Lerivon® [Mianserin]

Brand Schering-Plough

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Clinical Pharmacology

Lerivon is an antidepressant with a sedative component. The active substance of Lerivon - mianserin - belongs to the group of piperazine-azepine compounds (truly tetracyclic), which distinguishes the drug from tricyclic antidepressants. In the chemical structure of Lerivon there is no side chain, which determines the anticholinergic effect of tricyclic antidepressants. In terms of antidepressant activity, the efficacy of Lerivon is comparable with other modern antidepressants. At the same time, its peculiarity is anxiolytic effect and a positive effect on sleep.

Indications

Depressive syndrome of various genesis requiring pharmacotherapy.

Composition

One coated tablet contains: Mianserin hydrochloride 30 mg.

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Dosage and Administration

The dosage regimen is set individually and adjusted in the course of treatment, depending on the response of the patient. Adults are prescribed in an initial daily dose of 30-45 mg. Effective therapeutic dose ranges from 30-90 mg / day. The daily dose can be divided into several doses or, preferably, administered once a night (given the positive effect on sleep). It is advisable to continue antidepressant therapy for a few more months after the clinical effect is achieved. For elderly patients, doses are adjusted individually, starting at 30 mg / day. Then the daily dose may be gradually increased. The maintenance effective dose may be slightly lower than for middle-aged patients. For use in children there are no recommendations because of the limited experience of the clinical use of the drug in this category of patients.

Adverse reactions

Patients with depression show a number of symptoms directly related to the disease itself (dry mouth, persistent constipation, accommodation disturbances). Therefore, it is sometimes difficult to determine which symptoms result from the disease, and which results from treatment with Lerivon.

Class system organ	Calculated frequency of adverse effects
Class system organ	Often (> 1%)	Infrequently (0.1-1%)	Rarely (<0.1%)
Blood and lymphatic system disorders			Granulocytopenia or agranulocytosis
Metabolism and nutrition disorders	Weight gain
Mental disorders			Hypomania
Nervous system disorders	Sedation that occurs at the beginning of treatment and diminishes with continued treatment (N.B. dose reduction usually does not reduce sedation, but there is a danger regarding antidepressant efficacy)		Cramps Hyperkinesis (including restless legs syndrome) Neuroleptic Malignant Syndrome
Heart disorders			Bradycardia after the initial dose
Vascular Disorders		Hypotension
Hepato-biliary disorders	Increased liver enzymes		Jaundice
Violations of the skin and subcutaneous tissue		Exanthema
Musculoskeletal, connective tissue and bone disorders		Arthralgia
General violations	Edema

Contraindications

- Manic syndrome.
- Severe abnormal liver function.

Drug interactions

Lerivon does not change the body's response to the on / in the introduction of pressore amines of norepinephrine (norepinephrine) and tyramine. Lerivon does not affect the antihypertensive effects of propranolol (alone or in combination with hydralazine, guanethidine or betanidin). Lerivon does not affect the severity of the hypotensive effect of clonidine and methyldopa, either during one-time or long-term use. No clinically significant interaction of Lerivon with the anticoagulant Fenprocumone was observed. Adverse interaction of Lerivon with MAO inhibitors cannot be ruled out; therefore, the administration of MAO inhibitors should be stopped at least 14 days before the prescription of Lerivon.

Pregnancy and Lactation

The use of Lerivon during pregnancy is possible only if absolutely necessary.

Special instructions

It is necessary to observe the usual caution when prescribing Lerivon to patients with diabetes mellitus (some patients may require correction of hypoglycemic therapy), patients with diseases of the cardiovascular system, renal and hepatic failure. In the process of treatment with Lerivon, one should refrain from drinking alcohol due to the potentiation of the latter’s action on the central nervous system. A study of the pattern of peripheral blood is indicated in patients who have a rise in temperature, a sore throat, or signs of any infection during the treatment with Lerivon. Due to the absence of an anticholinergic action, the drug can be used in patients with prostate adenoma, glaucoma, and gastrointestinal dysfunction, but such patients require observation.Older patients and patients with cardiovascular diseases, as a rule, tolerate Lerivon well. In elderly patients, the use of Lerivon usually does not lead to the development of confusion. Patients taking Lerivon should refrain from potentially hazardous activities that require increased attention and quickness of psychomotor reactions (especially in the first few days of therapy).

Overdosage

When patients received Lerivon in a single dose of 1 g or more (for suicidal purposes), suchthe symptoms, as pronounced drowsiness, increased blood pressure, in rare cases - arterial hypotension, sinus tachycardia or bradycardia, vomiting, dizziness, ataxia. There were no cases of seizures, arrhythmias, coma.
Treatment: after ingestion of a toxic dose of Lerivon, gastric lavage should be performed for 2 hours, and measures should be taken to maintain the function of the cardiovascular system. Hemodialysis and hemoperfusion are not recommended.