Generalized anxiety disorder and disorders occurring in the somatic form.
Composition:
1 tabl contains 50 mg of opipramol dihydrochloride. The tablets contain lactose and sunset yellow.
Action:
A drug from the group of non-selective monoamine reuptake inhibitors. It has a high affinity for receptorssigma (type 1 and type 2) and acts antagonistically on type 1 histamine receptors. The affinity for serotonin type 2A, type 2 Dopamine receptors and α-adrenergic receptors is lower. Unlike structurally similar tricyclic antidepressants, opipramol has low anticholinergic activity and does not inhibit the re-uptake of serotonin and noradrenaline. It works calming, anxiolytic and improves the mood. Opipramol is absorbed quickly and completely after oral administration. Partial metabolism to dehydroxyethylpipramol occurs during the first pass through the liver. It binds about 91% of plasma proteins. It is metabolized mainly by the CYP2D6 isoenzyme. In patients with CYP2D6 deficiency, the maximum concentration of opipramol in the blood may be up to 2.5 times higher than in people with normal metabolism. In the case of long-term use of T0,5 it is not prolonged in the elimination phase, therefore opio- clolol accumulation should not be expected in slow metabolic patients. T0,5 is about 11 hours.
Contraindications:
Hypersensitivity to the preparation ingredients and tricyclic antidepressants. acute alcohol intoxication, hypnotics, analgesics and psychotropics. Acute urinary retention. Acute delirium. Untreated narrow-angle glaucoma. Hyperplasia of the prostate gland with retention of urine. Obstructed bowel obstruction. A pre-existing upper-degree AV block or supraventricular and ventricular conduction abnormalities. Concomitant use of MAO inhibitors.
Precautions:
It should not be used for prostatic hyperplasia without residual urine, revealed liver and kidney disease, increased tendency to convulsions (eg brain damage of various origin, epilepsy, alcoholism), cerebrovascular insufficiency and pre-existing cardiac damage, especially with conduction disorders . Patients with pre-existing atrio-ventricular block Ist. or other conduction disorders should only be treated if an ECG test is often performed. During treatment, blood counts should be monitored, especially if you develop fever, flu-like infection or sore throat. During long-term treatment, liver function is recommended. If allergic skin reactions occur, the drug should be discontinued. Due to the lactose content, the preparation should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
There are no data on the effects of opipramol during pregnancy. In pregnant women, especially in the first trimester, opipramol should only be used when it is absolutely necessary. Opipramol should not be used during breast-feeding because the active substance is excreted in milk in small amounts. If opipramol is indicated clearly, breast-feeding should be discontinued.
Side effects:
Common: especially at the beginning of treatment - tiredness, dry mouth, feeling of a blocked nose, hypotension and orthostatic pressure drops. Uncommon: dizziness, drowsiness, impaired urination, disturbed accommodation, tremors, weight gain, thirst, tachycardia, palpitations, constipation, periodically increased liver enzymes, skin allergic reactions (rash, urticaria), ejaculation disorders, erectile dysfunction . Rare: changes in the blood picture (especially leukopenia), agitation, headache, paresthesia, especially in elderly patients, confusion and delirium (especially associated with sudden discontinuation or long-term use of high doses of opipramol), agitation, sweating, sleep disturbances , collapse, conduction abnormalities, exacerbation of existing heart failure, gastrointestinal disorders, dysgeusia, paralytic ileus (especially in the case of abrupt withdrawal of opipramol or long-term treatment with high doses), nausea, vomiting, edema, urinary retention, m akerx.Very rare: agranulocytosis, cerebral seizures, motor disorders (akathisia, dyskinesias), ataxia, polyneuropathy, sudden glaucoma, anxiety, severe liver problems, long-term treatment of jaundice and chronic liver damage, hair loss.
Dosage:
Orally. Treatment under medical supervision. Adults: 50 mg in the morning and at noon and 100 mg in the evening; depending on the efficacy and tolerability of the drug, the dose can be reduced to 50 mg or 100 mg once a day (overnight) or increased to 100 mg 3 times a day. Children over 6 years: 3 mg / kg, up to 100 mg daily (experience in the use of opipramol in children is small, therefore the dosage should be taken as a guide). The preparation should be used for at least 2 weeks, the recommended average duration of treatment is 1-2 months. The tablets should be taken during or immediately after meals with water.
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