Rabeprazole (Lat. rabeprazole.) - Anti-sized medicine, proton pump inhibitor.

Rabeprazole is an international non-proprietary name (MNN) of the medicinal product. According to the pharmacological pointer, Rabeprazole refers to the group "Proton pump inhibitors". By ATC - to the group "Proton pump inhibitors" and has the code A02BC04. Rabeprazole, in addition, the trade name of the medicine is generic of Russian production.

Rabeprazole - chemical

Rabeprazole is a substituted derivative of benzimidazole: 2 - [[methyl] sulfinyl] benzimidazole. Empirical formula C 18 H 21 N 3 O 3 S. Molecular weight 381.43.

Rabeprazole sodium - white or slightly yellowish-white substance, very well soluble in water and methanol, soluble in ethanol, chloroform and ethyl acetate and non-soluble on air and n-hexane. Weak base. Rabeprazole stability depends on the acidity of the medium - it is rapidly destroyed in moderate acids and is more stable in an alkaline medium.

Indications for the use of Rabeprazole

Contraindications for the use of Rabeprazole

• hypersensitivity to RabnAzolu
• pregnancy
• lactation

Restrictions on the use of Rabeprazole

• heavy liver insufficiency
• childhood
• with long-term or in large doses, receiving Rabeprazole increases the risk of fractures of the thigh, wrists and spine ("FDA warns")

The method of application of Rabbrazole and dose

Tablets Rabeprazole swallow completely not chewing and non-shred. Doses and duration of the application of Rabelrazole depend on the disease:
Time of reception and food do not affect the activity of Rabeprazole, but it is believed that patients are better thanking the prescribed treatment regimen if Rabeprazole is accepted in the morning, half an hour before meals (with a one-time reception per day).

There are studies proving that the separation of the daily dose of Rabeprazole by 2-4 admission per day reduces the acidity of the stomach, but such a fractional reception may be a reverse negative side - a decrease in the adherence to treatment (Evyutin Yu.V.).

Neckless preparations Rabeprazole

In Russia, the following drugs Rabeprazole are admitted to a non-receptible sale: Berth, Noflux, Pariet, Rabita, dosage form Capsules containing 10 mg of Rabeprazole sodium (or Rabeprazole). General rule when receiving non-densite proton pump inhibitors (including Rabeprazole): in the absence of an effect during the first three days, a specialist consultation is needed. The maximum term of treatment with non-receptible proton pump inhibitors without appeal to the doctor - 14 days. The interval between the 14 day courses should be at least 4 months.

Rabeprazole in a decreased compared to the therapeutic dose is allowed for vacation in pharmacies in Australia since 2010, later - in the UK. *

All non-receptible forms are characterized by a reduced content of the active substance and have the purpose "for the treatment of frequent heartburn."

* Boardman H.F., Heeley G. The Selection of the Pharmacist in the Selection and Use of Over-the-Counter Proton-Pump Inhibitors. INT J CLIN PHARM (2015) 37: 709-716. DOI 10.1007 / S11096-015-0150-Z.

Professional medical publications regarding the use of Rabelzole

• Pakhomova I.G. A polymorbid patient with GERD and the pathology of the cardiovascular system receiving antiagregative therapy. The possibility of choosing a proton pump inhibitor on a clinical example. Medical advice. 2019; (14): 10-16.


• Maev I.V., Goncharenko A.Yu., Kucheryavy Yu.A. The effectiveness of monotherapy with omeprazolezole and Rabeprazole in patients with erosive reflux-esophagitis in old age // Clinical perspectives of gastroenterology, hepatology. - 2007. - № 2. - p. 31-36.


• Warrington Steve, Baisley Kathy, Dunn Kate et al. Effects of a single reception of Rabeprazole 20 mg and Ezomeprazole 40 mg on indicators of intragastric 24-hour pH metry in healthy volunteers // EUR J Clin Pharmacol. - 2006. - №62. - from. 685-691.


• Havkin A.I., Rachkov N.S., Zhikhareva N.S., Khanakaeva ZK Prospects for the use of proton pump inhibitors in pediatrics // Russian Medical Journal. - 2003. - Volume 11. - No. 3. - p. 134-138.


• Morozov S.V., Tsodykova OM, Isakov V.A. et al. Comparative efficiency of antisecretory action Rabeprazole and Ezomeprazole in individuals, quickly metabolizing proton pump inhibitors // Experimental and clinical gastroenterology. - 2003. - №6.


• Rudakova A.V. Pharmacoeconomic aspects of the use of Rabelzole and Ezomeprazole in patients with gastroesophageal reflux disease // Consilium-Medicum. - 2006. - Volume 8. - № 2.


• Yastrebkova L.A. Comparative clinical efficacy and safety of Rabeprazole (Pariet) and Ezomeprazole (nonxium) - treatment of acid-dependent diseases of the gastrointestinal tract // Medgazeta. 07.07.2009.


• Abdulganiyev D.I. The variability of the daily pH-metry indicators in patients with a duodenal ulceneous disease after a single reception of Rabeprazole // Rzhggg 2010. No. 6. P. 76-80.


• Marelli S., PACE F. The use of Rabbrazole for the treatment of acid-dependent diseases // Reprint. Expert Review Gastroenterology & Hepatology 6 (4), 423-435 (2012).


• Shulpekova Yu.O. The use of Raboverrazole in the practice of a gastroenterologist // Medical Council. Gastroenterology. № 14. 2016, P. 26-31.


• Kareva E.N. Rabeprazole through the prism "Metabolism - Efficiency" // RMW. 2016. October.


• Starodubtsev A.K., Fedorov S.P., Silver S.Yu. and others. Evaluation of the clinical efficacy of Rabeprazole, depending on the individual type of reception of parietal cells at various acid-dependent samples. Stomach and DPK // Biomedicine. 2010. No. 1. P. 69-77.

The site in the section "Literature" has a subsection "Rabeprazole", containing publications for health professionals, devoted to the treatment of busty Rabeprazole organs.

Pharmacokinetics Rabeprazole

Rabeprazole is quickly absorbed from the small intestine, C Max in the blood plasma is achieved by about 3.5 hours after receiving a dose of 20 mg. C MAX and AUC linearly depend on the Dose of Rabeprazole in the dose range from 10 to 40 mg. Bioavailability after taking inside 20 mg is about 52% mainly due to metabolism at the first passage through the liver. Bioavailability does not change in repeated reception of Rabeprazole. In healthy T1 Rabeprazole from blood plasma is about an hour (40-90 min), and the total clearance - (283 ± 98) ml / min.

Patients S. chronic diseases AUC liver is twice as high as healthy, which indicates a decrease in the metabolism of the first passage, and T½ Rabeprazole from blood plasma is increased by 2-3 times. Food and reception time during the day do not affect the Absorption of Rabeprazole.

The degree of binding of Rabeprazole with plasma proteins is about 97%.

The main metabolites present in the blood plasma are thioether and carboxylic acid. In addition, in small concentrations there are secondary metabolites: sulfon, dememetiltio ester and Mercpturic acid conjugate.

After a single reception of 20 mg of Rabeprazole, labeled carbon isotope 14 C, the removal of Rabeprazole is not observed unchanged with urine. About 90% of Rabeprazole is derived with urine in the form of two metabolites: Mercpturic acid conjugate and carboxylic acid and about 10% - with feces.

After a single reception of 20 mg of Rabeprazole, with close weight of the body and the growth of noticeable differences in pharmacokinetics in men and women are absent.

In patients with stable terminal renal failure, in need of hemodialysis (creatinine clearance - ≤5 ml / min / 1.73 m 2), the distribution of Rabeprazole differs little from the distribution in healthy. AUC and C MAX in such patients are about 35% lower than in healthy. On average, T½ Rabeprazole was 0.82 hours in healthy, 0.95 hours in patients during hemodialysis and 3.6 hours after hemodialysis. Clearance of Rabeprazole in patients with kidney diseases in need of hemodialysis is about 2 times higher than in healthy.

After a single reception of 20 mg of Rabeprazole in patients with chronic liver failure, AUC doubles, and T½ increases by 2-3 times compared to healthy. After receiving Rabeprazole, 20 mg per day for 7 days AUC increases only 1.5 times, and C max is 1.2 times. T1 Rabeprazole in patients with hepatic insufficiency about 12.3 hours compared with 2.1 hours - in healthy. The pharmacodynamic response observed with the help of intragastric pH metry, in both groups is close.

In the elderly patients, Rabeprazole is deducted. After 7 days of reception of Rabeprazole, 20 mg per day in the elderly AUC was about twice as much as the C MAX is increased by 60% compared with young and healthy patients. At the same time, the signs of the accumulation of Rabeprazole are not marked.

In patients with slow metabolism CYP2C19 after 7 days of reception of Rabeprazole in a dose of 20 mg per day AUC increases 1.9 times, and T1 is 1.6 times compared in the same parameters in patients with rapid metabolism, while C Max increases by 40%.

Pharmacodynamics Rabeprazole

Rabeprazole in an acidic medium of chopping cells of the stomach mucosa converts into an active sulfenamide form that interacts with proton pump (H + / K + -ATPhase). Inhibits (partially reversible) proton pump of the shepherd cells and dose-dependent blocks the secretion of hydrochloric acid. The antisecretory effect of Rabeprazole is manifested within an hour after receiving inside the dose of 20 mg. The maximum reduction in the acidity of the stomach occurs 2-4 hours after receiving the first dose. In the first day, the average daily acidity rate is 6% (this is about 88% of the decline in secretion achieved on the 8th day of treatment). The acidity of the stomach is an average of about 3.4 pH; The time during which acidity is saved at a level of more than 3 pH - 55.8%. Partial dissociation of the complex with proton pump causes less than that of irreversible proton pump inhibitors duration of action.

The duration of the inhibition of basal and stimulated secretion reaches two days, a stable antisecretory effect develops in three days of treatment. Cancellation is not accompanied by an acid rickest phenomenon, restoring secretory activity occurs within 2-3 days as the synthesis of new proton pumps. It has antichelicobacter activity: the minimum overwhelming concentration is 4-16 μg / ml. Accelerates the manifestation of the antihelicobacter activity of a number of antibiotics. When carrying out triple eradication therapy (Rabeprazole at 20 mg twice a day with clarithromycin and amoxicillin) 90% eradication Helicobacter pylori. (HP) is achieved within 4 days. HP eradication at the end of the 7-day course of therapy is noted in 100, 95, 90 and 63% of cases in 100, 95, 90 and 63% of cases in combination with clarithromycin + metronidazole, clarithromycin + amoxicillin, amoxicillin + metronidazole or only with claroomycin. In erosive or ulcerative gastroesophageal reflux disease from the first day of treatment (10-20 mg) reduces heartburn. Effective with 8-week treatment of erosive reflux-esophagitis in 84% of patients. It is also effective in pathological hypersecreator states, including Zollinger-Ellison syndrome. In the first 2-8 weeks of long-term admission, the concentration of gastrin in serum is temporarily increasing (with histological examination, an increase in the number of enterochromaffod-like cells, the frequency of the intestinal metaplasia, the colonization of HP) is noted. When taking inside the pills with an acid-resistant intestinal shell, absorption begins in the small intestine) and is carried out quickly and completely. Absolute bioavailability - 52% (the pronounced effect of the "first passage" through the liver). Food and reception time Rabeprazole do not change bioavailability. C MAX is achieved within 2-5 hours (on average 3.5 hours) after receiving at a dose of 20 mg. There is a linear dependence of the values \u200b\u200bof C Max and AUC from a dose in the range from 10 to 40 mg. T½ is 0.7-1.5 hours; Total clearance - 283 ml / min. Against the background of hepatic cell insufficiency, the effect of the "first passage" through the liver is not expressed, the AUC is increased by 2 times (after one-time reception) and 1.5 times (after 7 days of therapy), T1 reaches 12.3 hours. Rabeprazole is metabolized in the liver with the participation of the isoenzymes of the cytochrome R450 CYP2C19 and CYP3A4 system to form inactive metabolites and dememethythyl ether, which has a weak antisecretory activity. In the case of slow motion biotransformation after 7 days of reception at a dose of 20 mg / day T1 reaches 1-2 hours (on average 1.6 hours), C MAX increases by 40%. It is removed mainly with urine in the form of conjugates of mercapturic and carboxylic acids. In the elderly, Biotransformation of Rabeprazole slows down, C MAX rises by 60%, AUC - 2 times. Even at the stage of terminal renal failure in patients with dialysis, pharmacokinetic parameters are changed slightly - C Max and AUC decrease by 35%, T1 during hemodialysis is 0.95 hours, after 3.6 hours.

Application of Rabeprazole during pregnancy and breastfeeding

Risk Category for FDA when taking Rabeprazole Pregnant - C * (animal research revealed a negative effect of drugs on the fetus, and proper research in pregnant women did not have, but the potential benefits associated with the use of this medicine in pregnant women can justify its use, Despite the risk).

At the time of treatment, breastfeeding should be stopped.

Note. * Earlier, before changing the 2014 year, Rabeprazole had a category B.

Side effects Rabeprazole

• digestive system: diarrhea, nausea; less often - vomiting, abdominal pain, meteorism, constipation; rarely - dry mouth, belching, dyspepsia; In isolated cases - violation of taste sensations, anorexia, stomatitis, gastritis, increasing transaminase activity
• nervous system and sense organs: headache; less often - dizziness, asthenia, insomnia; very rarely - nervousness, drowsiness; In some cases, depression, impairment of vision
• musculoskeletal system: rarely - Malgy; very rarely - arthralgia, seizures of calf muscles
• respiratory organs: rarely - inflammation or upper infection respiratory tract, coughing; very rarely - sinusitis, bronchitis
• allergic manifestations: rarely - rash, skin itch
• other: rarely - pain in the back, chest, limbs, swelling, urinary tract infection, fever, chills, influencing syndrome; In isolated cases - increased sweating, increase in body weight, leukocytosis

Rabeprazolet interaction with other drugs

Rabeprazole reduces the concentration of ketoconazole in plasma by 33%, increases the concentration of digoxin by 22%. Does not interact with liquid antacids. Rabeprazole is compatible with drugs, metabolizing R450 system, such as warfarin, phenytoin, theophylline and diazepam.

If it is necessary to simultaneously receive inhibitors of proton pump and clopidogrel, the American Heart Association, instead of Rabeprazole, recommends the reception of Pantoprazole (Bordin D.S.). However, recently there were publications that argue that it was Rabeprazole that it should be a drug of choice among other IPSs in the joint admission of clopidogrel and IPP (Pakhomov I.G.).

Overdose Rabeprazole

Symptoms of overdose of Rabeprazole are not known. With suspected overdose, the slavement is recommended supporting and symptomatic therapy. Dialysis is ineffective.

Precautions for therapy Rabeprazole

Before starting treatment, Rabelzolez must eliminate the malignant neoplasm of the stomach, since the symptomatic improvement in the reception of Rabeprazole may difficult timely diagnosis. It is recommended to be careful when I first appoint Rabelrazole patients with severe liver function disorders. In the event of drowsiness, it should be abandoned from driving a car and other similar activities. Patients simultaneously with Rabelrazole receiving ketoconazole or digoxin require additional observation, as it may be necessary to adjust the dose of these drugs.

Comparison of Rabeprazole with other proton pump inhibitors

In the Russian market, Rabeprazole is sold in the original version under the trademark "Pariet". Being one of the most modern drugsLowering the acidity of the stomach, Pariet differs from other antisecretory drugs with a high price. Russian gastroenterologists have no consensus with respect to the unique properties and economic efficiency of the use of pariet. These issues are considered in more detail in the article " Pariet "In the" Comparison of Parieties with other proton pump inhibitors. "

Slide from the report S.Yu. Silver "Original IPPs and generics: modern problems Recognition Estimates »At the Food Conference - 2015

Drugs with the existing substance Rabeprazole

In Russia, the following drugs with the operating substance Rabeprazole are registered for sale in pharmacies: In Kazakhstan - Rabimak 10 and Rabibeak 20, in Ukraine - Rabimak (Ukr. Rabymak), as well as Rabelock (Ukr. Slave) made by Cadila Pharmaceuticals, Ltd., India. In addition, in the pharmaceutical markets of countries - the former republics of the USSR there are a number of other drugs that are not registered in Russia with the active substance Rabeprazole, in particular: Barol-20 (Themis Laboratories Pvt. Ltd., India), geerdine - powder for the preparation of injection solutions And Pharmaceuticals, India and Mili Healthcare Ltd, United Kingdom), Rabaset (Med-Interplast, India), Rabeprazole-Health (Ukraine), Ramp 20 (Bayojenix Limited, India) and others.

In addition, specifically for eradication Helicobacter pylori. combined drugs containing preparations corresponding to one of the eradication schemes are available. An example of such a medicine presented in the Ukrainian market is an ornistite containing Rabeprazole and two antibiotics: Clarithromycin and Ornisadol.

Optical Isomer Rabeprazole, Dekrabeprazole, from 2015 included in ATX and is assigned to the A02BC07 code.

D.M. D.S. Bordin presents the results of the daily pH monitoring of the patient before and after the parenteral administration of Rabeprazole (40th Scientific Session of the Central Committee of Gastroenterology)

Rabeprazole has contraindications, side effects and features of application, consultation with a specialist is needed.

Rabeprazole-C3 - effective domestic drug For the treatment of acid-forming diseases digestive system. Available for use in complex therapy Alcohol addiction.

Rabeprazole-C3 is an effective domestic drug for the treatment of acid-forming diseases of the digestive system.

International non-proprietary title

Rabeprazole

ATH and registration number

Pharmacotherapeutic group Rabeprazole C3

Proton pump inhibitors. Funds lowering the secretion of the glands of the stomach.

Rabeprazole C3 action mechanism

Reduces excessive secretion of the gastric glands, the angry enzyme of the shepherd cells. Interacts with the cystic proton pump. The decrease in the basal, stimulated producing hydrochloric acid does not depend on the genesis of irritants.

Communication with the enzyme carrying hydrogen ions contributes to the inhibition of the final stage of the secretion of hydrochloric acid.

The high selective ability is due to the action of the drug only in the acidic area of \u200b\u200bthe stomach. Reduces the average daily acidity rate of 60% on the first day of use. The maximum decrease is achieved after 3 hours.

Does not cause cancellation syndrome. It has a cytoprotective effect.

The beginning of action is marked after 1 hour after reception. The antisecretory effect is preserved up to 48 hours at a fairly high level.

The suppression of the secretion of the gastric glands causes an increase in the concentration of gastroph. The effect is reversible.
Due to acid resistant shell, quickly dissolves in thin intestines. Plasma proteins are connected by 97%. Absorption does not depend on food and reception time.

Rabeprazole-SZ is the only remedy that has an extrahepatic path of metabolism. This feature does not require dose adjustments when functional disorders Liver.

The kidneys remove a 90% of the drug in the form of inactive metabolites.

Reduces the damaging effect of gastric content and exposure time in the esophagus.
Shows an antihelicobacter effect. Creates optimal conditions for eradication therapy.

Enhances the action antibacterial drugs Due to the stabilization of acidity and increasing the concentration of substances into the gastric mucosa.

The action on vacuoles of osteoblasts is proved, which affects the mineral density of bone tissue.

Composition and form of release

Produced in solid, gelatin, intestinal-soluble capsules. The contents of the capsules constitute the microspheres of a spherical shape.

In the core pellets, Rabeprazole sodium is concluded, which is a valid substance. Additional components are located in the capsule housing. The content of each is indicated in the instructions for use.

Capsules for the appropriate dose of the active ingredient have a characteristic color:

• 10 mg is produced in capsules with a white housing and a dark red lid;
• 20 mg is contained in yellow capsules, a brown lid.

Available in a cardboard pack of 14 and 28 capsules for each dosage.

From which RabnAzol C3 helps

The proton pump inhibitor is used in the treatment of acid-forming diseases of the digestive tract.

Proved its effectiveness in the treatment:

• ulcer of stomach;
• peptic, stress ulcers;
• reflux Ezophagitis different shapes and stages;
• ugone dyspepsia;
• gastroesophageal disease;
• states of pathological secretion;
• eradication Helicobacter Pilori in a complex with antibiotics;
• peptic disease duodenal gut;
• zollinger-Ellison syndrome.

Used B. complex treatment Chronic alcoholic gastritis, exacerbations of pancreatitis, ugly dyspepsia. It is permissible to use the drug with compensatory liver alcoholic cirrhosis.

It is used in cardiological practice in the treatment of acute coronary syndrome.

Contraindications

The use of drug is contraindicated:

• children under 18;
• in the presence of hypersensitivity to the components of the drug;
• pregnancy and breastfeeding;
• oncological diseases of the digestive tract;
• fructose intolerance, galactose failure.

With severe hepatic and renal failure, apply with caution. It is impossible to make joint admission with alcohol.

Method of application and dosage

Capsules are designed for oral administration. Swallow not chewing, drink with a small amount of water. The action of the drug does not depend on the meal, the time of day.

For therapy of ulcerative disease, 10 mg or 20 mg of substance is prescribed for one reception. The course of treatment is from 4 to 6 weeks.

It is possible to extend the term of treatment at the discretion of the doctor, after an additional examination.

Gastroesophageal reflux disease requires a longer course of therapy. Take in the same doses, not less than 8 weeks. Increase the terms of therapy is possible only by appointment of a doctor.

For eradication, Helicobacter Pilori is accepted according to the scheme together with antibiotics. Treatment lasts up to 7 days.

Hyperscecretory states require the use of large doses. Start with 60 mg per day, gradually increasing the dose of up to 100 mg at the reception. Treatment is long.

special instructions

Rabeprazole-SZ is not used for therapy on demand. You can not combine reception with alcohol. It has an increased load on the hepatobiliary system.

Alcoholic drinks of any fortress increase the risk of developing side effects, reduce the efficiency of the drug.

In integrated therapy of acid-forming diseases with alcoholism, it is necessary to control the functions of hepatic enzymes. The reduced enzymatic liver activity requires the appointment of minimum doses.

The effect of hydrochloric acid inhibitor can hide the symptoms of oncological pathology, making it difficult to form an accurate diagnosis.

Joint reception with dimensions derivatives requires revision of doses.

During pregnancy and lactation

Pregnant women are not prescribed. There are no proven data. The need to treat after childbirth requires breastfeeding.

In childhood

It is considered safe and effective for the treatment of gastroesophageal reflux disease in children from 12 years. The term of treatment should not exceed 8 weeks. In other cases, not used.

In old age

For the senior age groups, there is no need to change the therapeutic doses of the medication.

In the treatment of alcoholic chronic gastritis, it is necessary to control the level of acidity, eliminate the use of alcoholic beverages.

The elimination of active ingredients by the kidney slows down, but the cumulative effect is not marked. Not used with decomposed liver alcoholic cirrhots. Assign should be prescribed for a short period.

When violations of the liver function

In the treatment of alcohol addiction, it is necessary to take into account the change in the level of hepatic enzymes, the severity of the state. IN initial stages Alcoholism is permissible to use therapeutic doses short course.

With violations of the kidney function

Average therapeutic doses are used. Careful destination requires a severe degree of renal failure.

Side effects

When using the drug, the development of adverse reactions is possible. There are rarely found. Depend on compliance with the rules of admission, the duration of the therapy.

Adverse reactions from the digestive tract are manifested by dyspecical phenomena, hypospalivation, signs of stomatitis.

There is an increase in the concentration in the blood plasma of hepatic transaminases.

In persons suffering from alcoholism, side effects develop on the background of polyorgan deficiency. There are dizziness, drowsiness, sleep disorders. Violations of violation are possible, a change in taste.

The active ingredient affects hemopoies. The development of thrombocytopenia, leukopenia is noted.

The respiratory system responds to the development of inflammatory diseases of the nose, pharynx. The appearance of cough is possible. The occurrence of skin rashes indicates the development of an allergic reaction to the medication.

It has an impact on the development of osteoporosis, an increase in the risk of bone fractures. The use of Rabeprazole-SZ can cause pain in the muscles, back, hyperhydrosis, feverish state.

From the side of the urinary system, infection is possible urinary tract, interstitial jade.

Together with alcohol, enhances the manifestation of side effects, weights the course of the disease, lengthens the periods of rehabilitation.

Impact on the management of the vehicle

The development of weakness, drowsiness, visual disorders serves as a reason to refuse to manage transport, carrying out work related to increased concentration of attention.

Overdose

The drug is not cumulated in the body. Overdose is rare. No specific antidote. Hemodialysis is not used.

Symptomatic therapy is carried out, maintaining the normal life of the body.

Medicinal interaction

For proper dosing, the achievements of clinical results it is necessary to take into account the interaction of drugs. Joint reception of medicines, the absorption of which depends on the level of acidity, can affect the bioavailability of substances, weaken or enhance their action.

The absorption of drug derivatives increases by 30% when admission. The bioavailability of the antifungal drug of ketoconazole is reduced.

If it is not possible to avoid such a combination of medicines, it is necessary to monitor the state, control the content of serum substances. In some cases, the joint acceptance cannot be recommended.

There are a number of drugs whose metabolism is provided by the cytochrome system. The use of warfarin, diazepam, theophylline with anti-sized means is permissible.

Interaction with antacid substances also did not reveal clinical significance. Sharing Does not cause side effects, does not reduce the effectiveness of medicines of different groups.

Compatible with alcohol

Alcohol changes the morphological structure of the gastric mucosa, prevents regeneration, causes edema and hyperemia, which contributes to the development of erosion and ulcers.

The enzyme liver system is activated, changing the metabolism and the effect of the drug.

The decay of alcohol slows down, enhanced it toxic action. The development of unpredictable adverse reactions is possible. To allow for joint use with alcohol is impossible.

Conditions of vacation from pharmacies

Released in the specified dosage by the doctor's prescription.

Price

The price of Rabeprazole-SZ for a dosage of 10 mg is ranging from 121 to 202 rubles per pack. The price of a capsule with a dosage of 20 mg varies from 165 to 328 rubles.

Storage conditions

In a dark, dry, inaccessible place for children.
Storage temperature should not exceed + 25̊ C.

Shelf life

3 years from the date of release.

Manufacturer

CJSC North Star. Russia.

Analogs

Anti-sized preparations containing active substance Rabeprazole, possess a similar pharmacological action.

Analogue Rabeprazole C3 - Parietian Preparation.

We are produced by different manufacturers in the form of tablets covered with an intestinal-soluble shell:

• Pariet;
• Zulbex;
• Hailaise;
• Differently;
• Controls;
• Nalpaza.

The active in the drugs in the drugs and nolpase is Pantoprazole. Between themselves are distinguished by bioavailability, chemical structure, pharmacokinetics, the onset of clinical remission, price.

What is the difference from ordinary Rabeprazole

Rabeprazole-SZ form of release, which allows you to achieve the highest possible effect.
Convenient and safe to use. It guarantees early, persistent clinical result. The best tolerance and the minimum risk of developing adverse reactions. Allowed for long-term reception and supporting therapy. Provides long-term remission.

Rabeprazole Sodium (Rabeprazole)

Composition and form of release of the drug

Tablets covered with intestinal-soluble shell From light yellow to yellow, round, dual-binding.

Auxiliary substances: magnesium oxide, hypronzes (hydroxypropylcellulose), hypimloles, sodium stearil fumarate.

Composition of a tablet shell 1:oddraya colorless 03k19229 (hypimosellos, triacenetin, talc), magnesium oxide.
Tablet shell composition 2: Schuraliz colorless E-7-19040 (ethyl cellulose, ammonium hydroxide, medium-chain triglycerides, oleic acid).
Tablet shell composition 3: Acrylic II yellow 493Z220000 (methacrylic acid and ethyl acrylate copolymer (1: 1), talc, titanium dioxide, halfsamer 407, calcium silicate, sodium lauryl sulfate, yellow oxide dye).

7 pcs. - Packaging cell contour (1) - packs cardboard.
7 pcs. - Packaging cell contour (2) - packs cardboard.
7 pcs. - Packaging cell contour (4) - packs cardboard.
7 pcs. - Packaging cell contour (8) - packs cardboard.
10 pieces. - Packaging cell contour (1) - packs cardboard.
10 pieces. - Packaging cell contour (2) - packs cardboard.
10 pieces. - Packaging cell contour (3) - packs cardboard.
10 pieces. - Packaging cell contour (5) - packs cardboard.
10 pieces. - Packaging cell contour (6) - packs cardboard.
10 pieces. - Packaging cell contour (9) - packs cardboard.
10 pieces. - Packaging cell contour (10) - packs cardboard.
14 pcs. - Packaging cell contour (1) - packs cardboard.
14 pcs. - Packaging cell contour (2) - packs cardboard.
14 pcs. - Packaging cell contour (4) - packs cardboard.
14 pcs. - Banks (1) - Cardboard packs.
28 pcs. - Banks (1) - Cardboard packs.
30 pcs. - Banks (1) - Cardboard packs.
60 pcs. - Banks (1) - Cardboard packs.

pharmachologic effect

Anti-sized, inhibitor H + -K + -atf-Aza (proton pump). The mechanism of action is associated with the oppression of the enzyme H + -K + -atf-Ase in the stomach parietal cells, which leads to blocking the final stage of the formation of hydrochloric acid. This action is dose-dependent and leads to the oppression of both basal and stimulated secretion of hydrochloric acid, regardless of the nature of the stimulus.

Pharmacokinetics

After receiving inside, absorbed from the gastrointestinal tract. At a dose of 20 mg C MAX is achieved through 3.5 hours. Changes C Max and AUC are linear in nature (in the dose range from 10 to 40 mg). Absolute bioavailability is about 52% due to the effect of the "first passage" through the liver. Biogeneity of Rabeprazole does not increase with repeated reception.

Meal and reception time during the day do not affect the Absorption of Rabeprazole.

Binding with proteins is 97%.

Rabeprazole Sodium is subjected to the effect of the "first passage". Metabolized in the liver with the participation of the isoenzymes of the CYP system.

The main metabolites (thioether and carboxylic acid) and secondary metabolites (sulfon, dimethylthioether and meringicopuric acid conjugate) are present at low concentrations.

In healthy volunteers t 1/2 is about 1 h, the overall clearance - about 283 approximately 90% is excreted in the urine mainly in the form of two metabolites: the conjugate of mercaptopuric acid and carboxylic acid. In toxicological studies, laboratory animals have found 2 more unidentified metabolite. The rest is removed with the feces.

In patients with a stable terminal stage of chronic renal failure, in need of hemodialysis (QC less than 5 ml / min / 1.73 m 2) AUC and C Max were 35% lower than in healthy volunteers. On average, T 1/2 Rabeprazole was 0.82 hours in healthy volunteers, 0.95 hours - in patients during hemodialysis and 3.6 h - after hemodialysis. In kidney diseases, the clearance of Rabeprazole, in patients in hemodialysis was approximately 2 times higher than in healthy volunteers.

In patients with chronic hepatic insufficiency weak or middle degree After a single reception of Rabeprazole, an increase C Max, T 1/2, AUC was observed.

In the case of a delayed metabolism of CYP2C19 after receiving Rabeprazole, 20 mg / day for 7 days AUC and T 1/2 was 1.9 and 1.6, respectively, with extensive metabolism, while C Max increased by only 40%.

In elderly patients, Rabeprazole is somewhat slowed down.

Indications

Ulcerative ulcer of the stomach and duodenal intestine in the aggravation phase; Ulcery disease of the stomach and duodenalist associated with Helicobacter pylori. (in combination with antibiotics); Gastroesophageal reflux.

Contraindications

Pregnancy, lactation period (breastfeeding), increased sensitivity to slave sodium or substituted benzimidazoles.

Dosage

Take inside. Motherwise dose - 10-20 mg. The frequency and duration of use depend on the testimony and treatment regimen.

Side effects

From the digestive system: diarrhea, nausea, vomiting, meteorism, constipation; rarely - dry mouth, dyspepsia, belching; In isolated cases, anorexia, gastritis, stomatitis, increasing the activity of hepatic transaminases.

From the CNS and peripheral nervous system: Headache, asthenia, dizziness, insomnia; rarely - nervousness, drowsiness; In isolated cases, depression, violations of vision and taste sensations.

From the respiratory system: Possible - rhinitis, pharyngitis, cough; Rarely - sinusitis, bronchitis.

Allergic reactions: rarely - skin rash; In isolated cases - itching.

Others: back pain, influenza-like syndrome; rarely - Malgia, chest pain, chills, seizures of calf muscles, urinary tract infection, arthralgia, fever; In isolated cases, an increase in body weight, strengthening of sweating, leukocytosis.

Medicinal interaction

With simultaneous use with possible increase (from a small to moderate) concentration of digoxin in blood plasma.

With simultaneous use with ketoconazole, its bioavailability decreases.

special instructions

Before starting therapy, it is necessary to exclude malignant neoplasms of the stomach, because The use of Rabelrazole can mask symptoms and delay the correct diagnostics.

Patients with violations of the liver or kidney function of the dose correction is not required, however, in patients with severe violations of the liver function, Rabeprazole is recommended to be used with caution.

With simultaneous use with Rabelrazole, doses and digoxin should be adjusted.

IN experimental studies The carcinogenic action of Rabeprazole is not established, but when studying mutaging, ambiguous results were obtained. Tests on lymphoma cells in mice were positive, with a micronuclear test in vivo and the DNA Recovery Test in Vivo and In Vitro were negative.

Patients with violations of the dose correction liver disorders are not required, but in patients with severe liver disorders, Rabeprazole is recommended to be used with caution.

Content

Tablets Rabeprazole

This drug is intended for people suffering from diseases of the gastrointestinal diseases. He has a large number of analogues, so you need to consult with a doctor who clarifies what specifically the patient is suitable. The drug has an impressive range of side effects and contraindications, so before use you need to weigh all the factors in order not to harm yourself.

Structure

One tablet tools comprises:

Name of substance		Number in mg.
Rabeprazole Sodium
Mannitol
Magnesium oxide
Hyprolasa weakly-dressing
Hypoloza
Magnesium Stearat
Ethylcellulose
Halgonellosa phthalate
Diacetylated monoglyceride
Titanium dioxide
Iron oxide red
Karnubskaya wax

Pharmacodynamics and pharmacokinetics

Tablet Rabeprazole affects the enzyme H + -K + -atf-basic, produced in the parietal cells of the esophagus. He acts as a proton pump inhibitor. The resulting compound blocks the formation of hydrochloric acid at the final stage and lowers the level of stimulation of secretion, regardless of the type of stimulus. After receiving 20 mg, the preparation is completely absorbed after 3.5-4 hours. Taking time does not affect the bioavailability of the main connection and its absorption properties.

Indications for use

The drug is prescribed if the patient diagnosed the following diseases:

• Duodenal ulcer.
• Recognition of ulcerative disease provoked by the Bacteria Helicobacter Pylory (Helicobacter Pylory).
• Pathological hypersecretion.
• Gastritis (Helicobacter Pylorus Eradication), including chronic gastritis (using antibacterial drugs).
• Gastroesophageal reflux disease.
• Syndrome Zlinger Ellison.
• Ulcer stomach.

Instructions for the use of Rabeprazole

Capsules with the active substance must be used inside. Taking time does not affect anything, as well as eating before or after. The dosage of the drug and the frequency of use is completely dependent on the severity of the disease, the instructions of the specialist. Initial dose for patients with standard disease symptoms - 10 or 20 mg times per day. Treatment lasts two months (6 weeks). If the proper effect did not follow - the treatment is extended to the same.

special instructions

Presence should be deleted malignant formations The gastrointestinal tract, since the drug is characterized by the property of masking symptoms of oncology, which will complicate the diagnosis and timely detection of oncological diseases. With violations of the liver functions, the drug should be taken very carefully. Change the dosage of digoxin and ketonazole, the drug Rabeprazole does not allow them to be used as standard dosage. If your work requires a high concentration of attention or you drive transport - eliminate these actions if the drug causes drowsiness or fatigue.

During pregnancy

Official data on whether it is possible to apply the drug during pregnancy, no. Animal research did not show problems with the development of the fetus, but rats a small dose overcame the placental barrier, so the use during pregnancy should be carried out strictly under the control of the doctor. A similar situation with lactation: the drug enters milk, so during lactation it should not be used.

In childhood

It is forbidden to 18 years. The exception is GERD (gastroesophageal reflux disease) in children from 12 years. Studies have not proven absolute efficacy and safety for children with GERD. Efficiency for children who take the drug for other reasons, the research does not indicate, but the recommended dose that doctors are prescribed - 20 mg once a day for eight weeks.

Medicinal interaction

The main active ingredient absolutely does not interact with the antacids (type of drugs used to combat acid-dependent gastrointestinal diseases), but can affect the saturation of the blood plasma by ketoconazole or digoxin. For parallel use, diazepams, phenytoin, warfarin or theophylline are fully suitable. As a last resort, the drug can be used together with the proton pump inhibitor Pantoprazole. If in the list of assigned specified this drug, check with a dosage doctor.

Rabeprazole and alcohol

Alcohol use is strictly prohibited. Double liver load can aggravate the condition. The risk of occurrence of side effects will increase. Even excluding the drug itself, alcohol is invalid during the period of peptic diseases and leads to exacerbations. The use of beer is also banned.

Side effects and overdose

The use of the drug may cause disorders of the gastrointestinal tract, musculoskeletal system, nervous and respiratory systems. Among side effects:

• Allergic reaction, rash.
• Diarrhea.
• Reduced appetite, flatulence.
• Stomatitis, increasing the activity of hepatic transaminases.
• Vomiting and nausea, dry mucosa, constipation.
• Fever.
• Dizziness, asthenia.
• Influencing syndrome.
• Drowsiness, thrombocytopenia.
• Violation of vision, taste receptors.
• Leukopenia, headache.
• High fatigue.
• Back pain.
• Cramps, arthralgia, Malgy.
• Sinusitis, cough, pharyngitis, rhinitis.
• Stevenson-Jones syndrome.

Contraindications

It is strictly forbidden to take the drug during pregnancy or lactation. It is impossible to use in individual intolerance or hypersensitivity to certain components of the drug (Barpazole or substituted benzimidazole). Do not use with sugar deficiency, fructose intolerance or glucose-galactose failure. If you have severe renal or liver failure, the drug is also contraindicated.

Terms for sale and storage

The drug is stored as room temperature (not higher than 25 degrees Celsius), should be protected from moisture and direct ingress of sunlight. At the end of the shelf life is prohibited.

Analogs

Analogs of Rabeprazole is a wide range of drugs. The cost of analogs exceeds the cost of the original twice, if not more. From major competitors (in chemical composition The main active ingredient is not indicated):

• Omeprazole. Manufacturer - Ukraine, Russia, Israel, Hungary. The composition is almost identical. Release form - 20 mg capsules. The average cost - from 28 rubles per pack.
• Noflux. Manufacturer - Hungary. Composition - magnesium oxide, mannitol, etc. Release form - Tablets at 10, 20 mg. The average cost - from 828 to 1296 rubles per pack.
• Highurezol. Manufacturer - India. The composition is magnesium oxide, mannitol, corn crumbmal. Release form - Tablets at 10, 20 mg. The average cost - from 368 rubles.
• Zulbex. Manufacturer - Slovenia. The composition is mannitol, magnesium oxide, hypolosis. Release form - Tablets at 10, 20 mg. The average cost - 315 rubles.
• Ontym. Manufacturer - "Teva", Russia. The composition is low-substituted hypolosis, magnesium oxide, mannitol. Release form - Tablets at 10, 20 mg. The average cost - from 577 rubles.

Pills.ru.

Rabeprazole-SZ Capsules intestinal-soluble 10 mg 14 pcs.

Rabeprazole-SZ Capsules intestinal-soluble 20 mg 14 pcs.

Eaktec.ru.

Parity tablets 20 mg 14 pcs.

Aptekamos.ru.

Tablets 10 mg

Beret pills 20 mg

Dosage form: & nbspTO apsula intestines-soluble. Structure:

1 capsule contains:

Active substance :

rabeprazole Pellets - 118 mg, 236 mg

in terms of Rabeprazole Sodium - 10 mg, 20 mg

[core Pellet: Rabeprazole sodium - 10.00 mg, 20.00 mg, sugar (sucrose, starchy) - 71.47 mg, 142.94 mg, sodium carbonate - 1.65 mg, 3.30 mg, talc - 1.77 mg, 3.54 mg, titanium dioxide - 0.83 mg, 1.66 mg, hypimosellos (hydroxymethyl cellulose) - 14.75 mg, 29.50 mg;

shell pellets: Hyprocellosis of phthalate (hydroxypropylmethyl phthalate cellulose) - 15.93 mg, 31.86 mg, Cetyl alcohol - 1.60 mg, 3.20 mg].

Excipients :

Capsules solid gelatin number 3 (dosage 10 mg):

case:titanium dioxide - 2.0%, gelatin - up to 100%;

lion: Azorubin dye (carmicine dye) - 0.6619%, indigocarmin - 0.0286%, titanium dioxide - 0.6666%, gelatin - up to 100%.

Capsules solid gelatin No. 1 (dosage 20 mg):

case: Titanium dioxide - 1.0%, iron oxide yellow - 0.192% gelatin - up to 100%;

lion: Iron oxide black - 0.53%, iron oxide - 0.93%, titanium dioxide - 0.3333%, iron oxide yellow - 0.20%, gelatin - up to 100%.

Description:

Solid gelatin capsules No. 3, white housing with a dark red lid (for a dosage of 10 mg); Solid gelatin capsules No. 1, yellow body with brown lid (for dosage 20 mg).

The contents of the capsules are spherical pellets from almost white to white with a creamy or yellowish colors.

Pharmacotherapeutic Group:gastric glands secretion lower remedy - proton pump inhibitor ATH: & NBSP

A.02.b.c. Protonic pump inhibitors

A.02.b.c.04 Rabeprazole

Pharmacodynamics:

Rabeprazole refers to the class of antisecretory substances, benzimidazole derivatives. Suppresses the secretion of the gastric juice by the specific inhibition of H + / K + -TF-Ase on the secretory surface of the stomach parietal cells. Blocks the final stage of the secretion of hydrochloric acid, reducing the content of basal and stimulated secretion, regardless of the nature of the stimulus.

Possessing high lipophilicity easily penetrates into parietal stomach cells, concentrates in them, having a cytoprotective effect and increasing the secretion of bicarbonate.

Antisecretory action after oral administration 20 mg of Rabeprazole, it occurs within 1 hour and reaches a maximum in 2-4 hours; The inhibition of basal and stimulated food secretion of acid 23 hours after receiving the first dose is 62 and 82%, respectively, and lasts up to 48 hours. With the termination of admission, secretory activity is restored within 1-2 days.

During the first 2-8 weeks of Rabeprazole therapy, the gas plasma concentration in the blood plasma increases, (which is a reflection of the inhibitory effect on the secretion of hydrochloric acid) and returns to the initial levels 1-2 weeks after its cancellation.

Rabeprazole does not have anticholinergic properties, does not affect the central nervous system (CNS), cardiovascular and respiratory system.

Against the background of receiving Rabeprazole, stable changes in the morphological structure of enterochromafine-like cells, into the degree of gastritis severity, in the frequency of atrophic gastritis, intestinal metaplasia or the distribution of infection Helicobacter pylori.not detected.

Pharmacokinetics:

Absorption

Rabeprazole is quickly absorbed from the intestine, and its maximum plasma concentrations are achieved by about 3.5 hours after receiving a dose of 20 mg. The change in the maximum concentrations in the plasma (with M ah) and the values \u200b\u200bof the area under the concentration-time curve (AUC) Rabeprazole are linear in the dose range from 10 to 40 mg. Absolute bioavailability after oral administration 20 mg (compared to intravenous administration) It is about 52%. In addition, bioavailability does not change in repeated reception of Rabeprazole. In healthy volunteers, the half-life of plasma is about 1 h (varying from 0.7 to 1.5 h), and the total clearance is 3.8 ml / min / kg.

In patients with chronic lesion, AUC liver is doubled compared to healthy volunteers, which indicates a decrease in the metabolism of the first passage, and the half-life of plasma is increased by 2-3 times.

Not the time of receiving the drug during the day or antacids do not affect the Absorption of Rabeprazole. Reception of the drug with fatty food slows down the Absorption of Rabeprazole for 4 hours or more, but neither Mach nor the degree of absorption changes.

Distribution

In person, the degree of binding of Rabeprazole with plasma proteins is about 97%.

Metabolism and elimination

W. healthy people

After receiving a single oral dose of 20 mg of 14 C-labeled Rabeprazole, there was no unchanged drug in the urine. About 90% of Rabeprazole is derived from urine mainly in the form of two metabolites: Mercpturic acid conjugate (M5) and carboxylic acid (M6), as well as in the form of two unknown metabolites identified during toxicological analysis.

The remaining part of the received Rabeprazole is derived from the feces.

The total removal is 99.8%. These data indicate a small excavation of Rabelrazole metabolites with biliary. The main metabolite is thioether (M1). The only active metabolite is desmetic (M3), but it was observed in a low concentration of only one participant in the study after receiving 80 mg of Rabeprazole.

Terminal Stage of Renal Insufficiency

In patients with stable renal failure in the terminal stage, which requires supporting hemodialysis (creatinine clearance< 5 мл/мин/1,73м 2), выведение рабепразола схоже с таковым для здоровых добровольцев. AUC и С m ах у этих пациентов были примерно на 35% ниже, чем у здоровых добровольцев. В среднем период полувыведения рабепразола составлял 0,82 ч у здоровых добровольцев, 0,95 ч у пациентов во время гемодиализа и 3,6 ч после гемодиализа. Клиренс препарата у пациентов с заболеваниями почек, нуждающихся в гемодиализе, был приблизительно в два раза выше, чем у здоровых добровольцев.

Chronic compensated cirrhosis

Patients with chronic compensated liver cirrhosis are transferred at a dose of 20 mg 1 time per day, although AUC doubled and with M AH increased by 50% compared with healthy proper volunteers.

Elderly patients

In the elderly patients, Rabeprazole elimination is somewhat slowed. After 7 days of reception of Rabeprazole, 20 mg per day in the elderly, AUC was roughly twice as much as the M AH is elevated by 60% compared with young healthy volunteers. However, the signs of Cumulation Rabeprazole was not noted.

CYP 2C 19 polymorphism

In patients with slow metabolism CYP 2C 19 after 7 days of reception of Rabeprazole in a dose of 20 mg per day AUC increases 1.9 times, and the half-life is 1.6 times compared to the same parameters from "fast metabolizers" at that time As with M ah increases by 40%.

Indications:

Ulcerative ulcer of the stomach in the stage of exacerbation and anastomosis ulcer;

Ulcent duodenal disease in the aggravation stage;

Erosive and ulcerative gastroesophageal reflux disease (GERD) - adults and children from 12 years or reflux-esophagitis;

Supporting therapy of gastroesophageal reflux disease;

Non-erosive gastroesophageal reflux disease;

Zolinger Ellison syndrome and other states characterized by pathological hypersecretion;

In combination with appropriate antibacterial therapy for eradication Helicobacter.pylori. in patients with ulcerative disease.

Contraindications:

Hypersensitivity to Rabnazole, substituted benzimidazoles or to the auxiliary components of the drug;

Sakaraz / isomaltase deficiency, fructose intolerance, glucose-galactose failure;

Pregnancy;

Breastfeeding period;

Children's age up to 18 years old, with the exception of GERD (children under 12 years old).

Carefully:

Severe renal failure;

Heavy liver failure.

Pregnancy and lactation:

There is no data on the safety of the application of Rabeprazole during pregnancy.

Reproductive research on rats and rabbits did not reveal signs of disruption of fertility or defects of the development of the fetus caused by Rabeprazole; However, rats in small quantities penetrate the placental barrier. Do not apply during pregnancy.

It is not known whether it stands out with breast milk. Relevant studies on the use of the drug during breastfeeding period were not conducted. At the same time, it was found in the milk lactating rats, and therefore it is impossible to use women during breastfeeding period.

Method of use and dose:

With stomach peptic disease in the exacerbation stage and anastomosis ulcers it is recommended to take inside of 10 mg or 20 mg once a day. Typically, the cure occurs after 6 weeks of therapy, but in some cases the duration of treatment can be increased by another 6 weeks.

For ulcerative duodenal disease in the stage of exacerbation it is recommended to take 20 mg inward once a day. In some cases therapeutic effect It occurs when taking 10 mg once a day. The duration of treatment is from 2 to 4 weeks. If necessary, the duration of treatment can be increased for another 4 weeks.

In the treatment of erosive gastroesophageal reflux disease (GERD) or reflux-esophagitis it is recommended to take inside 10 mg or 20 mg once a day. The duration of treatment is from 4 to 8 weeks. If necessary, the duration of treatment can be increased by another 8 weeks.

With supporting therapy of gastroesophageal reflux disease (GERD) It is recommended to take inside 10 mg or 20 mg once a day. The duration of treatment depends on the patient's condition.

With non-erosive gastroesophageal reflux disease (NERB) withoutezophagita It is recommended to take inside 10 mg or 20 mg once a day.

If after four weeks of treatment symptoms do not disappear, additional study of the patient should be carried out. After relieving the symptoms to prevent their subsequent occurrence, the drug should be taken inside at a dose of 10 mg once a day on demand.

For the treatment of Zolinger Ellison syndrome and other states, characterized by pathological hypersecretion , Dose is selected individually. The initial dose is 60 mg per day, then the dose increases and prescribe a drug at a dose to 100 mg per day with a single reception or 60 mg twice a day. For some patients, fractional dosing of the drug is preferred. Treatment should continue as the clinical need. In some patients with Zolinger-Ellison syndrome, Rabeprazolese treatment was up to one year.

For eradication Helicobacter.pylori. it is recommended to take inside 20 mg 2 times a day according to a specific scheme with the appropriate combinations of antibiotics. The duration of treatment is 7 days.

Patients with renal and liver failure

Dose correction to patients with renal failure is required.

In patients with hepatic insufficiency of light and moderate severity, the concentration of Rabeprazole in the blood is usually higher than in healthy volunteers.

When appointing the drug Rabeprazole-SZ patients with a severe severity of hepatic insufficiency should be taken care.

Elderly patients

Dose correction is not required.

Children

Safety and efficacy of Rabeprazole 20 mg for short-term (up to 8 weeks) treatment of GERD in children aged 12 years and more confirmed by extrapolation of the results of adequate and well-controlled studies supporting the efficiency of Rabeprazole for adults and safety and pharmacokinetics for patients children's age. The recommended dose for children aged 12 years and more is 20 mg 1 time per day for up to 8 weeks.

The safety and efficacy of Rabeprazole for the treatment of GERD in children under the age of 12 is not installed. The safety and efficacy of Rabeprazole for use for other indications is not established for childhood patients.

Side effects:

In the course clinical studies The following undesirable reactions were noted when taking Rabeprazole: Headache, dizziness, asthenia, abdominal pain, diarrhea, meteorism, dry mouth, rash.

Unwanted reactions are systematized in accordance with WHO classification:

Very often (\u003e 1/10);

Often (\u003e 1/100,< 1/10);

Infrequently (\u003e 1/1000,< 1/100);

Rarely (\u003e 1/10000,< 1/1000);

Rarely (< 1/10000);

The frequency is unknown (it is impossible to determine based on the available data).

From side immune system : rarely - acute system allergic reactions (including face swelling, hypotension, shortness of breath).

From the blood and lymphatic system : Rarely thrombocytopenia, neutropenia, leukopenia.

From the metabolism and nutrition : rarely - anorexia; The frequency is unknown - hyponatremia, hypomagnation.

From the nervous system : often - insomnia, headache, dizziness; infrequently drowsiness, nervousness; rarely - depression; The frequency is unknown - the confusion confusion.

From the authority of sight : rarely - violation.

From the vessels : The frequency is unknown - peripheral swelling.

From the respiratory system : often - cough, pharyngitis, rhinitis; Infrequently - sinusitis, bronchitis.

From the digestive system : often - abdominal pain, diarrhea, flatulence, nausea, vomiting, constipation; Infrequently - dyspepsia, belching, dry mouth; rarely - stomatitis, gastritis, violation of taste.

From the hepatobiliary system: rarely - hepatitis, jaundice,hepatic encephalopathy.

From the kidneys and urinary tract : Infrequently infectionurinary tract; Rarely - interstitial jade.

From the side of the skin and subcutaneous fabrics : rarely - bullous rashes, urticaria; Very rarely - multiform erythema, toxic epidermal necroliza, Stevens-Johnson syndrome.

From the bone-muscular system : often - pain in the back; Infrequently - Malgia, Arthralgia, Savor of Muscles Foot, Fracture Bones of Hip, Wrist or Spine.

From the reproductive system : The frequency is unknown - gynecomastia.

From laboratory and instrumental research : rarely - an increase in the activity of "liver" transaminases, an increase in body weight.

Others : often infection.

Overdose:

Symptoms

Data on intentional or accidental overdose is minimal.

Treatment

Specific antidote for Rabeprazole is unknown. It is well associated with plasma proteins, and therefore is weakly excreted during dialysis. In case of overdose, it is necessary to conduct symptomatic and supportive treatment.

Interaction:

Slows down the removal of certain medicines metabolizing in the liver by microsomal oxidation (, indirect anticoagulants).

The joint use of Rabbrazole with ketoconazole or itraconazole can lead to a significant decrease in the concentration of antifungal drugs in the blood plasma.

Rabeprazole inhibits cyclosporin metabolism.

With simultaneous reception of IPP and methotrexate, it is assumed to increase the concentration of the last and / or its metabolite of hydroxymethototrexate and an increase in the half-life.

With the simultaneous use of Rabeprazole, amoxicillin and clarithromycin, the AUC and M AH indicators for clarithromycin and amoxicillin were similar when comparing combination therapy with monotherapy. The Rabeprazole AUC and C M AH indicators increased by 11% and 34%, respectively, A AUC and M AH 14-hydroxyclarithromycin (active clarithromycin metabolite) increased by 42% and 46%, respectively. This increase in the indicators was not recognized as clinically significant.

The simultaneous use of Rabeprazole and suspensions of antacids containing aluminum and / or magnesium hydroxide does not lead to clinically significant interaction.

special instructions:

The response of the patient on therapy Rabeprazole does not exclude the presence of malignant neoplasms in the stomach.

The drug capsules Rabeprazole-SZ should be swallowed entirely. It has been established that nor the time of day, nor food intake affects the activity of Rabeprazole.

In a special study in patients with light or moderate disorders, the liver function was not detected to significantly differences in the side effects of the drug Rabeprazole-SZ from those from selected on the floor and age of healthy persons, but, despite this, caution is recommended for the first appointment of the drug Rabeprazol SZ Patients with severe liver function disorders.

Patients with impaired kidney or liver function Adjustment of the dose of the drug Rabeprazole-SZ is not required. AUC Rabeprazole in patients with severe liver function is about two times higher than in healthy patients.

Gipicomagnia

In the treatment of IPS, for at least 3 months, in rare cases, cases of symptomatic or asymptomatic hypomagnias were noted. In most cases, these messages came in a year after therapy. Serious by-phenomena There were tenania, arrhythmias and convulsions. Most patients needed treatment of hypomagnesia, including the replacement of magnesium and cancellation of IPP therapy. In patients who will receive long-term treatment or which are taken with drugs with drugs, such as or drugs that can cause hypomagnias (for example, diuretics), medical professionals must control the content of magnesium before the treatment of IPS and during the treatment period.

Fractures

The IPA therapy may lead to an increase in the risk associated with the osteoporosis of the fractures of the thigh, wrist or spine. The risk of fractures was increased in patients who received high doses of IPPs for a long time (year or more).

Simultaneous use of Rabeprazole with methotrexate

According to literary data, the simultaneous reception of IPP with methotrexate (primarily in high doses) can lead to an increase in the concentration of methotrexate and / or its hydroxymethototrexate metabolite and increase the half-life, which can lead to the manifestation of methotrexate toxicity. If it is necessary to use high doses of methotrexate, the possibility of temporary termination of the IPP therapy can be considered.

Infectionscaused by salmonellaCampylobacter and Clostridium Difficile

The IPP therapy may lead to an increase in the risk of gastrointestinal infections, such as infections caused by Salmonella, Campylobacter.and Clostridium.difficile .

Impact on the ability to control the transc. cf. And Meh.:

Based on the peculiarities of the pharmacodynamics of Rabeprazole and its profile of undesirable effects, it is unlikely that Rabeprazole-SZ affects the ability to driving vehicles and managing mechanisms. However, in case of the appearance of drowsiness, these activities should be avoided.

Release form / Dosage:

Inheist-soluble capsules, 10 mg and 20 mg.

Packaging:

10 or 14 capsules in the contour cell packaging.

30, 60 or 100 capsules in a polymer or into a polymer bottle.

Each bank or vial, 2, 3, 6 contour cellular packs of 10 capsules, 1, 2, 4 contour cellular packs of 14 capsules along with the application instructions are placed in a cardboard pack.

Storage conditions:

In the dry place protected from light, at a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

Do not use the expiration date specified on the package.

Conditions of vacation from pharmacies:On prescription Registration number:LP-003466. Registration date:17.02.2016 / 21.07.2016 Execution Date:17.02.2021 Registration Certificate Owner:Northern Star, Nao Russia Manufacturer: & NBSP Representation: & NBSPNorthern Star ZAO Russia Date of updating information: & NBSP31.07.2016 Illustrated instructions