Remeron

Remeron – tetracyclic antidepressant with preferential sedative action.

Form of release and structure

Dosage form – tablets, film coated:

• 15 mg: yellow color, oval, convex from two parties, on one party the squeezed-out TZ code over "3" from two parties lengthways risks, on other party - "ORGANON";
• 30 mg: red-brown color, oval, convex from two parties, on one party the squeezed-out TZ code over "5" from two parties lengthways risks, on other party - "ORGANON";
• 45 mg: white color, oval, convex from two parties, on one party the squeezed-out TZ code over "7" from two parties lengthways risks, on other party - "ORGANON".

Tablet kernel – the homogeneous pressed structure, white color.

Tablets are packed up on 10 pieces in blisters, 1 or 3 blisters are located in a cardboard pack.

Active agent of Remeron: миртазапин, in 1 tablet – 15, 30 or 45 mg.

Auxiliary components: silicon dioxide colloid, magnesium stearate, lactoses monohydrate, hypro rod, starch corn.

Structure of a cover:

• Tablets of 15 mg: Опадрай 04F22715 yellow (titanium dioxide, macrogoal 8000, gipromelloza, dye ferrous oxide yellow);
• Tablets of 30 mg: Опадрай 04F23084 orange (titanium dioxide, macrogoal 8000, gipromelloza, dyes ferrous oxide yellow and ferrous oxide red);
• Tablets of 45 mg: Опадрай OY-S-28914 white (titanium dioxide, macrogoal 8000, gipromelloza).

Indications to use

Remeron – drug for treatment of a depression.

Contraindications

• Age up to 18 years;
• Lactose intolerance, deficit of lactase, glyukozo-galaktozny malabsorption;
• Lactation period;
• Hypersensitivity to any component of drug.

With care:

• Epilepsy;
• Organic lesions of a brain;
• Renal/liver failure;
• Heart diseases (stenocardia, conductivity disturbance, recently postponed myocardial infarction);
• Cerebrovascular diseases (including an ischemic stroke in the anamnesis);
• Arterial hypotonia or states which can lead to its development (including with a hypovolemia and dehydration);
• Abuse of medicines;
• Medicinal dependence on the drugs influencing the central nervous system;
• Manias and hypomanias;
• Disturbances of an urination, including at a prostate hyperplasia;
• Diabetes mellitus;
• Acute closed-angle glaucoma, the increased intraocular pressure;
• Simultaneous use of benzodiazepines;
• Pregnancy (if the expected advantage surpasses possible risks).

Route of administration and dosage

Remeron it is necessary to accept inside, swallowing of tablets entirely and washing down if necessary with liquid.

The recommended initial dose makes 15-30 mg. The effective daily dose is defined individually.

At patients with a liver and renal failure the clearance of a mirtazapin can be reduced that should be considered at selection of a dose of drug.

It is possible to accept Remeron 1 time a day, it is desirable at the same time, in the evening before going to bed. 2-times reception is also possible, in this case the daily dose is divided into 2 parts – lower (it is accepted in the morning) and higher (it is accepted for the night).

Treatment duration – before total disappearance of symptoms of a depression, usually makes 4-6 months then the dose is gradually reduced, up to full drug withdrawal.

The most admissible daily dose – 45 mg.

If within 2-4 weeks improvement of a state is not noted, treatment should be stopped.

Side effects

• From a nervous system: very often (≥1/10) – drowsiness (usually arises in the first weeks of treatment, can lead to disturbance of concentration of attention), a headache, sedation; often (> 1/100 and ≤1/10) – a tremor, dizziness, a lethargy; infrequently (> 1/1000 and ≤1/100) – a syncope, a syndrome of "uneasy legs", paresthesia; seldom (> 1/10 000 and ≤1/1000) – a myoclonus; very seldom (≤1/10 000, including isolated cases) – paresthesias of a mucous membrane of an oral cavity, a serotoninovy syndrome, spasms (stroke);
• From mentality: often – confusion of consciousness, unusual dreams, sleeplessness, alarm; infrequently – psychomotor excitement (including an akathisia, a hyperkinesia), agitation, a mania, nightmares, hallucinations; frequency is not established – suicide behavior, the suicide ideas;
• From blood and lymphatic system: frequency is not established – an agranulocytosis, aplastic anemia, a granulocytopenia, thrombocytopenia, an eosinophilia;
• From skeletal and muscular and connecting fabric: often – a dorsodynia, an arthralgia, a mialgiya;
• From vessels: often – orthostatic hypotension; infrequently – arterial hypotension;
• From digestive tract: very often – dryness in a mouth; often – diarrhea, nausea, vomiting; infrequently – decrease in sensitivity of a mucous membrane of an oral cavity; frequency is not established – hypostasis of a mucous membrane of an oral cavity;
• From a liver and biliary tract: seldom – increases in activity of transaminases of serum;
• From endocrine system: frequency is not established – disturbance of secretion of antidiuretic hormone;
• From a metabolism and food: very often – the increased appetite, increase in body weight;
• From skin and hypodermic fabrics: often – skin rashes;
• Others: often – local hypostasis; infrequently – fatigue.

At a depression a number of symptoms which are difficult for differentiating from side effects therefore it is difficult to distinguish can be observed, they are caused by a disease or Remeron's reception.

Special instructions

At Remeron's use it must be kept in mind:

• The paranoid ideas can amplify;
• The depressive phase of maniac-depressive psychosis against the background of therapy can be transformed to a maniacal phase;
• Deterioration in psychotic symptoms can be noted;
• People of advanced age are usually more sensitive to drug, especially concerning side effects;
• At young people 24 years with mental disturbances or a depression antidepressants are younger increase risk of emergence of suicide thoughts and behavior therefore drug it is necessary to appoint advantage/risk after careful assessment of a ratio, and during treatment to establish special observation in time to reveal disturbances or changes of behavior;
• Reduction of a dose at drowsiness usually does not lead to smaller sedation, but can reduce efficiency of antidepressant.

At emergence of symptoms of jaundice Remeron it is necessary to cancel.

During treatment it is recommended to avoid alcohol intake.

Oppression of functions of marrow (granulocytopenia or agranulocytosis) at use of a mirtazapin is observed seldom. Nevertheless, the patient should be warned about need to see a doctor in case of emergence in it of such symptoms as a pharyngalgia, stomatitis, fervescence and other signs of a grippopodobny syndrome.

Remeron does not cause accustoming. However during post-registration experience it was established that at the sharp termination of treatment after long use of drug development of a withdrawal is possible. It was most often reported about its such symptoms as alarm, agitation, a headache, dizziness, nausea. It should be noted that the same signs can be connected with a basic disease, but nevertheless it is recommended to cancel drug gradually.

As well as other antidepressive drugs, Remeron can promote decrease in concentration of attention therefore during treatment it is necessary to refrain from management of transport and performance of potentially dangerous works demanding the speed of psychophysical reactions and special attention.

Medicinal interaction

Remeron it is necessary to apply with care along with HIV protease inhibitors, powerful inhibitors of an isoenzyme CYP3A4 (for example, ketokonazoly), azolny antifungal means, nefazodony, erythromycin as increase in concentration of a mirtazapin in plasma is possible.

CYP3A4 isoenzyme inductors (carbamazepine, Phenytoinum) increase clearance of a mirtazapin approximately twice that leads to 45-60% to decrease in its concentration in plasma. At use of similar combinations increase in a dose of Remeron, and after cancellation of the inductor of an isoenzyme of CYP3A4 – decrease can be required.

Cimetidinum can increase bioavailability of a mirtazapin more than by 50% therefore reduction of a dose of Remeron can be required, and after cancellation of Cimetidinum – increase.

Mirtazapin it is not necessary to appoint combined with monoamine oxidase inhibitors and within two weeks after their cancellation.

Mirtazapin in a daily dose of 30 mg caused small increase in the international normalized relation (INR) in the patients receiving warfarin. It is impossible to exclude more expressed effect at reception of higher dose of a mirtazapin. For this reason it is necessary to control MNO at use of this combination.

Remeron can strengthen sedative effect of benzodiazepines and other sedatives, and also depressive impact of alcohol on the central nervous system.

At simultaneous use with mirtazapiny other serotonergic medicines (for example, a venlafaksin or selective serotonin reuptake inhibitors) the risk of development of a serotoninovy syndrome appears. And though, according to data of post-registration experience, such probability is minimum, at use of a similar combination it is necessary to select doses with care and to control a condition of the patient in time to reveal signs of the beginning of steady serotonergic superstimulation.

Terms and storage conditions

To store at a temperature from 2 to 30 °C in the place protected from light and moisture unavailable to children.

Period of validity – 3 years.