How Valdoxan affects potency

Clinical and pharmacological group

Terms of dispensing from pharmacies

Released by prescription.

Form of release and composition

The tablets are oblong, film-coated, yellow-orange in color, one side shows the logo of the manufacturer.

• The tablets contain 25 mg of the active substance - agomelatine per dose;
• Excipients: lactose monohydrate, magnesium stearate, corn starch, povidone, colloidal silicon dioxide, sodium carboxymethyl starch and stearic acid;
• The film coat consists of glycerol, hypromellose, yellow iron oxide dye, macrogol and other components.

Pharmacological effect

Valdoxan has the following therapeutic effect on the human body:

• stimulates melatonin receptors;
• reduces body temperature;
• normalizes sleep;
• increases the production of dopamine and norepinephrine, thereby improving mood;
• improves mood and psycho-emotional state.

Affects the brain, in particular the prefrontal zone, by stimulating certain receptors that enhance the release of norepinephrine and dopamine. Substances included in the composition are absorbed completely and quickly. Equilibrium concentration is reached one to two hours after taking the tablets. The metabolism of the active ingredient occurs in the liver.

Indications for use

The main indication for prescribing the drug is the presence of confirmed depression. The drug can also be used to treat neuropathic pain of central and peripheral origin as part of complex therapy, used as a therapeutic and prophylactic agent for migraine.

Contraindications

The drug should not be prescribed in the following cases:

• For lactose intolerance (lactase deficiency, galactosemia, glucose or galactose malabsorption syndrome).
• Under the age of 18.
• For severe liver failure.
• For hypersensitivity to agomelatine and excipients of the drug.
• Women during the lactation period.

The drug should be taken with caution in the following groups of patients:

• Persons with suicidal tendencies.
• Patients with manic or hypomanic episodes.
• Elderly patients aged 65 and over;
• Pregnant women;
• Patients suffering from moderate or severe renal insufficiency associated with major depressive episodes.
• Persons who abuse alcohol or take drugs that contribute to the development of functional disorders of the liver.

Use during pregnancy and lactation

There are no or limited data on the use of agomelatine in pregnancy (less than 300 pregnancy outcomes).

Animal studies have not revealed direct or indirect harmful effects on pregnancy, embryonic and fetal development, labor and postnatal development. As a precautionary measure, it is recommended to avoid prescribing Valdoxan during pregnancy.

It is not known whether agomelatine passes into breast milk in lactating women. In experimental animal studies, agomelatine and its metabolites have been shown to pass into breast milk. If treatment with agomelatine is necessary, breastfeeding should be discontinued.

Instructions for use

The instructions for use indicate that Valdoxan is intended for oral use. Film-coated tablets should be swallowed whole without crushing. Accepted regardless of the meal, but it is recommended to do this in the evening. If you miss the next dose, you should take the pill as soon as possible, but if it's time for the next dose, you should not double the dose (the missed pill is not taken). For ease of control of admission, a calendar is placed on the blister.

The duration of therapy and the dose of Valdoxan is determined by the doctor.

• The average recommended daily dose is 25 mg agomelatine (1 Valdoxan tablet). If the therapeutic effect is insufficient, 2 weeks after the start of treatment, the dose of agomelatine can be increased to 50 mg per day (2 tablets of Valdoxan in the evening).

During therapy with Valdoxan, it is recommended to monitor liver function (as a rule, samples are taken before starting therapy, as well as 3, 6, 12 and 24 weeks after the start of treatment). Also, monitoring of liver function is necessary when increasing the dose of agomelatine. Clinical depression should be treated for at least 6 months to completely stop symptoms and prevent relapse. At the end of therapy with agomelatine, a gradual dose reduction is not required.

Side effects

In most cases, many patients in the first 14 days from the start of therapy experienced the development of Side effects on the drug, which are the norm and, as a rule, do not require discontinuation of treatment.

Side effects were as follows:

At first, while taking the drug, the patient may be disturbed by feelings of anxiety, anxiety, irritability, and nightmares.

Overdose

Reviews of Valdoxan contain little data on cases of drug overdose.

Overdose of Valdoxan is manifested by: epigastric pain, drowsiness, weakness, anxiety, agitation, tension, cyanosis, dizziness, malaise.

Treatment of overdose with Valdoxan is symptomatic, with monitoring of the patient's condition in the hospital.

Special Instructions

Given such side effects of Valdoxan as dizziness and drowsiness, it is not recommended to drive vehicles and complex mechanisms during treatment.

Drug interaction

Valdoxan interacts with other drugs as follows:

• Inhibitors of the isoenzyme CYP1A2 (Ciprofloxacin, Fluvoxamine) - the concentration of agomelatine increases.
• Rifampicin reduces the bioavailability of the active ingredient.

We have selected some reviews of people about Valdoxan who tell how they feel after it:

Despite the reviews of people, the choice of an antidepressant should be approached with special responsibility and only drugs prescribed by a specialist in a certain dosage should be taken.

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

Consult your doctor before using analogues.

Storage conditions and shelf life

The shelf life of the drug is 3 years from the date of manufacture. It is recommended to store the tablets away from children at a temperature not exceeding 25 degrees.

Antidepressant Valdoxan

Antidepressant: Valdoxan (Valdoxan) Manufacturer: Laboratories Servier Industry, France Active ingredient: Agomelatine.

Valdoxan instructions and usage

Valdoxan is a drug related to psychoanaleptics. Its main action is aimed at normalizing the central nervous system. Also, due to the main active ingredient - agomelatine, the antidepressant successfully copes with suppressed feelings and depression.

When it enters the gastrointestinal tract, the active substances penetrate through the mucous membrane into the blood. Reviews of doctors and patients are identical. The drug normalizes sleep, relieves depression, reduces irritability and improves well-being.

An additional feature of agomelatine is the absence of suppression of sexual function and addiction.

Excretion from the body is fast, up to 80% is provided by the kidneys. In urine, % is minimal.

Instructions for use

Pharmacological action

The pharmacological action of Valdoxan is antidepressant. The active substance is agomelatine. Agomelatine is a serotonin 5-HT2C receptor antagonist and an MT1 and MT2 melatonergic receptor agonist.

Indications for use

Valdoxan is indicated for major depressive disorders in adults.

How to use it

When administered, Valdoxan is taken orally as a whole, without chewing. There are no categorical recommendations for eating. The recommended daily dose of the drug is 1 tablet. You need to take it at night.

If there is no positive effect within 14 days, the dosage is doubled. Terms of treatment - six months, or until recovery.

Reducing the dosage is not regulated, since the effect of addiction has not been recorded.

Side effects

In the first 2 weeks, side effects may be moderate or insignificant. Most often, patients report attacks of nausea, dizziness, fatigue, sweating, blurred vision and increased anxiety.

All side effects are of a transient type and do not oblige to stop treatment.

Contraindications

Prim Valdoxan is contraindicated:

• with individual intolerance to the main or auxiliary substance;
• for liver failure;
• when used simultaneously with Ciprofloxacin, Fluvoxamine and other isoenzyme inhibitors;
• children under 18;
• for lactose intolerance;
• in case of renal insufficiency, the drug can be used, but with caution;
• When drinking alcohol or taking drugs that can harm the liver, agomelatine should be used with caution.

Pregnancy and lactation

Using agomelatine during pregnancy is undesirable as there are no data on its use.

There is a risk of exposure to agomelatine while breastfeeding.It is better to temporarily refuse breastfeeding when using the drug.

Interaction with other drugs

Due to slowing down the metabolism of agomelatine, simultaneous administration of the drug with strong inhibitors of the isoenzyme is prohibited.

The appointment of Valdoxan with caution when taking Propranol, Grepafloxacin and other moderate inhibitors of the isoenzyme is allowed, but with caution. These estrogens are able to significantly increase the concentration of agomelatine.

It is acceptable to use with Fluconazole, Paroxetine and other drugs used in psychiatric activities, since no interaction has been recorded.

Also, no interactions have been recorded when taking drugs that bind to plasma proteins.

Overdose

In case of overdose, the following are noted:

• general malaise;
• drowsiness;
• signs of dizziness;
• weakness;
• alarm condition;
• pain syndromes in the epigastric region;
• anxiety;
• cyanosis

In case of an overdose of agomelatine, there is no specific treatment. It is recommended that the patient be observed in the hospital and symptomatic therapy.

Issue Form

Produced in cardboard packaging:

• tablets 10 pcs. in a blister. Number of blisters - 10 pcs;
• tablets 14 pcs. in a blister. Number of blisters - 1 and 2 pcs;
• For hospitals, the drug is packed in blister packs of 14 tablets. Number of blisters - 7 pcs

Storage conditions

Keep away from children, at temperatures up to 30 C.

Oblong type tablets. Color yellow-orange. Film coated. The active substance of Valdoxan is agomelatine. The content in 1 tablet of the main substance is 25 mg.

• stearic acid - 2.6 mg;
• lactose monohydrate - 61.84 mg;
• sodium carboxymethyl starch - 3.9 mg;
• magnesium stearate - 1.3 mg;
• colloidal silicon dioxide - 0.26 mg;
• corn starch - 26 mg.

The shell of the tablets consists of titanium dioxide, glycerol, magnesium stearate, dye, hypromellose and macrogol.

Terms of dispensing from pharmacies

Valdoxan is available by prescription.

Expiration date

The shelf life of the drug is 3 years.

Antidepressants, part 2 Valdoxan

After the failed treatment with Paxil, I stopped thinking about treatment with antidepressants for a while. Let me remind you that I considered (and still think so today) the main reason for my condition - a malfunction - with the blood circulation of the brain by 80-90% and only a maximum of 20% - give - in favor of depression, which, in my opinion, is present, of course, I don’t argue, but it started precisely because of my constant poor health.

For those who came to this page directly from a search, here are my complaints:

Slight dizziness, fog in the head, periodic not severe headaches Sleep problems - early awakening, sleep no more than 6-6.5 hours, weakness in the morning Fatigue, reduced performance Increased irritability, sometimes touchiness, frequent lack of mood Moreover, recently there has been a periodicity conditions: for a couple of weeks I feel pretty good, then for sure a week or two worsening. But the improvement in well-being is clearly not up to the feeling of a healthy person, which I am already starting to forget, to be honest.

I got the experience of using Valdoxan, in general, unexpectedly. One friend offered to talk with his psychotherapist friend, which I hastened to take advantage of. I do not leave hope at least a little to improve the situation with my early awakenings and lack of sleep, which clearly complicate my already gloomy existence.

The hope for a psychotherapist did not come true, I felt a clear lack of his interest in my problem during the conversation, monosyllabic -cold-recommendations, and as a result, I was advised at least a month and a half course of Valdoxan, the advertisement of which was on his desk (I immediately noted this but did not protest). Valdoxan was recommended as a new generation antidepressant, I believe in everything new and advanced, so I decided to try the drug on myself

Valdoxan, an antidepressant. Active substance - agomelatineAgomelatine is active in validated models of depression (learned helplessness test, despair test, moderate chronic stress), as well as in models with desynchronization of circadian rhythms, as well as in experimental situations of anxiety and stress. It has been shown that agomelatine does not affect the uptake of monoamines and has no affinity for a-, b-adrenergic receptors, histamine receptors, cholinergic receptors, dopamine and benzodiazepine receptors.

Agomelatine enhances the release of dopamine and norepinephrine, especially in the prefrontal cortex, and does not affect the concentration of extracellular serotonin.In experimental animal studies with modeled circadian desynchronization, agomelatine has been shown to restore circadian rhythm synchronization through stimulation of melatonin receptors.

Agomelatine helps to restore the normal structure of sleep, reduce body temperature and release melatonin.

Short-term use of agomelatine (6-8 weeks therapy) at doses of 25-50 mg in patients with major depressive episodes has been shown.

The use of agomelatine has also been shown to be effective in patients with more severe forms of depressive disorder (Hamilton score 25). Agomelatine was also effective for initially high levels of anxiety, as well as for a combination of anxiety and depressive disorders.

Dosage The recommended dose is 25 mg (1 tab.) 1 time / day in the evening. In the absence of clinical dynamics after two weeks of treatment, the dose may be increased to 50 mg (2 tablets) 1 time / day in the evening.

It is recommended to monitor liver function at the beginning of therapy and then periodically, after 3 weeks, after 6 weeks (end of the stopping period of therapy), 12 weeks and 24 weeks (end of the maintenance period of therapy) after the start of therapy, and thereafter in accordance with clinical situation.

Drug therapy for depression should be carried out for at least 6 months to completely stop symptoms.

In case of discontinuation of treatment, there is no need to gradually reduce the dose.

Side effects In clinical studies, more than 3900 patients with depression received Valdoxan. Side effects were most often mild or moderate and were observed in the first 2 weeks of treatment. Nausea and dizziness were the most frequently reported. Reported side effects were generally transient and generally did not require discontinuation of treatment. In some cases, it is difficult to distinguish between the symptoms of a depressive disorder and the side effects of agomelatine therapy.

The frequency of side effects of agomelatine is given as the following gradation: very often (1/10), often (1/100,