Velaksin tablets instructions for use
Velaksin belongs to the group of antidepressants.
Release form and composition
Velaksin is available in tablets, in dosages of 37.5 mg and 75 mg, 14 tablets per pack. Tablets in blisters (7 pieces each) with the instruction are placed in a carton.
The main active ingredient is venlafaxine hydrochloride.
Auxiliary components: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silicon dioxide, magnesium stearate.
Pharmacodynamics. Venlafaxine is an antidepressant. The chemical structure differs from other groups of this class of drugs (tetracyclic, tricyclic, etc.). The therapeutic effect of venlafaxine is due to its ability to potentiate the transmission of nerve impulses to the central nervous system. The active substance and its active metabolite have a strong inhibitory (inhibitory) effect on the reuptake of serotonin and norepinephrine, and a weak inhibitory effect on the reuptake of dopamine. Venlafaxine and its metabolite also reduce the activity of β-adrenergic receptors, both after a single use and with regular long-term use.
Venlafaxine has no affinity for M-cholinergic receptors, H-cholinergic receptors, H-1 histamine receptors and α-1 brain adrenergic receptors. Does not inhibit the activity of MAO. Does not affect phencyclidine, opioid, benzodiazepine receptors.
Pharmacokinetics. Venlafaxine is well absorbed from the digestive tract. The maximum concentration of the active substance in the blood is noted 2.4 hours after taking the drug, the maximum concentration of the active metabolite is 4.3 hours. If the drug is taken with food, the maximum concentration of a substance in the blood plasma is achieved 20-30 minutes faster. The maximum concentration and bioavailability do not change.
Venlafaxine is metabolized in the liver. 27% of venlafaxine and 30% of the active metabolite bind to plasma proteins. Their half-life is 5 and 11 hours, respectively. Active ingredients and inactive metabolites are excreted by the kidneys.
Indications for use
Velaksin is prescribed for the treatment and prevention of depressions of various nature.
Velaksin is contraindicated:
- with severe functional disorders of the liver;
- with severe functional impairment of the kidneys;
- with simultaneous treatment with MAO inhibitors;
- under the age of 18 years (the efficacy and safety of the use of Velaxin for this age group of patients has not been proven);
- during pregnancy and breastfeeding;
- with individual intolerance or hypersensitivity to the main or one of the auxiliary components of the drug.
Dosing and Administration
Velexin tablets are taken whole inside, during the meal. The initial recommended daily dose of the drug is 75 mg (37.5 mg in two doses). If after 2-3 weeks of treatment there is no marked therapeutic effect, the daily dose is increased to 150 mg per day (75 mg twice).
In severe depressive disorders and conditions requiring hospital treatment, an initial daily dose of 150 mg (75 mg in two doses) is prescribed, after which every 2-3 days the dose is increased by 75 mg to achieve the desired therapeutic effect. The maximum allowable daily dosage of Velaxin is 375 mg. The daily dose of the drug may gradually decrease after reaching the expected therapeutic effect.
For maintenance treatment and prevention of relapse, Velaksin is prescribed in the minimum effective therapeutic dosages used in the treatment of a depressive episode. The duration of maintenance therapy may be 6 months or more.
During treatment with Velaxin, undesirable side effects from various body systems can develop:
- on the part of the nervous system - dizziness, the appearance of unusual dreams, insomnia and nervous irritability, stupor, paresthesias, increased muscle tone and tremor, yawning; apathy and hallucinations rarely develop; epileptic seizures and manic reactions are rarely observed;
- on the part of the senses - visual impairment, disturbance of accommodation (the ability to clearly distinguish objects at different distances), mydriasis (dilated pupil), disturbance of taste perception;
- on the part of the cardiovascular system - hyperemia of the skin, tachycardia , postural hypotension, arterial hypertension;
- on the part of the hematopoietic system - ecchymosis (hemorrhages in the skin and mucous membranes), thrombocytopenia, lengthening the duration of bleeding;
- on the part of the digestive system and liver - dry mouth, loss of appetite, nausea and vomiting, constipation, rarely - hepatitis;
- on the part of the metabolism - an increase in serum cholesterol concentration, weight loss, impaired liver function tests, hyponatremia, insufficient secretion of ADH;
- on the part of the excretory system - dysuria (often difficulties at the beginning of the act of urination), urinary retention;
- on the part of the reproductive system - erectile dysfunction, anorgasmia, decreased libido, menragia;
- from other organs and systems - increasing fatigue, weakness;
- dermatological reactions - increased sweating, photosensitization;
- allergic reactions - skin rash, erythema multiforme, anaphylactoid reactions.
With prolonged therapy, the incidence and severity of side effects is reduced and, as a rule, no drug withdrawal is required.
Dropping and headache, fatigue and drowsiness, dry mouth, nausea and vomiting, diarrhea, anorexia, insomnia, anxiety and anxiety, nervous irritability, disorientation, paresthesia, sweating. Such phenomena are usually mild and do not require special treatment, they pass on their own. To prevent the development of withdrawal syndrome at the end of treatment, a slow, gradual reduction in the dose of Velaxin is recommended.
With an overdose of Velaxin, there is a change in the electrocardiogram, ventricular or sinus tachycardia, hypotension, bradycardia, a change in consciousness (decrease in wakefulness), convulsive states. If you exceed the doses of Velaxin in combination with alcohol and / or use of other psychotropic drugs, a lethal outcome is possible.
Treatment of Velaxin poisoning is symptomatic. At the same time, continuous monitoring of vital functions (blood circulation, heart, respiration) is carried out. Sorbents are assigned to reduce the absorption of the substance. There is a risk of aspiration, so vomiting is not recommended. The active substance and its metabolites are not excreted during dialysis. There are no specific antidotes for venlafaxine.
During the appointment and use of Velaxin, it is important to consider the following points:
- in depressive disorders, it is important to consider the possibility of suicidal attempts, therefore, to reduce the risk of overdose, the drug is prescribed in the minimum effective dosage, and the patient is under constant medical supervision;
- patients with affective disorders may develop hypomania or manic conditions, therefore, during treatment, patients with manic conditions should be under the constant supervision of a physician;
- if an epileptic seizure develops while taking Veloxin, treatment should be interrupted;
- In some patients, a dose-dependent increase in blood pressure is observed when taking Velaxin, therefore, constant monitoring of blood pressure is required, especially with increasing doses;
- The drug is used cautiously in patients with tachyarrhythmia, as it can cause an increase in heart rate (when taking high doses - especially);
- elderly patients may have dizziness and imbalance;
- it is necessary to take into account the content of lactose tablets when prescribing to patients with lactose intolerance;
- during treatment can not drink alcohol;
- in patients with liver cirrhosis, the concentration of the active substance and metabolites in the blood increases, the rate of their elimination decreases;
- with mild hepatic insufficiency, doses are not adjusted;
- in moderate liver failure, the recommended dosage of the drug is reduced by 50%;
- in case of severe hepatic insufficiency, it is not recommended to prescribe Velaksin (reliable data on the safety of treatment of such patients are not available with Velaxin);
- in mild renal insufficiency, dosage adjustment of the drug is not required;
- in moderate renal failure, the half-life of the active ingredient is reduced, therefore, the dosage of the drug for these patients should be reduced by 25–50% (with the prescribed daily dose taken once);
- in case of severe renal insufficiency, Velaksin is not recommended (reliable data on the safety of the drug in severe renal impairment are absent);
- the drug is not prescribed during hemodialysis;
- Velaksin can be administered after the end of the hemodialysis session at a dosage 50% less than the usual recommended daily dose;
- with caution, the drug is prescribed to elderly patients due to the high probability of renal impairment (it is recommended to use the lowest effective therapeutic dose, and if necessary, the patient should be under the constant supervision of doctors);
- at the end of the treatment course, the dosage of Velaxin decreases gradually, which eliminates the risks associated with discontinuation of the drug (the time to reduce the dose of the drug is determined individually, taking into account the dosage regimen used, the duration of treatment and the patient's response to dose reduction);
- with the simultaneous conduct of electroconvulsive therapy, caution is required (there is no clinical experience with the use of Velaxin in such conditions);
- The drug affects the nervous system, so during treatment can not drive vehicles and other mechanisms.
Velaksin is prescribed with caution in the following diseases and conditions:
- recent myocardial infarction;
- unstable angina ;
- arterial hypertension;
- convulsions ;
- angle-closure glaucoma;
- increased intraocular pressure;
- manic states;
- history of epileptic seizures;
- increased tendency to bleedings and hemorrhages from the skin and mucous membranes;
- low body weight.
- concurrent administration of Velaxin with MAO inhibitors is contraindicated;
- the time interval between the start of taking Velaxin and the end of treatment with MAO inhibitors should be at least 14 days (except for taking a reversible MAO inhibitor moclobemide - in this case, the interval between taking the drugs can be 24 hours);
- MAO inhibitors can be taken at least 7 days after the end of taking Velaxin;
- with the simultaneous use of Velaxin with haloperidol, the concentration of haloperidol in the blood and its therapeutic effect increase;
- in combination with diazepam, the pharmacokinetics of both drugs do not change;
- in combination with clozapine, its concentration in the blood increases, and the resulting side effects (such as epileptic seizures) increase;
- when taken simultaneously with risperidone, the pharmacokinetics of both drugs do not change;
- in combination with alcohol, psychomotor reactions increase;
- in combination with cimetidine, the metabolism of Velaxin slightly decreases (more pronounced in the elderly and patients with impaired liver function);
- with simultaneous use with warfarin anticoagulant effect of the latter increases;
- Velaxin does not interact with hypoglycemic agents and antihypertensive drugs (ACE inhibitors, β-blockers, diuretics);
- in combination with indinavir, Velaksin reduces its maximum concentration in the blood.
Pregnancy and lactation
There is no reliable data on the safety of Velaxin for pregnant women. Therefore, the drug is prescribed during pregnancy only in those situations when the expected benefit to the mother outweighs the potential risks to the fetus.
If the drug was taken by a pregnant woman shortly before giving birth, the newborn may develop withdrawal syndrome.
Venlafaxine and its metabolites are excreted in breast milk, so if necessary, treatment with breastfeeding should be canceled (no data on the safety of the drug for infants).
The structural analogs of Velaksin containing the same active ingredient include drugs: Efevelon, Venlaksor, Velafax, Efectin.
Terms and conditions of storage
Velaksin is stored protected from moisture and sunlight, out of the reach of children. Shelf life is 5 years. Do not use tablets after the expiration date indicated on the package.
Velaksin tablets 75mg - 850-1050 rubles.
Velaksin tablets 37.5 mg - 670-850 rubles.