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.
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.
Valdoxan tablet p/pl/o 25 mg N14 (Servier)
Elderly patients The effectiveness of the drug in elderly patients (aged 65 years and older) has not been established. There is limited data on the use of Valdoxan® for major depressive episodes in patients aged 65 years and older. When prescribing the drug to elderly patients, caution should be exercised (see section "Special Instructions"). Patients with renal failure In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. However, 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. Bipolar disorders/mania/hypomania Caution should be exercised when using Valdoxan® in patients with a history of bipolar disorders, manic or hypomanic episodes. If symptoms of mania appear, you should stop taking the drug. Suicide/suicidal behavior When you are depressed, there is an increased risk of suicidal ideation, self-harm and suicide (suicide-related events). The risk remains until a clear remission occurs. Patients should be under medical supervision until the condition improves (after starting therapy, it may take several weeks for the condition to improve). Clinical experience suggests that the risk of suicide may increase in the early stages of remission. Patients with a history of events associated with suicide, as well as patients who had suicidal intentions before starting therapy, are at risk and should be under close medical supervision during therapy. The results of a meta-analysis of clinical trials of antidepressants in patients with mental disorders indicate an increased risk of suicidal behavior in patients under the age of 25 years while taking antidepressants compared with placebo. During the treatment period, patients, especially those at risk, should be under close medical supervision, especially at the beginning of therapy and when changing the dose of the drug. Patients (and their caregivers) should be advised to seek immediate medical attention if their condition worsens, if they experience suicidal or unusual behavior, or if they experience suicidal thoughts. Concomitant use with inhibitors of the CYP1A2 isoenzyme Caution should be exercised when simultaneous use of agomelatine with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, grepafloxacin, enoxacin) due to the possibility of increasing the concentration of agomelatine (see section “Interaction with other drugs and other types of interactions”). . Increased transaminase activity in the blood serum In studies while taking the drug Valdoxan®, especially at a dose of 50 mg, an increase in transaminase activity in the blood serum was noted (more than 3 times compared to the upper limit of normal) (see section “Side effects”) . As a rule, after cessation of therapy, these indicators returned to normal values. It is recommended to monitor liver function at the beginning of therapy and then periodically, after 3 weeks, after 6 weeks (end of the relief 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 the clinical situation. If transaminase activity in the blood serum increases, a repeat test should be performed within 48 hours. If transaminase activity is more than 3 times the upper limit of normal, the drug should be discontinued. In the future, the functional state of the liver should be regularly monitored until transaminase activity normalizes. Caution should be exercised when prescribing Valdoxan® to patients with elevated transaminase activity before starting therapy (above the upper limit of normal, but not more than 3 times the upper limit of normal). If symptoms of liver dysfunction develop, liver function tests should be performed. Taking into account laboratory data and the clinical picture, a decision should be made to discontinue or continue therapy with Valdoxan®. If jaundice develops, it is necessary to discontinue therapy. Caution should be exercised when prescribing Valdoxan® to patients with risk factors for developing liver dysfunction, such as obesity/overweight/non-alcoholic fatty liver disease, patients who drink alcohol in significant quantities or are taking drugs that can cause impairment liver functions.
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.
Valdoxan®
Liver function monitoring
Cases of liver damage (including liver failure, increases in liver enzyme levels more than 10 times the ULN, hepatitis and jaundice) have been reported in patients taking Valdoxan® in the post-marketing period. Most of these disorders occurred in the first months of treatment. The nature of liver damage appears to be primarily hepatocellular. As a rule, after cessation of therapy, transaminase levels returned to normal values.
It is recommended to monitor liver function at the beginning of therapy and then periodically, after 3 weeks, after 6 weeks (end of the relief 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 the clinical situation. When increasing the dose, liver function should be monitored at the same frequency as at the beginning of the drug.
If the activity of transaminases in the blood serum increases, a repeat test should be performed within 48 hours. If the activity of transaminases is more than 3 times higher than the ULN, the drug should be discontinued. In the future, the functional state of the liver should be regularly monitored until transaminase activity normalizes.
If you experience symptoms and signs of possible liver dysfunction (such as dark urine, discolored stools, yellow skin/eyes, pain in the right upper abdomen, new persistent and unexplained fatigue), Valdoxan should be stopped immediately.
Caution should be exercised when prescribing Valdoxan® to patients with elevated transaminase activity before starting therapy (above the ULN, but not more than 3 times the ULN).
Caution should be exercised when prescribing Valdoxan® to patients with risk factors for developing liver dysfunction, such as obesity/overweight/non-alcoholic fatty liver disease, diabetes mellitus, drinking significant amounts of alcohol, or taking medications that can cause liver dysfunction.
Elderly patients
The effectiveness of the drug in elderly patients (aged 65 years and older) has not been established. There is limited data on the use of Valdoxan® for major depressive episodes in patients aged 65 years and older. When prescribing the drug to elderly patients, caution should be exercised.
Patients with kidney failure
In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. However, experience with the use of the drug for major depressive episodes in patients with moderate or severe renal failure is limited. When prescribing Valdoxan® to such patients, caution should be exercised.
Bipolar disorders/mania/hypomania
Caution should be exercised when using Valdoxan® in patients with a history of bipolar disorders, manic or hypomanic episodes. If symptoms of mania appear, you should stop taking the drug.
Suicide/suicidal behavior
People who are depressed have an increased risk of suicidal ideation, self-harm, and suicide (suicide-related events). The risk remains until a clear remission occurs. Patients should be under medical supervision until the condition improves (after starting therapy, it may take several weeks for the condition to improve). Clinical experience suggests that the risk of suicide may increase in the early stages of remission.
Patients with a history of events associated with suicide, as well as patients who had suicidal intentions before starting therapy, are at risk and should be under close medical supervision during therapy.
The results of a meta-analysis of clinical trials of antidepressants in patients with mental disorders indicate an increased risk of suicidal behavior in patients under the age of 25 years while taking antidepressants compared with placebo.
During the treatment period, patients, especially those at risk, should be under close medical supervision, especially at the beginning of therapy and when changing the dose of the drug. Patients (and their caregivers) should be advised to seek immediate medical attention if their condition worsens, if they experience suicidal or unusual behavior, or if they experience suicidal thoughts.
Combined use with CYP1A2 isoenzyme inhibitors
Caution should be exercised when using agomelatine simultaneously with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, grepafloxacin, enoxacin) due to the possibility of increasing the concentration of agomelatine.
Impact on the ability to drive vehicles and operate machinery
No studies have been conducted to study the effect of Valdoxan® on the ability to drive a car or use other mechanisms. It should be remembered that dizziness and drowsiness are common side effects of agomelatine.
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.
Agomelatine
Cases of liver damage have been reported, including liver failure (leading in exceptional cases to death or requiring liver transplantation in patients with pre-existing risk factors for liver damage), elevation of liver enzymes more than 10 times the ULN, hepatitis and jaundice in patients taking agomelatine during the post-registration period. Most of these disorders occurred in the first months of treatment. The nature of liver damage appears to be primarily hepatocellular. As a rule, after cessation of therapy, transaminase levels returned to normal values. It is recommended to monitor liver function at the beginning of therapy and then periodically, after 3, 6 (end of the relief period of therapy), 12 and 24 weeks (end of the maintenance period of therapy) after the start of therapy, and thereafter in accordance with the clinical situation. When increasing the dose, liver function should be monitored at the same frequency as at the beginning of the drug.
If transaminase activity in the blood serum increases, a repeat test should be performed within 48 hours. If transaminase activity is more than 3 times the ULN, the drug should be discontinued. In the future, the functional state of the liver should be regularly monitored until transaminase activity normalizes.
If symptoms and signs of possible liver dysfunction occur (such as dark urine, discolored stools, yellow skin/eyes, pain in the right upper abdomen, new persistent and unexplained fatigue), the drug should be stopped immediately.
Caution should be exercised when prescribing the drug to patients with risk factors for developing liver dysfunction, such as obesity (excess body weight), non-alcoholic fatty liver disease, diabetes mellitus, drinking significant amounts of alcohol, or taking drugs that can cause liver dysfunction.
The effectiveness of the drug in elderly patients (aged 75 years and older) has not been established. Therefore, agomelatine should not be prescribed to patients in this age group.
The drug should not be prescribed for the treatment of major depressive episodes in elderly patients with dementia (due to the lack of data on the effectiveness and safety of the drug in this group of patients).
In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. However, experience with agomelatine for major depressive episodes in patients with moderate to severe renal impairment is limited. Caution should be exercised when prescribing the drug to such patients.
Caution should be exercised when using agomelatine in patients with a history of bipolar disorder, manic or hypomanic episodes. If symptoms of mania appear, you should stop taking the drug.
People who are depressed have an increased risk of suicidal ideation, self-harm, and suicide (suicide-related events). The risk remains until a clear remission occurs. Patients should be under medical supervision until the condition improves (after starting therapy, it may take several weeks for the condition to improve). Clinical experience suggests that the risk of suicide may increase in the early stages of remission.
Studies have not been conducted to study the effect of the drug agomelatine on the ability to drive a car or use other mechanisms. It should be remembered that dizziness and drowsiness are common side effects of agomelatine.
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.
VALDOXAN film-coated tablets 25 mg No. 14
Elderly patients The effectiveness of the drug in elderly patients (aged 65 years and older) has not been established. There is limited data on the use of Valdoxan® for major depressive episodes in patients aged 65 years and older. When prescribing the drug to elderly patients, caution should be exercised (see section "Special Instructions"). Patients with renal failure In patients with severe renal failure, no significant changes in pharmacokinetic parameters were observed. However, 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. Bipolar disorders/mania/hypomania Caution should be exercised when using Valdoxan® in patients with a history of bipolar disorders, manic or hypomanic episodes. If symptoms of mania appear, you should stop taking the drug. Suicide/suicidal behavior When you are depressed, there is an increased risk of suicidal ideation, self-harm and suicide (suicide-related events). The risk remains until a clear remission occurs. Patients should be under medical supervision until the condition improves (after starting therapy, it may take several weeks for the condition to improve). Clinical experience suggests that the risk of suicide may increase in the early stages of remission. Patients with a history of events associated with suicide, as well as patients who had suicidal intentions before starting therapy, are at risk and should be under close medical supervision during therapy. The results of a meta-analysis of clinical trials of antidepressants in patients with mental disorders indicate an increased risk of suicidal behavior in patients under the age of 25 years while taking antidepressants compared with placebo. During the treatment period, patients, especially those at risk, should be under close medical supervision, especially at the beginning of therapy and when changing the dose of the drug. Patients (and their caregivers) should be advised to seek immediate medical attention if their condition worsens, if they experience suicidal or unusual behavior, or if they experience suicidal thoughts. Concomitant use with inhibitors of the CYP1A2 isoenzyme Caution should be exercised when simultaneous use of agomelatine with moderate inhibitors of the CYP1A2 isoenzyme (such as propranolol, grepafloxacin, enoxacin) due to the possibility of increasing the concentration of agomelatine (see section “Interaction with other drugs and other types of interactions”). . Increased transaminase activity in the blood serum In studies while taking the drug Valdoxan®, especially at a dose of 50 mg, an increase in transaminase activity in the blood serum was noted (more than 3 times compared to the upper limit of normal) (see section “Side effects”) . As a rule, after cessation of therapy, these indicators returned to normal values. It is recommended to monitor liver function at the beginning of therapy and then periodically, after 3 weeks, after 6 weeks (end of the relief 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 the clinical situation. If transaminase activity in the blood serum increases, a repeat test should be performed within 48 hours. If transaminase activity is more than 3 times the upper limit of normal, the drug should be discontinued. In the future, the functional state of the liver should be regularly monitored until transaminase activity normalizes. Caution should be exercised when prescribing Valdoxan® to patients with elevated transaminase activity before starting therapy (above the upper limit of normal, but not more than 3 times the upper limit of normal). If symptoms of liver dysfunction develop, liver function tests should be performed. Taking into account laboratory data and the clinical picture, a decision should be made to discontinue or continue therapy with Valdoxan®. If jaundice develops, it is necessary to discontinue therapy. Caution should be exercised when prescribing Valdoxan® to patients with risk factors for developing liver dysfunction, such as obesity/overweight/non-alcoholic fatty liver disease, patients who drink alcohol in significant quantities or are taking drugs that can cause impairment liver functions.
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 .
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.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Agomelatine, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Agomelatine is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!
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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. Servier Rus LLC 1440 rub. order
Pharmacy Dialogue
- Valdoxan tablets 25 mg No. 28 Serdix LLC
RUB 1,442 order
- Valdoxan (tablet p/o 25 mg No. 28)Servier Rus LLC
RUB 1,397 order
- Valdoxan (tablet p/o 25 mg No. 28)Servier Rus LLC
RUB 1,407 order
- Valdoxan tablets 25 mg No. 28Servier
RUB 1,402 order
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