Ornistat

General characteristics. Structure:

Active ingredient: 20 mg of a rabeprazol of sodium.

Excipients: lactose, cellulose microcrystallic, povidone, sodium methylparaben (E219), sodium propylparaben (E217), magnesium stearate, talc, silicon dioxide colloid anhydrous, sodium krakhmalglikolit, starch corn, cellulose ацетилфталат, dye: ferrous oxide yellow (E172), talc, titanium dioxide (E171), polyethyleneglycol.

Active ingredient: 500 mg of an ornidazol.

Excipients: cellulose microcrystallic, sodium methylparaben (E219), sodium propylparaben (E217), magnesium stearate, talc, silicon dioxide colloid anhydrous, sodium krakhmalglikolit, starch corn, a gidroksipropilmetiltsellyuloza, talc, titanium dioxide (E171), polyethyleneglycol.

Active ingredient: 500 mg of a klaritromitsin.

Excipients: lactose, cellulose mirokristalichesky, povidone, sodium methylparaben (E219), sodium propylparaben (E217), magnesium stearate, talc, silicon dioxide of kolloidniya anhydrous, sodium krakhmalglikolit, starch corn, a gidroksipropilmetiltsellyuloza, talc, titanium dioxide (E171), polyethyleneglycol, dye – erythrosine (E127).

The combined drug with the most bystry and the expressed anti-secretory, protivokhelikobakterny and reparative activity.

Pharmacological properties:

Ornistat – a complex of three drugs for the treatment of chronic gastritis, a peptic ulcer of a stomach and a duodenum associated with H. pylori.

Pharmacodynamics. Rabeprazol of sodium belongs to a class of anti-secretory connections which in the chemical relation are the replaced benzim_dazola, reduces secretion of gastric acid by specific oppression of H+/K enzyme +-Atfazy on the secretory surface of covering cells of a stomach. This fermental system is considered an acid (proton) pomp, therefore рабепразол carry to inhibitors of a proton pomp of a stomach which blocks a final stage of secretion of gastric acid.

Ornidazol: the mechanism of action of an ornidazol is connected with disturbance of structure of DNA of microorganisms, sensitive to it. Ornidazol is active concerning Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), Haelicobacter Pylori, and also some anaerobic bacteria, such as Bacteroides and Clostridium spp., Fusobacterium spp. and anaerobic cocci, кларитромицин has antibacterial effect by oppression of proteinaceous synthesis due to binding with 50S a ribosome subunit.

Pharmacokinetics. Rabeprazol of sodium. After oral administration of a rabeprazol the anti-secretory effect occurs within 1 hour and reaches a maximum in 2 - 4 hours. Oppression by basal and stimulated food of secretion of gastric acid comes in 23 hours after reception of the first dose of a rabeprazol. Stable oppression of secretion is reached after 3 days of reception of a rabeprazol.

Thanks to a special dosage form рабепразол it is absorbed in intestines. Drug is quickly absorbed from intestines and its high concentration in a blood plasma is reached in 3,5 hours after reception in a dose of 20 mg.

Ornidazol. Absorption: after oral administration of 90% of an ornidazol it is soaked up from a digestive tract. The maximum concentration in a blood plasma is reached within 3 hours. Linkng of an ornidazol with proteins of a blood plasma makes about 13%. Depending on the dosing mode optimum concentration of active agent makes 6 - 36 mkg/l. Ornidazol well gets into cerebrospinal fluid and other liquids and body tissues

Removal: the elimination half-life makes about 13 hours. After single use of drug of 85% of a dose it is removed within the first 5 days. It is removed preferential with urine (63%) and a stake (22%). About 4% of the entered dose are removed by kidneys in not changed state. The cumulation coefficient after reusable administration of drug in a dose of 500 mg or 1000 mg by healthy volunteers each 12 h makes 1,5 - 2,5.

Klaritromitsin – at clinical trials it is established that in 2 hours after oral administration of 500 mg of a klaritromitsin drug level in plasma makes 1,97 mkg/ml. Time of semi-removal of drug has dozozavisimy character. Klaritromitsin is metabolized in a liver, is active concerning H. Pylori (MPK - the 90th value of 0,03 mkg/l) that allows to use drug in schemes for an eradikation of H. pylori.

Indications to use:

Eradikation Haelicobacter Pylori at chronic gastritis, a peptic ulcer of a stomach and duodenum, a round ulcer of a stomach and duodenum.

Route of administration and doses:

Each blister contains two tablets of a rabeprazol (20 mg), two tablets of an ornidazol (500 mg), two tablets of a klaritromitsin (500 mg). One blister is appointed to one day of treatment. 1 tablet of a rabeprazol, 1 tablet of an ornidazol and 1 tablet of a klaritromitsin accept in the morning, also on one tablet of a rabeprazol, the ornidazol and a klaritromitsin needs to be accepted in the evening. The recommended treatment duration – within 7 days.

Features of use:

It is forbidden to apply Ornistat during pregnancy as components of drug can negatively affect pre-natal fetation, and also it is necessary to avoid use during feeding by a breast.

For the period of administration of drug feeding by a breast should be stopped.

It is forbidden to apply to children aged up to 18 years.

Renal and liver failure. Klaritromitsin is allocated with bile. The dose for patients with a liver and renal failure should be modified.

Rabeprazol – a dose at a liver failure has to be reduced. Symptomatic improvement in response to therapy rabeprazoly can happen also in the presence of a malignant new growth of a stomach therefore before therapy by Ornistat it is necessary to exclude such diseases. It is recommended to be drug, careful at early stages of therapy, by Orn_itat of patients with heavy renal failures.

Ornidazol – with care apply at diseases of a liver and alcoholism

At Ornistat's appointment to patients with diseases of the central nervous system, for example, epilepsy, multiple sclerosis, in case of exaggeration of the recommended dose, increases risk of emergence of side effects.

Drug contains lactose, patients should mean it with a lactose intolerance.

Drug can influence speed of response at control of motor transport or work with other mechanisms therefore it is necessary to avoid driving, work with mechanisms and other potentially dangerous types of activity.

Side effects:

Drugs of the combined complex are transferred well. Side effects arise seldom.

From a digestive tract and a liver: dryness in a mouth, in isolated cases – dyspepsia, at prolonged use in high doses it is rare – a hepatotoxic action.

From the central nervous system: poorly expressed and quickly passing drowsiness, a headache, fatigue, in certain cases – excitement is possible, it is very rare – a tremor, rigidity, an incoordination, spasms, confusion of consciousness.

Allergic reactions: very seldom – a Quincke's disease, rash on skin, an itch, urticaria.

However drug components Orn_itat can cause such side reactions:

Ornidazol. From a digestive tract and a liver: dryness in a mouth, unpleasant smack in a mouth, a language oblozhennost, disturbance of flavoring feelings, disturbance of hepatic tests, the dyspepsia phenomena: nausea, weight and morbidity in epigastric area, an eructation, a meteorism, diarrhea, appetite loss.

From the central nervous system and peripheral nervous system: drowsiness, a headache, an ataxy, confusion of consciousness, a hyperemia, neuropathy, spasms, muscle tension, a lack of coordination, a temporary loss of consciousness, fatigue, dizziness, symptoms of the touch or mixed peripheral neuropathy, it is rare – excitement, a tremor of extremities.

Allergic reactions: rash on skin, the itch, urticaria, is seldom possible a Quincke's disease.

Others: moderate leukopenia, darkening of color of urine, cardiovascular frustration.

Klaritromitsin. The phenomena with purity of emergence of 1-10% during clinical trials:

From the central nervous system and peripheral nervous system: a headache, change of taste, a spasm, dizziness, loss of flavoring sensitivity, an anosmia, disturbance of flavoring sensitivity (a dysgeusia, a parosmiya, вертиго, confusion of consciousness, a hallucination, uneasiness, sleeplessness, dreadful dreams, a ring in ears, a disorientation, an ageusia, psychosis and depersonalization, a depression, a uveitis.

From a digestive tract and a liver: diarrhea, vomiting, an abdominal pain, dyspepsia, acute pancreatitis, stomatitis, a glossitis, language discoloration, discoloration of teeth, nausea, pseudomembranous colitis, development of hepatic dysfunction ї, including change of indicators of tests of hepatic function, the hepatitis and a cholestasia which was followed or not being followed by jaundice, cholestatic jaundice.

Infections and invasions: candidiasis of an oral cavity.

From system of blood and lymphatic system: leukopenia, thrombocytopenia. Seldom – increase in creatinine in blood serum.

From immune system: anaphylactic reactions, hypersensitivity.

Metabolism disturbances: hypoglycemia.

From a musculoskeletal system and the interfaced fabric: mialgiya, arthralgia.

From an acoustic organ and labyrinth disturbances: a hearing loss (it is recovered after therapy cancellation), dizziness, a sonitus.

Disturbances from skin and hypodermic cellulose: seldom - Stephens-Johnson's syndrome, a toxic epidermal necrolysis, a small tortoiseshell, rash, a Quincke's disease.

From kidneys and urinary system: intersticial nephrite, renal failure development of intersticial nephrite.

From the party of cardiovascular system: ventricular tachycardia and piruetny tachycardia, lengthening of an interval of QT.

Laboratory researches: increase in creatinine in blood serum, increase in activity of liver enzymes.

Rabeprazol. From digestive tract: nausea, feeling of dryness in a mouth, diarrhea, a meteorism, an abdominal pain, vomiting, a lock, anorexia, gastritis, increase in body weight.

From the central and peripheral nervous system: adynamy, headache, dorsodynia, spasms of gastrocnemius muscles, stethalgia, nervousness, drowsiness, depression, dizziness, vision disorder, taste disturbance.

From a musculoskeletal system and the interfaced fabric: mialgiya.

From ENT organs: grippopodobny syndrome, cough, bronchitis, sinusitis, fever, pharyngitis, rhinitis.

Disturbances from skin and hypodermic cellulose: an erythema, a small tortoiseshell an itch, skin rash, the increased perspiration.

From an urinary system: infection of an urinary system.

From system of blood and lymphatic system: leukopenia, leukocytosis, neutropenia, thrombocytopenia.

Laboratory researches: increase in liver enzymes.

Interaction with other medicines:

Use of a rabeprazol with antacids does not bring into combinations to considerable clinical changes in concentration of a rabeprazol in plasma. Causing considerable and long suppression of products of hydrochloric acid, рабепразол can interact with medicines which absorption depends on an indicator рН stomach contents.

Simultaneous use of a rabeprazol with ketokonazoly reduces concentration of the last in a blood plasma by 33%, but increases concentration of digoxin by 22% that demands correction of doses.

Ornidazol can interact with indirect anticoagulants, prolonging effect of bromide. At simultaneous use extends effect of warfarin. Drug does not inhibit an atsetaldegiddegidrogenaza therefore drug is not compatible to alcohol.

Klaritromitsin should not be appointed in parallel with ergotamine or its derivatives through possible provocation of an arterial spasm which can lead to ischemia. Klaritromitsin changes kinetics of carbamazepine and interacts with warfarin, ranitidine or antacids which contain magnesium or aluminum.

Use of erythromycin and klaritromitsin by patients which are in parallel medicated which are metabolized by P450 cytochrome can cause increase in level of these drugs in serum. In this regard it is not necessary to appoint along with klaritromitsiny терфенадин, цизаприд, пімазид, астемизол. Concentration of these drugs in serum has to be controlled strictly.

Parallel use of a triazolam can increase pharmacological effect of ergotamine.

It is necessary to control a prothrombin ratio at patients to whom along with klaritromitsiny appointed other anticoagulants.

Simultaneous use with klaritoromitsiny a zidovudine reduces its adsorption. Simultaneous use of a ritonavir and klaritromitsin leads to essential increase in concentration of a klaritromitsin in blood serum and to considerable reduction in serum of its metabolite – a 14-gidroksiklaritromitsina.

At simultaneous use of a klaritromitsin and colchicine, the second shows toxic effect, especially at elderly people with a renal failure.

Contraindications:

Hypersensitivity to components of drug of a rabeprazol, an ornidazol and a klaritromitsin. Children's age up to 18 years. It is forbidden to apply Ornistat during pregnancy, and also it is necessary to avoid use during feeding by a breast.

For the period of administration of drug feeding by a breast should be stopped.

Ornidazol:
• organic diseases of the central nervous system
• epilepsy, multiple sclerosis
• blood circulation disturbance
• alcoholism

Rabeprazol of sodium:
• heavy renal failure

Klaritromitsin:
• liver diseases

Overdose:

Rabeprazol: there is no experience of overdose of a rabeprazol. Maximum known overdoses – 80 mg. A specific antidote to a rabeprazol the unknown. Sodium рабепразол well contacts proteins of plasma and therefore difficult gives in to dialysis. At overdose it is necessary to carry out the symptomatic and supporting treatment

Ornidazol: nausea, vomiting, anorexia, a disorientation, spasms, a depression, peripheral neuritis - can be observed after use of the exceeded drug dose.

Treatment: symptomatic therapy. There is no specific antidote

Klaritromitsin: nausea, vomiting, diarrhea, abdominal pain.

Overdoses it is necessary to treat a gastric lavage and symptomatic therapy.

Storage conditions:

To store at a temperature not above 25 °C in original packaging and the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

1 blister contains 6 tablets (2 tablets of a rabeprazol of sodium, 2 tablets of an ornidazol, 2 tablets of a klaritromitsin). On 7 blisters in cardboard packaging.