Index of drugs

Treatment of major depressive episodes.

1 tabl powl. contains 30 mg of mirtazapine.

Antidepressant. Centrally acting presynaptic α₂-antagonist, which enhances central noradrenergic and serotonergic neurotransmission mediated by 5-HT receptors₁. 5-HT receptors₂ and 5-HT₃ they are blocked by mirtazapine. Antagonistic activity against H-receptors₁ is considered the basis of the sedative effect of mirtazapine. 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 of about 50%), reaching C_max after about 2 h. Approximately 85% of the drug is bound to plasma proteins. Medium T_0,5 is 20-40 hours; occasional prolonged half-lives were observed - up to 65 h, and also shorter. Steady state is achieved after 3-4 days. Mirtazapine is metabolised in the liver (with the participation of cytochrome P-450: 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. Concomitant use with MAO inhibitors.

Do not use in children and adolescents under 18 (no long-term studies on safety, mainly growth, maturation, cognitive and behavioral development, and an increased risk of hostility and suicidal behavior in this age group). All patients treated with the preparation should be monitored for signs of suicidal ideation and behavior (especially in early recovery and after a change in the dose). This particularly applies to young adults (under 25 years of age) and patients with behavior or suicidal thoughts in an interview. When using antidepressants in patients with schizophrenia or other psychotic disorders, psychotic symptoms and paranoid thoughts may increase. During the treatment of the depressive phase in bipolar disorder, the phase may change to manic. In the event of manic symptoms, treatment should be discontinued. Mirtazapine should be used with caution in patients with: epilepsy or organic brain injury (in patients with epileptic seizures, treatment with mirtazapine should be started with caution, treatment should be discontinued if the patient experiences seizures or an increase in seizures); impaired liver or kidney function (after oral administration of 15 mg mirtazapine in a single dose in patients with mild to moderate liver disorders, the clearance of mirtazapine may be approximately 35% lower compared to normal liver function, the mean plasma concentration of mirtazapine was increased by approximately After oral administration of 15 mg mirtazapine in a single dose in patients with moderate and severe renal impairment, the clearance of mirtazapine was reduced by 30% and 50% compared to patients with normal renal function, the mean plasma concentrations of mirtazapine were increased by approximately 55% and 115%); heart diseases (e.g., conduction disorders, angina pectoris, recent myocardial infarction); low blood pressure; diabetes (there may be a need to change the dose of insulin or oral antidiabetic agents); the risk of hyponatremia (elderly or simultaneously treated with preparations that cause hyponatraemia); impaired urination (e.g., prostatic hyperplasia), acute narrow-angle glaucoma and increased intraocular pressure. The preparation should be used with caution in elderly patients. Caution should be exercised when using mirtazapine in combination with serotoninergic agents (risk of serotonin syndrome). Treatment should be discontinued if bone marrow suppression or jaundice occurs. The preparation contains lactose - do not use in patients with hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

Limited data on the use of mirtazapine in pregnant women do not show an increased risk of congenital malformations. Caution should be exercised when prescribing mirtazapine to pregnant women. If the preparation is taken during pregnancy or shortly before delivery, it is recommended that the newborn be observed for signs of withdrawal. Mirtazapine is excreted in human milk in very small amounts. The decision on whether to continue or stop breastfeeding or to continue or stop treatment with the product should be made after taking into account the benefits of breastfeeding for the child and the benefits of therapy for the woman.

Very common: weight gain, drowsiness, sedation, headache, dry mouth, increased appetite. Common: lethargy, dizziness, tremor, nausea, diarrhea, vomiting, constipation, rash, pain in the joints, muscles, back, orthostatic hypotension, peripheral edema, fatigue, unusual dreams, confusion, anxiety, insomnia. Uncommon: paresthesia, restless legs syndrome, syncope, hypoaesthesia, hypotension, nightmares, mania, agitation, hallucinations, psychomotor restlessness (including akathisia, hyperkinesia). Rare: aggressive behavior, myoclonus, pancreatitis, increase in serum transaminases. In addition: bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia, thrombocytopenia, eosinophilia), convulsions (seizures), serotonin syndrome, oral paresthesia, dysarthria, oral edema, increased salivation, hyponatremia, suicidal thoughts, suicidal behavior, inappropriate secretion of antidiuretic hormone, Stevens-Johnson syndrome, dermatitis, erythema multiforme, toxic epidermal necrolysis, rhabdomyolysis, urinary retention, somnambulism, generalized and local edema, increased creatine kinase activity. Abrupt discontinuation after long-term administration may sometimes cause withdrawal symptoms (headache, dizziness, agitation, anxiety, nausea) that disappear spontaneously.

Orally. Adults: The starting dose is 15-30 mg per day. The maintenance dose is 15-45 mg per day. Patients with liver problems or moderate and severe kidney problems may need to reduce the recommended doses. In the elderly, dose modification is not necessary. The effect of the drug usually occurs after 1-2 weeks of use. Treatment with the right dose should provide a positive response within 2-4 weeks. If the response is insufficient, the dose can be increased to the maximum dose. If no response is observed within the Next 2-4 weeks of treatment with the maximum dose, treatment should be discontinued gradually. After receiving the desired response, treatment should be continued until the symptoms of depression are completely resolved, which usually lasts for at least 6 months.
The drug can be taken in a single dose immediately before bedtime; can also be given in 2 divided doses (one dose in the morning and the other, a larger dose in the evening). Coated tablets should be swallowed whole with a sufficient amount of liquid; do not chew.