Hyrabezol pills 20mg, 30pcs

Composition

Active Ingredient: rabeprazole sodium — 20 mg. Auxiliary ingredients: magnesium oxide 69 mg, mannitol 40 mg, corn starch 2.5 mg, povidone-K 30 1.5 mg, low-substituted hyprolose 24 mg, sodium stearyl fumarate 2 mg. Shell: cellacefate 18 mg, titanium dioxide 1.6 mg, iron oxide yellow dye 0.16 mg

Pharmacological action

Means that reduces the secretion of gastric glands-proton pump inhibitor.

Pharmacodynamics

An anti-ulcer agent from the group of proton pump inhibitors (H+/K+-ATPASE), it is metabolized in the parietal cells of the stomach to active sulfonamide derivatives that inactivate the sulfhydryl groups of H+/K+ – ATPASE.

Blocks the final stage of hydrochloric acid secretion, reducing the content of basal and stimulated secretion, regardless of the nature of the stimulus.

It has a high lipophilicity, easily penetrates the parietal cells of the stomach and concentrates in them, having a cytoprotective effect.

The antisecretory effect after oral use of 20 mg occurs within 1 hour and reaches a maximum in 2-4 hours; inhibition of basal and food — stimulated acid secretion 23 hours after the first dose is 62% and 82%, respectively; duration of action-48 hours. After the end of the reception, secretory activity normalizes within 2-3 days.

In the first 2-8 weeks of therapy, the concentration of gastrin in the blood serum increases and returns to baseline levels within 1-2 weeks after discontinuation of the drug. It does not affect the central nervous system, cardiovascular and respiratory systems. Pharmacokinetics

Absorption occurs in the small intestine (due to the presence of an acid-resistant enteric membrane) is high, the time to reach the maximum concentration is 3.5 hours. The values of the maximum concentration (Cmax) and the area under the Active ingredient concentration — time curve (AUC) are linear in the dose range from 10 to 40 mg. It is metabolized in the liver with the participation of cytochrome P-450 isoenzymes CYP2C19 and CYP3A4. Bioavailability — 52%, does not increase with repeated use. Half-life (T1 / 2) – 0.7-1.5 hours, clearance-283 ± 98 ml / min. In patients with mild or moderate chronic hepatic insufficiency after a single dose, AUC increases by 2 times, T1 / 2-by 2-3 times. After taking 20 mg of rabeprazole for 7 days, the AUC increases by 1.5 times, T1 / 2-by 1.2 times. In patients with stable end-stage renal failure requiring hemodialysis (creatinine clearance less than 5 ml/min/1.73 m2), the distribution of rabeprazole sodium is close to that in healthy individuals. In elderly patients, after taking rabeprazole for 7 days, the AUC is 2 times higher, the Cmax is 60% higher than in young patients. Binding to plasma proteins is 97%. Excreted by the kidneys-90% in the form of two metabolites: a conjugate of mercapturic acid (M5) and carbolic acid (M6); intestines — 10%. In patients with delayed CYP2C19 metabolism, after 7 days of taking rabeprazole at a dose of 20 mg per day, the AUC increases by 1.9 times, and the half-life by 1.6 times compared to the same parameters in “fast metabolizers”, while Cmax increases by 40%.

Indications

Acute gastric ulcer and anastomotic ulcer;Acute duodenal ulcer;Erosive and ulcerative gastroesophageal reflux disease or reflux esophagitis;Maintenance therapy for gastroesophageal reflux disease;Non-erosive gastroesophageal reflux disease;Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion;In combination with appropriate antibacterial therapy for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Use during pregnancy and lactation

Rabeprazole should not be prescribed to pregnant women (there are no data on the safety of rabeprazole during pregnancy). Breast-feeding should be discontinued for the duration of treatment. It is not known whether rabeprazole is excreted in breast milk. No relevant studies have been conducted in lactating women.

Recommendations for use

Hairabezol tablets should not be chewed or crushed. Tablets should be swallowed whole. It was found that neither the time of day nor food intake affect the activity of rabeprazole. In case of acute gastric ulcer and anastomotic ulcer, it is recommended to take 10 mg or 20 mg orally once a day. Usually, recovery occurs after 6 weeks of therapy, but in some cases, the duration of treatment can be extended by another 6 weeks. In case of acute duodenal ulcer disease, it is recommended to take 20 mg orally once a day. In some cases, the therapeutic effect 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 extended by another 4 weeks. When treating erosive gastroesophageal reflux disease (GERD) or reflux esophagitis, it is recommended to take 10 mg or 20 mg orally once a day. The duration of treatment is from 4 to 8 weeks. If necessary, the duration of treatment can be extended by another 8 weeks. For maintenance therapy of gastroesophageal reflux disease (GERD), it is recommended to take 10 mg or 20 mg orally once a day. The duration of treatment depends on the patient’s condition. For non-erosive gastroesophageal reflux disease (GERD) without esophagitis, it is recommended to take 10 mg or 20 mg orally once a day. If the symptoms persist after four weeks of treatment, additional testing of the patient should be performed. After the relief of symptoms, to prevent their subsequent occurrence, the drug should be taken orally at a dose of 10 mg once a day on request. For the treatment of Zollinger-Allison syndrome and other conditions characterized by pathological hypersecretion, the dose is selected individually. The initial dose is 60 mg per day, then the dose is increased and the drug is prescribed at a dose of up to 100 mg per day with a single dose or 60 mg twice a day. For some patients, fractional dosage of the drug is preferred. Treatment should be continued as clinically necessary. In some patients with Zollinger-Allison syndrome, the duration of treatment with rabeprazole is up to one year. For the treatment of duodenal ulcer disease or chronic gastritis associated with H. pylori infection, a course of treatment lasting 7 days is recommended with one of the following drug combinations: : Hyrabezol 20 mg 2 times a day + clarithromycin 500 mg 2 times a day and amoxicillin 1 g 2 times a day. Hyrabezol 20 mg 2 times a day + clarithromycin 500 mg 2 times a day and metronidazole 400 mg 2 times a day. Patients with renal and hepatic insufficiencycorrection of the dose in patients with renal insufficiency is not required. In patients with mild to moderate hepatic insufficiency, the concentration of rabeprazole in the blood is usually higher than in healthy patients. Caution should be exercised when prescribing Hirabezol to patients with severe hepatic insufficiency. Elderly patients No dose adjustment is required. The safety and efficacy of rabeprazole 20 mg for short-term (up to 8 weeks) treatment of GERD in children aged 12 years and older is confirmed by extrapolating the results of adequate and well-controlled studies supporting the effectiveness of rabeprazole for adults and safety and pharmacokinetics studies for children. The recommended dose for children aged 12 years and over is 20 mg once a day for up to 8 weeks. The safety and efficacy of rabeprazole for the treatment of GERD in children under 12 years of age has not been established. The safety and efficacy of rabeprazole for other indications has not been established for paediatric patients.

Contraindications

Hypersensitivity to rabeprazole, substituted benzimidazoles or other auxiliary components of the drug; pregnancy; lactation; children (up to 12 years). With caution: Severe hepatic insufficiency, severe renal insufficiency.

Side effects

Based on the experience of clinical trials, it can be concluded that rabeprazole is usually well tolerated by patients. Side effects are generally mild or moderate and transient. When taking rabeprazole in clinical studies, the following side effects were noted: headache, abdominal pain, diarrhea, flatulence, constipation, dry mouth, dizziness, rash, peripheral edema. The following side effects have been reported during post-marketing use of rabeprazole: elevated liver enzymes, rarely hepatitis and jaundice. Hepatic encephalopathy has rarely been reported in patients with cirrhosis of the liver. Also, in rare cases, thrombocytopenia, neutropenia, leukopenia, bullous rashes, urticaria, acute systemic allergic reactions, myalgia, arthralgia, hypomagnesemia were noted. Interstitial nephritis, gynecomastia, erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome have been reported very rarely. According to post-marketing surveillance data, taking proton pump inhibitors may increase the risk of fractures (see the section “Special instructions”).

Interaction

Rabeprazole slows down the elimination of certain drugs that are metabolized in the liver by microsomal oxidation (diazepam, phenytoin, indirect anticoagulants). Reduces the concentration of ketoconazole by 33%, digoxin-by 22%. It does not interact with liquid antacids. It is compatible with drugs that are metabolized by the CYP450 system (warfarin, phenytoin, theophylline, diazepam).

Overdose

Symptoms:Data on intentional or accidental overdose are minimal. There were no cases of severe overdose with rabeprazole. Treatment:The specific antidote for rabeprazole is unknown. Rabeprazole binds well to plasma proteins, and therefore is poorly excreted during dialysis. In case of overdose, it is necessary to carry out symptomatic and supportive treatment.

Special instructions

The patient’s response to rabeprazole therapy does not exclude the presence of malignancies in the stomach. Hairabezol tablets should not be chewed or crushed. Tablets should be swallowed whole. It was found that neither the time of day nor food intake affect the activity of rabeprazole. In a special study in patients with mild or moderate hepatic impairment, there was no significant difference in the frequency of side effects of rabeprazole from those in healthy individuals selected by gender and age, but, despite this, caution is recommended when first prescribing rabeprazole to patients with severe hepatic impairment. Patients with impaired renal or hepatic function do not need to adjust the dose of Hayrabezol. The AUC of rabeprazole in patients with severe hepatic impairment is approximately twice as high as in healthy patients. Hypomagnesemia When treated with proton pump inhibitors for at least 3 months, cases of symptomatic or asymptomatic hypomagnesemia have been reported in rare cases. In most cases, these reports were received one year after therapy. Serious adverse events included tetany, arrhythmia, and seizures. Most patients required treatment for hypomagnesemia, including magnesium replacement and discontinuation of proton pump inhibitor therapy. In patients who will be receiving long-term treatment or who are taking proton pump inhibitors with medications such as digoxin or medications that may cause hypomagnesemia (such as diuretics), healthcare professionals should monitor their magnesium levels before starting treatment with proton pump inhibitors and during treatment. According to observational studies, therapy with proton pump inhibitors can lead to an increased risk of hip, wrist, and spine fractures associated with osteoporosis. The risk of fractures was increased in patients who took high doses of proton pump inhibitors for a year or more.

Storage conditions

Store in a dry place, protected from light, at a temperature of 8 °C to 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Rabeprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

Children over 12 years of age, Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Gastric and duodenal ulcers, Gastrointestinal infections caused by Helicobacter Pylori, Reflux Esophagitis