Composition, form of production and packaging
Tablets are round, flat, white or almost white, with a bevel, with the inscription "10 mg" on one side and with the risk - on the other.
1 tab.
vinpocetine 10 mg
Excipients: Magnesium stearate - 2 mg, silicon dioxide colloid - 2.5 mg, talc - 5 mg, lactose monohydrate - 83 mg, corn starch - 97.5 mg.
15 pcs. - blisters (2) - packs of cardboard.
15 pcs. - blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
A drug that improves cerebral circulation and brain metabolism. Improves the metabolism of the brain, increasing the intake of glucose and oxygen by brain tissue. Increases the resistance of neurons to hypoxia, enhancing the transport of glucose to the brain via the BBB; translates the process of decay of glucose into an energetically more economical aerobic pathway; selectively blocks Ca 2+ -dependent phosphodiesterase; increases the levels of AMP and cGMP brain. Increases the concentration of ATP and the ratio of ATP / AMP in the brain tissues; enhances the metabolism of noradrenaline and serotonin of the brain; stimulates the ascending branch of the noradrenergic system, has an antioxidant effect.
Reduces platelet aggregation and increased blood viscosity; increases the deforming ability of erythrocytes and blocks the utilization of adenosine by red blood cells; helps to increase the oxygen release of red blood cells. Strengthens the neuroprotective effect of adenosine.
Increases cerebral blood flow; reduces the resistance of cerebral vessels without a significant change in the systemic blood circulation (BP, minute volume, heart rate, OPSS). Not only does it not have the effect of "stealing," but it also increases blood supply primarily in ischemic areas brain with low perfusion.
PHARMACOKINETICS
Suction
After oral administration, it is rapidly absorbed. C max in blood plasma is achieved 1 h after administration. Absorption occurs mainly in the proximal parts of the gastrointestinal tract. When passing through the wall of the intestine is not exposed to metabolism. C max in tissues is noted 2-4 hours after ingestion. Bioavailability is 7%.
Distribution
With repeated oral administration at a dose of 5 mg and 10 mg, the kinetics is linear.
It binds to plasma proteins by 66%. Penetrates through the placental barrier.
Metabolism and excretion
Clearance 66.7 l / h exceeds the plasma volume of the liver (50 l / h), which indicates extrahepatic metabolism.
T 1/2 is 4.83 В± 1.29 hours. It is excreted in urine and feces in a ratio of 3: 2.
INDICATIONS
- to reduce the severity of neurological and mental symptoms in various forms of cerebral circulatory insufficiency (including post-ischemic stroke, reconstructive hemorrhagic stroke, the consequences of a stroke, transient ischemic attack, vascular dementia, vertebrobasilar insufficiency, atherosclerosis of cerebral vessels, posttraumatic and hypertensive encephalopathy);
- Chronic vascular diseases of the eyes (vascular and retinal lesions);
- in otorhinolaryngological practice (for treatment of perceptual hearing loss, Meniere's disease, idiopathic tinnitus).
DOSING MODE
The duration of the course of treatment and the dose are determined individually.
Inside, after eating.
The average daily dose is 15-30 mg (5-10 mg 3 times / day). The initial daily dose is 15 mg. The maximum daily dose is 30 mg.
The therapeutic effect develops about a week after the start of the drug. To achieve the full therapeutic effect, it takes 3 months.
With violations of the kidney and liver, correction of the dosing regimen is not required, the lack of cumulation allows for long-term treatment.
SIDE EFFECT
From the cardiovascular system: ECG change (ST depression, QT interval prolongation); tachycardia, extrasystole (however, the presence of a causal relationship is not proven, because in the natural population these symptoms are observed with the same frequency); lability of blood pressure, sensation of hot flashes.
From the side of the central nervous system: sleep disturbances (insomnia, increased drowsiness), dizziness, headache, general weakness (these symptoms may be manifestations of the underlying disease), increased sweating.
On the part of the digestive system: dry mouth, nausea, heartburn.
Allergic reactions: skin rash, hives.
CONTRAINDICATIONS
- acute phase of hemorrhagic stroke;
- severe form of ischemic heart disease;
- severe arrhythmias;
- Pregnancy;
- lactation (breastfeeding);
- children and adolescence under 18;
- Hypersensitivity to vinpocetine or other components of the drug.
PREGNANCY AND LACTATION
Cavinton В® Forte is contraindicated in pregnancy; vinpocetine penetrates the placental barrier. At the same time, its concentration in the placenta and in the fetal blood is lower than in the pregnant woman's blood. When taken in high doses, it is possible to develop placental bleeding and spontaneous abortion, probably as a result of increased placental blood supply.
Within 1 hour with breast milk 0.25% of the dose of the drug is allocated. If it is necessary to use the drug during lactation, breastfeeding should be stopped.
APPLICATION FOR FUNCTIONS OF THE LIVER
In case of violations of the kidney function, correction of the dosing regimen is not required, the absence of cumulation allows for long-term treatment.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In case of violations of liver function, correction of the dosing regimen is not required.
SPECIAL INSTRUCTIONS
The presence of the syndrome of prolonged QT interval and the simultaneous administration of drugs that cause prolongation of the QT interval requires periodic ECG monitoring.
In case of lactose intolerance, it should be borne in mind that one tablet of Cavinton В® Forte contains 83 mg of lactose monohydrate.
Use in Pediatrics
Cavinton В® Forte should not be given to children and adolescents under the age of 18 due to the lack of data on its use in this category of patients.
Impact on the ability to drive vehicles and manage mechanisms
Data on the effect of taking Cavinton В® Forte on the ability to drive and working mechanisms are not present.
OVERDOSE
Currently, data on the overdose of Cavinton В® Forte are limited.
Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.
DRUG INTERACTION
There is no interaction with simultaneous application with beta-adrenoblockers (chloranolol, pindolol), clopamid, glibenclamide, digoxin, acenocoumarol and hydrochlorothiazide, imipramine.
Simultaneous use of Cavinton В® Forte and methyldopy sometimes caused some strengthening of the hypotensive effect, therefore, when using this combination, regular monitoring of blood pressure is required.
Despite the lack of data confirming the possibility of interaction, it is recommended to exercise caution when concurrently appointing Cavinton Forte with drugs of central action, antiarrhythmics and anticoagulants.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children at a temperature of 15 В° to 30 В° C. Shelf life - 5 years.
