Index of drugs

Treatment of the depressive syndrome.

1 tabl powl. contains 10 mg or 30 mg of mianserine hydrochloride.

Four-ring antidepressant from the group of pyrazinazepine derivatives, which additionally has sedative properties. The mechanism of action is blocking the noradrenergic α-presynaptic receptor₂ and central 5-HT serotonin receptors_1c, 5-HT₂ and 5-HT₃. Sugserin metabolites - 8-hydroxymianserine and demethylmianserine are weak inhibitors of noradrenaline doneuronic uptake. Antidepressant effect occurs after a few days of treatment, while clinical improvement is usually found after a few weeks. At the initial stage of treatment, there may be relatively strong sedative and hypnotic effects, mainly due to the blocking of histamine receptors. In comparison with tricyclic antidepressants, mianserin has no significant cholinolytic activity, does not affect dopaminergic transmission, in therapeutic doses does not affect the circulatory system. After oral administration, mianserin is absorbed quickly but not completely from the gastrointestinal tract (the bioavailability is about 30%). The maximum concentration in the blood reaches after 2-3 h. To a large extent (90%) is bound to plasma proteins. Easily penetrates tissues, including o.u.n. It is metabolized in the liver by hydroxylation of the aromatic ring, N-oxidation and N-demethylation. It is excreted in the urine in unchanged form (4-7%) and in approximately 70% in the form of metabolites; in small amounts it is excreted with faeces. T_0,5 it is on average 17 h (6-39 h).

Hypersensitivity to mianserin or any of the excipients. Concomitant use of such drugs as MAO inhibitors and up to 2 weeks after their use. Manic arousal condition. Severe liver damage.

Depression is associated with an increased risk of suicidal thoughts, self-mutilation and suicide. This risk persists until full remission is achieved. Patients should be closely monitored until recovery and at an early stage of recovery (increased risk of suicide). Patients with a history of suicide-related events or patients exhibiting a significant degree of suicidal tendency before commencing treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, particularly in patients below 25 years of age. During treatment, especially at the beginning of therapy and when the dose is changed, patients should be closely monitored, particularly those at high risk. Caution should be exercised in patients who have recently had a heart attack or in patients with a heart block or bone marrow injury. Caution is also recommended in elderly patients, although mianserin is usually better tolerated than tricyclic antidepressants. Avoid administering the drug to patients with epilepsy. Special care is required in patients with diabetes, liver failure and / or kidneys taking other medications. Mianserin does not have a therapeutic effect at the therapeutic doses of cholinolytics, however caution is advised in patients with narrow-angle glaucoma and in patients with prostatic hyperplasia. In susceptible bipolar patients treated with mianserin, hypomania may occur. In this case, mianserin should be discontinued. The drug may increase the inhibitory effect of alcohol on o.u.n. In the case of planned surgery, the anesthesiologist should be informed about the admission of mianserin. During the first 3 months of treatment, especially in elderly patients, complete blood counts should be monitored every 4 weeks. If the number of white blood cells in the peripheral blood is lower than 3,000 / mm³, the treatment should be discontinued and a blood smear test performed after the interval. In addition, liver and kidney function should be checked periodically.Patients with diabetes should be regularly monitored for blood Glucose and blood pressure should be regularly measured in patients with hypertension. Because improvement can only occur after 2-4 weeks of treatment, patients treated with mianserin should be under special control during this period. In some cases, improvement of the clinical condition is achieved only after several months of administering mianserin. Treatment should be discontinued if jaundice occurs. Treatment should be discontinued if seizures occur. The use of mianserin in children is not recommended.

The medicine can be used during pregnancy only in cases where, in the doctor's opinion, the benefit for the mother outweighs the potential risk to the fetus. The drug should not be used in women who are breastfeeding.

Common: weight gain, sedation (occurring at the beginning of treatment, decreasing with continuation of therapy, dose reduction generally does not lead to less sedation, but may jeopardize the effectiveness of the drug), drowsiness (especially in the first days of drug administration), increase in enzyme levels liver, edema. Uncommon: orthostatic hypotension, skin rashes, arthralgia. Rare: abnormal blood composition usually manifesting itself as granulocytopenia or agranulocytosis, hypomania, convulsions, hyperkinesia (restless legs syndrome), neuroleptic malignant syndrome, bradycardia after the initial dose, jaundice. Frequency unknown: anemia, increased appetite, suicidal thoughts, suicidal behavior, phase change in patients with bipolar disorder, worsening of psychotic symptoms, dizziness, liver damage, excessive sweating, tremor, weakness, gynecomastia, tenderness of nipples, mycotox.

Orally. Adults: initially for the first few days 30 mg daily in a single evening dose or in divided doses. The maintenance dose is usually 30-90 mg per day. Some patients may require higher doses of the drug. The drug is usually well tolerated when it is used in divided doses up to 200 mg daily, however, the maximum dose for the treatment of depression is 120 mg daily. Antidepressant treatment should be continued for at least several months (4-6 months) after resolution of depression. Elderly patients should not exceed 30 mg daily at the initial stage of treatment. The dose should be increased with caution. A satisfactory therapeutic effect is usually obtained after administering a lower maintenance dose. The tablets should be swallowed whole without chewing.