N10 aminazine 0,1g

General characteristics. Structure:

International and chemical names: chlorpromazine; 2-hlor-10-(3 dimethylaminopropyl) fenotiazina hydrochloride; main physical and chemical properties: tablets are biconvex, coated, from light orange till dark orange color. On cross section two layers are visible;
structure: 1 tablet contains Chlorpromazinum of a hydrochloride 0,05 g or 0,1 g;
excipients: the tselaktoza, aerosil, aluminum hydroxide (gidrargilit), calcium stearate, stearic acid, talc, a gipromeloza (hydroxypropyl-methyl cellulose), titanium dioxide, dye yellow "sunset".

Pharmacological properties:

Pharmacodynamics. Blocks the central adrenergic and dofaminergichesky receptors. Possesses strong sedation (in comparison with other neuroleptics). The general calm at the same time is combined with oppression of conditioned-reflex activity, first of all motive defensive reflexes, reduction of a spontaneous physical activity, relaxation of skeletal muscles, decrease in reactivity. Use of high doses causes somnolent effect. Oppresses various interoceptive reflexes, the m - cholinolytic and prolaktinogenny activity possesses expressed antiemetic and protivoikotny by effects, anti-histamine. Has hypothermal effect. Moderately reduces expressiveness of inflammatory reaction, reduces permeability of vessels, lowers activity of kinin and hyaluronidase. Reduces systolic and diastolic the ABP, causes tachycardia. Has the expressed kataleptogenny properties. The main feature of Aminazine is the combination of antipsychotic action to ability to influence the emotional sphere. Stops different types of psychomotor excitement, nonsense and hallucinations, fear and alarm at patients with psychoses and neurosises.

Pharmacokinetics. In digestive tract it is soaked up badly. The maximum concentration in blood is reached in 2–4 hours. A considerable part is metabolized in a liver with formation of a number of active and inactive metabolites. Possesses high extent of linkng with proteins of plasma (95–98%). It is widely distributed in an organism, gets through a blood-brain barrier, at the same time its concentration in a brain exceeds concentration in plasma. The elimination half-life makes about 30 h, elimination of metabolites is longer. It is removed with urine and with bile in the form of metabolites.

Indications to use:

In psychiatry – acute and chronic paranoid and/or hallucinatory states, psychomotor excitement, including at patients with schizophrenia (hallucinatory and crazy, hebephrenic, catatonic syndromes); maniacal excitement at maniac-depressive psychosis; the agitated depression (at presenile and maniac-depressive psychosis); and also other diseases with productive symptomatology and excitement. In neurology – increase in a muscle tone, a torpid pain syndrome, persistent sleeplessness. As an antiemetic – Menyer's disease, pernicious vomiting at treatment by antineoplastic drugs, radiation therapy.

Route of administration and doses:

Doses and schemes of treatment are established individually depending on indications and a condition of the patient. Accept after food.
At treatment of mental diseases the daily dose of Aminazine for adults at intake makes 0,3–0,6 g (in 1–3 receptions) in days. A course of treatment – from 3 weeks to 2–4 months and more.
In some cases the daily dose of Aminazine at use can be inside increased to 0,7–1,0 g (especially at patients with chronic disease and psychomotor excitement). In this case the daily dose is divided into 4 receptions (in the morning, in the afternoon, in the evening and at night). Treatment duration high doses of drug should not exceed 1–1,5 months, at insufficient effect it is reasonable to pass to treatment with other drugs.
To the weakened patients and patients of advanced age appoint up to 300 mg/days.
The highest doses for adults inside: one-time – 0,3 g, daily – 1,5 g.
Children of 3–5 years are recommended to apply Aminazine tablets on 0,025 g.
At alcoholic psychoses Aminazine is appointed inside on 0,2–0,4 g a day.

Features of use:

Aminazine is emitted with breast milk, in need of its use in the period of a lactation, breastfeeding should be stopped.
With extra care apply to treatment of patients with pathological changes of a picture of blood, at abnormal liver functions, kidneys, a drunkenness, a syndrome to Reja, oncological diseases of a mammary gland, cardiovascular diseases, predisposition to glaucoma, Parkinson's disease, a peptic ulcer of a stomach and a duodenum, an ischuria, chronic diseases of a respiratory organs, epileptic attacks, at elderly (increase in risk of excessive sedative and hypotensive action), at the weakened patients. Work with mechanisms and driving is not allowed.
During treatment alcohol intake is not allowed. In case of development of a hypothermia it is necessary to stop administration of drug. At drug use by the patient with an atony of an intestinal path and an akhiliya it is recommended to appoint at the same time gastric juice or hydrochloric acid, to watch a diet and functioning of intestines. At treatment by Aminazine patients should not be exposed to UF-radiation in connection with a possibility of a photosensitization of skin. At prolonged treatment by drug control of a picture of blood, function of a liver and kidneys is necessary.

Side effects:

Extrapyramidal frustration (parkinsonichesky syndrome, tremor, akathisia, indifference, slowness of reactions, sight illegibility, dystonic reactions), late dyskinesia, depression, lowering of arterial pressure, tachycardia, thermal control disturbance, dispeptic phenomena (nausea, vomiting, lock). Seldom – spasms, jaundice, an agranulocytosis, a leukopenia, a xanthopathy, a phacoscotasmus, difficulty of an urination, disturbance of a menstrual cycle, impotence, increase in body weight, allergic reactions (rash, hypostases, a photosensitization, exfoliative dermatitis, a multiformny erythema).

Interaction with other medicines:

At simultaneous use with the drugs oppressing the central nervous system and also with ethanol or etanolsoderzhashchy drugs, strengthening of oppression of the central nervous system, respiratory depression is possible; with tricyclic antidepressants, Maprotilinum or monoamine oxidase inhibitors – increase in risk of development of an antipsychotic malignant syndrome, with anticonvulsant drugs – decrease in a convulsive threshold; with drugs for treatment of a hyperthyroidism – the risk of development of an agranulocytosis increases; with the drugs causing extrapyramidal reactions – increase in frequency and weight of extrapyramidal disturbances; with hypotensive drugs – the expressed orthostatic hypotension is possible; with ephedrine – easing of vasoconstrictive effect. Aminazine weakens effect of cardiac glycosides; exponentiates anticholinergic effects of other drugs, at the same time its antipsychotic action can decrease.
Barbiturates strengthen Aminazine metabolism, inducing microsomal enzymes of a liver, and reduce its concentration in blood. Antacids, Cimetidinum, protivoparkinsonichesky means, drugs of lithium break Aminazine absorption, estrogen increases its antipsychotic effects.

Contraindications:

Individual sensitivity or hypersensitivity (allergy) to drug components. A heavy liver and renal failure, the progressing general diseases of a head and spinal cord (slow neuroinfections, multiple sclerosis), brain injuries, comas, dekompensirovanny heart diseases, active rheumatism, a thromboembolic syndrome, the expressed hemopoiesis oppression, a myxedema, closed-angle glaucoma. Zhelchekamenny and urolithic diseases, an exacerbation of erosive and ulcer diseases of digestive tract, acute pyelonephritis, an ischuria at a prostate hyperplasia. Pregnancy and period of a lactation.

Overdose:

Symptoms: an antipsychotic syndrome (parkinsonism, an akathisia, indifference, the slowed-down reaction to external irritants, a long depression), persistent hypotension, a hypothermia, a coma, later – toxic hepatitis. Treatment: symptomatic therapy. For reduction of a depression appoint stimulators of the central nervous system (Sydnocarbum). Neurologic complications decrease or stopped by purpose of protivoparkinsonichesky means (Cyclodolum, Tropacinum). At kollaptoidny states introduction of Cordiaminum, caffeine, a phenylephine hydrochloride is recommended.

Storage conditions:

Conditions and periods of storage. In dry, protected from light, the place, unavailable to children, at a temperature not above 25 °C.

Period of validity – 3 years.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, on 0,05 g or 0,1 g, No. 10, No. 10х2, No. 20 in blister strip packagings