Valdoxan

Instructions for use of Valdoxan

The drug is taken exclusively orally, swallowing without chewing the tablet, before, after or during meals. If the time for taking the medicine was missed, the next time passes without increasing (doubling) the dose. There is a calendar on the packaging of the tablets, with which the patient can keep track of taking the medicine. Usual dose: 1 tablet (25 mg) taken at bedtime. If the course of treatment does not have a positive effect within two weeks, then the dose is increased to two tablets once a day. At the same time, there is a risk of increasing the level of transaminases.

When increasing the dose to 50 mg, liver function tests should be monitored, which should be done in all patients before therapy with Valdoxan. The duration of the course can only be determined by a specialist, and it will depend on the type and complexity of the mental problems of a particular person. Treatment, according to the instructions, cannot last more than six months. At the end of the course there is no need to gradually reduce the dosage.

Dosage and regimen of use

Valdoxan is usually prescribed one tablet per day, unless otherwise directed by your doctor.
It is recommended to take before going to bed. The tablet must be swallowed completely. It is not advisable to chew or divide the medicine into pieces. The use of the drug does not depend on food intake. If a therapeutic effect is not observed, the doctor can increase the dosage to 50 milligrams, that is, two tablets per day in the evening.

The duration of use to increase the effectiveness of treatment and prevent relapses of depression is at least six months.

Since the medication does not have a withdrawal effect, there is no need to gradually reduce the dosage before stopping the use of the tablets.

Use during pregnancy and lactation

The number of studies conducted regarding the pregnancy period is limited. Therefore, you can take Valdoxan tablets while carrying a child only if a specialist determines that the benefit to the woman will outweigh the risk to the health of the unborn child.

Studies have shown that the active substance passes into breast milk. That is why, when prescribing medication, nursing mothers must stop breastfeeding.

Can it be prescribed to children?

The drug is contraindicated for use by patients under eighteen years of age. Studies have shown that the use of pills in children provokes suicidal behavior, aggressiveness and irritability.

special instructions

During pregnancy, the drug should be taken with caution. During treatment, you must stop breastfeeding. It is important to monitor liver function while taking the pills. There have been cases of damage to this organ (including liver failure, hepatitis, jaundice). Violations are possible in the first months of therapy. After stopping the course of taking the pills, transaminase levels returned to normal. When increasing the dosage, one should observe: if the activity of transaminases in the blood serum increases, then another study must be carried out within 48 hours.

It has not been established whether Valdoxan is effective for older people (75 years of age and older), so this category of patients should not take the medicine. The same applies to pensioners with dementia. Caution should be exercised when treating patients with renal failure and bipolar disorders. The latter should stop taking the drug if manic symptoms occur.

With depression, thoughts of suicide may occur; they persist even in the early stages of remission, so it is important for such patients to be treated under the supervision of a doctor. Clinical studies show that taking antidepressants in patients under 25 years of age with mental disorders leads to a risk of suicidal behavior. They should be monitored if the dosage is changed.

Caution should be exercised when using Valdoxan simultaneously with moderate inhibitors of the CYP1A2 isoenzyme (propranolol, enoxacin), since the concentration of agomelatine may increase. Patients with lactose intolerance should not take an antidepressant. It should be borne in mind that after taking the drug, drowsiness and dizziness are possible; these side effects can affect the reaction speed when driving a car.

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Pharmacological profile

Valdoxan has the following therapeutic effects on the human body:

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

It affects the brain, in particular the prefrontal zone, by stimulating certain receptors that enhance the release of norepinephrine and dopamine.

The substances included in the composition are absorbed completely and quickly. Equilibrium concentration is achieved one to two hours after taking the tablets. Metabolism of the active component occurs in the liver.

Protein binding in plasma is greater than 95 percent. The distribution of the substance does not depend on age and the presence of renal dysfunction. In the form of metabolites, it is quickly excreted from the body by the kidneys and during urination.

Interaction with other drugs

As a result of combined use of Valdoxan with isoenzyme inhibitors, such as Fluvoxamine, a slowdown in the metabolism of agomelatine may occur, contributing to an increase in its content in the blood. The use of these drugs at the same time is unacceptable. Rifampin, which affects the metabolism of agomelatine, reduces its effectiveness. A similar effect can be observed in heavy smokers. The interaction of agomelatine with other drugs is not negative or has not been identified.

Valdoxan

There are no or limited data on the use of agomelatine during 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 precaution, it is recommended to avoid prescribing Valdoxan® during pregnancy.

It is not known whether agomelatine passes into breast milk in women during lactation. Experimental studies in animals have shown that agomelatine and its metabolites pass into breast milk. If treatment with agomelatine is necessary, breastfeeding should be discontinued.

Use for liver dysfunction

The drug is contraindicated in liver failure.

Use for renal impairment

In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. Experience with the use of Valdoxan® for major depressive episodes in patients with moderate to severe renal failure is limited. When prescribing Valdoxan to such patients, caution should be exercised.

Use in children

Contraindicated in children under 18 years of age (due to lack of sufficient experience in clinical use). In children and adolescents taking other antidepressants, suicidal behavior (suicide attempts and suicidal thoughts) and hostility (mainly aggressiveness, conflict behavior, irritation) were observed more often compared to the placebo group

Use in elderly patients

The effectiveness and safety of agomelatine (at a dose of 25-50 mg/day) has been confirmed in elderly patients (younger than 75 years) with depression. There is no evidence of a significant effect in patients aged 75 years and older. In this regard, Valdoxan® should not be prescribed to patients in this age group. No dose adjustment is required depending on age.

Side effects

Taking Valdoxan may lead to undesirable consequences, which should be reported to your doctor immediately so that he can adjust the course of treatment. Among the side effects:

• mental disorders (anxiety, irritability, aggressiveness, restlessness, nightmares at night, hallucinations, mania, thoughts of suicide);
• disruption of the nervous system (drowsiness, headache, dizziness, sleep disturbances);
• problems with the digestive system (diarrhea, constipation, vomiting, pain, nausea);
• hepatitis, liver failure, jaundice;
• skin problems (itching, sweating, eczema, rash);
• Possible visual impairment.

Side effects

When using Valdoxan, the following possible side effects from various organ systems are:

• nervous – dizziness, sleep disturbance, headache, in rare cases – suicidal thoughts;
• digestive – diarrhea, constipation, nausea, abdominal pain;
• skin – increased sweating, erythematous rashes.

In addition, vision may deteriorate and back pain may appear.

Overdose

After conducting research, isolated cases of overdose were recorded. The body of patients with minor drug poisoning returns to normal on its own, without serious disturbances in the functioning of the cardiovascular system or changes in laboratory tests. Antidotes for the treatment of overdose are unknown. Doctors recommend hospitalization for observation and monitoring. The following symptoms indicate an overdose:

• restlessness, anxiety;
• drowsiness, weakness, dizziness;
• stomach ache;
• excessive stress;
• cyanosis.

VALDOXAN

Film-coated tablets

oblong, biconvex, orange-yellow.

Excipients: lactose monohydrate – 61.84 mg, magnesium stearate – 1.3 mg, corn starch – 26 mg, Povidone-K30 – 9.1 mg, colloidal anhydrous silicon dioxide – 0.26 mg, sodium carboxymethyl starch (type A) – 3.9 mg, stearic acid – 2.6 mg.

Film shell composition:

glycerol – 0.19665 mg, hypromellose – 3.26871 mg, iron dye yellow oxide (E 172) – 0.19509 mg, macrogol 6000 – 0.20872 mg, magnesium stearate – 0.19665 mg, titanium dioxide (E 171) – 0.43418 mg.

10 pieces. – blisters (PVC/Al) (10) – cardboard packs. 14 pcs. – blisters (PVC/Al) (1) – cardboard packs. 14 pcs. – blisters (PVC/Al) (2) – cardboard packs.

14 pcs. – blisters (PVC/Al) (7) – cardboard packs.

Packaging for hospitals:

10 pieces. – blisters (PVC/Al) (10) – cardboard packs. 14 pcs. – blisters (PVC/Al) (7) – cardboard packs.

pharmachologic effect

Pharmacodynamics

Agomelatine is an agonist of melatonergic MT1 and MT2 receptors and an antagonist of serotonin 5-HT2C receptors.

Agomelatine is an antidepressant 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.

Agomelatine has been shown to have no effect on monoamine uptake and has no affinity for alpha, beta adrenergic, histaminergic, cholinergic, dopaminergic 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 animal experiments with circadian rhythm desynchronization, agomelatine has been shown to restore circadian rhythm synchronization through stimulation of melatonin receptors.

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

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

Agomelatine was also effective for initially high levels of anxiety, as well as for combined anxiety and depressive disorders.

The supporting antidepressant effect of agomelatine was confirmed (with a study duration of 6 months) at a dose of 25-50 mg 1 time / day.

The results of the study confirmed the anti-relapse efficacy of agomelatine, which was assessed by the time to disease relapse (p=0.0001).

The relapse rate in the group of patients taking agomelatine was 22%, in the placebo group - 47%.

The efficacy of agomelatine was demonstrated in six of seven clinical studies (benefit (2 studies), or comparable efficacy (4 studies)) in heterogeneous populations of adult patients with depression, compared with SSRIs/SNRIs (sertraline, escitalopram, fluoxetine, venlafaxine or duloxetine) . Antidepressant effect was assessed using the Hamilton scale (17-item version) as either a primary or secondary endpoint.

Agomelatine does not have a negative effect on alertness and memory; in patients with depression, agomelatine at a dose of 25 mg increases the duration of the slow-wave sleep phase without changing the number and duration of REM sleep phases. Taking agomelatine at a dose of 25 mg also promotes a faster onset of sleep with a decrease in heart rate and improved sleep quality (starting from the first week of treatment); however, there is no inhibition during the daytime.

When taking agomelatine, there was a tendency to reduce the frequency of sexual dysfunction (impact on arousal and orgasm).

The effectiveness of agomelatine at a dose of 25-50 mg 1 time / day was confirmed in elderly depressed patients under 75 years of age during an 8-week clinical trial. There is no evidence of a significant effect in patients aged 75 years and older.

The tolerability of agomelatine in elderly patients is comparable to that in young patients.

In a 3-week, controlled study of patients with major depressive disorder who had experienced insufficient therapeutic response to paroxetine (SSRI) or venlafaxine (SNRI), withdrawal symptoms were observed when switching from these antidepressants to agomelatine. Withdrawal syndrome appeared both after immediate cessation of treatment with previously prescribed SSRIs/SNRIs, and during their gradual withdrawal, which could be mistakenly taken as a manifestation of the low effectiveness of agomelatine at the initial stage of treatment.

The number of patients experiencing at least one withdrawal symptom one week after stopping an SSRI/SNRI was lower in the long-dose taper group (gradually tapering the SSRI/SNRI dose over 2 weeks) than in the rapid taper group. dosage (gradual reduction of SSRI/SNRI dose over 1 week), and than with immediate withdrawal: 56.1%, 62.6% and 79.8% of patients, respectively.

Contraindications

Taking Valdoxan is justified if the course of treatment is prescribed by a doctor. According to the instructions, the drug is not harmless and has a lot of contraindications, which is important for patients to take into account. The medicine is not recommended for children and adolescents; use the antidepressant with caution in persons over 65 years of age, patients with suicidal tendencies, manic-depressive psychoses, and alcoholics. Valdoxan is prohibited for use if the patient:

• lactose intolerance;
• renal failure;
• ailments for which inhibitors of the CYP1A2 isoenzyme are used;
• susceptibility to the components of the drug

Scope of application and contraindications

The antidepressant Valdoxan is used in the treatment of the following disorders:

• depressive states accompanied by despair, apathy, helplessness, irritability;
• anxiety disorders;
• severe stress;
• major depressive disorder;
• disorders of the nervous system due to depression.

The official instructions indicate that Valdoxan is contraindicated for use in the following cases:

• galactosemia (lactose intolerance);
• malabsorption of galactose or glucose;
• lactase deficiency;
• liver pathologies in the acute stage;
• age up to eighteen years;
• hypersensitivity to any component of the drug;
• breast-feeding.

Also, a limitation to taking tablets is the simultaneous use of the drug with Fluvoxamine and Ciprofloxacin, which are powerful isoenzyme inhibitors.

The drug is prescribed with caution and under medical supervision to patients of advanced age, with renal failure, diabetes mellitus, obesity, alcohol abuse, manic behavior and suicidal thoughts. When carrying a child, the medicine should also be taken carefully.

Analogues of Valdoxan

The drug may cause intolerance in the patient and lead to side effects. In such cases, the doctor may change the treatment by choosing a Valdoxan analogue. There is only one drug on the market that has the same active ingredient, it is called Agomelatine. It is prescribed to treat depression and bipolar psychosis. The remaining drugs are analogues of Valdoxan only in the pharmacological group. Among the antidepressants:

• Adepress. An antidepressant that helps fight stress and anxiety. Active ingredient: paroxetine hydrochloride.
• Adaptol. A tranquilizer that helps eliminate attacks of anxiety, restlessness, and fear. Active ingredient: mebicar.
• Azafen. Tricyclic antidepressant. Acts as a sedative and fights depression. Active ingredient: pipofezin.
• Amizol. Sedative and antidepressant. Contains amitriptyline hydrochloride.
• Velaxin. Antidepressant, active substance: venlafaxine. Helps in the fight against depression. Available in tablets and capsules.
• Coaxil. The drug is prescribed for depressive disorders. Active substance: tianeptine sodium.
• Negrustin. The antidepressant is available in capsule form. Prescribed for depression, fears, anxiety. Main component: dehydrated St. John's wort extract.
• Prozac. Prescribed for depression and stressful conditions. Active substance: fluoxetine hydrochloride.
• Pyrazidol. The antidepressant is suitable for the treatment of withdrawal symptoms, depression, and Alzheimer's disease. Contains pyrlindole hydrochloride.
• Fluoxetine. It has an anorexigenic effect and fights depression.

Real application experience

Reviews from doctors and opinions of people who have undergone or are undergoing treatment with Valdoxan.

According to experts

Valdoxan is excellent for helping with sleep disorders and depression. However, it is important to understand that the prescription of the drug, dosage adjustment and duration of therapy should be determined by the treating specialist.

For each case, such a scheme is selected individually. In addition to taking the drug, psychotherapeutic work is necessary for maximum effect.

Anton Sergeevich, psychotherapist

This drug belongs to the group of antidepressants. Its effectiveness in the treatment of depression in adults has been confirmed. Helps improve sleep, mood, and emotional state. Allows you to return to normal activities. It is prescribed to patients with suicidal behavior or exacerbation of depression, but such treatment should only be carried out under medical supervision.

Valentina Ivanovna, psychotherapist of the highest category

Voice of the people

Four months ago, my father died as a result of a serious illness. After the funeral, complete apathy set in - I lost my appetite, I didn’t want to go to work. Friends advised me to see a specialist. The psychotherapist prescribed Valdoxan. The product is not cheap, but I bought it. After a few weeks, the nightmares stopped, I even began to smile sincerely.

This is my second month on the pills. I believe that completing the full course will help my body fully recover from the stress it has experienced.

Elena Viktorovna, 31 years old

A year ago I was in an accident. After this, I started having nightmares, anxiety, panic attacks, even hysteria with tears. I started self-medicating and tried taking sedatives. There was no effect. After hypnosis with a psychotherapist, I started taking Valdoxan before bed. The drug helped within a month – I started working normally.

The doctor said that it is necessary to take the pills for a long time. I took it for seven months. When I quit, there was no withdrawal effect.

Maxim Andreevich, 34 years old

People's opinions about how they feel after taking the pills

Patients claim that after taking the medicine, sleep and mood improve, anxiety and apathy disappear. Side effects occur extremely rarely.

I took this drug for depression. I would like to note that I began to sleep better after just two weeks. Adverse reactions included a feeling of heat in the body. I did not observe any other phenomena.

A noticeable effect occurs no earlier than a month of therapy. Improvements in sleep and mood are noticeable, anxiety and obsessive thoughts have disappeared. I want to sleep within half an hour after taking the pills. I started to feel a little better, although I won’t say that it’s absolutely perfect. There is fatigue after taking it.

Oleg Stanislavovich, 32 years old

Patients who have used the drug are advised to adhere to the recommendations of specialists regarding the use of tablets. Most of them claim that the effect of use is observed only with complex therapy and with long-term use of the drug.

Olga

Advantages and disadvantages

An important advantage of the drug is its relative safety, since it does not affect heart rate and blood pressure. In addition, this drug does not affect sexual function. Another advantage is the absence of withdrawal effects, since Valdoxan is not addictive.

The disadvantage is the relatively expensive cost of the tablets.