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The instruction for medical use of drug

Gastrotipin-Darnitsa (Gastrotipine-Darnitsa)

international and chemical names: Pirenzepine; - 5,11-digidro-11-[(4-metilpiperazinit) acetyl] - bn-pirido [2,3-] [1,4], benzodiazepine - 6 - it is dihydrochloride, monohydrate;

Main physical and chemical characteristics: tablets white or white, with a cream shade of color, with a notch;

Structure 1 tablet contains a pirenzepin of dihydrochloride of monohydrate (in recalculation on a pirenzepin dihydrochloride) 0,025 g;

other components: lactoses monohydrate (sugar milk), potato starch, polyvinylpirrolidone low-molecular medical, aerosil, magnesium stearate.

Release form. Tablets.

Farmakoterapevtichesky group. Means for treatment of a round ulcer. Code of automatic telephone exchange A02BX03.

Pharmacological Pharmacodynamics properties. Gastrotipin-Darnitsa selektivno blocks M1-holinoretseptory obklad eye and main cells of a mucous membrane of a stomach and brakes stimulating influence of a vagus nerve on gastric secretion, selectively suppresses basal and stimulating secretion of Acidum hydrochloricum and pepsinogen," significantly does not influence M-holinoretseptory of sialadens, unstriated muscles, hearts, an eye and other bodies. Increases firmness of cells of a mucous membrane of a stomach to irritation.

Pharmacokinetics. Due to the expressed hydrophilic properties after intake Gastrotipin-Darnitsa gradually is soaked up from a digestive tract. The maximum concentration in a blood plasma - in 1,5-2 hours after oral administration. Bioavailability, on average, makes 40%, at a concomitant use with food - 10-20%. Therapeutic concentration in blood (30-60 ng/ml) keeps within 12 hours, the elimination half-life makes 10-12 hours. The elimination half-life of Gastrotipin-Darnits correlates with clearance of creatinine. Linkng with proteins of plasma - 10-16%. Does not get in clinically significant quantities through placental and hematoencephalic barriers, has no, unlike the majority of tricyclic connections, the central action.

Gastrotipin-Darnitsa is slightly metabolized in a liver. It is removed in an invariable look: kidneys, with urine about 8-10%, other part - through a digestive tract with excrements. The hemodialysis reduces the level of a pirenzepin in blood by 25%.

Indications for use. Treatment and prevention of a peptic ulcer of a stomach and duodenum; chronic hyperacid gastritis; an erosive esophagitis at a reflux disease; prevention of side effects at treatment by non-steroidal anti-inflammatory drugs.

Way of use and dose. Gastrotipin-Darnitsa appoint in a dose 50-150 mg a day, having divided a dose into 2 receptions, in the morning and in the evening, in 30 minutes prior to food, washing down with a small amount of water. In need of the first 2-3 days of treatment possible reception of an additional dose

in the afternoon. The course of treatment makes 4-6 weeks, without dose decline (even in case of subjective improvement of a state). To children from 3 to 7 years Gastrotipin-Darnitsa appoint 12,5 mg, 2 times a day, in the morning and in the evening, in 30 minutes prior to food, washing down with a small amount of water. To children from 7 to 14 years appoint in a dose 50 mg to days, having divided a dose into 2 receptions.

Side effect. At Gastrotipin-Darnits's reception increase of appetite and sometimes, liquid emptying can be observed. In isolated cases there can be a tranzitorny deterioration in accommodation, arise dryness in a mouth, is caused by decrease a slyunovydeleniye.

Contraindications. Hypersensitivity to drug components, pregnancy (1 trimester).

Overdose. Not the known cases of intoxication for the person. The described cases of intake of 200 mg of a pirenzepin of dihydrochloride; at the same time were observed dryness in a mouth and a vision disorder within 5 hours, other symptoms were not noted.

Treatment: symptomatic. In some an overdose case, if necessary introduction of a prozerin is possible.

Features of use. Gastrotipin-Darnitsa it is necessary to apply with care priglaukom, prostatauxes. The elimination half-life of Gastrotipin-Darnits correlates with clearance of creatinine therefore drug dose adjustment is necessary for patients with a renal failure who have a clearance of creatinine less 10ml/minutes. At prolonged use it is necessary to control intraocular pressure. Safety of use of Gastrotipin-Darnits during pregnancy is not established. Therefore, for the purpose of safety, use of drug at pregnancy is not recommended. Gastrotipin-Darnitsa gets into breast milk and can oppress a lactation. Use of drug in therapeutic doses in the period of a lactation has no undesirable action on the child.

Interaction with other medicines. Gastrotipin-Darnits's use along with Metoclopramidum reduces its action on a peristaltics of a digestive tract. Sharing with opioid analgetics increases risk of emergence of a heavy lock or ischuria. Gastrotipin-Darnitsa can oppress gastric secretion, stimulated remedies and foodstuff (caffeine, alcohol, etc.); reduces the frequency of side effects from a digestive tract at reception of non-steroidal anti-inflammatory drugs, without reducing their effect. At a hyperacid state with continuous like secretion it is reasonable to combine Gastrotipin-Darnitsa with blockers H2-repeptoriv of a histamine.

Conditions and periods of storage. To store in dry, protected from light and the place, unavailable to children, at a temperature not higher than +25 Pages. A period of validity - 2 years.

"Gastrosidin   Gastrotipin-Darnitsa solution for injections"