Active material: Tioridazin
When ATH: N05AC02
CCF: Antipsychotic drug (anxiolytic)
When CSF: 02.01.01.01
Manufacturer: Sun Pharmaceutical Industries Ltd. (India)
DOSAGE FORM, STRUCTURE AND PACKAGING
Pills, Film-coated от светло-оранжевого цвета до светло-оранжевого цвета с розовым оттенком, round, с делительной риской с одной стороны.
| 1 tab. |
| тиоридазина гидрохлорид | 10 mg |
Excipients: lactose, starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, talc, эудражит Е100, sodium lauryl, polyethylene glycol, Dyes (закатно-желтый, indigokarmin, Titanium dioxide).
10 PC. – blisters (10) – packs cardboard.
10 PC. – aluminum strips (10) – packs cardboard.
Pills, Film-coated blue, round, с делительной риской с одной стороны.
| 1 tab. |
| тиоридазина гидрохлорид | 100 mg |
Excipients: lactose, starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, talc, эудражит Е100, sodium lauryl, polyethylene glycol, Dyes (закатно-желтый, indigokarmin, Titanium dioxide).
10 PC. – blisters (10) – packs cardboard.
10 PC. – aluminum strips (10) – packs cardboard.
Pills, Film-coated blue, round, с делительной риской с одной стороны.
| 1 tab. |
| тиоридазина гидрохлорид | 25 mg |
Excipients: lactose, starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, talc, эудражит Е100, sodium lauryl, polyethylene glycol, Dyes (закатно-желтый, indigokarmin, Titanium dioxide).
10 PC. – blisters (10) – packs cardboard.
10 PC. – aluminum strips (10) – packs cardboard.
Pills, Film-coated yellow color, round, с делительной риской с одной стороны.
| 1 tab. |
| тиоридазина гидрохлорид | 50 mg |
Excipients: lactose, starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, talc, эудражит Е100, sodium lauryl, polyethylene glycol, Dyes (закатно-желтый, indigokarmin, Titanium dioxide).
10 PC. – blisters (10) – packs cardboard.
10 PC. – aluminum strips (10) – packs cardboard.
Pharmacological action
A piperidine derivative of phenothiazine; It has antipsychotic, tranquilizing, antidepressant, protivozudnoe, and alpha-adrenergic- and m-anticholinergic action. In small doses, it has anxiolytic effects; reduces the feeling of tension and anxiety, higher doses of antipsychotic exhibits (neuroleptic) properties. In the medium therapeutic doses does not cause extrapyramidal disorders and sleepiness. It has weak antiemetic effect, moderate – gipotenzivnoe.
Testimony
Schizophrenia, affective insanity; neuroses, accompanied by fear, excitation, voltage, compulsions; tics, abstinence symptom (drug abuse, alcoholism), psychomotor agitation of various origins.
Contraindications
Hypersensitivity, severe cardiovascular diseases (decompensated chronic heart failure, hypotension), pronounced inhibition of the central nervous system and coma of any etiology; ChMT, progressive systemic diseases of the brain and spinal cord, pregnancy, lactation, childhood (to 2 years).C care. Alcoholism (predisposition to hepatotoxicity), blood dyscrasias (hemodyscrasia), mammary cancer (as a result of phenothiazine-induced prolactin increase the potential risk of disease progression and resistance to treatment with endocrine and cytostatic drugs), zakrыtougolynaya glaucoma, prostatic hyperplasia with clinical manifestations, liver and / or kidney failure, peptic ulcer and 12 duodenal ulcer (during the exacerbation); disease, accompanied by an increased risk of thromboembolic complications; Parkinson's disease (intensified extrapyramidal effects); epilepsy; myxedema; chronic diseases, accompanied by respiratory failure (especially in children); Reye's syndrome (increased risk of hepatotoxicity in children and adolescents); kaxeksija, vomiting (antiemetic effect of phenothiazines may mask vomiting, associated with overdose, etc.. PM). Advanced age.
Side effects
From the nervous system: fainting, confusion, psychomotor disturbances, pozdnyaya dyskinesia, ažitaciâ, excitation, insomnia, hallucinations, increased psychotic reactions, and extrapyramidal dystonic reactions, parkinsonizm, emotional disturbances, violation of thermoregulation, decrease seizure threshold. From the senses: photophobia, visual impairment. From the digestive system: giposalivaciâ, Hypertrophy of tongue papillae, decreased or increased appetite, dyspepsia, nausea, vomiting, diarrhea, paralytic ileus, cholestatic hepatitis. On the part of the endocrine system: dysmenorrhoea, hyperprolactinemia, gynecomastia, false positive pregnancy tests, weight gain. Allergic reactions: skin rash (incl. эritematoznaya), angioedema, exfoliative dermatitis. From the CCC: decrease in blood pressure, tachycardia, nonspecific ECG changes. From the side of hematopoiesis: suppression of bone marrow hematopoiesis (agranulocytosis, leukopenia, granulocytopenia, eozinofilija, thrombocytopenia, aplasticheskaya anemia, pancytopenia). The respiratory system: brohospastichesky syndrome, nasal congestion. From the urogenital and urinary system: paradoxical ischuria, dizurija, decreased libido, abnormal ejaculation, priapism. Other: melasma (long-term use in high doses).Overdose. Symptoms: drowsiness, confusion, urinary retention, disorientation, coma, areflexia, hyperreflexia, dry mouth, nasal congestion, orthostatic hypotension, depression of the respiratory center, convulsions, gipotermiя. Treatment: symptomatic, aimed at reducing the absorption and excretion of the drug acceleration. No specific antidote.
Dosing and Administration
Inside. In light of mental and emotional disorders – 30-75 mg / day, in moderate disorders – 50-200 mg / day. In acute psychosis, mania, schizophrenia and depression azhitatsionnyh: on an outpatient basis – 150-400 mg / day; hospital – 250-800 mg / day. Babies 4-7 years – 10-20 mg / day 2-3 admission, 8-14 years – by 20-30 mg / day 3 once a day, 15-18 years – 30-50 mg / day.
Cautions
During the period of treatment is necessary to control the morphological composition of the blood; refrain from the use of ethanol and Occupation potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Cooperation
Reduces the effects of levodopa and amphetamine. Reduces anorectics PM (except for fenfluramine). Reduces the effectiveness of the action of the emetic apomorphine, enhances its depressing effect on the central nervous system. Increases in plasma concentration of prolactin and inhibits the action of bromocriptine. The synergy of action with general anesthetics, opiatami, ethanol, atropynom. When concomitantly with antiepileptic drugs (incl. ʙarʙituratami) reduces their effect (reduces epileptic threshold). In combination with beta-blockers enhances the antihypertensive effect, It increases the risk of irreversible retinopathy, arrhythmias and tardive dyskinesia. Probucol, astemizol, cisapride, disopyramide, Erythromycin, pimozid, procainamide, quinidine, and promote further lengthening of the QT interval, which increases the risk of ventricular tachycardia. Ephedrine helps paradoxical decrease in blood pressure. Agonists enhance the arrhythmogenic effect. Amitriptyline and antihistamine drugs increase the activity of anticholinergic. Antithyroid drugs increase the risk of agranulocytosis. In a joint application with tricyclic antidepressants, Maprotiline, MAO inhibitors may lengthening and strengthening of sedative and anticholinergic effects, with thiazide diuretics – strengthening of hyponatremia, with drugs Li +- reduced absorption in the gastrointestinal tract, an increase in the rate of excretion by the kidneys Li +, increased severity of extrapyramidal disorders, Early signs of intoxication Li + (nausea and vomiting) antiemetic can mask the effect of thioridazine. PM, suppress bone marrow hemopoiesis, increase the risk of myelosuppression.
