Cavinton Comfort pills 90 dispersible
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Active ingredients
Vinpocetine
Release form
Pills
Composition
Vinpocetine 10 mg; Excipients: mannitol - 75.6 mg, pregelatinized corn starch - 38 mg, butyl methacrylate copolymer - 9 mg, low-substituted hyprolose - 8 mg, crospovidone - 8 mg, magnesium stearate - 2.85 mg, sodium stearate fumarate - 2.8 mg colloid - 1.6 mg, aspartame - 1.28 mg, stearic acid - 1.26 mg, sodium lauryl sulfate - 0.9 mg, dimethicone - 0.39 mg, orange flavoring - 0.32 mg.
Pharmacological effect
The mechanism of action of vinpocetine consists of several elements: it improves cerebral blood flow and metabolism, has a beneficial effect on the rheological properties of blood.; The neuroprotective effect is realized by reducing the adverse cytotoxic effect of excitatory amino acids. Blocks Na + and Ca + channels and NMDA and AMPA receptors. Vinpocetine stimulates metabolism in the brain: it increases the absorption and consumption of glucose and oxygen. Increases tolerance to hypoxia: increases the transport of glucose, the only energy source for brain tissue, through the BBB; shifts the metabolism of glucose towards an energetically more favorable aerobic pathway. Selectively inhibits Ca2 + -calmodulin-dependent cGMP-phosphodiesterase. Increases the metabolism of serotonin and noradrenaline in the brain, stimulates the noradrenergic neurotransmitter system and has an antioxidant effect. Improves microcirculation in the brain by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, increasing the deformability of erythrocytes and inhibiting the reuptake of adenosine; promotes the transition of oxygen into the cells by reducing the affinity of red blood cells. Selectively increases cerebral blood flow by reducing cerebral vascular resistance without significantly affecting systemic blood circulation parameters (BP, cardiac output, heart rate, OPSS); does not cause the "steal".
Pharmacokinetics
Absorption; Vinpocetine is rapidly absorbed after ingestion and after 1 h reaches Cmax. Absorption occurs mainly in the proximal intestine. It does not undergo metabolism when passing through the intestinal wall.; Distribution; In preclinical studies of the administration of radioactively labeled Vinpocetine, it was determined in the highest concentrations in the liver and gastrointestinal tract. Cmax in the tissues is noted 2-4 hours after ingestion.; The amount of radioactive isotope in the brain did not exceed that in the blood.Binding to proteins in the human body - 66%. Vd is 246.7 ± 88.5 L, indicating a significant binding to tissues. Oral bioavailability - 7%; With repeated intake in doses of 5 mg and 10 mg, the kinetics is linear; plasma Css was 1.2 ± 0.27 ng / ml and 2.1 ± 0.33 ng / ml, respectively.; Metabolism and elimination; Clearance is 66.7%, which exceeds the total plasma volume of the liver (50 l / h) and indicates extrahepatic metabolism. T1 / 2 in humans is 4.83 ± 1.29 hours. In studies with a radiolabeled drug, it was found that the main ways of elimination are kidney excretion through the intestine in a 3: 2 ratio. In preclinical studies, the highest radioactivity was determined in bile, however, no evidence of significant enterohepatic circulation was found. Apovinkamic acid is excreted by the kidneys by simple glomerular filtration, T1 / 2 depends on the dose taken and the route of administration for Vinpocetine. The main metabolite of vinpocetine is apovincaminic acid (AVK), whose share in humans is 25-30%. After taking Vinpocetine inside the AUC AVK is 2 times greater than that after iv administration. This suggests that AVK is formed in the process of metabolism of the first passage of Vinpocetine. Other known metabolites are hydroxyquinpocetin, hydroxy-AVK, dihydroxy-AVK-glycinate, as well as their conjugates with glucuronides and / or sulfates. In unchanged form, vinpocetine is released in a small amount. An important and useful characteristic of vinpocetine is the lack of dose adjustment for liver and kidney diseases due to lack of cumulation due to its metabolic characteristics.; Pharmacokinetics in special groups of patients; It was revealed that the pharmacokinetics of vinpocetine in vinpocetine Elderly patients are not significantly different from those in young patients, the drug does not accumulate. Therefore, Vinpocetine can be prescribed to patients with impaired liver and kidney function for a long time and in usual doses.
Indications
Neurology: - symptomatic treatment of the consequences of ischemic stroke, vascular vertebrobasilar insufficiency, vascular dementia, cerebral arteriosclerosis, post-traumatic, hypertensive encephalopathy.; Ophthalmology: - chronic vascular diseases of the retina and choroid. - Meniere's disease; - noise in ears.
Contraindications
- acute phase of hemorrhagic stroke; - severe form of coronary artery disease; - severe arrhythmias; - phenylketonuria; - pregnancy; - lactation period (breastfeeding); - children and adolescents up to 18 years (due to insufficient data); - known hypersensitivity to vinpocetine and other components of the drug.
Use during pregnancy and lactation
Vinpocetine crosses the placental barrier and is therefore contraindicated in pregnancy. Moreover, its concentration in the placenta and in the blood of the fetus is lower than in the blood of the pregnant woman. At high doses, placental bleeding and spontaneous abortions are possible, probably as a result of an increase in placental blood supply.; Within an hour, 0.25% of the received dose of the drug gets into breast milk. When using the drug must stop breastfeeding.
Dosage and administration
The course of treatment and the dose are determined by the attending physician.; The drug is prescribed inside, after eating. The daily dose of the drug is 30 mg (1 tab. 10 mg 3 times / day). The therapeutic effect develops approximately in a week from the beginning of the drug intake.; Kavinton dispersible pills; Comfort can be swallowed whole with a small amount of water, in case of difficulty swallowing, the tablet should be placed on the tongue for resorption. If the patient likes the orange flavor of dispersible Cavinton pills; Comfort, they can be taken by sucking.; In diseases of the kidneys and liver, the drug is prescribed in the usual dose.
Side effects
Side effects are rare. Data are presented by system-organ classes in accordance with the MedDRA classification and with the following frequency: infrequently (from ≥1 / 1,000 to <1/100); rarely (from ≥1 / 10,000 to <1/1,000); very rarely (<1/10 000); From the side of blood and lymphatic system: rarely - leukopenia, thrombocytopenia; very rarely - anemia, agglutination of erythrocytes.; On the part of the immune system: very rarely - hypersensitivity.; On the part of metabolism and nutrition: infrequently - hypercholesterolemia; rarely - loss of appetite, anorexia, diabetes mellitus. Mental disorders: rarely - insomnia, sleep disturbances, agitation, restlessness; very rarely - euphoria, depression. From the nervous system: infrequently - headache; rarely - dizziness, taste disturbances, stupor, hemiparesis, drowsiness, amnesia; very rarely - tremorspasms.; From the organ of vision: rarely - swelling of the optic nerve head; very rarely - conjunctival hyperemia. On the part of the organ of hearing and the labyrinth: infrequently - vertigo; rarely - hyperacusia, hypoacusia, tinnitus. From the heart: rarely - ischemia / myocardial infarction, angina pectoris, bradycardia, tachycardia, extrasystoles, palpitations; very rarely - arrhythmia, atrial fibrillation. From the side of blood vessels: infrequently - arterial hypotension; rarely - arterial hypertension, "hot flashes", thrombophlebitis; very rarely - fluctuations in blood pressure. From the gastrointestinal tract: infrequently - abdominal discomfort, dry mouth, nausea; rarely - abdominal pain, constipation, diarrhea, dyspepsia, vomiting; very rarely - dysphagia, stomatitis. On the side of the skin and subcutaneous tissues: rarely - erythema, excessive sweating, itching, hives, rash; very rarely - dermatitis.; General disorders and disorders at the injection site: rarely - asthenia, fatigue, feeling hot; very rarely - chest discomfort, hypothermia. Effect on laboratory and instrumental studies: infrequently - decreased blood pressure, rarely - increased blood pressure, increased serum triglyceride concentration, ST-segment depression on ECG, decreased / increased eosinophil count, changes in activity liver enzymes; very rarely - an increase / decrease in the number of leukocytes, a decrease in the number of red blood cells, a reduction in thrombin time, an increase in body weight.
Overdose
Currently, data on overdose with Vinpocetine is limited. Treatment: gastric lavage, taking activated charcoal, symptomatic treatment.
Interaction with other drugs
There was no interaction with simultaneous use with beta-blockers (chloranolol, pindolol), clopamide, glibenclamide, digoxin, acenocoumarol, hydrochlorothiazide, and imipramine. Simultaneous use of vinpocetine and methyldopa sometimes caused some effect of the hypotensive effect, a hypotensive effect, an effect effect, a hypotensive effect, an effect pattern, an effect effect, sometimes an effect effect, sometimes an effect effect, sometimes an effect, an effect, an antihypertensive effect, methipodine, imipramine can be used. Despite the lack of data confirming the possibility of interaction, it is recommended to exercise caution while appointing Cavinton; Comfort with drugs of central, antiarrhythmic and anticoagulant action.
special instructions
The presence of a syndrome of prolonged QT interval and taking drugs that cause lengthening of the QT interval, require periodic ECG monitoring.; In a dispersible Cavinton tablet; Comfort 10 mg contains 1.28 mg of aspartame, a source of phenylalanine, so the drug is contraindicated in patients with phenylketonuria.; Effects on ability to drive and work with mechanisms; Studies on the effect on ability to drive vehicles have not been conducted In the event of undesirable reactions of the nervous system, care should be taken when driving and working with machinery.