Thioryl

General characteristics. Structure:

Active ingredients: 25 mg or 100 mg of thioridazine.

Excipients: dibasic calcium phosphate (anhydrous), starch, polyvinyl пирролидон K-30, magnesium stearate, talc.

Pharmacological properties:

Pharmacodynamics. Thioryl (thioridazine a hydrochloride) - piperidinovy derivative a fenotiazina. Renders antipsychotic, moderate sedative (without the expressed block) action. At use in small doses has anxiolytic effect, reduces feeling of tension and alarm, has moderate antidepressive activity. Antiemetic and extrapyramidal action are expressed poorly.

Pharmacokinetics. Time of achievement of the maximum concentration (With max) – after intake is quickly soaked up 1-4 hours from digestive tract; it is metabolized in a liver. An elimination half-life (Т½) – 6-40 hours. It is removed by kidneys, with bile.

Indications to use:

The schizophrenia, psychotic frustration which are followed by a hyperactivity and psychomotor excitement; the behavior disorders connected with psychotic frustration and/or neurologic diseases; moderate depressive frustration; the neurosises which are followed by alarm, agitation, tension, fear.

Route of administration and doses:

Is selected individually taking into account genesis of symptoms and degree of their expressiveness. The daily dose for adults and children is more senior than 12 years makes 20 - 600 mg/days, frequency rate of use – 2-4 times a day. The maximum dose - 800 mg a day. The course of treatment by high doses is continued by no more than 4 weeks.

To children aged from 2 up to 5 years - 1 mg/kg/days. To children 5 years usually are more senior appoint 75 mg/days, frequency rate of reception – 2-4 times a day.

Features of use:

Pregnancy and lactation. At pregnancy use of Thioryl is possible only if the expected advantage for mother exceeds potential risk for a fruit. Adequate and well controlled safety of a research drug at pregnancy was not conducted. In need of purpose of Thioryl in the period of a lactation breastfeeding should be stopped.

With care apply at patients with disturbances of a cordial rhythm, heart diseases, a serious illness of a respiratory organs, a renal failure, Parkinson's disease, closed-angle glaucoma, a prostatauxe, a myasthenia, epilepsy, a pheochromocytoma. During treatment not to allow alcohol intake.

Patients with diseases of a liver need regular control of function of a liver. The elderly patients exhausted or having diseases of kidneys or a liver are recommended to appoint a low initial dose with its gradual increase.

Influence on ability to driving of motor transport and to control of mechanisms. During treatment it is necessary to abstain from potentially dangerous types of activity requiring special attention and bystry psychomotor reactions.

Side effects:

From TsNS: drowsiness, confusion of consciousness, concern, an akathisia, a headache, vision disorders are possible; in isolated cases – a malignant antipsychotic syndrome; spasms, since. Thioryl can reduce a threshold of convulsive readiness. At prolonged use extrapyramidal frustration are possible. In high doses more often than other fenotiazina, causes a pigmental retinopathy. Seldom or never at prolonged use are possible late dyskinesia.

From the alimentary system: the lock, nausea, vomiting, a hypertrophy of nipples of language are possible dryness in a mouth, it is rare - paralytic Ilheus, cholestatic hepatitis.

From cardiovascular system: are possible postural hypotension (especially at patients of advanced age), disturbances of a cordial rhythm, tachycardia. In high doses, as well as other fenotiazina, especially at the accompanying hypopotassemia, change of an ECG – lengthening of an interval of QT, smoothing of a tooth of T, emergence of a tooth of U can cause.

From system of a hemopoiesis: in isolated cases – a leukopenia, an agranulocytosis, thrombocytopenia, aplastic anemia, a granulocytopenia, an eosinophilia, a pancytopenia.

From endocrine system: the giperprolaktinemiya, disturbances of a menstrual cycle, disturbance of an ejaculation, decrease in a libido are possible.

From a metabolism: at prolonged use in high doses development of a melanosis is possible.

From respiratory system: nose congestion.

Allergic reactions: skin rash, an itch, a Quincke's disease, exfoliative dermatitis are possible.

Others: the incontience or an ischuria are possible; seldom - increase in body weight, photophobia, a vision disorder.

Interaction with other medicines:

At simultaneous use of Thioryl with other drugs having the oppressing effect on TsNS, and also ethanol and etanolosoderzhashchy drugs strengthening of a depression of TsNS is possible; with a levodopa – reduction of protivoparkinsonichesky action; with lithium drugs – perhaps neurotoxic action.

Thioryl can lower concentration of phenobarbital in plasma, reduce effect of anticoagulants and peroral antidiabetic means.

Undesirable anticholinergic effect of Thioryl can amplify at simultaneous use with anticholinergic drugs.

Contraindications:

The expressed depressions, comas, the expressed oppression of TsNS, blood disease in the anamnesis, children's age up to 2 years, a serious illness of cardiovascular system, a liver failure, hypersensitivity to thioridazine and other derivatives of a fenotiazin.

Overdose:

Symptoms: the increased drowsiness, confusion of consciousness, an ischuria, oppression of a respiratory center, arterial hypotension, orientation disturbance, an areflexia, a hyperreflexia, spasms, arrhythmia. In hard cases of a lump, a collapse.

Treatment: a gastric lavage, with the subsequent purpose of absorbent carbon. The symptomatic treatment, at arterial hypotension is shown administration of plasma substitutes.

Storage conditions:

To store at a temperature below 30 °C in the place protected from light and moisture. To store in the place, unavailable to children. A period of validity - 3 years from the date of production. Not to use after the term specified on packaging

Issue conditions:

According to the recipe

Packaging:

10 tablets in the blister from PVC of a film and aluminum foil. 3 blisters or 10 blisters on 10 tablets with the application instruction in a cardboard pack. A sample not for sale: 4 or 10 tablets in the blister from PVC of a film and aluminum foil. 1 blister with the application instruction in a cardboard pack.