Expiration date: 05/2025
Structure and Composition:
1 tablet contains divisible tiapride hydrochloride 100 mg in blister 10 pcs., In box 2 of the blister.
1 ampoule with 2 ml solution for injection - 100 mg in blister 6 pieces in box 2 of the blister..
Pharmachologic effect:
Selectively blocking central dopamine D2-receptor without affecting the D1-receptors.
Pharmacokinetics:
After the / IM injection of 200 mg Cmax (2,5 mg / ml) was determined 30 minutes after administration of 200 mg orally (1.3 mg / ml) - after 1 h Bioavailability -. 75% (reception immediately before meal increases bioavailability 20%, Cmax - 40%). Absorption is slowed down in the elderly. Distribution quick: after 1 hour was determined in many tissues and organs passes the BBB and placental barrier, enters the breast milk (concentration in milk is half that of blood plasma). Almost does not bind to plasma proteins, red blood cells. T1 / 2 - 2.9 hours in women and in men 3.6 h. Moderately undergoes metabolism: 70% of the dose found in the urine in unchanged form. Withdrawal takes place in the kidneys is 330 Cl mL / min. Patients with impaired renal excretory function of the degree of reduction of excretion correlates with the magnitude of Cl creatinine. The daily dose for Cl creatinine less than 20 ml / min must be reduced 2-fold, less than 10 ml / min - 4 times.
Description of the pharmacological actions:
It has antipsychotic and anxiolytic effects, including in the treatment of alcohol, opiate and nicotine withdrawal. It eliminates dyskinesia, promotes clarity of thought in elderly patients, has analgesic properties.
Indications:
Conduct disorders (agitation, aggressiveness), especially in patients with alcoholism pain (intense nekupiruyuschayasya) dyskinesia (spontaneous, late, Huntington's chorea).
Contraindications:
Hypersensitivity, pheochromocytoma (including estimated), pregnancy, breast-feeding.
Application of pregnancy and breastfeeding:
Contraindicated. At the time of treatment should stop breastfeeding.
Side effect:
With prolonged use at high doses may sometimes be drowsiness, hypotonia, dyskinesia (early - spastic, torticollis, trismus, oculomotor disturbances and later), extrapyramidal symptoms, muscle relaxation, lower blood pressure, amenorrhea, galactorrhea, hyperprolactinemia, gynecomastia, impotence, frigidity, increase body weight, neuroleptic malignant syndrome (unexplained hyperthermia - requires discontinuation of the drug).
Drug Interactions:
Incompatible with alcohol and levodopa. Can enhance the effects of drugs which depress the central nervous system, as well as ACE inhibitors and others. Antihypertensives.
Dosage and administration:
Inside, motor disorders - at 300-800 mg / day when disorders - adults - 200-300 mg / day for 1-2 months, if necessary, repeat the course for children older than 7 years - 100-150 mg / day 2-3 hours, increase the dose if necessary - up to 300 mg / day nekupiruyuschayasya pain - 200-400 mg / day orally or contents 2-4 ampoules / m or / in. When delirious (predelirioznom) state - i / m or / every 4-6 hours at a daily dose - 400-1200 mg (1800 mg) (the contents of ampoules of 4-12). Daily doses should redutsirovatsya depending Cl creatinine.
Precautionary measures:
Be wary appoint patients with epilepsy, severe cardiovascular disease, renal failure, Parkinson's disease, in the elderly, newborns during the drivers of vehicles and people skills relate to the high concentration of attention. There should be continuous monitoring when combined with the appointment means oppressive central nervous system, hypotensive drugs, including ACE inhibitors.
