Included in the formulation
Pharmacodynamics:The drug has antidepressant, anxiolytic, sedative and antiulcer action.
It weakens adrenergic transmission in the synapses of the central nervous system, blocks the re-uptake of norepinephrine. It has anticholinergic, antiserotonin and antihistamine action. Relieves depression, raises mood, eliminates apathy, depression, state of inner tension and fear. Has a therapeutic effect in vegetative disorders of neurotic origin. A distinctly antidepressant effect appears after 2-3 weeks of continuous admission. Has spasmolytic activity, moderate peripheral vasodilating, myorelaxing and anticonvulsant influence; does not stimulate the central nervous system, does not inhibit monoamine oxidase.
Pharmacokinetics:Quickly and fully absorbed from the gastrointestinal tract, metabolized in the liver with the participation of the cytochrome P450 isoenzyme CYP2D6 to pharmacologically active dimethyldisepine, further glucuronidized and excreted in urine, half-life 28-52 hours; distributed on the tissues, is found in the lungs, heart, brain, liver.
Indications:Depression, anxiety and sleep disorders in neuroses, alcoholism, organic diseases of the central nervous system, psychoneurotic disorders with anxiety, depression,psychotic depression (including the involutionary, reactive-depressive phase of manic-depressive psychosis). In general therapeutic practice - peptic ulcer of duodenum, dumping syndrome, premenstrual syndrome, chronic pain in cancer patients, skin itching, chronic idiopathic urticaria.
V.F20-F29.F28 Other Inorganic Psychotic Disorders
V.F30-F39.F32 Depressive episode
V.F40-F48.F40.0 Agoraphobia
V.F40-F48.F41.0 Panic disorder [episodic paroxysmal anxiety]
V.F60-F69.F60.8 Other Specific Personality Disorders
V.F60-F69.F60 Specific personality disorders
XI.K20-K31.K26 Duodenal ulcer
XII.L20-L30.L29 Itching
Contraindications:Hypersensitivity, zakratougolnaya glaucoma, AV-blockade, adenoma of the prostate gland, pregnancy, breast-feeding, children's age (under 12 years).
Carefully:With prolonged treatment, its sudden discontinuation is not recommended because of the risk of withdrawal syndrome (nausea, headache, general weakness).
Pregnancy and lactation:The drug is contraindicated in pregnancy and lactation.
Dosing and Administration:Inside, with moderate depression and / or anxiety appoint 75 mg per day, then select an individually effective dose (usually 75-150 mg per day). With a significant severity of depression and anxiety, the effective dose is 300 mg per day; in patients with minimal disturbances, effective doses of 25-50 mg per day. The daily dose is taken 1-2 times (a single dose should not exceed 150 mg). In sleep disorders, most of the daily dose is taken in the evening; the average duration of treatment is 2-3 weeks.
Side effects:Dry mouth, nausea, vomiting, anorexia, taste disorders, aphthous stomatitis, diarrhea, constipation, urinary retention, visual impairment, general weakness, flushing, dizziness, tinnitus, headache, drowsiness, disorientation, hallucinations , paresthesia, ataxia, extrapyramidal disorders, convulsions, tremor, hypotension, tachycardia, photosensitivity, allergic reactions (skin rash, itching, angioedema, eosinophilia); rarely - leukopenia, agranulocytosis, thrombocytopenia, increased or decreased libido, testicular edema, gynecomastia (in men),breast enlargement, galactorrhea (in women), hypo- or hyperglycemia, syndrome of inadequate secretion of antidiuretic hormone, alopecia.
Overdose:Drowsiness, stupor, hallucinations, impaired vision, dilated pupils, dry mouth, nausea, respiratory depression, severe arterial hypotension, coma, convulsions, muscle stiffness, tachycardia, arrhythmias characteristic of tricyclic antidepressant changes in ECG changes (especially QRS).
Interaction:Cimetidine increases the concentration in the plasma and enhances the effect. In patients with diabetes mellitus, when combined with tolazamide, it is possible to develop severe hypoglycemia. Chlorpromazine increases the likelihood of hyperpyrexia.
Special instructions:Do not engage in activities that require an increased rate of mental and motor reactions; during the period of treatment is not allowed to drink alcohol, the use of inhibitors monoamine oxidase.