Expiration date: 02/2025

Structure and Composition:

1 film-coated tablet contains 30 mg of mirtazapine in blister 10 pcs., In box 1 or 3 blisters.

Characteristic:

Tablets are oval biconvex shape with labeled «Organon» on one side and on the other code. Tablets are reddish-brown in color with the code TZ / 5 with a transverse groove.

Pharmachologic effect:

Blocks presynaptic alpha2-adrenergic receptors in the central nervous system and enhances noradrenergic transmission of nerve impulses. Also amplifies serotonergic transmission (this effect is realized only via the 5-HT1 receptors, since NT2--5 and 5-HT3 receptors are blocked.

Pharmacokinetics:

After intake of rapidly absorbed, bioavailability - about 50%, the Cmax in the blood is reached after about 2 hours Linking blood plasma -. About 86%. Equilibrium concentration in the blood is set after 3-4 days of continuous use. The recommended dose range of pharmacokinetic parameters have a linear dependence on the dose. Extensively metabolized in the liver by demethylation and oxidation followed by conjugation. Demetilmirtazapin pharmacologically active as well as the starting material. Return with urine and feces, T1 / 2 is 20-40 hours, sometimes - up to 65 hours (which allows you to take the drug 1 time per day), T1 / 2 of young people is shorter than the elderly. Clearance may be reduced in patients with renal or hepatic insufficiency.

Description of the pharmacological actions:

The antidepressant activity manifestation spatial involved two enantiomers of mirtazapine and S (+) - enantiomer and the locks alfa2- 5-HT2 receptors, and R (-) - enantiomer blocking 5-HT3 receptors.

Blocks H1-receptors, has a sedative effect. At therapeutic doses, practically no anticholinergic action and does not affect the function of the cardiovascular system.

Clinical Pharmacology:

It reduces the severity of symptoms such as anhedonia, psychomotor retardation, sleep disturbances (especially in the form of early awakenings), weight loss, loss of interest in life, suicidal tendencies and mood swings. The antidepressant effect appears after 1-2 weeks of treatment.

Dosage:

Approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation April 15, 1999 Minutes ?3

INSTRUCTION for medical use of the drug Remeron (REMERON)

Composition

Remeron Tablets contain 30 mg of active ingredient and mirtazapine are oval biconvex shape with labeled «Organon» on one side and on the other code.

properties

Remeron belongs to the group of antidepressants. Most effective in the presence of clinical symptoms of depression such as the inability to experience pleasure (anhedonia), psychomotor retardation, sleep disturbances, particularly in the form of early awakenings, weight loss, loss of interest in life, suicidal tendencies and mood swings.

Remeron antidepressant effect appears after 1-2 weeks of treatment.

pharmacological properties

pharmacodynamics

The active ingredient Mirtazapine Remeron is an antagonist of presynaptic alpha 2-adrenergic receptors in the central nervous system and enhances central noradrenergic and serotonergic neurotransmission. This enhancement of serotonergic transmission is realized only through NT1- receptors, since mirtazapine blocks NT2- and HT3 receptors. The antidepressant activity manifestation spatial involved two enantiomers of mirtazapine and S (+) - enantiomer and the locks alfa2- HT2 receptors, and R (-) - enantiomer blocks HT3 receptors.

In addition, mirtazapine blocks H1 receptors, which accounts for its sedative effect.

At therapeutic doses mirtazapine almost no anticholinergic action and does not affect the function of the cardiovascular system, whereby the drug is usually well tolerated by patients.

Pharmacokinetics

After oral tablets Remeron mirtazapine its active ingredient is rapidly absorbed (bioavailability - about 50%), reaching Cmax in plasma after about 2 hours about 86% of mirtazapine associated plasma proteins.. The average T1 / 2 ranging between 20-40 hours, sometimes marked and longer T1 / 2 -. To 65 hours, usually T1 / 2 of young people is shorter than the elderly. The long T1 / 2 allows you to take the drug mirtazapine 1 time per day. Stable concentration in plasma is reached after 3-4 days and will not change. The recommended dose range pharmacokinetic mirtazapine have a linear dependence on the dose administered.

Mirtazapine is extensively metabolised and excreted in the urine and faeces within a few days. The main ways of its metabolism in the body are demethylation and oxidation followed by conjugation. Demetilmirtazapin pharmacologically active and apparently has the same pharmacological effect as the starting material.

Cl mirtazapine may be decreased in patients with renal or hepatic insufficiency.

testimony

Depressive states.

Contraindications

Hypersensitivity to mirtazapine.

Pregnancy and breast-feeding

Animal studies have not revealed any Remeron teratogenicity, however the safety of the use during pregnancy has not been investigated in humans. Remeron should be used during pregnancy only if absolutely necessary. In the treatment of Remeron should use reliable methods of contraception.

Animal studies have shown that mirtazapine in small amounts excreted in breast milk. Due to lack of data on the allocation of breast milk in humans is not recommended the use of Remeron in women during lactation.

Side effects

Patients with depression exhibit a number of symptoms caused by the disease. Therefore, it is sometimes difficult to distinguish the symptoms associated with the disease, and symptoms caused by the use of Remeron.

In the treatment of Remeron most often are the following adverse effects: increased appetite and weight gain, somnolence / sedation, usually manifested during the first few weeks of treatment (dose reduction generally does not lead to a decrease in inhibition, but can weaken the antidepressant activity).

In rare cases: orthostatic hypotension, mania, convulsions, tremors, myoclonus, fluid retention and the accompanying weight gain, sharp oppression blood (eosinophilia, granulocytopenia, agranulocytosis, aplastic anemia and thrombocytopenia), increased plasma transaminase activity in blood, skin reactions.

Interaction

It enhances the sedative effect of benzodiazepines (caution should be exercised in their simultaneous appointment with Remeron), the inhibitory effect of alcohol on the central nervous system function (patients should abstain from alcohol during treatment). Incompatible with the simultaneous application with MAO inhibitors or within 2 weeks after discontinuation of their use.

Overdose

The clinical safety of Remeron in overdose has not been investigated. Toxicity studies show no clinically significant cardiotoxicity in overdose Remeron. During clinical trials Remeron overdose was not observed any clinically significant effects, except sedative action.

In case of overdose, the patient should undertake a gastric lavage and symptomatic treatment is appropriate to maintain the function of vital organs and systems.

Dosing and Administration

Inside. Tablets should be swallowed without chewing, with some liquid if necessary. The daily dose should preferably be taken in one go, before going to bed. However, taking divided doses distributed throughout the day (1 time in the morning and 1 time in the evening), also valid.

Adults Treatment should be initiated with a daily dose of 15 mg. The dose should be gradually increased to achieve optimal clinical response. Typically, the effective daily dose is 15-45 mg.

Recommended doses correspond to doses for older adults. In order to achieve a satisfactory effect and safety, increasing the dose should be under close medical supervision in elderly patients.

Since Remeron efficacy and safety in children has not been studied, the treatment of children with this drug is not recommended.

In the presence of renal or hepatic impairment the clearance of mirtazapine is reduced, which should be considered in these patients.

Remeron desirable to continue treatment for 4-6 months, until complete disappearance of clinical symptoms. Thereafter, treatment can be gradually discontinued. In applying the correct dose positive clinical effect is 2-4 weeks. In the absence of effect of the dose can be increased. If over the next 2-4 weeks the effect does not appear, the treatment should be discontinued.

Precautionary measures

Violates concentration and wakefulness. In the treatment of patients with antidepressants should avoid the performance of potentially hazardous activities that require high speed of psychomotor reactions, such as driving and control mechanisms.

In clinical use of most antidepressants observed inhibition of blood, usually in the form of granulocytopenia or agranulocytosis. Most often it manifests itself in 4-6 weeks and usually disappears after discontinuation of treatment. Reversible agranulocytosis rarely observed in clinical studies of Remeron. Physicians should pay attention to the appearance of symptoms such as fever, sore throat, stomatitis or other signs of infection should stop treatment and spend the CBC.

Careful selection of doses and regular medical supervision is required in patients with epilepsy, organic brain lesions (development of seizures), with hepatic or renal insufficiency, cardiac disease with conduction abnormalities, angina pectoris and acute myocardial infarction, arterial hypotension. Caution must be exercised in the appointment of patients with urinary disorders, including prostatic hypertrophy, acute angle-closure glaucoma, and increased intraocular pressure (however, these effects are unlikely because Remeron has a weak anticholinergic activity), diabetes mellitus. When jaundice Remeron treatment should be discontinued.

During therapy, as in the case of receiving other antidepressants, note the following:

• The application of antidepressants in patients with schizophrenia or other mental disorders may increase psychotic symptoms,
  
• The treatment of the depressive phase of bipolar affective psychosis can occur inversion affect the development of mania,
  
• Considering the possibility of suicidal tendencies, the patient should only issue a small number of Remeron tablets (especially at the beginning of treatment)
  
• Remeron abrupt withdrawal after long-term use can lead to nausea, headaches and a general deterioration of health,
  
• Elderly patients often more sensitive to antidepressants, especially to their side effects. In a clinical study of Remeron side effects in elderly patients were observed no more frequently than in other age groups, but the available information on this scarce.
  

release Form

30 mg tablets for oral administration of 10 or Table 30. packaged.

Storage conditions

At a temperature of 2-30 & ° C. In a dry, protected from light and out of reach of children.

Shelf life

3 years.