Buy Vasobral® pills 30 pcs
  • Buy Vasobral® pills 30 pcs

Vasobral®

Chiesi Pharmaceutical SpA
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2019-06-23
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Clinical Pharmacology

Part of Vasobyl alpha dihydroergocriptine - dihydrogenated derivative of ergot - blocks alpha1- and alpha2-adrenoreceptors of vascular smooth muscle cells. It has a stimulating effect on the dopamine and serotonin receptors of the central nervous system.
The use of the drug reduces platelet aggregation and red blood cells, decreases the permeability of the vascular wall, improves blood circulation and metabolic processes in the brain, increases the resistance of brain tissue to hypoxia.
CaffeineIt has a stimulating effect on the central nervous system, mainly on the cerebral cortex, respiratory and vasomotor centers. Increases mental and physical performance, reduces the feeling of fatigue.

Pharmacokinetics

When taken orally, the absorption of dihydroergocriptine is accelerated in the presence of caffeine (time to reach a maximum concentration of 0.5 hours).

The maximum concentration after oral administration of 8 mg of a-dihydroergocriptine is 227 pg / ml, and the half-life is less than 2 hours.

Indications

  • decrease in mental activity, impaired attention and memory, impaired orientation in space, caused by age-related changes;
  • cerebrovascular insufficiency (including due to cerebral atherosclerosis);
  • consequences of cerebral circulation;
  • migraine prophylaxis;
  • vestibular and labyrinth disorders (dizziness, tinnitus, hypoacuse) of ischemic genesis;
  • Meniere's disease;
  • retinopathy (diabetic and hypertensive);
  • disorders of the peripheral arterial circulation (Raynaud's syndrome and disease);
  • venous insufficiency.

Composition

1 tablet contains:
active ingredients: alpha-dihydroergocriptine mesylate 4 mg, caffeine 40 mg;
excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, anhydrous silicon colloid dioxide

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Vasobral®

Dosage and Administration

The recommended initial dose is 75 mg in 2 doses (37.5 mg 2 times / day) daily. If after several weeks of treatment there is no significant improvement, the daily dose can be increased to 150 mg (75 mg 2 times / day). If, in the opinion of the doctor, a higher dose is necessary (severe depressive disorder or other conditions requiring inpatient treatment), 150 mg can be prescribed immediately in 2 doses (75 mg 2 times / day). After that, the daily dose can be increased by 75 mg every 2-3 days until the desired therapeutic effect is achieved. The maximum daily dose of the drug Velaxin is 375 mg. After achieving the desired therapeutic effect, the daily dose can be gradually reduced to the minimum effective level. The duration of the period required to reduce the dose depends on the size of the dose, the duration of therapy, as well as the individual sensitivity of the patient.

At the end of the administration of Velaxin, it is recommended to gradually reduce the dosage of the drug, at least for a week, and monitor the patient's condition in order to minimize the risk associated with discontinuation of the drug. The duration of the period required to reduce the dose depends on the size of the dose, the duration of therapy, as well as the individual sensitivity of the patient.
Supportive care and relapse prevention.

Maintenance therapy may last 6 months or more. The drug is prescribed in the minimum effective doses used in the treatment of a depressive episode.

Use in violation of liver function:

In case of mild hepatic insufficiency (prothrombin time less than 14 sec) correction of the dosing regimen is not required. In moderate liver failure (prothrombin time from 14 to 18 seconds), the dose should be reduced by 50%. Venlafaxine is not recommended for patients with severe hepatic insufficiency, since reliable data on the safety of such therapy are not available.

Application in violation of the function of the soil:

In cases of mild severity of renal failure (creatinine clearance (QC) of more than 30 ml / min), no dosage regimen adjustment is required. In case of moderate renal failure (CC 10-30 ml / min), the dose should be reduced by 25-50%. In connection with the prolongation of T 1/2 of venlafaxine and its active metabolite (EFA), such patients should take the entire dose 1 time / day. Venlafaxine is not recommended for severe renal failure (CC less than 10 ml / min), since reliable data on the safety of such therapy are not available.

Patients on hemodialysis can receive 50% of the usual daily dose of venlafaxine after completing a hemodialysis session.

Use in elderly patients:

In elderly patients, the drug should be used with caution in connection with the possibility of impaired renal function. The smallest effective dose should be applied. At higher doses, the patient must be under close medical supervision.

Severe renal dysfunction (creatinine clearance less than 10 ml / min).
Severe abnormal liver function.
Simultaneous administration of MAO inhibitors.
Children and adolescents under 18 years of age (safety and efficacy for this category of patients has not been proven).
Established or suspected pregnancy.
Lactation period (breastfeeding).
Hypersensitivity to the drug.

Caution should be prescribed the drug in the following cases:
Recently transferred myocardial infarction.
Unstable angina.
Arterial hypertension.
Tachycardia.
Convulsions in history.
Intraocular hypertension.
Closed angle glaucoma.
Manic history in history.
Predisposition to bleeding from the skin and mucous membranes.
Initially reduced body weight.

Drug interactions

The simultaneous use of Velaxin with MAO inhibitors is contraindicated. Reception Velaxin®a can begin no less than 14 days after the end of therapy with MAO inhibitors. If a reversible MAO inhibitor (moccobemide) was used, this interval may be shorter (24 hours). Therapy with MAO inhibitors can begin no less than 7 days after discontinuation of the drug Velaxin.

The simultaneous use of venlafaxine with lithium can increase the level of lithium.

When applied simultaneously with imipramine, the pharmacokinetics of venlafaxine and its EFA metabolite do not change.

Possible enhancement of the effects of haloperidol due to an increase in its concentration in the blood when combined with Velaxin®om.

With simultaneous use with diazepam pharmacokinetics of drugs and their major metabolites are not significantly changed. Also, no effect on the psychomotor and psychometric effects of diazepam was found.

With simultaneous use with clozapine, an increase in its blood plasma level and the development of side effects (for example, epileptic seizures) can be observed.

With simultaneous use with risperidone (despite an increase in the AUC of risperidone), the pharmacokinetics of the sum of the active components (risperidone and its active metabolite) did not change significantly.

With simultaneous use of venlafaxine with ethanol, there was no decrease in psychomotor reactions. However, it is not recommended to drink alcohol during venlafaxine therapy.

Metabolism of venlafaxine with the formation of the active metabolite EFA occurs with the participation of the CYP2D6 isoenzyme. Unlike many other antidepressants, the dose of venlafaxine can not be reduced while used with CYP2D6 inhibitors, or in patients with a genetically determined decrease in CYP2D6 activity, since the total concentration of the active substance and metabolite (venlafaxine and EFA) does not change.

The main route of elimination of venlafaxine involves metabolism involving CYP2D6 and CYP3A4, therefore special care should be taken when prescribing venlafaxine in combination with drugs that are inhibitors of these two enzymes. The nature of this interaction has not yet been studied.

Venlafaxine is a relatively weak inhibitor of CYP2D6 and does not inhibit the activity of CYP1A2, CYP2C9 and CYP3A4 isoenzymes; therefore, one should not expect its interaction with other drugs in the metabolism of which these liver enzymes are involved.

Cimetidine inhibits venlafaxine metabolism during the “first pass” through the liver and does not affect the pharmacokinetics of EFA. In the majority of patients, only a slight increase in the total pharmacological activity of venlafaxine and EFA is expected (more pronounced in elderly patients and in impaired liver function).

No clinically significant interaction of venlafaxine with antihypertensive drugs (including beta-blockers, ACE inhibitors and diuretics) and hypoglycemic drugs was detected.

Since the plasma protein binding of venlafaxine and EFA is respectively 27% and 30%, no drug interaction due to a violation of plasma protein binding is assumed.

When taken simultaneously with warfarin, the anticoagulant effect of the latter can be enhanced.

When taken simultaneously with indinavir, there is a decrease in AUC of indinavir by 28% and a decrease in its C max by 36%, while the pharmacokinetic parameters of venlafaxine and EFA do not change. The clinical significance of this effect is unknown.

Pregnancy and Lactation

Pregnancy

The safety of using Velaxin during pregnancy is not proven. Therefore, use in pregnancy (or intended pregnancy) is possible only if the intended benefit to the mother outweighs the possible risk to the fetus.

Women of childbearing age should use reliable methods of contraception during the period of drug treatment and immediately consult a doctor in the event of pregnancy or pregnancy planning.

Lactation

Venlafaxine and the EFA metabolite are excreted in breast milk. The safety of these substances for newborns is not proven, so if you need to take the drug during lactation, you should decide on the termination of breastfeeding. If the mother’s treatment was completed shortly before delivery, the newborn may experience withdrawal symptoms.

Special instructions

Abrupt cessation of therapy with Velaxine (as well as other antidepressants), especially after using it in high doses, can cause withdrawal symptoms, and therefore it is recommended to gradually reduce its dose before discontinuation of the drug. The duration of the period required to reduce the dose depends on the size of the dose, the duration of therapy, as well as the individual sensitivity of the patient.

In patients with depressive disorders, the likelihood of suicidal attempts should be considered before starting any drug therapy. Therefore, to reduce the risk of overdose at the beginning of treatment, the drug should, if possible, be used in the minimum effective dose, and the patient should be under close medical supervision.

Patients with affective disorders in the treatment of antidepressants (including venlafaxine) may experience hypomania or manic states. Like other antidepressants, venlafaxine should be used with caution in patients with a history of mania. Such patients need medical supervision.

Velaxin (as well as other antidepressants) should be prescribed with caution in patients with a history of epileptic seizures. Treatment with venlafaxine should be interrupted when epileptic seizures occur.

Caution should be given to venlafaxine in patients who have recently had a myocardial infarction and have decompensated heart failure, since the safety of the drug in this category of patients has not been studied.

It is recommended to use the drug with caution in patients with tachyarrhythmia. On the background of drug treatment, an increase in heart rate is possible, especially while taking in high doses.

Patients should be warned about the need to immediately consult a doctor if a rash, urticarial elements or other allergic reactions occur.

In some patients, while taking venlafaxine, a dose-dependent increase in blood pressure has been noted, therefore, regular monitoring of blood pressure is recommended, especially during the period of clarification or dose increase.

Patients, especially the elderly, should be warned about the possibility of dizziness and imbalance.

Like other serotonin reuptake inhibitors, venlafaxine may increase the risk of hemorrhages in the skin and mucous membranes. At treatment of the patients predisposed to such states care is necessary.

While taking venlafaxine, especially in conditions of dehydration or reduction of BCC (including in elderly patients and patients taking diuretics), hyponatremia and / or syndrome of insufficient secretion of ADH may occur.

While taking the drug, mydriasis can be observed, and therefore it is recommended that intraocular pressure be monitored in patients prone to elevated or suffering from angle-closure glaucoma.

Conducted to date, clinical trials have not revealed tolerance to venlafaxine or dependence on it. Despite this, as with the treatment of other drugs acting on the central nervous system, the physician must establish careful monitoring of patients to identify signs of drug abuse. Careful monitoring and observation is necessary for patients with a history of indicating such symptoms.

When prescribing Velaxin tablets to patients with lactose intolerance, the lactose content should be considered (84.93 mg in each tablet 37.5 mg).

When taking venlafaxine, special care should be taken when conducting electroconvulsive therapy, since experience with venlafaxine in these conditions is missing.

During treatment with Velaxin, alcohol should be avoided.
Use in violation of the liver

In case of mild hepatic insufficiency (prothrombin time less than 14 sec) correction of the dosing regimen is not required. In moderate liver failure (prothrombin time from 14 to 18 seconds), the dose should be reduced by 50%. Venlafaxine is not recommended for patients with severe hepatic insufficiency, since reliable data on the safety of such therapy are not available.

Use in violation of kidney function

In cases of mild severity of renal failure (creatinine clearance (QC) of more than 30 ml / min), no dosage regimen adjustment is required. In case of moderate renal failure (CC 10-30 ml / min), the dose should be reduced by 25-50%. In connection with the prolongation of T 1/2 of venlafaxine and its active metabolite (EFA), such patients should take the entire dose 1 time / day. Venlafaxine is not recommended for severe renal failure (CC less than 10 ml / min), since reliable data on the safety of such therapy are not available.

Patients on hemodialysis can receive 50% of the usual daily dose of venlafaxine after completing a hemodialysis session.

Use in Pediatrics

The safety and efficacy of the drug in children and adolescents under the age of 18 years have not been studied.

Influence on ability to drive motor transport and control mechanisms

Despite the fact that venlafaxine does not affect psychomotor and cognitive functions, it should be borne in mind that any drug therapy with psychoactive drugs can impair mental processes and reduce the ability to perform motor functions. This should alert the patient before starting treatment. If such violations occur, the extent and duration of the restrictions must be established by the doctor.

Overdosage

Symptoms: ECG changes (prolongation of the QT interval, blockade of the bundle of the His bundle, expansion of the QRS complex), sinus or ventricular tachycardia, bradycardia, hypotension, convulsive states, altered consciousness (decreased wakefulness) With an overdose of venlafaxine while taking it with alcohol and / or other psychotropic drugs, death was reported.
Treatment: conducting symptomatic therapy. Specific antidotes are unknown. Continuous monitoring of vital functions (respiration and blood circulation) is recommended. The appointment of activated carbon to reduce the absorption of the drug. Do not induce vomiting due to the risk of aspiration. Venlafaxine and EFA are not displayed during dialysis.

  • Brand name: Vaseline
  • Active ingredient: Vaseline
  • Dosage form: Ointment for external use
  • Manufacturer: Samaramedprom
  • Country of Origin: Russia

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