2010/06/07

ORNISTAT

Pharmacological properties: an integrated drug for treatment of chronic gastritis, peptic ulcer and duodenal ulcer associated with Нelicobacter pylori. Rabeprazole - antisecretory drug group substituted benzimidazoles, blocks the secretion of hydrochloric acid in the stomach by specific inhibition of the enzyme H + / K +-ATPase at the secretory surface parietal cells (ie, a proton pump inhibitor).

The mechanism of action Ornidazole associated with DNA damage was sensitive to it microorganisms. Ornidazole active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), Helicobacter pylori, as well as some anaerobic bacteria such as Bacteroides and Clostridium spp., Fusobacterium spp. And anaerobic cocci.

Clarithromycin has an antibacterial effect by inhibition of protein synthesis by binding to the 50S-ribosomal subunit.

After receiving rabeprazole inside antisecretory effect develops within 1 h and reaches a maximum after 2-4 hours Inhibition of basal and stimulated gastric secretion observed after 23 h after the first dose of rabeprazole. Stable inhibition of gastric secretion is achieved after 3 days of receiving rabeprazole. Thanks to a special dosage form of rabeprazole absorption occurs in the intestines. The drug is rapidly absorbed from the intestine, its maximum plasma concentration achieved after 3.5 h after oral administration at a dose of 20 mg.

Once inside absorbed 90% Ornidazole. Maximum plasma concentration achieved after 3 h. The binding Ornidazole with blood plasma proteins is approximately 13%. Depending on the dosage regimen the concentration of active substance in the blood serum of 6-36 mg / liter. Ornidazole well into the CSF, other body fluids and tissues. The half-life is about 13 hours After a single dose of 85% of drug output during the first 5 days, 63% - in the urine, 22% - with the feces. Approximately 4% of applied dose excreted in the urine in unchanged form. The coefficient of cumulation after repeated taking the drug at a dose of 500 or 1000 mg of healthy volunteers every 12 hours is 1,5-2,5.

The concentration of clarithromycin in plasma 2 h after oral administration at a dose of 500 mg of 1,97 mg / ml. The half-life of the drug dozozavisim. Clarithromycin is metabolized in the liver. Active against H. pylori (IPC 90 = 0,03 mg / l), which makes it possible to use the drug in the schemes for eradication of H. pylori.

INDICATIONS: eradication of H. pylori in chronic gastritis, peptic ulcer of stomach and duodenum.

APPLICATION: Each blister Ornistata contains 2 tablets of rabeprazole (20 mg), 2 tablets Ornidazole (500 mg) and 2 tablets of clarithromycin (500 mg). A blister is calculated at 1 day treatment. Take 1 tablet of rabeprazole, 1 tablet Ornidazole and 1 tablet of clarithromycin in the morning and evening. The recommended duration of treatment - 7 days.

CONTRAINDICATIONS: Hypersensitivity to rabeprazole, clarithromycin and ornidazole, during pregnancy.

SIDE EFFECTS: Dry mouth, in a few cases - dyspepsia, prolonged use at high doses are rarely - Hepatotoxic effects, expressed mild and quickly passing drowsiness, headache, fatigue, in some cases - excitement, very rarely - tremor, muscular rigidity , violations of coordination, convulsions, confusion, angioedema, rash, itching, hives.

Cautions: The components of the drug are excreted with breast milk, so it is recommended to stop breast-feeding during treatment.

Clarithromycin is allocated by the liver and kidneys, so the dose in patients with hepatic and renal insufficiency should be adjusted. The dose of rabeprazole should be reduced in hepatic failure. Ornidazole used with caution in liver disease and chronic alcoholism.

In appointing Ornistata patients with diseases of the CNS (eg epilepsy, multiple sclerosis, in the case of exceeding the recommended dose) increases the risk of side effects.

INTERACTION: Appointment of rabeprazole in combination with antacids does not cause clinically significant change in the concentration of rabeprazole in plasma. Ornidazole may interact with indirect anticoagulants, as well as to prolong the effect of vecuronium bromide. Clarithromycin should not be given concurrently with ergotamine or its derivatives in connection with the possibility of a spasm of the arteries, which may lead to ischemia. Clarithromycin alters the pharmacokinetics of carbamazepine and interacts with warfarin, ranitidine and magnesium or aluminum containing antacids. Appointment of clarithromycin to patients who are simultaneously taking drugs metabolized by cytochrome P450 may increase their level in blood serum, which requires the monitoring of concentration.

OVERDOSE: describes reception of rabeprazole 80 mg. Overdosing was not accompanied by any clinical symptoms. A large overdose can occur Ornidazole disorientation, nausea and vomiting, clarithromycin overdose - nausea, vomiting, diarrhea, abdominal pain. Carry out gastric lavage, appoint symptomatically.

Storage: Store in dark place at a temperature of 15-25 ° C.