Vinpocetin forte - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate dihydrate 30 mg, lactose monohydrate (sugar milk) 95.5 mg, povidone 1.4 mg, crospovidone 2.4 mg, magnesium stearate 0.7 mg.

Description:Tablets are white or white with a yellowish hue of color, flat-cylindrical with a bevel.

Pharmacotherapeutic group:cerebral blood flow improver

ATX: & nbsp

N.06.B.X.18 Vinpocetine

Pharmacodynamics:

Improves the metabolism of the brain, increasing the intake of glucose and oxygen by brain tissue. Increases the resistance of neurons to hypoxia, increases the transport of glucose to the brain through the blood-brain barrier; translates the process of the decay of glucose into an energetically more economical, aerobic pathway; selectively

blocks Ca2 + -dependent phosphodiesterase; increases the levels of adenosine monophosphate (AMP), cyclic guanosine monophosphate (cGMP) and adenosine triphosphate (ATP) of the brain. Increases the exchange of norepinephrine and serotonin of the brain; has an antioxidant effect. Reduces platelet aggregation and increased blood viscosity; increases the elasticity of erythrocytes and blocks the utilization of adenosine by erythrocytes; helps to increase the return of oxygen in the erythrocytes. Increases cerebral blood flow; reduces the resistance of cerebral vessels without a significant change in the indices of the systemic circulation. It does not have the effect of "stealing" and increases blood supply, especially in ischemic areas of the brain.

Pharmacokinetics:

Suction: when ingested quickly and completely absorbed in the gastrointestinal tract (mainly in the proximal parts of the small intestine). Bioavailability when taking on an empty stomach - about 7%, after eating - about 60%. The maximum concentration in blood plasma is reached after 1 hour, in tissues - in 2-4 hours. When passing through the wall of the intestine is not exposed to metabolism. When introducing repeated doses, the kinetics is linear.

Distribution: communication with plasma proteins - 66%. Easily penetrates through the histohematological barriers (including through the blood-encephalic barrier). Penetrates into breast milk (0.25% within 1 hour), through the placental barrier.

Metabolism: clearance - 66.7 l / h exceeds the plasma volume of the liver (50 l / h), which indicates extrahepatic metabolism. The main metabolite is apovincamine acid, which has some pharmacological activity. Other inactive metabolites are hydroxy-vinpocetine, hydroxy-apovincamine acid, hydroxy-vinpocetine-glycinate.

Excretion: the half-life (T1 / 2) is 4.83 ± 1.29 hours. It is excreted by the kidneys and intestines in the ratio 3: 2. With urine, a few percent vinpocetine is unchanged, the rest is metabolites.

Indications:

Neurology (as part of complex therapy): as a symptomatic agent for various forms of cerebral circulatory insufficiency (ischemic stroke, restorative stage of hemorrhagic stroke, consequences of a stroke, transient ischemic attack, vascular dementia, vertebrobasilar insufficiency, atherosclerosis of vesselsbrain; chronic insufficiency of cerebral circulation of hypertonic and post-traumatic origin.

Ophthalmology: chronic vascular diseases of the choroid and / or retina (including occlusion of the central artery or retinal vein).

Reduction of hearing acuity of perceptual type; Meniere's disease; idiopathic noise in the ears.

Contraindications:Hypersensitivity, acute phase of hemorrhagic stroke, severe ischemic heart disease, severe heart rhythm disturbances, pregnancy, lactation, age of 18 years, lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Pregnancy and lactation:The drug is contraindicated for use during pregnancy and during breastfeeding.

Dosing and Administration:

Inside, after eating, the standard daily dose - 10 mg 2-3 times a day. The maximum daily dose is 30 mg. The course of treatment - 1-3 months. Possible repeated courses 2-3 times a year. Before cancellation of the drug should gradually reduce the dose.

With kidney and / or liver disease, dose reduction is not required.

Side effects:

Classification of WHO frequency of development of side effects:

often from> 1/100 to <1/10 of appointments (> 1% and <10%);

infrequently - from> 1/1000 to <1/100 of prescriptions (> 0.1% and <1%);

rarely from> 1/10000 to <1/1000 appointments (> 0.01% and <0.1%);

very rarely - <1/10000 prescriptions (<0.01%).

From the cardiovascular system:

Rarely: depression of the ST segment and prolongation of the QT interval, tachycardia, extrasystole (the association of these disorders with the use of the drug is questionable due to their spontaneous appearance); infrequently: minor fluctuations in blood pressure (BP) (mainly in the direction of decline), phlebitis.

From the central nervous system:

infrequently: sleep disturbance (insomnia, drowsiness), dizziness, headache, weakness.

From the digestive system:

infrequently: dry mouth, nausea, heartburn.

From the skin:

infrequently: increased sweating, flushing of the skin.

Allergic reactions:

infrequently: skin rash.

Overdose:

Symptoms: increased severity of dose-dependent side effects.

Treatment: gastric lavage, reception of activated charcoal, symptomatic treatment.

Interaction:

With the simultaneous use of vinpocetine with glibenclamide, digoxin, acenocoumarol, hydrochlorothiazide, imipramine, with preparations containing pindolol, chloranolol, clopamid. Interactions are not observed.

It is possible to intensify the hypotensive effect with simultaneous application with methyldopa (blood pressure control is necessary).

Increases the risk of hemorrhagic complications against heparin therapy.

Despite the lack of evidence to support the existence of interaction, caution is recommended, while the use central drugs of antiarrhythmic and anticoagulation action.

Special instructions:

In the case of the original interval extension QT, as well as with simultaneous use with drugs that extend the interval QT, during the treatment with vinpocetine, periodic electrocardiographic monitoring is necessary.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets of 10 mg.

Packaging:

For 10 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 3, 5 contour cell packs of 10 tablets or 1, 3 contour packs of 30 tablets together with the instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001757

Date of registration:25.04.2011

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia