Lerivon

Lerivon – antidepressant with sedative and anxiolytic action.

Form of release and structure

Dosage form – tablets, film coated: oval, convex from two parties, white color, on one of the parties – dividing risk, over which two squeezed-out ST codes, under risky – figure "7", on the opposite side of a tablet – a text of "ORGANON" (on 10 pieces in packaging planimetric cell, 2 packagings in a pack cardboard; on 20 pieces in packaging planimetric cell, 1 packaging in a pack cardboard).

Active ingredient: a mianserina a hydrochloride, in 1 tablet – 30 mg.

Additional components: magnesium stearate, silicon dioxide colloid anhydrous, methyl cellulose, potato starch, calcium hydrophosphate, titanium dioxide (Е 171), macrogoal, gipromelloz.

Indications to use

Lerivon – drug for treatment of depressions of various etiology.

Contraindications

Absolute:

• Liver diseases with the expressed dysfunction;
• Mania;
• Age up to 18 years;
• Hypersensitivity to drug.

Relative:

• Renal/liver failure;
• Diabetes mellitus;
• Prostatauxe;
• Closed-angle glaucoma;
• Chronic heart failure.

According to data of results of experiments on animals and to limited data concerning the person, миансерин does not render pre-natal or neonatal harm, and with maternal milk it is removed in very small quantities. Nevertheless the possibility of use of drug during pregnancy and a lactation has to be estimated individually taking into account the expected advantage and possible risks.

Route of administration and dosage

Lerivon it is necessary to accept inside, swallowing of tablets entirely and, if necessary, washing down with enough water.

Doses are established individually depending on a clinical situation. The initial dose makes 30 mg a day (1 tablet). If the effect is not enough, each several days increase a dose until the optimum clinical answer is reached. The average effective daily dose for adults makes 60-90 mg (2-3 tablets). Lower dose can be required by elderly people.

Due to the favorable effect of Lerivon on a dream it is preferable to accept a daily dose in 1 reception before going to bed, but in need of it it is possible to divide into several receptions.

Treatment by the appointed dose has to lead to the affirmative clinical answer in 2-4 weeks, otherwise the dose should be increased. If 2-4 more weeks later the effect is absent, drug should be cancelled.

Duration of antidepressive therapy – 4-6 months after approach of clinical improvement.

Side effects

Patients with a depression have a number of symptoms which can be connected directly with a disease (such as dryness in a mouth, obstipation and disturbances of accommodation). It is in certain cases difficult to determine by this reason what of the developed side effects are a consequence of use of Lerivon and what – diseases.

Side effects (it is frequent – more than at 1% of patients, infrequently – in 0,1-1% of cases, it is rare – less than at 1% of patients):

• Blood and lymphatic system: seldom – an agranulocytosis or a granulocytopenia;
• Metabolism and food: often – increase in weight;
• Mental disturbances: seldom – a hypomania;
• Nervous system: often – sedation (arises at the beginning of therapy and decreases at treatment continuation); seldom – a hyperkinesia (including a syndrome of uneasy legs), spasms, an antipsychotic malignant syndrome;
• Cardiovascular system: infrequently – hypotension; seldom – bradycardia (usually arises after an initial dose);
• Gepatobiliarny system: often – increase in activity of liver enzymes; seldom – jaundice;
• Musculoskeletal system: infrequently – an arthralgia;
• Skin and hypodermic fabrics: infrequently – a dieback;
• Others: often – hypostases.

At the sharp termination of a course of treatment by Lerivon in rare instances there is a withdrawal.

Special instructions

Drug is not used for treatment of children and teenagers aged up to 18 years because, according to data of clinical trials, this age group is more subject to suicide behavior (suicide thoughts and attempts) and hostility (preferential to aggression, anger and suppozitsionny behavior). Besides, there are no data on an occasion of long-term safety of use for children and teenagers concerning maturing, growth, behavioral and cognitive development. If the doctor nevertheless makes the decision on purpose of drug, during treatment of the patient has to be under special control.

It must be kept in mind that the depression is always connected with the increased risk of suicide thoughts and actions which remains before significant remission. For this reason within the first several weeks, there will not occur significant clinical improvement of a state yet, patients have to be under constant control.

Young people, and also patients with suicide gestures in the anamnesis who prior to treatment showed high degree of suicide imagination are subject to bigger risk of suicide intentions. Therefore also these categories of patients during treatment have to be under careful control. The patients and people who are carrying out behind them leaving have to be warned that it is necessary to control sudden emergence of suicide thoughts, and in case of emergence by it of symptoms – urgently to ask for medical care.

During treatment by Lerivon cases of oppression of the marrow which is shown an agranulocytosis or a granulocytopenia are known. More often these reactions arise in 4-6 weeks of therapy, usually have reversible character (at drug withdrawal), are observed in all age groups, but are more often noted at patients of advanced age. In case of fever, stomatitis, pharyngitis or other symptoms of an infection it is necessary to stop treatment and to check the developed blood count.

As well as all antidepressants, Lerivon can cause a hypomania in the susceptible people having a bipolar depressive disease. Drug in this case should be cancelled.

Under careful observation during treatment there have to be patients with heart diseases, a diabetes mellitus, a renal or liver failure. The same concerns patients with symptoms of a prostatauxe or closed-angle glaucoma.

If during treatment there is jaundice or spasms, drug needs to be cancelled.

Lerivon can exert a negative impact on psychomotor activity therefore during therapy it is recommended to refrain from performance of types of activity with potentially dangerous effects, including from driving of the car.

Medicinal interaction

Lerivon it is contraindicated to apply along with monoamine oxidase inhibitors and within 2 weeks after their cancellation.

Drug can break metabolism of derivatives of coumarin (including warfarin) therefore in need of their simultaneous application the patient has to be found under constant control.

Lerivon does not interact with guanetidiny, a clonidine, betanidiny, metildopy and propranolol (including in a combination with gidralaziny). Nevertheless at the patients receiving anti-hypertensive drugs it is recommended to control blood pressure.

Mianserina a hydrochloride can strengthen the oppressing effect of ethanol on the central nervous system therefore during treatment it is necessary to refrain from the use of alcoholic beverages.

Terms and storage conditions

To store in the place unavailable to children protected from light and moisture. To adhere to temperature condition 2-30 ºС.

Period of validity – 5 years.