Valdoxan, 25 mg, film-coated tablets, 14 pcs.

Heavy physical and emotional stress associated with the fast pace of life, stress and a difficult family situation cause the development of prolonged depression.

Antidepressants help cope with the disease. One of these is Valdoxan .

Pharmacodynamics and pharmacokinetics

Agomelatine is a substance with an antidepressant effect aimed at validated models of depression and some other abnormalities in the activity of the nervous system. At the same time, drugs created on its basis do not have a strong negative effect on the activity of other body systems.

Taking agomelatine helps normalize sleep structure, lower body temperature and improve the release of melatonin . The drug can be used to treat nervous system disorders of varying degrees of complexity, therefore both short-term and long-term therapy is allowed.

As a result of internal administration, absorption occurs quite quickly and almost completely. The maximum concentration in plasma is achieved 1-2 hours after administration of the drug. When distributed within the body, the substance is almost completely bound to plasma proteins, regardless of the concentration of the drug, the age of the patient, or the presence of renal impairment. A fairly rapid elimination of the drug from the body was noted, mainly in the form of metabolites through the kidneys. A small part of the unchanged substance is also excreted in the urine.

pharmachologic effect

Valdoxan (an analogue of agomelatine) counteracts the functioning of melatonin MT1 and MT2 receptors and serotonin 5-HT2c receptors.

As a result of scientific research, the activity of Valdoxan in the treatment of:

• Models of depression that meet established requirements, such as acquired helplessness, despair, moderate chronic stress;
• Modeled depression caused by disruption of cyclical fluctuations in the intensity of biological processes associated with the change of day and night (circadian rhythms);
• In situations of experimentally induced anxiety and stress.

It has been proven that Valdoxan has no effect on the uptake of monoamines and does not affect the functioning of α-, β-adrenergic receptors, histamine receptors, cholinergic receptors, dopamine and benzodiazepine receptors.

Valdoxan enhances the release of norepinephrine and dopamine, especially in the prefrontal cortex, and does not affect the concentration of serotonin outside cells.

Research results have shown that by stimulating melatonin receptors, Valdoxan promotes the release of melatonin. This restores circadian rhythms, normalizes sleep patterns and lowers body temperature, slowing down physiological processes.

Even short-term use of Valdoxan (6-8 weeks) 25-50 mg per day is effective for major depressive episodes, more severe forms of depression, with initially high levels of anxiety and with a combination of depressive and anxiety disorders. Research confirms the long-term supportive antidepressant and anti-relapse effects of Valdoxan.

Daily intake of 25 mg of Valdoxan in patients with depression does not affect memory and attention. Promotes rapid falling asleep and improves sleep quality (the duration of the long-term sleep phase increases, the number and duration of REM sleep phases do not change). At night, the heart rate decreases, and during the day there is no lethargy. There is a tendency to reduce sexual dysfunction, and a positive effect on sexual arousal and orgasm is noted.

During the daytime, the heart rate, pulse and blood pressure of patients do not change from taking Valdoxan, and body weight is stable.

Withdrawal syndrome does not occur even if the medication is abruptly stopped; Valdoxan does not cause addiction syndrome.

Side effects

As a rule, the manifestation of side effects is observed at the very beginning of treatment. Patients are especially often concerned about: nausea, dizziness, drowsiness, headache, insomnia, fatigue, anxiety, sweating, and so on. All these symptoms are not severe and usually do not require additional treatment. Gradually their manifestation decreases and completely disappears.

When does Valdoxan accumulate and begin to act?

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Instructions for Valdoxan (Method and dosage)

The tablets are intended to be taken orally, regardless of food, whole - without crushing or chewing. If the next dose of the drug was missed, then no additional medication is required, and the next tablet is taken as usual.

At the same time, the instructions for use of Valdoxan indicate that you need to take 25 mg or 1 tablet daily. If there is no improvement within 2 weeks, it is possible to increase the dosage as prescribed by the doctor.

During treatment, it is necessary to monitor liver function at the initial stage, then periodically throughout therapy. The average treatment course is 6 months or until the unwanted symptoms completely disappear.

Compound

Valdoxan (reviews from patients who took the drug indicate its high effectiveness) is a drug that acts directly on the centers of the brain responsible for the level of mood, a sense of joy, a positive perception of the world around us and current events.

The table below describes in detail the constituent components of this antidepressant, indicating their concentration and pharmacological purpose.

The drug Valdoxan has a simple chemical composition that is considered completely safe for the human body. A distinctive feature of the drug is that, unlike other antidepressants, it can cause a minimal number of side effects.

Overdose

In practical medicine, isolated cases of agomelatine . In this case, such undesirable symptoms arise as: drowsiness , stomach pain, restlessness, anxiety, weakness, tension, dizziness , and so on.

If the overdose is insignificant, then the condition will soon normalize on its own, without deviations in the activity of the cardiovascular and nervous systems, or disturbances in laboratory parameters.

If necessary, carry out symptomatic treatment and monitor the general condition of the patient.

Indications for use

Valdoxan is a modern and safe antidepressant that is indicated for use in the complex treatment of episodes of deep depression with a prolonged feeling of psycho-emotional depression, apathy, and lack of interest in the world around us and the events occurring in it.

This drug can be used to prevent episodes of depression caused by exacerbation of bipolar disorder. In the latter case, the medication is used with extreme caution, and the patient’s mental state is also monitored. According to reviews from patients who took the drug, Valdoxan does not interfere with the functions of the cardiovascular and reproductive systems.

Valdoxan has the following pharmacological properties, the presence of which provides the drug with an excellent therapeutic effect:

• eliminates signs of depression;
• normalizes the functions of the central nervous system that have been disrupted by prolonged episodes of depression or bipolar disorder;
• improves mood, restoring a positive perception of the world around us and daily events;
• increases the resistance of the central nervous system to stressful situations and prolonged psycho-emotional stress;
• allows you to successfully combat insomnia of a neurological origin (at the same time, Valdoxan does not cause drowsiness during the daytime, and also does not provoke the development of addiction syndrome);

  

• prevents the occurrence of complications in people who suffer from prolonged and severe depression (the appearance of mental illness, signs of suicidal behavior, accompanied by attempts to commit suicide);
• restores the stable course of circadian rhythms, which has a positive effect on the general condition of the body, improving the central and peripheral nervous system.

  

The pharmacological properties of Valdoxan are provided by drug stimulation of melatonin receptors. At the same time, this drug is devoid of severe side effects that are characteristic of most other antidepressants that have a similar therapeutic effect.

Interaction

The simultaneous use of this drug and various isoenzyme inhibitors, for example, fluvoxamine, Ciprofloxacin , leads to a significant slowdown in the metabolism of agomelatine , and accordingly to an increase in its concentration. Therefore, simultaneous therapy with these drugs is contraindicated.

Also, Rifampicin , which takes part in the metabolism of agomelatine, can reduce its bioavailability. This can also occur in patients who abuse smoking. As for the potential effect of agomelatine on other types of drugs, it is insignificant or not fully studied.

Contraindications

Valdoxan, according to the instructions, is contraindicated:

• Children under 18 years of age;
• In severe liver failure - various liver diseases in the active phase;
• For lactose intolerance – galactosemia, lactase deficiency, glucose/galactose malabsorption syndrome;
• In case of hypersensitivity to agomelatine and other excipients;
• Simultaneous use with strong inhibitors of the CYP1A2 isoenzyme - ciprofloxacin, fluvoxamine;
• Women during breastfeeding.

Valdoxan, according to the instructions, should be prescribed with caution and mandatory medical supervision in the following cases:

• Elderly patients over 65 years of age;
• Patients with severe or moderate renal failure during major depressive episodes;
• When taken simultaneously with moderate inhibitors of the CYP1A2 isoenzyme - grepafloxacin, propranolol, enoxacin;
• Patients with hypomanic or manic episodes;
• Patients with suicidal tendencies or suicide attempts before starting the drug;
• During pregnancy;
• Patients who abuse alcohol or use drugs that provoke functional liver disorders.

Analogues of Valdoxan

Level 4 ATC code matches:
Pipofezin

Bethol

Incazan

Melitor

Azafen

Miaser

Velafax

Mirtazonal

Venlaxor

Remeron

Venlafaxine

Lerivon

Mirtazapine

Cymbalta

Velaxin

Coaxil

Pyrazidol

Deprim

Gelarium Hypericum

Negrustin

The main analogue is Agomelatine . There are also other analogues of Valdoxan, for example – Adaptol and Paxil .

Radar

Valdoxan was included in the system of medicines registered in Russia on September 16, 2015.

Basic information about the drug:

• name – Valdoxan;
• pharmacotherapeutic group – antidepressants;
• ATX code - N06AX22;
• active ingredient – ​​agomelatine;
• release form - tablets (oblong, covered with an orange-yellow coating);
• terms of sale - according to prescription.

Reviews about Valdoxan

This remedy is quite often used in clinical practice. At the same time, its mild but effective effect was noted. Some patients report that the treatment was quite successful, without unwanted symptoms or intolerance reactions.

However, there are also reviews of Valdoxan when patients were bothered by: a feeling of nausea , attacks of aggression , and a lack of appetite . Such symptoms persisted not only at the initial stage, so it was necessary to change the drug.

In any case, the choice of an antidepressant must be approached with special responsibility and only take drugs prescribed by a specialist in a certain dosage.

Precautionary measures

The prescription and further use of a psychotropic drug requires periodic monitoring of test data reflecting liver functionality.

One of the rare side effects is liver damage, which is expressed in a sharp increase in the level of liver enzymes, the development of jaundice, and hepatitis. To prevent such complications, the attending physician refers the patient to laboratory tests to measure transaminase levels.

Minor changes in the liver occur in most patients in the first month of therapy, but then the situation often stabilizes. Upon completion of the course of treatment, all indicators return to normal without additional use of pharmacological agents.

• In clinical trials, less than 300 cases of pregnant women were considered, so it is too early to draw conclusions on the relativity of the effect of the active substance on the body of the expectant mother based on scant information. Animal studies have not shown direct or indirect threats to the female and fetus.

• Also, no negative effects of the antidepressant on the process of delivery or postnatal development were recorded. However, pharmacologists recommend using the drug with caution not only during pregnancy, but also during lactation.

• The ability of the active substance to be absorbed into breast milk is also not known for certain, but data from animal studies confirmed this fact. If a patient who is breastfeeding a child is prescribed the antidepressant Valdoxan, breastfeeding is stopped.

Special attention should be paid to the use of the product elderly people. The effectiveness of the drug for people over 65 years of age has not been established, but there are instructions from the manufacturer to limit the dosage for this group of patients.

Valdoxan price, where to buy

This drug can be bought in Moscow, in almost any pharmacy. At the same time, the price of Valdoxan varies from 1670 to 2060 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Valdoxan tablets p.p.o.
  25 mg 28 pcs. LLC Servier Rus 1323 rub. order

Pharmacy Dialogue

• Valdoxan tablets 25 mg No. 14Servier

  RUB 846 order

• Valdoxan tablets 25 mg No. 14Servier/Serdix

  RUB 859 order

• Valdoxan tablets 25 mg No. 28Servier

  RUB 1,432 order

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"Azafen"

Azafen has a different active ingredient than Valdoxan, but belongs to the same group of drugs and has a similar mechanism of action. But if Valdoxan is able to cope with severe depressive disorder, then Azafen is indicated for mild to moderate depression.

The advantage of the drug is its low price, in comparison with Valdoxan, which is partly due to Russian production. In addition, there is no risk of developing glaucoma among the contraindications, unlike most drugs for the treatment of depression. The drug has also shown itself in the treatment of depressive disorders associated with alcohol intake.