Instruction for use: Lerivon

Dosage form: full coated tablets

Active substance: Mianserin*

ATX

N06AX03 Mianserin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F31 Bipolar affective disorder: Mood disorders bipolar; Affective bipolar psychosis; Manic-melancholic psychosis; Intermittent psychosis; Circular psychosis; Cyclophrenia; Bipolar disorders; Bipolar disorders; Bipolar psychosis; Affective insanity; Manic-depressive syndrome; Psycho Manic-Depressive; Depressive episode of bipolar disorder

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F33 Recurrent depressive disorder: Major depressive disorder; Secondary depression; Double Depression; Depressive pseudodement; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive syndrome; Depressed masks; Depression; Depression is smiling; Involutional depression; Involutional depression; Masked Depression; Melancholic Attack; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F41.2 Mixed anxiety and depressive disorder: Depression with anxiety-depressive components; Mixed anxiety-depressive conditions; Anxiety Depression; Anxious and depressing mood; Anxiety-depressive state; Anxious-depressive conditions; Anxiety-depressive syndrome; Anxious-Neurotic Conditions

Composition and release form

1 coated tablet contains myanserin hydrochloride 30 mg, as well as auxiliary substances (potato starch, silicon dioxide colloid, magnesium stearate, methylcellulose, calcium hydrophosphate, methyl hydroxypropylcellulose, polyethylene glycol, titanium oxide); in a contour acheive box 10 pcs., in a cardboard bundle 2 packs.

Characteristic

The coated tablets are white, oblong, biconvex with a code on the front side and an "Organon" marking on the other, with a transverse risk on the front surface.

It belongs to the piperazino-azepine group and differs from tricyclic antidepressants (TCAs) in the absence of a side chain characteristic of TCAs.

Pharmachologic effect

Pharmacological action - antidepressant.

It blocks presynaptic alpha 2-adrenergic receptors, increases the release of the mediator into the synaptic cleft, increases adrenergic transmission in the brain. Affects alpha 1-adrenergic receptors and H1-histamine receptors. Has a sedative effect.

Pharmacokinetics

When ingestion is rapidly absorbed from the digestive tract, bioavailability is 20%. Cmax in the blood is reached after 3 hours. Binding to blood proteins is about 95%. Equilibrium concentration in the blood is achieved after 6 days of admission. Metabolised in the liver by demethylation and oxidation followed by conjugation of metabolites. It is excreted in urine and feces. T1 / 2 - 21-61 h (which allows the drug to be used once a day).

Clinical Pharmacology

When used in therapeutic doses, it shows no cholinolytic activity, does not have a significant effect on the cardiovascular system.

Effective with depression in combination with anxiety, as well as with sleep disorders on a background of depression.

Indications for the Lerivon

Depressive states of various genesis.

Contraindications

Hypersensitivity, manic syndrome, severe violations of the liver, acute period of myocardial infarction, pregnancy, breast-feeding, age to 18 years.

Application in pregnancy and lactation

Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.

Side effects

From the nervous system and sensory organs: drowsiness (in the first days of admission), convulsions, hypomania, hypokinesia.

From the cardiovascular system and blood (blood, gemostaz): in rare cases - violation of hemopoiesis, agranulocytosis, arterial hypotension.

Other: arthralgia, peripheral edema, gynecomastia, abnormal liver function, exanthema.

Interaction

Increases the inhibitory effect of alcohol on the central nervous system. Incompatible with MAO inhibitors. Lerivon does not affect the action of such drugs, such as betanidine, clonidine, methyldopa, guanethidine or propranolol, incl. in combination with hydralazine.

Dosing and Administration

Inside (tablets are swallowed without chewing, washed down with water or other liquid), preferably in one session at night, but you can divide the daily dose into several doses. Doses and the duration of the course of treatment are selected individually. Adults, the recommended initial dose is 30 mg / day with a possible increase to achieve the optimal therapeutic effect, 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 somewhat lower than for patients of adulthood). With insufficient effectiveness after 2-4 weeks of therapy, the daily dose can be increased, in the absence of a positive effect for the next 2-4 weeks, treatment with Lerivon is stopped. After the achieved clinical improvement, the treatment should be continued for 4-6 months.

Overdose

Symptoms: prolonged sedation, possible - cardiac arrhythmia, convulsions, severe arterial hypotension and respiratory depression.

Treatment: gastric lavage, symptomatic therapy aimed at maintaining vital functions. There is no specific antidote.

Precautionary measures

It should not be used simultaneously with MAO inhibitors and within the next 2 weeks after the end of the course of treatment with these drugs. In the process of combined therapy with antihypertensive drugs, it is necessary to monitor blood pressure.

Patients undergoing treatment, especially at first, are advised to refrain from driving a car, controlling moving plants and other activities requiring increased attention and quickness of reactions, as well as from drinking alcohol.

With the development of hypomanic conditions, convulsive reactions, jaundice treatment should be discontinued. Perhaps the appearance of granulocytopenia and agranulocytosis after 4-6 weeks of treatment (bone marrow function is completely restored after the course is over). Required blood test for fever, pharyngitis, stomatitis or other signs of infectious diseases. Patients with narrow-angle glaucoma and suspected hypertrophy of the prostate should be under medical supervision.

Storage conditions for Lerivon

In dry, the dark place at a temperature of 2-30 ° C.

Keep out of the reach of children.

Shelf life of Lerivon

5 years.

Do not use after the expiry date printed on the package.