Razo pills 20mg 30pcs

Composition

Each enteric coated tablet contains 20 mg: Active ingredient: Rabeprazole sodium 20 mg Excipients: Low-substituted mannitolgiprolosis Magnesium Oxide Heavy Hypromellose (5cps)Sodium Laurylsulfataltalmagnesium Stearatobolochka: Zein Triethyl Citrate The shell is enteric: Methacrylic acid and ethyl acrylate copolymer [1: 1] (Methacrylic acid copolymer (Type C)) Triethyl Citrate Talc shell: Opadray yellow OY-52945 (hypromellose 5 cP, Titanium dioxide (E 171) macrogol-400 Iron Oxide Yellow dye (E172)) Composition of red ink for writing on a tablet 20 mg: Shellac glaze 45%Dye Red charming (E 129) N-butanol Denatured ethanol Titanium Dioxide (E 171) Propylene glycol isopropyl alcohol Ammonia solution concentrated 28%

Pharmacological action

Pharmacodynamics Mechanism of action Rabeprazole belongs to the class of antisecretory agents that are chemically substituted with benzimidazoles. Rabeprazole inhibits the activity of the H+/K+ATPASE enzyme (“proton pump”), thereby blocking the final stage of hydrochloric acid synthesis. This effect is dose-dependent and leads to inhibition of both basal and stimulated hydrochloric acid secretion, regardless of the stimulus. Rabeprazole has no anticholinergic properties. Antisecretory activityafter oral use of 20 mg of rabeprazole, the antisecretory effect occurs within an hour. Inhibition of basal and stimulated hydrochloric acid secretion 23 hours after the first dose of rabeprazole is 62% and 82%, respectively, and lasts up to 48 hours. This duration of pharmacokinetic action is much longer than the predictable half-life (T1/2), which is approximately 1 hour. This effect can be explained by the binding of the drug to the H+/K+ATPASE of gastric parietal cells. The inhibitory effect of rabeprazole on acid secretion reaches a plateau after three days of taking rabeprazole. Upon discontinuation of the drug, secretory activity is restored within 1-2 days. Effect on the concentration of gastrin in the blood serum At the beginning of rabeprazole therapy, the concentration of gastrin in the blood serum increases, which is a reflection of the inhibitory effect on the secretion of hydrochloric acid. Gastrin concentrations usually return to baseline levels within 1-2 weeks after discontinuation of treatment. Effect on enterochromaffin-like cellsexamination of fundus and antral gastric biopsy samples from more than 500 patients treated with rabeprazole or a reference drug lasting up to 8 weeks did not reveal changes in the morphological structure of enterochromaffin-like (ECL) cells, the severity of gastritis, the frequency of atrophic gastritis, intestinal metaplasia, or the prevalence of Helicobacter pylori infection. In a study involving more than 400 patients treated with rabeprazole at a dose of 10 mg/day or 20 mg/day, lasting up to 1 year, the incidence of hyperplasia was low and comparable to that of patients treated with omeprazole at a dose of 20 mg / day. There were no cases of adenomatous changes or carcinoid tumors observed in rats. Other Effectsthere is currently no evidence that rabeprazole causes systemic effects from the central nervous system( CNS), cardiovascular and respiratory systems. When taken orally at a dose of 20 mg for 2 weeks, rabeprazole does not affect thyroid function, carbohydrate metabolism, as well as blood concentrations of parathyroid hormone, cortisol, estrogen, testosterone, prolactin, secretin, glucagon, follicle-stimulating hormone, luteinizing hormone, renin, aldosterone and somatotropin. Pharmacokineticsabsorption Rabeprazole is rapidly absorbed from the intestine, and its maximum plasma concentration (Cmax) is reached approximately 3.5 hours after taking a dose of 20 mg. Changes in the Cmax and area under the pharmacokinetic curve “concentration-time” (AUC) of rabeprazole are linear in the dose range from 10 to 40 mg. The absolute bioavailability after oral use of 20 mg (compared to intravenous use) is about 52%. In addition, the bioavailability does not change with repeated use of rabeprazole. Neither the time of taking the drug during the day, nor antacids do not affect the absorption of rabeprazole. Taking rabeprazole with fatty foods slows the absorption of rabeprazole by 4 hours or more, but neither Cmax nor the degree of absorption changes. Distribution In humans, the degree of binding of rabeprazole to plasma proteins is about 97%. Metabolism Rabeprazole is metabolized in the body in two ways. A significant part of it is metabolized systemically in a nonenzymatic way with the formation of thioester derivatives. Rabeprazole is also metabolized in the liver by cytochrome P 450 to form sulfonic and desmethyl derivatives. In healthy volunteers, the plasma half-life is about 1 hour (varies from 0.7 to 1.5 hours), and the total clearance is 3.8 ml / min/kg. Excretion After a single oral dose of 20 mg of 14C-labeled rabeprazole, about 90% of rabeprazole is excreted by the kidneys, mainly in the form of carboxylic acid thioester, its glucuronide, and mercapturic acid derivatives. Unchanged rabeprazole is not detected in the urine. The remainder of the rabeprazole taken is excreted through the intestines. The total elimination rate is 99.8%. End-stage renal insufficiencyin patients with stable end-stage renal insufficiency who require maintenance hemodialysis (creatinine clearance AUC and Cmax in these patients were approximately 35% lower than in healthy volunteers. The average T1/2 of rabeprazole was 0.82 hours in healthy volunteers,0.95 hours in patients during hemodialysis, and 3.6 hours after hemodialysis. The clearance of rabeprazole in patients with kidney disease requiring hemodialysis was approximately twice as high as in healthy volunteers. Chronic compensated cirrhosis Patients with chronic compensated cirrhosis of the liver tolerate rabeprazole at a dose of 20 mg once a day, although the AUC is doubled and Cmax is increased by 50%, compared with healthy volunteers. Elderly patients In elderly patients, the elimination of rabeprazole is somewhat delayed. After 7 days of taking rabeprazole at a dose of 20 mg once a day, the AUC was approximately twice as high and the Cmax was increased by 60% in elderly subjects compared to young healthy volunteers; there were no signs of accumulation of rabeprazole. CYP2C19 polymorphism in patients with delayed metabolism by the CYP2C19 isoenzyme 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 with the same parameters in “fast metabolizers”, while Cmax increases by 40%.

Indications

• Peptic ulcer in the acute stage and anastomosis ulcer;

• ulcer disease of the duodenum in the acute phase;

• ulcerative and erosive gastroesophageal reflux disease, or reflux esophagitis;

• maintenance therapy of gastroesophageal reflux disease;

• non-erosive gastroesophageal reflux disease;

• zollingerellison syndrome, and other conditions characterized by pathological hypersecretion;

• in combination with appropriate antibacterial therapy for Helicobacter pylori eradication in patients with peptic ulcer disease.

Use during pregnancy and lactation

There are no data on the safety of rabeprazole use during pregnancy. Reproductive studies in rats and rabbits have shown no signs of fertility disorders or fetal defects caused by rabeprazole; however, in rats, small amounts of the drug penetrate the placental barrier. The drug Razo® should not be used during pregnancy, except in cases where the expected positive effect for the mother exceeds the possible harm to the fetus. It is not known whether rabeprazole passes into breast milk. No relevant studies have been conducted in lactating women. However, rabeprazole is found in the milk of lactating rats, so the drug should not be used in nursing women.

Contraindications

Hypersensitivity to rabeprazole, substituted benzimidazoles or auxiliary components of the drug; pregnancy; breast-feeding period; children under 12 years of age. With caution: Severe renal failure, children’s age (over 12 years).

Side effects

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 frequency of side effects is described in accordance with the following gradation:  very often (>1/10);>

• often (1/10-1/100);

• infrequently (1/100 – 1/1000);

• rarely (1/1000 – 1/10000);

• very rarely ( 

Immune system disorders

• Rarely – acute systemic allergic reactions.

• Disorders of the blood and lymphatic system

• Rarely-thrombocytopenia, neutropenia, leukopenia.

• Metabolic and nutritional disorders

• Rarely-hypomagnesemia.

Disorders of the hepatobiliary system Occasionally-increased activity of “liver” enzymes, hepatitis, jaundice, hepatic encephalopathy.Kidney and urinary tract disorders

• Very rarely – interstitial nephritis.

Skin and subcutaneous tissue disorders

• Rarely-bullous rashes, urticaria;
• very rarely-erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Musculoskeletal and connective tissue disorders

• Rarely-myalgia, arthralgia.

Reproductive system disorders

• Very rarely – gynecomastia.

No changes in laboratory parameters were observed during rabeprazole use. When taking proton pump inhibitors, the risk of bone fractures may increase (see the section “Special instructions”).

Interaction

When used concomitantly with digoxin, it is possible to increase (from small to moderate) the concentration of digoxin in blood plasma.

When used concomitantly with ketoconazole, its bioavailability decreases.

How to take, course of use and dosage

Razo ® tablets are taken orally whole, without chewing or grinding. 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 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. In case of acute duodenal ulcer disease, it is recommended to take 20 mg orally 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. In the treatment of erosive and ulcerative gastroesophageal reflux disease or reflux esophagitis, it is recommended to take 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, it is recommended to take 20 mg orally once a day. The duration of treatment depends on the patient’s condition. For non-erosive gastroesophageal reflux disease, it is recommended to take 20 mg orally once a day. If after four weeks of treatment the symptoms do not disappear, an additional examination of the patient should be performed. After the symptoms are relieved, the drug should be taken orally once a day on demand to prevent their subsequent occurrence. For the treatment of Zollinger-Ellison 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-Ellison syndrome, the duration of treatment with rabeprazole may be up to one year. To eliminate Helicobacter pylori, it is recommended to take 20 mg twice a day orally according to a certain scheme with an appropriate combination of antibiotics. The duration of treatment is 7 days. 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 Razo to patients with severe hepatic insufficiency. Elderly patients: No dose adjustment is required. The safety and efficacy of rabeprazole in children aged 12 years and older has been established for short-term (up to 8 weeks) treatment of GERD. The recommended dose for children aged 12 years and older is 20 mg once a day for up to 8 weeks. The safety and efficacy of rabeprazole in paediatric patients for other indications has not been established.

Special instructions

The patient’s response to rabeprazole therapy does not exclude the presence of malignancies in the stomach. Razo ® 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 using rabeprazole for the first time in patients with severe hepatic impairment. The AUC of rabeprazole in patients with severe hepatic impairment is approximately twice as high as in healthy patients. Patients with impaired renal or hepatic function do not need to adjust the dose of rabeprazole. 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 hypomagnesaemia, 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. Patients should not take other acid-reducing agents, such as H2-receptor blockers or proton pump inhibitors, at the same time as rabeprazole. Bone Fracturesaccording to observational studies, it can be assumed that therapy with proton pump inhibitors may lead to an increased risk of hip, wrist, or spine fractures associated with osteoporosis. The risk of fractures was increased in patients who received high doses of PPIs for a long time (one year or more). Concomitant use of rabeprazole with methotrexate According to literature data, concomitant use of PPIs with methotrexate (especially in high doses) may lead to an increase in the concentration of methotrexate and / or its metabolite hydroxymethotrexate and increase the elimination half-life, which may lead to methotrexate toxicity. If high doses of methotrexate are required, temporary discontinuation of PPI therapy may be considered. Clostridium Difficile Therapy may increase the risk of gastrointestinal infections such as Clostridium difficile. Based on the specific pharmacodynamics of rabeprazole and its undesirable effects profile, it is unlikely that rabeprazole affects the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions. However, in case of drowsiness or dizziness, these activities should be avoided.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf

life is 2 years (in cans),3 years (in blisters). Do not use after the expiration date indicated on the package.

Active ingredient

Rabeprazole

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults by doctor’s prescription, Children by doctor’s prescription, Children over 12 years of age

Indications

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