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Valdoxan (Agomelatinum, Agomelatine) - has an antidepressant effect.

Agomelatine - MT1 and MT2 agonist melatoninergic receptor antagonist and serotonin 5-HT2S receptors. Agomelatine is an antidepressant active on validated models of depression (learned helplessness test, despair test, chronic stress moderate severity), as well as on models with desynchronization of circadian rhythms, as well as in experimental situations of anxiety and stress. It has been shown that agomelatine has no effect on the capture of monoamines and has no affinity for the alpha, beta adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.

Agomelatine increases the release of dopamine and norepinephrine, particularly in the prefrontal cortex and has no effect on the concentration of extracellular serotonin. In animal experiments with simulated with desynchronization of circadian rhythms, it was shown that agomelatine recovers synchronization of circadian rhythms by melatonin receptor stimulation.

Agomelatine helps to restore normal sleep patterns, decrease in body temperature and release of melatonin.

The effectiveness of short-term use of agomelatine (therapy 6-8 weeks) at doses of 25-50 mg in patients with major depressive episodes. efficacy of agomelatine in patients with more severe depressive disorder is also shown (estimated on the Hamilton scale ≥ 25). Agomelatine was also effective in initially high levels of anxiety, as well as the combination of anxiety and depressive disorders.

Affirmed the antidepressant effect of agomelatine supports (if the duration of the study 6 months) at a dose of 25-50 mg once a day. Results of the study confirmed the efficacy of anti agomelatine, which was estimated at the time to the onset of disease recurrence (p = 0,0001). The frequency of recurrence in the group of patients treated with agomelatine was 22% in the placebo group - 47%.

Agomelatine has no negative impact on attention and memory in patients with depression, agomelatine 25 mg increases the duration of slow wave sleep phase without changing the number and duration of REM sleep phases. Admission agomelatine 25 mg also contributes to a more rapid onset of sleep and improve its quality (since the first week of treatment) and decrease in heart rate; thus inhibition is not observed in the daytime.

In patients receiving agomelatine showed a tendency to decrease in the frequency of sexual dysfunction (effects on arousal and orgasm).

Admission agomelatine has no effect on body weight, heart rate and blood pressure, does not cause sexual dysfunction, does not cause a syndrome of "lifting" (even with abrupt discontinuation of treatment), and the syndrome of "habituation".

Testimony:

Treatment of major depressive disorder.

Contraindications:

  • Hypersensitivity to agomelatine and / or any of the excipients of the drug agomelatine.
  • Hepatic impairment (eg, cirrhosis, or liver disease in the active phase) (see sections "Dosage and Administration" and "Cautions".).
  • Concomitant use of potent inhibitors of CYP1A2 isoenzyme (such as fluvoxamine, ciprofloxacin) (see "Interaction with other medicinal products and other forms of interaction" section.).
  • Children under the age of 18 years (due to lack of sufficient clinical experience). In children and adolescents in the patients receiving other antidepressants suicidal behavior (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, conflict behavior, anger) were more frequent than with placebo.

Do not use the drug in patients with lactose intolerance: lactase deficiency, galactosemia and glucose-galactose malabsorption.

CAREFULLY. Elderly patients (65 years and older) with major depressive episodes in patients with moderate to severe renal insufficiency, while the appointment of agomelatine with moderate inhibitors of isoenzyme of CYP1A2 (such as propranolol, grepafloksatsin, enoxacin), patients with a manic or hypomanic episodes in the history of patients with a history of events were associated with suicide, as well as patients who had suicidal intentions before therapy; treatment of major depressive episodes in elderly patients with dementia (due to lack of data on efficacy and safety of the drug in this patient group).

Caution should be exercised when administering the drug to patients who use alcohol in large quantities or receiving drugs that can cause abnormal liver function.

Suggested Use:

Agomelatine is taken orally.

The recommended dose - 25 mg (1 tab.) 1 time per day in the evening. If necessary, after two weeks of treatment dose can be increased to 50 mg (Table 2). 1 time per day in the evening.

Side effects:

Agomelatine clinical trials included more than 4,600 patients. More than 2,400 patients with depression received the drug in doses of 25-50 mg / day. At these doses, in the short-term, placebo-controlled trials, the number of adverse events did not differ from those in the group receiving placebo. Side effects are usually mild or moderate and observed are expressed in the first 2 weeks of treatment. The most frequently observed dizziness, nausea, diarrhea, dry mucous membranes of the mouth, abdominal pain and itching. The incidence of headache in most cases did not differ from that in the placebo treatment. Side effects were transient and generally did not require discontinuation of treatment.

In short-term placebo-controlled clinical trials adverse reactions that were seen as possibly related to treatment in the agomelatine 25-50 mg / day, are presented below. In parentheses indicate the incidence of side effects in patients treated with agomelatine compared to the placebo group.

Determining the frequency of adverse reactions: very often -> 1/10; often -> 1/100, 1/1000, 1/10000, CNS and peripheral nervous system: often - dizziness (5.4% and 3.1%); sometimes - paresthesia (0.9% and 0.1%).

From the digestive system: often - nausea (7.7% and 7.1%), dry mouth (3.3% and 3%), diarrhea (2.9% and 2.2%), epigastric pain ( 2.3% and 1.3%); 0.5% - in patients receiving a dose of agomelatine 25-50 mg / day (and 0.2% in the placebo group) were observed transient increases in AST 3 times the upper limit of normal. In most cases, these parameters return to normal without treatment discontinuation.

Dermatological reactions: often - itching (1% and 0.5%); sometimes - dermatitis (0.5% and 0.4%), eczema (0.2% and 0.1%), erythematous rash (0.2% and no reaction).

From the side of view: sometimes - blurred vision (0.6%, and the lack of response).

Within the double-blind trials of agomelatine over 6 months in the doses of 25-50 mg / day newly detected frequency of side effects was similar to that as compared with placebo. With long-term use of the drug did not reveal any new adverse effects.

The type and incidence of adverse events did not depend on age and sex of patients.

Packaging:

  • Comes in original packaging. Item is brand new and unopened.

Storage:

  • Keep away from direct sunlight.
  • Keep locked and away from children.
  • Store in dry place at room temperature.
  • Do not exceed storage temperature higher than 25 C

Important notice- the outer box design may vary before prior notice!

 

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