Product Overview
Composition
1 tablet contains:
active components:
dihydroergocriptine a-mesylate - 4.0 mg
caffeine - 40.00 mg;
Excipients:
lactose monohydrate - 94.1 mg,
microcrystalline cellulose (Avicel PH102) - 60.0 mg,
magnesium stearate - 1.5 mg,
anhydrous silicon colloidal dioxide (Aerosil 200) - 0.4 mg.
pharmachologic effect
The combined drug.
Caffeine has a psychostimulating and analeptic effect, enhances the excitation processes in the cerebral cortex - increases mental and physical performance, reduces fatigue and drowsiness, increases the reflex excitability of the spinal cord, stimulates the respiratory and vasomotor centers, and has a diuretic effect.
Pharmacokinetics
When administered, the absorption of dihydroergocriptine is accelerated in the presence of caffeine (the time to reach the maximum concentration (Tmax) is 0.5 hours). After oral administration of 8 mg of a-dihydroergocriptine, the maximum concentration (Cmax) is 227 pg / ml, and the half-life (t1 / 2) is less than 2 hours.
a-dihydroergocriptine is a dihydrogenated ergot alkaloid derivative that blocks a1- and a2-adrenergic receptors. It has a dopaminergic, serotonergic effect, reduces platelet and red blood cell aggregation, reduces the permeability of the vascular wall, increases the number of functioning capillaries, improves blood circulation and metabolic processes in the brain, and increases the resistance of brain tissue to hypoxia.
Caffeine has a psychostimulating and analeptic effect, enhances the excitation processes in the cerebral cortex - increases mental and physical performance, reduces fatigue and drowsiness, increases the reflex excitability of the spinal cord, stimulates the respiratory and vasomotor centers, and has a diuretic effect.
Pharmacokinetics
When administered, the absorption of dihydroergocriptine is accelerated in the presence of caffeine (the time to reach the maximum concentration (Tmax) is 0.5 hours). After oral administration of 8 mg of a-dihydroergocriptine, the maximum concentration (Cmax) is 227 pg / ml, and the half-life (t1 / 2) is less than 2 hours.
Indications
• Cerebrovascular insufficiency (including due to cerebral atherosclerosis).
• Consequences of cerebrovascular accident.
• Vestibular and labyrinth disorders (dizziness, tinnitus, hypoacusia) of ischemic origin.
• Meniere's disease.
Pregnancy and lactation
There are no clinical data on the use of Vazobral during pregnancy and lactation.
The use of the drug during breastfeeding can lead to a decrease in lactation.
Contraindications
Increased individual sensitivity to the components of the drug.
Contraindication for long-term use: signs of the presence of heart valve defects detected by echocardiography performed prior to the use of the drug.
Contraindication for long-term use: signs of the presence of heart valve defects detected by echocardiography performed prior to the use of the drug.
Side effects
The frequency of occurrence of adverse events / adverse reactions (AE / NR) when taking the drug is presented in accordance with the following gradation (World Health Organization classification): very often ≥10%; often ≥1% and <10%; infrequently ≥0.1% and <1%; rarely ≥0.01% and <0.1%; very rarely <0.01%.
Violations of the gastrointestinal tract
Nausea is possible (especially when taking the drug on an empty stomach), gastralgia, dyspepsia, with these manifestations, drug withdrawal is not required.
Disturbances from the heart
Very rarely: tachycardia, decreased blood pressure, heart defects (including defects with blood regurgitation) and their associated conditions (pericarditis, effusion into the pericardial cavity).
Disturbances from the nervous system Rarely: dizziness, agitation, headache.
Immune system disorders Very rare: allergic reactions.
Violations of the gastrointestinal tract
Nausea is possible (especially when taking the drug on an empty stomach), gastralgia, dyspepsia, with these manifestations, drug withdrawal is not required.
Disturbances from the heart
Very rarely: tachycardia, decreased blood pressure, heart defects (including defects with blood regurgitation) and their associated conditions (pericarditis, effusion into the pericardial cavity).
Disturbances from the nervous system Rarely: dizziness, agitation, headache.
Immune system disorders Very rare: allergic reactions.
Interaction
With the simultaneous administration of the drug Vazobral and antihypertensive drugs, an additional decrease in blood pressure is possible.
Caffeine weakens the effect of sleeping pills.
How to take, course of administration and dosage
Inside (with meals, with a small amount of liquid) 1 / 2-1 tablet 2 times a day.
The duration of the course of treatment is 2-3 months, if necessary, treatment courses can be carried out 1-2 times a year.
Overdose
An overdose can cause vomiting.
Symptoms of an overdose - increased severity of side effects.
The treatment is symptomatic.
Special instructions
Vazobral has a vasodilating effect, without affecting systemic blood pressure.
Prescribing Vazobral to patients with arterial hypertension does not exclude the need for antihypertensive drugs. The caffeine contained in the preparation can cause sleep disturbance, tachycardia. Avoid fasting.
In patients taking dihydroergocriptine, especially in high doses and for a long time, the development of effusion into the pericardial cavity and pleural cavity, as well as the development of pleural and pulmonary fibrosis and constrictive pericarditis, were sometimes reported.
Patients with unexplained pleuropulmonary disorders should be examined, and discontinuation of treatment with dihydroergocriptine should be considered. Rare cases of retroperitoneal fibrosis have been reported, especially with high doses and with long-term treatment with dihydroergocriptine.
In order to diagnose retroperitoneal fibrosis at a reversible stage, such patients should be regularly monitored for clinical signs of development of retroperitoneal fibrosis (back pain, swelling of the lower extremities, renal failure).
When diagnosing or suspecting fibrotic changes in the retroperitoneal space, treatment with dihydroergocriptine should be discontinued.
Athletes should be warned that this drug contains a substance that can cause a positive reaction in tests performed during the doping control.
Impact on the ability to drive vehicles and engage in other potentially hazardous activities.
The drug in rare cases can cause a decrease in blood pressure, dizziness. When such side effects occur, driving or engaging in other potentially hazardous activities is contraindicated.
Release form
Pills
Storage conditions
At a temperature of 15 - 25 ° C, out of the reach of children
Shelf life
4 years. Do not use after expiration date.
