Directions for use and doses
Orally (tablets are swallowed without chewing, washed down with water or other liquid), preferably in one dose at night, but the daily dose can be divided into several doses. Doses and duration of treatment are selected individually. For adults, the recommended initial dose is 30 mg/day with a possible increase until the optimal therapeutic effect is achieved, the average effective dose is 60–90 mg/day; elderly patients - starting with 30 mg per day, followed by a gradual increase in dose (the maintenance effective dose may be slightly lower than for elderly patients). If there is insufficient effectiveness after 2-4 weeks of therapy, the daily dose can be increased; if there is no positive effect over the next 2-4 weeks, treatment with Lerivon is stopped. After clinical improvement has been achieved, treatment should be continued for 4–6 months.
Lerivon
Use during pregnancy and breastfeeding
Although animal experiments and limited human data indicate that mianserin does not cause intrauterine or neonatal harm and that mianserin is excreted in human milk only in very small quantities, the use of Lerivon during pregnancy or lactation should be beneficial assess the possible risks to the fetus or newborn.
Use for liver dysfunction
Contraindicated in liver diseases with severe dysfunction.
Use with caution in case of liver failure.
Use for renal impairment
Use with caution in case of renal failure.
Use in children
Lerivon should not be used in children and adolescents under 18 years of age.
Use in elderly patients
The dosage regimen for elderly patients is determined individually. The initial dose should be 30 mg. This dose can be gradually increased every few days. A lower dose than usual for adults may be required for satisfactory clinical response.
special instructions
Use in children and adolescents under 18 years of age
Lerivon should not be used in children and adolescents under 18 years of age. In clinical studies, suicidal behavior (suicidal attempts and suicidal ideation) and hostility (primarily aggression, oppositional behavior, and anger) were observed more frequently among children and adolescents treated with antidepressants compared with those receiving placebo. If, based on clinical need, a decision is made to proceed with treatment, the patient should be closely monitored for the occurrence of suicidal symptoms. In addition, there are no long-term safety data in children and adolescents regarding growth, maturation, and cognitive and behavioral development.
Suicide/suicidal thoughts
Depression is associated with an increased risk of suicidal ideation, self-harm and suicide (suicidal gestures). This risk persists until significant remission occurs. Because improvement may not occur within the first few weeks, patients should remain under close supervision until improvement occurs.
Patients with a history of suicidal gestures, those who exhibit a high degree of suicidal ideation before treatment, and young adults are at greater risk for suicidal ideation or suicide attempts and should be closely monitored during treatment.
Patients (and caregivers) should be warned to monitor for sudden onset of suicidal thoughts and to seek immediate medical attention if such symptoms occur.
Bone marrow suppression has been reported during treatment with Lerivon, usually manifesting as granulocytopenia or agranulocytosis. These reactions occurred most frequently after 4 to 6 weeks of treatment and were usually reversible when treatment was discontinued; they were observed in all age groups, but more often in elderly patients. If the patient develops fever, pharyngitis, stomatitis or other signs of infection, then treatment should be stopped and the complete blood count checked.
Lerivon, like other antidepressants, may cause hypomania in susceptible subjects suffering from bipolar depressive illness. In this case, treatment with Lerivon should be discontinued.
During treatment with Lerivon, particularly careful monitoring of patients with liver or kidney failure, heart disease, and diabetes is recommended.
Patients with angle-closure glaucoma or symptoms of prostatic hypertrophy should be monitored due to the unpredictability of anticholinergic side effects during treatment with Lerivon.
If jaundice occurs, treatment with the drug should be discontinued.
If seizures occur, treatment with the drug should be discontinued.
Effect on the ability to drive a car or operate machinery
Lerivon may affect psychomotor activity during the first few days of treatment. Patients undergoing treatment with Lerivon should avoid activities that pose a potential danger, such as driving or operating machinery.
Precautionary measures
It should not be used simultaneously with MAO inhibitors and for the next 2 weeks after completing the course of treatment with these drugs. During concomitant therapy with antihypertensive drugs, it is necessary to control blood pressure.
Patients undergoing treatment, especially at first, are advised to refrain from driving a car, operating moving equipment and other activities that require increased attention and speed of reactions, as well as drinking alcohol.
If hypomanic conditions, convulsive reactions, or jaundice develop, treatment should be discontinued. Granulocytopenia and agranulocytosis may appear after 4–6 weeks of treatment (bone marrow function is completely restored after completion of the course). A blood test is required if fever, pharyngitis, stomatitis or other signs of infectious diseases occur. Patients with narrow-angle glaucoma and suspected prostatic hypertrophy should be under medical supervision.
Lerivon®
Use in children and adolescents under 18 years of age
Lerivon® should not be used in children and adolescents under 18 years of age. In clinical studies, suicidal behavior (suicidal attempts and suicidal ideation) and hostility (primarily aggression, oppositional behavior, and anger) were observed more frequently among children and adolescents treated with antidepressants compared with those receiving placebo.
If, based on clinical need, a decision is made to proceed with treatment, the patient should be closely monitored for the occurrence of suicidal symptoms. In addition, there are no long-term safety data in children and adolescents regarding growth, maturation, cognitive and behavioral development.
Suicide/suicidal thoughts or worsening clinical picture
Depression is characterized by an increased risk of suicidal ideation, self-harm and suicide (suicidal behavior). This risk persists until significant remission occurs. Since improvement may not occur within the first few weeks, patients should remain under the direct supervision of a specialist until improvement occurs. Accumulated clinical experience shows that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicidality or a high degree of suicidal ideation are at greater risk of suicidal ideation or suicide attempts and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders found an increased risk of suicidal behavior in patients under 25 years of age taking antidepressants compared with patients receiving placebo. As a result, patients should be monitored very closely during treatment with antidepressants, especially those at high risk and in the early stages of treatment, and also after changes in the dosage regimen of the drug. Patients and their caregivers should be warned to monitor for any clinical signs of worsening, suicidal behavior or suicidal ideation, or unusual changes in behavior and to seek immediate medical attention if such symptoms occur.
Taking into account the likelihood of suicide, especially at the beginning of treatment, the patient should be given a limited number of Lerivon® tablets.
Bone marrow suppression has been reported to occur during treatment with Lerivon®, usually in the form of granulocytopenia or agranulocytosis. These reactions occurred most frequently after 4 to 6 weeks of treatment and were usually reversible when treatment was discontinued. They were observed in all age groups, but more often in elderly patients. If the patient develops fever, pharyngitis, stomatitis, or other signs of infection, treatment should be stopped and a complete blood count should be performed.
Lerivon®, like other antidepressants, may cause hypomania in susceptible subjects suffering from bipolar depressive illness. In this case, treatment with Lerivon® should be discontinued.
When treating patients with liver or kidney failure, heart disease, or diabetes mellitus, the usual precautions should be observed and the dose of concomitant therapy should be monitored.
During post-marketing surveillance of mianserin, QT prolongation and ventricular arrhythmias (including torsade de pointes) have been reported (see section "Side Effects"). Lerivon® should be used with caution in patients with risk factors for QT prolongation/TdP, including congenital long QT syndrome, age over 65 years, female gender, structural heart disease/left ventricular dysfunction, renal disease, or liver, simultaneous use of drugs that inhibit the metabolism of the drug Lerivon®, and simultaneous use of other drugs that prolong the QTc interval (see section “Interaction with other drugs”). Hypokalemia and hypomagnesemia should be corrected before starting treatment. Discontinuation of Lerivon® or reduction of its dose should be considered if the QTc interval is >500 ms or increases by more than 60 ms.
Patients with angle-closure glaucoma or symptoms of prostatic hyperplasia should be monitored due to the unpredictability of anticholinergic adverse events during treatment with Lerivon®.
If jaundice occurs, treatment with the drug should be discontinued.
If seizures occur, treatment with the drug should be discontinued.
Use in elderly patients
Based on limited clinical trial data, elderly patients were less susceptible to adverse reactions such as agitation, confusion, and postural hypotension with mianserin than with tricyclic or tetracyclic antidepressants, but any therapy with these drugs should be used with caution in this group of patients.
Hypomania
Lerivon®, like other antidepressants, may cause hypomania in susceptible subjects suffering from bipolar depressive illness. In this case, treatment with Lerivon® should be discontinued.
Surgical interventions
If surgery is necessary during mianserin therapy, the anesthetist should be informed of the treatment being performed.
Pheochromocytoma
Caution must be exercised when treating patients with pheochromocytoma.
Epilepsy
Regular and careful monitoring is necessary, as well as adherence to the dosage regimen in patients with epilepsy and organic brain damage syndrome. Clinical experience shows that epileptic seizures are rare during treatment with antidepressants. Lerivon® should be used with caution in patients with a history of seizures. Treatment should be discontinued if seizures develop or if the frequency of seizures increases.
LERIVON (tablets)
Unfortunately, there are no tablets left in my supply for today, and I can’t clearly show this.
Why "Unfortunately? Because this medicine helps me very well. My problems: increased anxiety, neurosis, tears, suspiciousness, depression, insomnia, etc. I have been taking a lot of various antidepressants and sleeping pills for a long time. Some are good, others not so good, others useless. This one is great. About two years ago I was examined in the regional center for insomnia. And it was there that I first heard about the drug “Lerivon.” It was prescribed to me by a somnologist (a specialist in sleep disorders). For a long time I could not decide to buy medicine. Firstly, it’s expensive for me: 20 tablets cost 1000 rubles. Secondly, I read horror stories on the Internet about side effects, addiction and withdrawal symptoms. Although all the same phenomena, as a rule, are in the description of any antidepressant or sleeping pill. In general, I made up my mind. It turned out that the pharmacy had not even heard of such a drug. I wasn't surprised. More than once I have made some discoveries for pharmacists. “Lerivon” was delivered to order with prepayment. Since this drug, in addition to its antidepressant effect, has a hypnotic effect (which is very important for me), it is advisable to take it at night. I didn’t dare take the whole pill. I took half. And I began to listen to my feelings. Expect unpleasant side effects. I didn't notice how I fell asleep. I rarely sleep “like a human being,” but that night I slept. In the morning I felt great (which is very rare), there was no increased mental arousal. It was just calm. So, in order to save money and to be on the safe side, I drank Lerivon for 10 days. All was good. Then I switched to a whole tablet. Thus, the package lasted me 15 days. Although “Lerivon” is recommended to be taken over a long course (3-4 months), I decided to take a break. Still, I didn’t want to get used to it and, again, it was expensive. Therefore, I purchased this drug for the second time (also on order) three months later. It was really bad then. And I decided to take it once, when it really bothered me, and other means were powerless... That’s what I did. Over the course of two years, I drank 4 packs of Lerivon. If the drug were cheaper, I would definitely take it for a whole month to restore my psyche and sleep normally. I am sure that in a month or even two you will not get used to it. I just know that if you take it for a very long time (more than six months), you need to stop taking it by gradually lowering the dose. But for such courses you have to be an oligarch. So, for me, the frequency of taking Lerivon is directly related to finances.
If people close to me (knowing my experience with medications) ask what medicine can be taken to cope with neurosis, depression, apathy (you won’t be able to see a doctor or write a prescription), I will always talk about Lerivon.” but a reasonable person should always read the instructions for use and weigh everything before making a decision and taking the drug. Of course, you definitely need to consult a doctor. But when I asked the psychotherapist about Lerivon at the appointment, he said that he did not know such a drug and asked me to bring it to show it. Like this. Very often we find ourselves in a “help yourself” situation. And it’s good when someone already has experience, be it positive or negative - the main thing is that it exists. I sincerely wish everyone who reads the review about “Lerivon” peace of mind and sound, restful sleep without any pills!
