In combination with what drugs to take rabeprazole. Rabeprazole: instructions for use, analogues and reviews, prices in pharmacies in Russia

Content

Rabeprazole tablets

This drug is intended for people suffering from gastrointestinal diseases. He has a large number of analogues, so you need to consult a doctor who will clarify which one is suitable for the patient. The drug has an impressive number of side effects and contraindications, so before using it, you need to weigh all the factors so as not to harm yourself.

Composition

One tablet contains:

Substance name		Quantity in mg
Rabeprazole sodium
Mannitol
Magnesium oxide
Giprolose weakly substituted
Hyprolosis
Magnesium stearate
Ethyl cellulose
Hypromellose phthalate
Diacetylated Monoglyceride
Titanium dioxide
Iron oxide red
Carnauba wax

Pharmacodynamics and pharmacokinetics

The Rabeprazole tablet affects the H + -K + -ATPase enzyme produced in the parietal cells of the esophagus. It 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 taking 20 mg, the drug is completely absorbed after 3.5-4 hours. The time of administration does not affect the bioavailability of the main compound and its absorption properties.

Indications for use

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

• Duodenal ulcer.
• Recurrence of peptic ulcer disease provoked by the bacterium Helicobacter pylory.
• Pathological hypersecretion.
• Gastritis (Helicobacter pylorus eradication), including chronic gastritis (with the use of antibacterial drugs).
• Gastroesophageal reflux disease.
• Zollinger-Ellison Syndrome.
• Stomach ulcer.

Instructions for the use of Rabeprazole

The active ingredient capsules must be taken orally. The timing of the meal does not affect anything, nor does the meal before or after. The dosage of the drug and the frequency of use completely depend on the severity of the disease, the instructions of the specialist. The starting dose for patients with standard symptoms of the disease is 10 or 20 mg once a day. The treatment lasts two months (6 weeks). If the desired effect is not followed, the treatment is extended by the same amount.

special instructions

The presence of malignant tumors of the gastrointestinal tract should be excluded, since the drug has the property of masking the symptoms of oncology, which will complicate the diagnosis and timely detection of oncological diseases. In case of impaired liver function, the drug should be taken very carefully. Change the dosage of Digoxin and Ketonazole, rabeprazole does not allow them to be used in the standard dosage. If your work requires a high concentration of attention or you are driving transport, exclude these actions if the drug causes drowsiness or fatigue.

During pregnancy

There is no official data on whether the drug can be used during pregnancy. Animal studies have shown no problems with fetal development, but in rats a small dose crossed the placental barrier, so use during pregnancy should be strictly under medical supervision. The situation is similar with lactation: the drug passes into milk, so it should not be used during lactation.

In childhood

Under 18 is prohibited. An exception is GERD (gastroesophageal reflux disease) in children over 12 years of age. Studies have not proven absolute efficacy and safety for children with GERD. The effectiveness for children who take the drug for other reasons is not indicated in studies, but the recommended dose that doctors prescribe is 20 mg once a day for eight weeks.

Drug interactions

The main active ingredient does not interact at all with antacids (a type of medicine used to combat acid-dependent gastrointestinal diseases), but it can affect the saturation of blood plasma with ketoconazole or digoxin. Diazepam, Phenytoin, Warfarin or Theophylline are quite suitable for concurrent use. In extreme cases, the drug can be used together with the proton pump inhibitor drug Pantoprazole. If this drug is listed on the prescribed list, check with your doctor for the dosage.

Rabeprazole and alcohol

Drinking alcohol is strictly prohibited. Double stress on the liver can make the condition worse. The risk of side effects will increase. Even excluding the drug itself, alcohol is unacceptable during the period of ulcers and leads to exacerbations. Drinking beer is also prohibited.

Side effects and overdose

The use of the drug can cause disorders of the gastrointestinal tract, musculoskeletal system, nervous and respiratory systems. Side effects include:

• Allergic reaction, rash.
• Diarrhea.
• Decreased appetite, flatulence.
• Stomatitis, increased activity of hepatic transaminases.
• Vomiting and nausea, dry mouth, constipation.
• Fever.
• Dizziness, asthenia.
• Flu-like syndrome.
• Drowsiness, thrombocytopenia.
• Visual impairment, taste receptors.
• Leukopenia, headache.
• High fatigue.
• Back pain.
• Convulsions, arthralgia, myalgia.
• Sinusitis, cough, pharyngitis, rhinitis.
• Stevenson-Jones syndrome.

Contraindications

It is strictly forbidden to take the drug during pregnancy or lactation. Cannot be used in case of individual intolerance or hypersensitivity to certain components of the drug (raberpazole or substituted benzimidazole). Should not be used in case of sugar deficiency, fructose intolerance or glucose-galactose deficiency. If you have severe renal or hepatic impairment, the drug is also contraindicated.

Terms of sale and storage

The drug is stored at room temperature (not higher than 25 degrees Celsius), must be protected from moisture and direct sunlight. After the expiration date is prohibited for use.

Analogs

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

• Omeprazole. Manufacturer - Ukraine, Russia, Israel, Hungary. The composition is almost identical. Release form - capsules of 20 mg. Average cost - from 28 rubles per pack.
• Noflux. Manufacturer - Hungary. Composition - magnesium oxide, mannitol, etc. Release form - Tablets of 10, 20 mg. The average cost is from 828 to 1296 rubles per package.
• Khairabezol. Manufacturer - India. Ingredients - magnesium oxide, mannitol, corn starch. Release form - tablets of 10, 20 mg. Average cost - from 368 rubles.
• Zulbex. Manufacturer - Slovenia. Composition - mannitol, magnesium oxide, hyprolosis. Release form - tablets of 10, 20 mg. The average cost is 315 rubles.
• Ontime. Manufacturer - Teva, Russia. Composition - low-substituted hyprolose, magnesium oxide, mannitol. Release form - tablets of 10, 20 mg. Average cost - from 577 rubles.

Pilyuli.ru

Rabeprazole-SZ enteric capsules 10 mg 14 pcs.

Rabeprazole-SZ enteric capsules 20 mg 14 pcs.

Eapteka.ru

Parity tablets 20 mg 14 pcs.

PharmacyMos.ru

Beret tablets 10 mg

Take tablets 20 mg

Gross formula

C 18 H 21 N 3 O 3 S

Pharmacological group of the substance Rabeprazole

Nosological classification (ICD-10)

CAS code

117976-89-3

Characteristics of the substance Rabeprazole

Substituted benzimidazole derivative. Rabeprazole sodium is a white or slightly yellowish-white substance. It is highly soluble in water and methanol, soluble in ethanol, chloroform and ethyl acetate, insoluble in ether and n-hexane. Weak base. Stability depends on pH - degrades quickly in mild acids and more stable in alkaline environments. Molecular weight 381.43.

Pharmacology

pharmachologic effect - antiulcer.

It is a prodrug - in the acidic environment of parietal cells, it turns into an active sulfenamide form that interacts with cysteine \u200b\u200bof H + -K + -ATPase (proton pump). Inhibits (partially reversibly) H + -K + -ATPase of the gastric parietal cells and in a dose-dependent manner inhibits the basal and stimulated secretion of hydrochloric acid. The antisecretory effect is manifested within 1 hour after ingestion of a dose of 20 mg. The maximum decrease in the pH of the stomach environment is recorded 2-4 hours after the first dose. On the first day, it reduces the average daily acidity by 61% (this is about 88% of the decrease in secretion achieved on the 8th day of treatment). The average pH value over 24 hours is 3.4; and the time during which the pH remains at a level of more than 3 is 55.8%. Partial dissociation of the complex with H + -K + -ATPase leads to a shorter duration of action than irreversible proton pump inhibitors. The duration of inhibition of basal and stimulated secretion reaches 48 hours, a stable antisecretory effect develops after 3 days of treatment. Cancellation is not accompanied by the phenomenon of rebound, the restoration of secretory activity occurs within 2-3 days as new enzyme molecules are synthesized.

Possesses anti-Helicobacter activity: IPC 4-16 μg / ml. Accelerates the manifestation of the anti-Helicobacter activity of a number of antibiotics. When conducting triple eradication therapy (rabeprazole 20 mg 2 times a day in combination with clarithromycin and amoxicillin) 90% eradication Helicobacter pylori is achieved within 4 days. Eradication of Helicobacter at the end of the 7-day course of therapy is noted, respectively, in 100, 95, 90 and 63% when treated with rabeprazole in combination with clarithromycin + metronidazole, clarithromycin + amoxicillin, amoxicillin + metronidazole only with clarithromycin. With erosive or ulcerative gastroesophageal reflux disease from the first day of treatment (10-20 mg) reduces heartburn both during the day and at night. Effective in 8-week treatment of erosive reflux esophagitis in 84% of patients. It has been shown to be effective in pathological hypersecretory conditions, including Zollinger-Ellison syndrome. In the first 2-8 weeks of long-term administration, the concentration of gastrin in the blood serum temporarily increases (histological examination does not show an increase in the number of ECL cells, the frequency of intestinal metaplasia, colonization H. pylori).

When taken orally, absorption begins in the small intestine (due to the presence of an acid-fast enteric coating in the tablet) and is carried out quickly and completely. Absolute bioavailability - 52% (pronounced "first pass" effect through the liver). Food and timing do not alter bioavailability. C max is achieved within 2-5 hours (on average, 3.5 hours) after taking a dose of 20 mg. There is a linear dose dependence of C max and AUC values \u200b\u200bin the range from 10 to 40 mg. T 1/2 is 0.7-1.5 hours; total Cl - 283 ml / min. Against the background of hepatocellular failure, the effect of the "first pass" through the liver is not pronounced, AUC is doubled (after a single dose) and 1.5 times (after 7 days of therapy), T 1/2 reaches 12.3 hours. Metabolized in the liver with the participation of isoenzymes of the cytochrome P450 system (CYP2C19 and CYP3A) with the formation of inactive metabolites and demethylthioester, which has a weak antisecretory activity. In the case of delayed biotransformation after 7 days of administration at a dose of 20 mg / day, T 1/2 reaches 1-2 hours (on average 1.6 hours), C max increases by 40%. It is excreted mainly in the urine in the form of metabolites (conjugates of mercapturic and carboxylic acids). In old age, elimination slows down, C max increases by 60%, AUC - 2 times. Even at the stage of end-stage renal failure in patients on dialysis, pharmacokinetic parameters change insignificantly - C max and AUC decrease by 35%, T 1/2 during hemodialysis is 0.95 hours, after - 3.6 hours.

Application of the substance Rabeprazole

Peptic ulcer of the stomach and duodenum in the acute stage, gastroesophageal reflux disease; conditions characterized by pathological hypersecretion, incl. Zollinger-Ellison syndrome. Combined with antibacterial agents - eradication Helicobacter pylori in patients with gastric ulcer or chronic gastritis; treatment and prevention of ulcer recurrence in patients with peptic ulcer disease associated with Helicobacter pylori.

Contraindications

Hypersensitivity, incl. to substituted benzimidazoles, pregnancy, breastfeeding.

Restrictions on use

Severe hepatic impairment, childhood (there is no sufficient experience of use).

Application during pregnancy and lactation

Rabeprazole should not be given to pregnant women (there is no data on the safety of rabeprazole during pregnancy). Reproduction studies in rats and rabbits showed no signs of impaired fertility or fetal developmental defects due to rabeprazole; however, in rats, in small amounts, the drug crosses the placental barrier.

During treatment, breastfeeding should be discontinued. It is not known whether rabeprazole is excreted in breast milk; no corresponding studies have been conducted in lactating women. However, rabeprazole is found in the milk of lactating rats.

Side effects of the substance Rabeprazole

From the digestive tract: diarrhea, nausea, vomiting, abdominal pain, constipation, flatulence, increased activity of hepatic transaminases, dryness of the oral mucosa; rarely - decreased appetite, stomatitis.

From the nervous system and sensory organs: headache, dizziness, drowsiness, asthenia; rarely - depression, blurred vision or taste.

On the part of the cardiovascular system and blood (hematopoiesis, hemostasis): thrombocytopenia, leukopenia.

From the side of the musculoskeletal system: myalgia, calf muscle cramps, arthralgia.

From the respiratory system: pharyngitis, rhinitis; rarely - cough, sinusitis.

Allergic reactions: skin rash.

Others: back pain, flu-like syndrome, fever; rarely - weight gain, increased sweating.

Interaction

Rabeprazole is metabolized by hepatic microsomal isoenzymes of the cytochrome P450 system. Studies in healthy volunteers have shown that rabeprazole does not enter into clinically significant interaction with amoxicillin and other drugs that are metabolized by this enzyme system (warfarin, phenytoin, theophylline, diazepam). Due to the fact that rabeprazole causes a pronounced and long-term decrease in the production of hydrochloric acid, there was an interaction when taken simultaneously with drugs, the absorption of which depends on the acidity of the stomach contents. In healthy volunteers, taking rabeprazole caused a decrease in the concentration of ketoconazole in the blood plasma by 33% and an increase in the minimum concentration of digoxin by 22% (while taking it, the doses of ketoconazole or digoxin must be adjusted).

Concentrations of rabeprazole and the active metabolite of clarithromycin in plasma with simultaneous administration increase by 24 and 50%, respectively. This increases the effectiveness of this combination in eradication Helicobacter pylori... The study found no interaction of rabeprazole with liquid antacids. There was no clinically significant interaction of rabeprazole with food.

Research in vitro on microsomes of human liver showed that rabeprazole is metabolized by isoenzymes of the system CYP2C19 and CYP3A. It was found that at the expected plasma concentrations, rabeprazole has no stimulating or inhibitory effect on CYP3A4. These studies also suggest that rabeprazole has no effect on cyclosporine metabolism.

Overdose

Symptoms not described.

Treatment: if an overdose is suspected, supportive and symptomatic therapy is recommended. The specific antidote is unknown. Dialysis is ineffective (rabeprazole binds well to plasma proteins).

Route of administration

Inside.

Precautions for the substance Rabeprazole

Before starting treatment, it is necessary to exclude a malignant neoplasm of the stomach (symptomatic improvement during treatment with rabeprazole may complicate timely diagnosis). Caution is advised when first administering rabeprazole to patients with severely impaired liver function. In case of drowsiness, you should stop driving a car and other activities that require increased concentration. Patients receiving ketoconazole or digoxin concurrently with rabeprazole require additional monitoring (dose adjustment of these drugs may be required).

Interaction with other active ingredients

Trade names

Name	Value of the Vyshkovsky Index ®

Formula: C18H21N3O3S, chemical name: 2 - [[methyl] sulfinyl] benzimidazole.
Pharmacological group: organotropic agents / gastrointestinal agents / proton pump inhibitors.
Pharmachologic effect: antiulcer.

Pharmacological properties

Rabeprazole is a benzimidazole derivative, a prodrug that converts in the acidic environment of parietal cells into the active sulfenamide form, which interacts with the proton pump cysteine \u200b\u200b(H + -K + -ATPase). Rabeprazole inhibits (partially reversible) the work of the proton pump of the gastric parietal cells and inhibits (dose-dependent) stimulated and basal secretion of hydrochloric acid. After ingestion of 20 mg of rabeprazole for 1 hour, an antisecretory effect is manifested. The maximum decrease in gastric acidity is observed 2 to 4 hours after using the first dose. The average daily acidity index on the first day of taking rabeprazole decreases by 61% (this is approximately 88% decrease in secretion, which is achieved on the 8th day of therapy). The average acidity index during the day is 3.4. Partial dissociation of the complex with the proton pump results in a shorter duration of action when compared with irreversible proton pump inhibitors. The duration of inhibition of stimulated and basal secretion reaches 2 days, after 3 days of therapy, a stable antisecretory effect develops. Cancellation of rabeprazole by the phenomenon of ricochet is not accompanied by a recovery of secretory activity within 2 to 3 days as new enzyme molecules are formed. Rabeprazole has anti-Helicobacter activity: the sensitivity index of microorganisms is 4-16 μg / ml. Rabeprazole accelerates the anti-Helicobacter activity of some antibiotics. If triple eradication therapy is carried out (rabeprazole 2 times a day, 20 mg together with amoxicillin and clarithromycin), then 90% eradication of Helicobacter pylori is achieved within 4 days. At the end of the 7-day course of treatment, Helicobacter eradication is noted, respectively, in 63, 90, 95 and 100% when rabeprazole is taken together with clarithromycin, amoxicillin + metronidazole, clarithromycin + amoxicillin, clarithromycin + metronidazole. With peptic ulcer or erosive gastroesophageal reflux disease, rabeprazole from the first day of therapy (10 - 20 mg) reduces heartburn both at night and during the day. Rabeprazole is effective in 84% of patients with 8 weeks of therapy for erosive reflux esophagitis. In pathological hypersecretory conditions, including Zollinger-Ellison syndrome, the effectiveness of rabeprazole has also been shown. In the first 2 to 8 weeks of prolonged use of rabeprazole, the content of gastrin in the blood plasma temporarily increases (during histological examination, an increase in the number of ECL cells, colonization of H. pylori, intestinal metaplasia frequency).
After oral administration of rabeprazole, absorption begins in the small intestine (the tablet has an enteric acid-resistant membrane) and is carried out completely and quickly. The absolute bioavailability of rabeprazole is 52%, due to the pronounced effect of the first passage through the liver. Time of intake and food do not change bioavailability. The maximum concentration is reached within 2 to 5 hours (usually about 3.5 hours) after taking 20 mg. There is a linear relationship between the values \u200b\u200bof the area under the concentration-time curve and the maximum concentration in the dose range from 10 to 40 mg. The half-life of rabeprazole is 0.7-1.5 hours; the total clearance is 283 ml / min. In hepatocellular failure, the area under the concentration-time curve is increased 2 times (with a single dose) and 1.5 times (after 1 week of treatment), the effect of the first passage through the liver is not pronounced, the half-life reaches 12.3 hours. Rabeprazole is metabolized in the liver with the participation of isoenzymes of the cytochrome P450 system (CYP3A and CYP2C19), while inactive metabolites and demethylthioester are formed, which has a weak antisecretory activity. With delayed biotransformation after 1 week of using rabeprazole at a dose of 20 mg per day, the half-life reaches 1 to 2 hours (usually 1.6 hours), the maximum concentration increases by 40%. Rabeprazole is excreted mainly in the urine in the form of metabolites (conjugates of carboxylic and mercapturic acids). In elderly patients, excretion slows down, the maximum concentration increases by 60%, the area under the concentration-time curve increases by 2 times. Even with end-stage renal failure in patients on dialysis, the parameters of rabeprazole pharmacokinetics change insignificantly - the area under the concentration-time curve and maximum concentration decrease by 35%, the half-life during hemodialysis is 0.95 hours, after - 3.6 hours.

Indications

Gastroesophageal reflux disease; exacerbation of peptic ulcer of the duodenum and stomach; conditions characterized by pathological hypersecretion, including Zollinger-Ellison syndrome; together with antibacterial drugs for the eradication of Helicobacter pylori in patients with chronic gastritis or gastric ulcer; prevention and therapy of recurrent ulcers in patients with peptic ulcer disease associated with Helicobacter pylori.

Rabeprazole route and dose

Rabeprazole is taken orally, without crushing or chewing, in the morning, before meals, 1 time per day, 20 mg. Exacerbation of peptic ulcer - within 4 - 6 weeks, if necessary, you can take up to 12 weeks. Reflux esophagitis - 4 - 8 weeks, further supportive treatment is possible: 1 time per day 10 - 20 mg. Zollinger-Ellison syndrome dose and regimen are set individually. Helicobacter pylori infection is used as part of eradication treatment using appropriate combinations of antibiotics for 1 week.
Before starting to take rabeprazole, it is necessary to exclude malignant neoplasms of the stomach (with treatment with rabeprazole, symptomatic improvement can complicate timely diagnosis). Patients who have been using rabeprazole for a long time (in particular for more than one year) should be regularly examined. Patients with severe liver dysfunction are advised to be careful when first administering rabeprazole. Patients who take digoxin or ketoconazole together with rabeprazole need additional monitoring (it may be necessary to adjust the doses of these drugs). The risk of cross-reactions with substituted benzoimidazoles or other proton pump inhibitors cannot be excluded. With the development of drowsiness and other adverse reactions from the nervous system, it is necessary to abandon driving a car and other activities that require increased attention and speed of psychomotor reactions.

Contraindications to the use of rabeprazole

Hypersensitivity, including to substituted benzimidazoles, lactation, pregnancy.

Restrictions on use

Severe liver failure. Age up to 18 years (lack of sufficient experience of use)

Rabeprazole during pregnancy and breastfeeding

Rabeprazole is contraindicated in pregnant women (data on the safety of using rabeprazole during pregnancy are not available). In a reproductive study in rabbits and rats, no fetal defects or signs of impaired fertility were found, which would be due to rabeprazole; but in rats, small amounts of rabeprazole cross the placenta. During therapy with rabeprazole, you must stop breastfeeding. It is not known whether rabeprazole passes into breast milk. In lactating women, relevant studies have not been conducted. Rabeprazole is found in milk of lactating rats.

Side effects of rabeprazole

Digestive system: nausea, diarrhea, vomiting, constipation, dyspepsia, abdominal pain, flatulence, belching, increased liver transaminase activity, decreased appetite, dryness of the oral mucosa, gastritis, stomatitis, hepatitis, jaundice, hepatic encephalopathy.
Nervous system and senses: headache, drowsiness, dizziness, confusion, nervousness, depression, asthenia, insomnia, impaired taste or vision.
Blood (hemostasis, hematopoiesis): leukopenia, neutropenia, thrombocytopenia, leukocytosis.
Musculoskeletal system:cramps of the calf muscles, myalgia, arthralgia.
Respiratory system: pharyngitis, cough, rhinitis, bronchitis, sinusitis.
Allergic reactions: skin rash, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Others: flu-like syndrome, back pain, fever, excessive sweating, pruritus, gynecomastia, urinary tract infections, erythema, bullous rash, interstitial nephritis, hyponatremia, peripheral edema, anorexia, weight gain.

Interaction of rabeprazole with other substances

Rabeprazole is metabolized with the participation of hepatic microsomal isoenzymes of the cytochrome P450 system. In a study in healthy people, it was found that rabeprazole does not clinically significantly interact with amoxicillin and other drugs that are metabolized by this enzyme system (phenytoin, warfarin, diazepam, theophylline). Since rabeprazole is expressed and long-term reduces the production of hydrochloric acid, an interaction was noted when taken together with drugs, the absorption of which depends on the acidity in the stomach. In healthy people, taking rabeprazole reduced the serum ketoconazole content by 33% and increased the minimum digoxin level by 22% (when used together, the doses of digoxin and ketoconazole must be adjusted). The content of rabeprazole and the active metabolite of clarithromycin in serum, when used together, increases by 24 and 50%, respectively. This increases the effectiveness of this combination in the eradication of Helicobacter pylori. The study did not reveal the interaction of rabeprazole with liquid antacids. No clinically significant interaction of rabeprazole with food has been identified. Rabeprazole is metabolized by isoenzymes of the CYP3A and CYP2C19 systems. It was found that at expected serum levels, rabeprazole has neither inhibitory nor stimulatory effect on CYP3A4. Therefore, it is believed that rabeprazole does not affect the metabolism of cyclosporine. Proton pump inhibitors, including rabeprazole, should not be used with atazanavir.

Overdose

There is no data. If an overdose with rabeprazole is suspected, symptomatic and supportive treatment is recommended; there is no specific antidote; dialysis is ineffective due to high binding to plasma proteins.

This drug is intended for people suffering from gastrointestinal diseases. He has a large number of analogues, so you need to consult a doctor who will clarify which one is suitable for the patient. The drug has an impressive number of side effects and contraindications, so before using it, you need to weigh all the factors so as not to harm yourself.

Related Articles How to Take Pariet Acid Reflux Treatment Itrazol

Composition

One tablet contains:

Substance name		Quantity in mg
Rabeprazole sodium
Mannitol
Magnesium oxide
Giprolose weakly substituted
Hyprolosis
Magnesium stearate
Ethyl cellulose
Hypromellose phthalate
Diacetylated Monoglyceride
Titanium dioxide
Iron oxide red
Carnauba wax

Pharmacodynamics and pharmacokinetics

The Rabeprazole tablet affects the H + -K + -ATPase enzyme produced in the parietal cells of the esophagus. It 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 taking 20 mg, the drug is completely absorbed after 3.5-4 hours. The time of administration does not affect the bioavailability of the main compound and its absorption properties.

Indications for use

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

• Duodenal ulcer.
• Recurrence of peptic ulcer disease provoked by the bacterium Helicobacter pylory.
• Pathological hypersecretion.
• Gastritis (Helicobacter pylorus eradication), including chronic gastritis (with the use of antibacterial drugs).
• Gastroesophageal reflux disease.
• Zollinger-Ellison Syndrome.
• Stomach ulcer.

Instructions for the use of Rabeprazole

The active ingredient capsules must be taken orally. The timing of the meal does not affect anything, nor does the meal before or after. The dosage of the drug and the frequency of use completely depend on the severity of the disease, the instructions of the specialist. The starting dose for patients with standard symptoms of the disease is 10 or 20 mg once a day. The treatment lasts two months (6 weeks). If the desired effect is not followed, the treatment is extended by the same amount.

special instructions

The presence of malignant tumors of the gastrointestinal tract should be excluded, since the drug has the property of masking the symptoms of oncology, which will complicate the diagnosis and timely detection of oncological diseases. In case of impaired liver function, the drug should be taken very carefully. Change the dosage of Digoxin and Ketonazole, rabeprazole does not allow them to be used in the standard dosage. If your work requires a high concentration of attention or you are driving transport, exclude these actions if the drug causes drowsiness or fatigue.

During pregnancy

There is no official data on whether the drug can be used during pregnancy. Animal studies have shown no problems with fetal development, but in rats a small dose crossed the placental barrier, so use during pregnancy should be strictly under medical supervision. The situation is similar with lactation: the drug passes into milk, so it should not be used during lactation.

In childhood

Under 18 is prohibited. An exception is GERD (gastroesophageal reflux disease) in children over 12 years of age. Studies have not proven absolute efficacy and safety for children with GERD. The effectiveness for children who take the drug for other reasons is not indicated in studies, but the recommended dose that doctors prescribe is 20 mg once a day for eight weeks.

Drug interactions

The main active ingredient does not interact at all with antacids (a type of medicine used to combat acid-dependent gastrointestinal diseases), but it can affect the saturation of blood plasma with ketoconazole or digoxin. Diazepam, Phenytoin, Warfarin or Theophylline are quite suitable for concurrent use. In extreme cases, the drug can be used together with the proton pump inhibitor drug Pantoprazole. If this drug is listed on the prescribed list, check with your doctor for the dosage.

Rabeprazole and alcohol

Drinking alcohol is strictly prohibited. Double stress on the liver can make the condition worse. The risk of side effects will increase. Even excluding the drug itself, alcohol is unacceptable during the period of ulcers and leads to exacerbations. Drinking beer is also prohibited.

Side effects and overdose

The use of the drug can cause disorders of the gastrointestinal tract, musculoskeletal system, nervous and respiratory systems. Side effects include:

• Allergic reaction, rash.
• Diarrhea.
• Decreased appetite, flatulence.
• Stomatitis, increased activity of hepatic transaminases.
• Vomiting and nausea, dry mouth, constipation.
• Fever.
• Dizziness, asthenia.
• Flu-like syndrome.
• Drowsiness, thrombocytopenia.
• Visual impairment, taste receptors.
• Leukopenia, headache.
• High fatigue.
• Back pain.
• Convulsions, arthralgia, myalgia.
• Sinusitis, cough, pharyngitis, rhinitis.
• Stevenson-Jones syndrome.

Contraindications

It is strictly forbidden to take the drug during pregnancy or lactation. Cannot be used in case of individual intolerance or hypersensitivity to certain components of the drug (raberpazole or substituted benzimidazole). Should not be used in case of sugar deficiency, fructose intolerance or glucose-galactose deficiency. If you have severe renal or hepatic impairment, the drug is also contraindicated.

Terms of sale and storage

The drug is stored at room temperature (not higher than 25 degrees Celsius), must be protected from moisture and direct sunlight. After the expiration date is prohibited for use.

Analogs

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

• Omeprazole. Manufacturer - Ukraine, Russia, Israel, Hungary. The composition is almost identical. Release form - capsules of 20 mg. Average cost - from 28 rubles per pack.
• Noflux. Manufacturer - Hungary. Composition - magnesium oxide, mannitol, etc. Release form - Tablets of 10, 20 mg. The average cost is from 828 to 1296 rubles per package.
• Khairabezol. Manufacturer - India. Ingredients - magnesium oxide, mannitol, corn starch. Release form - tablets of 10, 20 mg. Average cost - from 368 rubles.
• Zulbex. Manufacturer - Slovenia. Composition - mannitol, magnesium oxide, hyprolosis. Release form - tablets of 10, 20 mg. The average cost is 315 rubles.
• Ontime. Manufacturer - Teva, Russia. Composition - low-substituted hyprolose, magnesium oxide, mannitol. Release form - tablets of 10, 20 mg. Average cost - from 577 rubles.

Rabeprazole or Omeprazole - which is better

Both drugs have advantages and disadvantages. Omeprazole has a smaller spectrum of side effects, less other analogs affect metabolism, better suppresses gastric secretion. Rabeprazole is considered the safest representative of the market, the body recovers faster after use, and it itself is in greater demand than its competitor.

Each enteric-coated tablet contains:

Rabeprazole -S 10 mg

Active substance:

Rabeprazole sodium 10 mg

Excipients:

tablet core: magnesium oxide, mannitol, hydroxypropyl cellulose, croscarmellose sodium, povidone, sodium stearyl fumarate; shell: hypromellose, eudragit L-100, dye iron oxide yellow (E172), titanium dioxide (E171).

Rabeprazole -S 20 mg

Active substance:

Rabeprazole sodium 20 mg

Excipients:

tablet core: magnesium oxide, mannitol, hydroxypropyl cellulose, corn starch, povidone, sodium stearyl fumarate; shell: hypromellose, eudragit L-100, dye iron oxide yellow (E172), titanium dioxide (E171).

Description

Rabeprazole -S 10 mg: Round, biconvex enteric-coated tablets, light yellow to yellow.

Rabeprazole -S 20 mg: Oval, biconvex enteric-coated tablets, light yellow to yellow

Pharmacotherapeutic group

Drugs used to treat peptic ulcers and gastroesophageal reflux disease. Proton pump inhibitors

ATX code: A02BC04

Pharmacological properties

Rabeprazole belongs to the class of antisecretory substances, benzimidazole derivatives, does not have anticholinergic activity, inhibiting activity against H2-histamine receptors, causes a decrease in the secretion of hydrochloric acid by suppressing a specific enzyme - H + / K + -ATPase (proton pump). This effect is dose-dependent and leads to the suppression of both basal and stimulated acid secretion, regardless of the stimulus.

Indications for use

Active peptic ulcer of the duodenum. Active benign stomach ulcer. Erosive or ulcerative gastroesophageal reflux disease (GERD). Long-term treatment of gastroesophageal reflux disease (GERD maintenance therapy). Symptomatic treatment of moderate to very severe gastroesophageal reflux (symptomatic treatment of GERD). Zollinger-Ellison Syndrome. In combination with appropriate antibacterial therapy regimens for the eradication of Helicobacter pylori in patients with gastric ulcer and duodenal ulcer.

Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any inactive ingredients of the drug. Pregnancy and breastfeeding. Children under 12 years of age

Dosage regimen

Adults / Seniors.

Active duodenal ulcer and active benign gastric ulcer:the recommended oral dose for the treatment of active duodenal ulcer and active benign gastric ulcer is 20 mg taken once daily in the morning.

Most patients with active duodenal ulcers recover within four weeks. However, some patients may need an additional four weeks of therapy to recover.

Most patients with active benign gastric ulcers recover within six weeks. However, some patients may also require an additional six weeks of therapy to recover.

Erosive or ulcerativegastroesophageal reflux: The recommended oral dose for treating this condition is 20 mg, which should be taken once a day for four to eight weeks.

Long-term treatmentgastroesophageal reflux (maintenance therapy for GERD): for long-term use of a maintenance dose of the drug, it is necessary to take 20 mg or 10 mg once a day, depending on the patient's response.

Symptomatic treatment for moderate to very severegastroesophageal reflux (symptomatic treatment of GERD):10 mg once daily in patients without esophagitis. If symptom control is not achieved within four weeks, then the patient should be further evaluated. Once symptoms have subsided, follow-up control of symptoms can be achieved by taking 10 mg once daily.

SyndromeZollinger-Ellison: the recommended starting dose is 60 mg once daily. The dose can be increased by titration to 120 mg / day, based on the individual needs of the patient. Single daily doses of 100 mg / day can be administered. The 120 mg dose may require splitting: 60 mg twice daily. Treatment is continued if clinically necessary. The duration of treatment is determined individually.

Eradication N.pylori: patients with H. pylori infection should be treated with an appropriate combination of rabeprazole and antibiotics. The following combination is recommended, which is administered within 7 days:

- Rabeprazole 20 mg twice a day + clarithromycin 500 mg twice a day and amoxicillin 1 g twice a day.

For once daily indications, rabeprazole should be taken in the morning before meals. Although it has been shown that neither time of day nor food intake has any effect on rabeprazole activity, such a regimen will improve the effectiveness of treatment. Patients should be warned that the tablets should not be chewed or broken, but should be swallowed whole.

Impaired kidney and liver function: there is no need for dose adjustment for patients with impaired renal and hepatic function. Since there are no clinical data on the use of rabeprazole in patients with severe hepatic impairment, the physician should be careful when first prescribing such patients.

Adverse reactions

The most common adverse drug reactions reported during controlled clinical trials of rabeprazole were: headache, diarrhea, pain, asthenia, flatulence, rash, and dry mouth. Most of the adverse events that occurred during clinical trials were mild to moderate and transient in nature.

Side effects have been identified as a result of clinical studies and post-marketing experience. The frequency is defined as follows:

- Often (\u003e 1/100,

- Uncommon (\u003e 1/1000,

- Rarely (\u003e 1/10 000,

- Very rarely (

In each of these groups, side effects are presented in order of decreasing severity.

Infections and infestations. Often: infections.

On the part of the organs of vision. Seldom: visual impairment.

On the part of the blood and lymphatic system. Seldom: neutropenia, leukopenia, thrombocytopenia, leukocytosis.

From the immune system. Seldom: hypersensitivity reactions (include facial edema, hypotension and shortness of breath; erythema, bullous reactions and hypersensitivity reactions that usually disappeared after stopping therapy).

Metabolic disorders. Unknown: hyponatremia.

Mental disorders. Often: insomnia; infrequently: nervousness; seldom: depression; unknown: confusion of consciousness.

From the nervous system. Often: headache, dizziness; infrequently: drowsiness.

Vascular Disorders. Unknown: peripheral edema.

From the respiratory system. Often: cough, pharyngitis, rhinitis; infrequently: bronchitis, sinusitis.

From the digestive tract. Often: diarrhea, nausea, vomiting, abdominal pain, constipation, flatulence, stomach polyps (benign); infrequently: dyspepsia, dry mouth, belching; seldom: gastritis, stomatitis, disturbances in the sense of taste, anorexia; unknown: microscopic colitis.

From the liver and gallbladder. Seldom: hepatitis, jaundice, hepatic encephalopathy (there have been isolated reports of hepatic encephalopathy in patients with underlying disease - cirrhosis). When treating patients with severe liver dysfunction, the doctor should be careful when first prescribing the drug to such patients (see "Peculiarities of use").

On the part of the skin and subcutaneous tissues. Infrequently: rash, erythema (erythema bullous reactions and hypersensitivity reactions usually resolved after discontinuation of therapy); seldom: itching, increased sweating, bullous reactions (erythema, bullous reactions and hypersensitivity reactions usually resolved after stopping therapy); rarely: polymorphic erythema, toxicodermal necrolysis, Stevens-Johnson syndrome.

From the musculoskeletal tissue. Often: nonspecific pain, back pain; infrequently: myalgia, cramps of the lower extremities, arthralgia.

From the kidneys and urinary tract. Infrequently:urinary tract infections; seldom: interstitial nephritis.

From the reproductive system and mammary glands. Unknown: gynecomastia. Are common. Often: asthenia, flu-like diseases; infrequently: chest pain, chills, fever.

According to research. Infrequently: increased levels of liver enzymes. When treating patients with severe liver dysfunction, the doctor should be careful when first prescribing the drug to such patients (see "Peculiarities of use"); seldom: increase in body weight.

Overdose

The data accumulated to date on intentional or accidental overdose is minimal. The maximum effect of the drug is known for doses from 60 mg 2 times a day to 160 mg once a day. The observed changes in the well-being of patients were weakly expressed, fit into the profile of adverse reactions, were reversible without any medical influence. There is no specific antidote. Rabeprazole binds well to blood proteins, so dialysis is ineffective in case of an overdose of this drug. As with any overdose, treatment should be symptomatic and general supportive measures should be used.

Interaction with other medicinal products

Rabeprazole sodium causes deep and long-term suppression of gastric acid secretion. Interactions with substances whose absorption is pH dependent may occur. Concomitant use of rabeprazole and ketoconazole or itraconazole can lead to a significant decrease in plasma levels of antifungal drugs. Therefore, individual patients may require monitoring to determine if dose adjustment is required if ketoconazole or itraconazole is administered concurrently.

With the simultaneous use of antacids with the introduction of rabeprazole, no interaction was observed with antacids in the form of a liquid.

Concomitant use of atazanavir 300 mg / ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg once daily) resulted in a significant decrease in atazanavir exposure. The absorption of atazanavir is pH dependent.

Although not investigated, similar results are expected with other proton pump inhibitors. Therefore, proton pump inhibitors, including rabeprazole, should not be taken concomitantly with atazanavir (see "Peculiarities of use").

Precautions

A symptomatic reaction to rabeprazole therapy does not eliminate the presence of a malignant neoplasm of the stomach or esophagus, therefore, the possibility of a malignant tumor should be ruled out before starting treatment.

Patients undergoing long-term treatment (in particular those receiving more than one year) should be monitored regularly.

The risk of cross-sensitivity reactions to another proton pump inhibitor or substituted benzimidazole cannot be ruled out.

Patients should be warned that the tablets should not be alive or broken, but should be swallowed whole.

There are post-marketing reports of pathological changes in the blood (thrombocytopenia and neutropenia). In most cases, when an alternative etiology could not be determined, the events were uncomplicated and resolved with discontinuation of rabeprazole.

Abnormalities in liver enzymes have been observed during clinical trials and have been reported since marketing authorization. In most cases, when it was impossible to determine an alternative etiology, the phenomena were uncomplicated and resolved with discontinuation of rabeprazole.

No evidence of significant safety-related problems was observed during the study of patients with mild to moderate hepatic impairment compared with age and gender matched controls. Since there is no clinical data on the use of rabeprazole in patients with severe hepatic impairment, the physician should be careful when first prescribing such patients.

The doctor should be careful when prescribing the drug in the early stages of therapy to patients with severe renal impairment, since there are no clinical data regarding the use of the drug in patients of this group.

Elevated levels of chromogranin A (CgA) can distort test results for diagnostic tests to detect neuroendocrine tumors. To avoid this, proton pump inhibitors should be discontinued at least five days prior to measuring serum chromogranin levels. If CgA and gastrin levels have not returned to normal after the initial measurement, chromogranin should be re-determined 14 days after stopping proton pump inhibitors.

Pregnancy and lactation

Pregnancy

There is no data on the safety of using rabeprazole during human pregnancy. Rabeprazole is contraindicated during pregnancy.

Breastfeeding period

It is not known whether rabeprazole sodium passes into breast milk. There have been no studies involving women during lactation, so it should not be used while breastfeeding.

Influence on the ability to drive vehicles and work with machines and mechanisms

Based on the pharmacodynamic properties and profile of side effects, it is unlikely that taking rabeprazole will impair the ability to drive or affect the ability to operate machinery. If attention is impaired due to drowsiness, it is recommended to avoid driving and difficult machinery.

"Cipmedic Laboratories"

Fargpabad-121 003, India