Index of drugs

Episode of major depression.

1 tabl orally disintegrating contains 15 mg, 30 mg or 45 mg of mirtazapine.

Antidepressant. Mirtazapine is an antagonist of the presynaptic α receptors₂, increasing noradrenergic and serotonergic neurotransmission in o.u.n. Serotoninergic neurotransmission is specifically mediated by 5-HT receptors₁because 5-HT receptors₂ and 5-HT₃ they are blocked by mirtazapine. Both mirtazapine enantiomers are active. S (+) enantiomer blocks α receptors₂ and 5-HT₂, the R (-) enantiomer blocks 5-HT receptors₃. Antagonistic action of mirtazapine on H-receptors₁ is responsible for its sedative properties. The anticholinergic activity of mirtazapine is negligible, and at therapeutic doses the drug has no effect on the cardiovascular system. After oral administration, the drug is well and quickly absorbed from the gastrointestinal tract (bioavailability is about 50%) and reaches a maximum blood concentration after 1-2 h. Taking food does not affect the pharmacokinetics of mirtazapine. Medium T_0,5 is 20-40 hours; occasional longer periods of half-life were described - up to 65 h, and in young men they were shorter. Biotransformation takes place mainly through demethylation and oxidation followed by conjugation. Cytochrome P450 enzymes take part in it: CYP2D6, CYP1A2, CYP3A4. The drug is excreted in urine and faeces. Mirtazapine clearance may be reduced in patients with renal or hepatic impairment.

Hypersensitivity to mirtazapine or other ingredients of the preparation.

Due to the increased risk of suicidal thoughts and attempts, as well as self-injury, patients should be carefully monitored for significant remission of depressive symptoms and prescribed a limited number of tablets during this period. Patients with a history of suicide attempts and suicidal ideation, with significant suicidal tendencies prior to treatment and young adults should be closely monitored. The drug should be used with caution and careful observation should be carried out in patients with: epilepsy and organic brain injury (in patients with a history of mirtazapine seizures should be introduced with caution, treatment should be discontinued if the patient experiences seizures or an increase in seizures); hepatic or renal failure; heart diseases (e.g., conduction disorders, angina pectoris, recent myocardial infarction); low blood pressure. Treatment should be discontinued if jaundice occurs. Caution should be exercised in patients with gastrointestinal obstruction or bowel obstruction and micturition disorders (eg prostatic hyperplasia); narrow-angle glaucoma and increased intraocular pressure; diabetes mellitus (antidepressants may impair glycemic control - the dosage of insulins and / or oral hypoglycemic agents may need to be modified.) When antidepressants are used in patients with schizophrenia or other psychotic disorders, psychotic symptoms may be exacerbated during treatment of depressive episodes in manic psychosis Patients with a history of mania or hypomania should be carefully monitored and the patient should be discontinued and carefully discontinued. Elderly, the drug should not be used to treat children and adolescents below 18 years. In clinical trials, suicide behavior and hostility (aggression, rebellious behavior, anger) were more frequently observed in children and adolescents treated with antidepressants than in the placebo group. clinical decision will be made to treat, the patient should be carefully monitored for signs of suicide. There are no long-term studies on the safety of children and adolescents regarding growth, maturation, cognitive development and behavioral development. The preparation contains aspartame, a source of phenylalanine - it may be harmful for patients with phenylketonuria.

The preparation should not be used during pregnancy unless clearly indicated and after careful consideration of the benefits and risks. The drug is not recommended in women who are breastfeeding.

Common: increased appetite and weight gain, drowsiness - which can lead to worsening of concentration (usually found in the first few weeks of treatment), headache and dizziness, generalized or local swelling. Uncommon: nausea. Rare: bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia, thrombocytopenia), eosinophilia, hyponatraemia (mainly in elderly people), nightmares / scenic dreams, mania, agitation, confusion, hallucinations, anxiety, insomnia, psychomotor restlessness ( including akathisia, hyperkinesia), seizures (epileptic seizures), tremors, myoclonus, paraesthesia, restless leg syndrome, syncope, orthostatic hypotension, dry mouth, diarrhea, vomiting, increased serum transaminases, eczema, arthralgia, pains muscles, fatigue. Very rare: serotonin syndrome, paraesthesia around the mouth, hypoaesthesia around the mouth, swollen lips. Abrupt discontinuation after long-term use may sometimes cause withdrawal symptoms (headache, dizziness, agitation, anxiety, nausea).

Orally. Adults: The initial dose is 15-30 mg. The effective daily dose is 15-45 mg. The drug should be taken in a single daily dose, in the evening just before sleep or in doses divided evenly throughout the day (morning and evening). Patients with renal or hepatic impairment may require reduction of the recommended doses of the drug. Treatment should be continued for 4-6 months until the symptoms disappear completely. The effect of the drug usually occurs after 1-2 weeks of use. Treatment with the right dose should provide a favorable response within 2-4 weeks. If the response is insufficient, the dose can be increased to the maximum dose. If there is no response within the Next 2-4 weeks, treatment should be discontinued gradually.
The tablet breaks down quickly in your mouth and you should drink it with water.