mg N30
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Active ingredients
Nicergolin
Release form
Pills
Composition
Active ingredient: Nicergolin (Nicergolinum) Concentration of the active substance (mg): 5
Pharmacological effect
A drug that improves cerebral and peripheral blood circulation, alpha adrenergic blocker.nichergolin is a derivative of ergoline, improves metabolic and hemodynamic processes in the brain. reduces platelet aggregation and improves the rheological properties of blood, increases blood flow in the upper and lower extremities. It has an alpha1-adrenergic blocking effect, which leads to improved blood flow. It has a direct effect on cerebral neurotransmitter systems (noradrenergic, dopaminergic and acetylcholinergic), increasing their activity, which helps to optimize cognitive processes. As a result of prolonged therapy with nicergoline, a steady improvement in cognitive function and a decrease in the severity of behavioral disorders associated with dementia were observed.
Pharmacokinetics
Absorption After ingestion, nicergoline is rapidly and almost completely absorbed. Food intake or dosage form does not significantly affect the extent and rate of absorption of nicergoline. Nicergoline pharmacokinetics when administered in doses up to 60 mg is linear and does not change depending on the patient's age. Distribution and metabolism Nicergoline is actively (> 90%) bound to plasma proteins, and its affinity for α-glycoprotein is greater than for serum albumin . Nicergoline and its metabolites have been shown to be distributed in blood cells. The main products of nicergoline metabolism are 1,6-dimethyl-8β-hydroxymethyl-10α-methoxyergoline (MMDL, hydrolysis product) and 6-methyl-8β-hydroxymethyl-10α-methoxyergoline ( MDL, a product of demethylation under the action of CYP2D6 isoenzyme). The ratio of AUC values for MMDL and MDL when receiving nicergoline inwards indicates a pronounced metabolism during the first passage through the liver. After taking 30 mg of nicergoline Cmax MMDL (21 ± 14 ng / ml) and MDL (41 ± 14 ng / ml) was reached after about 1 and 4 hours, respectively, then the concentration of MDL decreased from T1 / 2 13-20 hours. confirm the lack of accumulation of other metabolites (including MMDL) in the blood. Excretion of Nickelgoline is excreted in the form of metabolites, mainly with urine (approximately 80% of the total dose),and in a small amount (10–20%) with feces. Pharmacokinetics in special clinical cases In patients with severe renal failure, a significant decrease in the degree of excretion of metabolic products with urine was observed compared with patients with normal renal function.
Indications
acute and chronic cerebral metabolic and vascular disorders (due to atherosclerosis, arterial hypertension, cerebral thrombosis or embolism of the brain, including acute transient cerebral circulation, vascular dementia (30 mg pills should be used) and vasospasm headache) - acute and chronic peripheral metabolic and vascular disorders (organic and functional arteriopathy of the extremities, Raynaud's disease, syndromes caused by impaired peripheral blood flow ka).
Contraindications
- recently transferred acute myocardial infarction; - acute bleeding; - severe bradycardia; - orthostatic regulation violation; - sucrase / isomaltase deficiency; fructose intolerance; glucose-galactose malabsorption; - children and adolescents under 18 years old; - pregnancy; - lactation period breastfeeding); - hypersensitivity to nicergoline, other ergotamine derivatives, auxiliary components of the drug.
Precautionary measures
The drug should be stored out of reach of children at a temperature not exceeding 25 ° C.
Use during pregnancy and lactation
Due to the lack of special studies, the use of the drug during pregnancy is contraindicated. At the time of taking the drug, it is necessary to refuse breastfeeding, because Nicergoline and its metabolic products are excreted in breast milk.
Dosage and administration
The drug is administered orally in 5-10 mg 3 times / day or 30 mg 2 times / day, at regular intervals, for a long time. In chronic cerebral blood circulation disorders, vascular cognitive impairment, post-stroke conditions Sermion is prescribed 10 mg 3 times / day. The therapeutic effect of the drug develops gradually, and the course of treatment should be at least 3 months. For vascular dementia, 30 mg is prescribed 2 times / day. In this case, the patient is advised to consult with the doctor every 6 months about the feasibility of continuing therapy. In acute cerebral circulation disorders, ischemic stroke due to atherosclerosis, thrombosis and cerebral vascular embolism, transient cerebral circulation disorders (transient ischemic attacks,hypertensive cerebral crises) it is preferable to start treatment with parenteral administration of nicergoline, then continue taking the drug inside. In case of disturbances in the peripheral circulation, Sermion is prescribed 10 mg 3 times / day for a long time (up to several months). In patients with impaired renal function (content serum creatinine ≥2 mg / dL) Sermion is recommended for use in lower therapeutic doses.
Side effects
On the part of the cardiovascular system: marked decrease in blood pressure (mainly after parenteral administration), dizziness, feeling hot. On the nervous system: confusion, headache, drowsiness or insomnia. On the part of the digestive system: dyspeptic phenomena, feeling of discomfort in the stomach , diarrhea, constipation, nausea. Metabolism: it is possible to increase the concentration of uric acid in the blood, and this effect does not depend on the dose and duration of therapy. Other: skin rashes.
Overdose
Symptoms: a transient pronounced decrease in blood pressure. Treatment: special treatment is usually not required, it is enough for the patient to take a horizontal position for several minutes. In exceptional cases, with a sharp disturbance in the blood supply to the brain and the heart, the introduction of sympathomimetic drugs under the constant control of blood pressure is recommended.
Interaction with other drugs
With simultaneous use, Sermion may enhance the action of antihypertensive agents. Nicergoline is metabolized under the action of CYP2D6 isoenzyme, therefore the possibility of interaction of Sermion with drugs that are metabolized with the participation of the same enzyme cannot be ruled out.
special instructions
In therapeutic doses, Sermion, as a rule, does not affect blood pressure, but in patients with hypertension it can cause a gradual decrease in blood pressure. The drug acts gradually, so it should be taken for a long time, while the doctor should periodically (at least every 6 months) to evaluate the effect of treatment and the expediency of its continuation. The effect on the ability to drive vehicles and control mechanisms. Despite the fact that Sermion improves concentration, the effect of the drug on The ability to drive vehicles and operate machinery has not been studied specifically.Given the nature of the underlying disease, patients should exercise caution in potentially hazardous activities.