Velafax
Velafax: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Drug interactions
- 10. Analogs
- 11. Terms and conditions of storage
- 12. Terms of dispensing from pharmacies
- 13. Reviews
- 14. Price in pharmacies
Latin name: Velafax
ATX code: N06AX16
Active ingredient: venlafaxine (venlafaxine)
Producer: Pliva Hrvatska doo (Croatia)
Description and photo update: 2019-14-08
Prices in pharmacies: from 351 rubles.
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Velafax is an antidepressant.
Release form and composition
Dosage form - tablets: yellow or light yellow, oblong, with a dividing line on both sides or round with an engraving "PLIVA" on one side and a line on the other (14 pcs. In blisters, in a cardboard box 2 or 4 blisters).
The active ingredient of Velafax is venlafaxine hydrochloride, in 1 tablet - 42.43 mg (equivalent to the content of venlafaxine 37.5 mg) or 84.86 mg (equivalent to the content of venlafaxine 75 mg).
Auxiliary components: colloidal silicon dioxide, corn starch, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate, iron dye yellow oxide (E172), talc.
Pharmacological properties
Pharmacodynamics
Venlafaxine is an antidepressant whose chemical structure is not identical to any known class of antidepressants (tetracyclic, tricyclic, or others). It is a racemate of two active enantiomers. The antidepressant effect of venlafaxine is due to its ability to enhance the transmission of nerve impulses to the central nervous system. Venlafaxine and its main metabolite O-desmethylvenlafaxine (EFA) are potent inhibitors of the reuptake of norepinephrine and serotonin by neurons and slightly inhibit the reuptake of dopamine. Venlafaxine and EFA reduce the beta-adrenergic reactivity of the central nervous system, both with a single dose and during a long course of treatment.
Venlafaxine does not have an affinity for α 1 -adrenergic, H 1 -histamine and m-cholinergic receptors in the brain, and does not inhibit MAO activity. The effect of Velafax on the release of norepinephrine from brain tissue was not found.
Pharmacokinetics
After oral administration, venlafaxine is well absorbed from the gastrointestinal tract. With a single dose of 25-150 mg, the maximum concentration of the substance in the blood plasma is reached within about 2.4 hours and is equal to 33-172 ng / ml. After taking Velafax simultaneously with a meal, the time to reach the maximum concentration of the active ingredient increases by 20-30 minutes, but the values of absorption and maximum concentration remain unchanged.
Venlafaxine is extensively metabolized during the "first pass" through the liver. The main metabolite is EFA, the maximum content of which in the blood plasma is reached approximately 4.3 h after administration and is equal to 61‒325 ng / ml. The range of daily doses of 75–450 mg determines the linear nature of the pharmacokinetic parameters of venlafaxine and EFA.
Venlafaxine and EFA bind to plasma proteins by about 27% and 30%, respectively. With repeated administration, equilibrium concentrations of these substances are reached within 3 days.
The half-lives of venlafaxine and EFA are 5 and 11 hours, respectively. EFA and other metabolites, as well as venlafaxine, are excreted unchanged in the urine.
In patients with cirrhosis of the liver, the level of venlafaxine and EFA in the blood plasma is increased, and the rate of their excretion is reduced. In patients with moderate and severe renal insufficiency (CC less than 30 ml / min), the total clearance of venlafaxine and EFA decreases, and the half-life increases.
The pharmacokinetics of Velafax are not determined by the age and sex of the patient.
Indications for use
According to the instructions, Velafax is indicated for the treatment of depression of various origins, including those with anxiety symptoms.
Contraindications
- Severe liver dysfunction;
- Severe renal dysfunction (creatinine clearance (CC) less than 10 ml / min);
- Age under 18;
- Simultaneous use of monoamine oxidase inhibitors (MAO);
- The period of pregnancy and breastfeeding;
- Hypersensitivity to drug components.
With caution, Velafax should be prescribed to patients with a history of convulsive syndrome, arterial hypertension, unstable angina pectoris, tachycardia, after a recent myocardial infarction, with a predisposition to bleeding (from the mucous membranes and skin), increased intraocular pressure, angle-closure glaucoma,, hypovolemia, hyponatremia, dehydration, suicidal tendencies, in combination with diuretics, in patients with initially reduced body weight.
Instructions for use Velafax: method and dosage
Velafax tablets are taken orally, during meals, without chewing, with a sufficient amount of liquid.
It is always recommended to take the drug at the same time.
The dosage regimen is prescribed by the doctor based on clinical indications, taking into account the patient's condition.
The recommended dosage of Velafax: an initial dose of 37.5 mg 2 times a day. In the absence of a therapeutic effect after several weeks of therapy, the dose can be increased to 75 mg 2 times a day. For patients with severe depressive disorders who are inpatient treatment, the initial dose may be 75 mg 2 times a day. It is recommended to increase the dose gradually (once every 2-3 days) until the desired clinical effect is achieved. The daily dose of the drug should not exceed 375 mg.
After stabilization of the patient's condition, it is recommended to gradually reduce the daily dose to the minimum effective dose. For the prevention of relapses and as maintenance therapy, the use of Velafax can last 6 months or more.
In case of mild renal failure (glomerular filtration rate (GFR) more than 30 ml / min), the dosing regimen does not need correction.
With moderate renal failure (GFR 10-30 ml / min), it is recommended to reduce the dose to 3/4 or 1/2 of the usual dose and take it in full once.
Patients on hemodialysis should be prescribed 1/2 of the usual daily dose after completion of hemodialysis.
In case of mild hepatic insufficiency (prothrombin time (PT) less than 14 seconds), dose adjustment is not required.
With hepatic insufficiency of moderate degree (PT from 14 to 18 seconds), the patient is prescribed 1/2 of the usual dose.
Elderly patients do not need a dose adjustment of Velafax, but when prescribing, the possibility of impaired renal function should be taken into account, therefore, treatment should be carried out using the lowest effective dose and be accompanied by careful medical supervision at each increase.
Cancellation of the drug should be made by gradually reducing the daily dose. For example, when taking 75 mg or more for 7 days or more, the cancellation should last at least a week, and in patients with a course of treatment for more than 6 weeks, the dose must be reduced for at least 2 weeks.
In the case of the development of symptoms of relapse of depression during the period of discontinuation of Velafax, the patient should be prescribed an initial dose and produce a longer and gradual decrease.
Side effects
- Nervous system: often - weakness, dizziness, asthenia, yawning, drowsiness, paresthesia, increased nervous irritability, insomnia, stupor, tremors, muscle hypertonicity, sedation, nightmares; infrequently - apathy, myoclonus, fainting, hallucinations; rarely - seizures, speech impairment, ataxia with disorders of coordination of movement and balance, hypomania and mania, epileptic seizures, symptoms similar to neuroleptic malignant syndrome, serotonin syndrome; in some cases - psychomotor anxiety or akathisia, delirium, extrapyramidal disorders, including dystonia, dyskinesia and tardive dyskinesia;
- Digestive system: often - dry mouth, decreased appetite, nausea, vomiting, constipation, abdominal pain, dyspepsia; infrequently - bruxism, increased activity of liver enzymes; rarely - hepatitis; in some cases - pancreatitis;
- Mental status: frequency not established - suicidal thoughts and behavior during and after treatment, depression;
- Metabolism: often - an increase or decrease in body weight, an increase in serum cholesterol (more often against the background of taking high doses or long-term therapy); infrequently - syndrome of insufficient secretion of antidiuretic hormone (ADH), hyponatremia; in some cases - an increase in the concentration of prolactin in the blood plasma;
- Hematopoietic system and lymphatic system: infrequently - thrombocytopenia, hemorrhages in the mucous membranes and skin (ecchymosis), hemorrhagic syndrome, prolonged bleeding time; in some cases - aplastic anemia, agranulocytosis, pancytopenia, neutropenia;
- Cardiovascular system: often - hyperemia of the skin, increased blood pressure (BP); infrequently - postural hypotension, decreased blood pressure, syncope, tachycardia, arrhythmia; very rarely - lengthening of the QT interval, arrhythmia of the "pirouette" type, ventricular fibrillation, ventricular tachycardia;
- Respiratory system: infrequently - shortness of breath; in some cases, pulmonary eosinophilia;
- Urinary system: often - urination disorder; infrequently - urinary retention;
- Sense organs: often - mydriasis, accommodation disturbances, ringing or noise in the ears, visual impairment; infrequently - a violation of taste;
- Reproductive system: often - anorgasmia in men, decreased libido, ejaculation or erection disorders, menorrhagia; infrequently - anorgasmia in women, menstrual irregularities;
- Dermatological reactions: often - increased sweating (including at night); infrequently - alopecia;
- Endocrine system: rarely - galactorrhea; in some cases - an increase in the content of prolactin;
- Musculoskeletal system: often - myalgia, arthralgia; infrequently - muscle spasms; in some cases - rhabdomyolysis;
- Allergic reactions: infrequently - itchy skin, rash, maculopapular rash, urticaria, angioedema, photosensitivity; rarely - Stevens-Johnson syndrome, erythema multiforme exudative; in some cases - anaphylactic reactions;
- Others: with a sharp cancellation or reduction of the dose, possibly - refusal to eat, headache, drowsiness, increased fatigue, asthenia, nausea, diarrhea, vomiting, dry mouth, anorexia, dizziness, insomnia, difficulty falling asleep, unusual dreams, anxiety, anxiety, irritability, emotional lability, confusion, paresthesia, disorientation, convulsions, tremors, excessive sweating, hypomania, paresthesia, tachycardia, noise or ringing in the ears.
It is necessary to gradually reduce the dose of Velafax, especially after using high doses, in order to prevent the development of withdrawal symptoms.
Many of the listed side effects are dose-dependent; with prolonged therapy, the frequency and severity of most of them decreases, without causing the need to discontinue the drug.
Overdose
Overdose symptoms most often occur when Velafax is combined with ethanol and are expressed in dizziness, sinus and ventricular bradycardia or tachycardia, decreased blood pressure, changes in the ECG (expansion of the QRS complex, bundle branch block, prolongation of the QT interval), seizures, impaired consciousness (from drowsiness to coma). Death is also possible.
In case of an overdose of Velafax, symptomatic therapy is prescribed, accompanied by continuous monitoring of the functions of vital organs and an ECG. Vomiting should not be induced due to the high risk of aspiration. It is necessary to provide adequate oxygenation and pulmonary ventilation, as well as airway patency. Since venlafaxine and EFA are not cleared by dialysis, hemodialysis is ineffective. There is no specific antidote.
special instructions
During the period of depression, the patient increases the risk of suicidal thoughts and attempts at suicide, which persists until a steady improvement in the condition occurs. Since remission can occur after several weeks of treatment or more, the patient needs constant monitoring during this period. The highest probability of suicidal attempts at the beginning of the use of Velafax and in the early stages of recovery, especially in patients with a history of suicidal behavior, in young patients (up to 25 years old), prone to the appearance of suicidal thoughts before starting therapy.
Caregivers should be advised of the need for ongoing monitoring and should be able to provide immediate medical attention to the patient when symptoms appear.
Withdrawal syndrome is caused by a sharp interruption in the drug intake, especially after high doses, therefore, dose reduction or discontinuation of therapy should be done gradually. The risk of withdrawal symptoms depends on the individual tolerance of the drug, the size of the dose and the duration of treatment.
With affective disorders while taking the drug, the patient may develop hypomanic or manic states, therefore, care should be taken when prescribing Velafax with a history of mania, the treatment of such patients should be carried out in a hospital.
The drug should not be prescribed for uncontrolled epilepsy, patients with a history of controlled epilepsy need to be monitored, and if epileptic seizures occur, therapy should be interrupted.
Against the background of the use of venlafaxine, the development of psychomotor anxiety is possible, the clinic of which resembles akathisia (syndrome of motor and mental anxiety). More often this condition is observed during the first weeks of therapy, increasing the dose during this period can cause a negative effect, therefore, it is necessary to consider the feasibility of further taking the drug.
If you develop a rash, hives, or other allergic reactions, see your doctor.
The use of Velafax should take place with regular monitoring of blood pressure, especially at the beginning of treatment and with the next increase in dose.
Due to the possibility of an increase in heart rate, patients prone to tachycardia should take the drug with caution.
It is necessary to warn patients, especially in old age, about the possibility of imbalance and dizziness.
Rarely, venlafaxine intake affects changes in the parameters of the electrocardiogram (prolongation of the PR interval, prolongation of the QT interval, expansion of the QRS complex).
Care is needed when treating patients prone to bleeding in the skin and mucous membranes, since taking Velafax increases the risk of these conditions.
With a decrease in circulating blood volume and dehydration, the risk of developing hyponatremia and / or syndrome of insufficient secretion of antidiuretic hormone increases.
During the period of treatment, mydriasis may appear, therefore it is recommended that in patients with angle-closure glaucoma or those who are prone to increased intraocular pressure, treatment should be accompanied by control of intraocular pressure.
Concomitant use with phentermine and other agents that promote body weight loss is contraindicated.
Treatment with Velafax should be carried out in strict adherence to the dosage regimen; in order to exclude the abuse of the drug, the doctor must ensure control when taking it.
Long-term therapy requires monitoring serum cholesterol levels.
There is no experience with electroconvulsive therapy with venlafaxine.
Alcohol consumption is contraindicated during the treatment period.
Due to the possibility of the development of significant side effects from the nervous system, patients are advised to be careful when driving vehicles and mechanisms during the treatment period.
Drug interactions
The possibility of the simultaneous use of other drugs during the treatment with Velafax should be determined by the attending physician, taking into account the clinical condition of the patient and the presence of concomitant pathologies.
Analogs
Analogues of Velafax are: Velafax MV, Venlaxor, Velaxin, Venlafaxine, Newvelong.
Terms and conditions of storage
Store at temperatures up to 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Velafax
According to reviews, Velafax is considered a very successful drug in terms of the effectiveness / safety ratio, therefore it is often prescribed for migraine attacks. It can potentiate the action of analgesics and reduce the symptoms of depression that often accompany severe headaches. After a course of treatment lasting 1.5 months, migraine attacks occurred less frequently and were less intense, which allowed the patient to further reduce the number of analgesics taken.
Many patients report good results of treatment with Velafax for depression. It is permissible to take it for a long period of time, and there are practically no adverse reactions that can lead to drug withdrawal.
Some patients report dizziness, insomnia, decreased appetite and nausea during the day at the beginning of therapy. After a few days, these side effects disappeared. There are also reports that after the abrupt withdrawal of Velafax, patients sometimes had suicidal thoughts, which led to the resumption of treatment and a gradual dose reduction.
Price for Velafax in pharmacies
The approximate price for Velafax in pharmacy chains is 454-626 rubles (dosage 37.5 mg) or 628-764 rubles (dosage 75 mg).
Velafax: prices in online pharmacies
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Drug name Price Pharmacy |
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Velafax 75 mg tablets 28 pcs. 351 r Buy |
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Velafax 37.5 mg tablets 28 pcs. 382 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
