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Zulbex - instructions for use, reviews, analogs and formulations (10 mg and 20 mg tablets) drugs for the treatment of stomach and duodenal ulcers with Helicobacter, GERD in adults, children and pregnancy. Composition

Zulbex - instructions for use, reviews, analogs and formulations (10 mg and 20 mg tablets) drugs for the treatment of stomach and duodenal ulcers with Helicobacter, GERD in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Zulbex. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Zulbeks in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Zulbeks in the presence of existing structural analogs. Use for treatment of stomach and duodenal ulcers with Helicobacter, GERD in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Zulbex - belongs to the class of antisecretory drugs, substituted benzimidazoles, which do not possess anticholinergic or antihistamine properties, and suppress gastric secretion by inhibiting the enzyme H / K-ATPase (proton pump). The effect of the drug depends on the dose and leads to suppression of basal and stimulated secretion of hydrochloric acid in the stomach, regardless of the stimulating factors. Studies in animals have shown that Rabeprazole (the active substance of the drug Zulbek) quickly disappears from the plasma and the mucous membrane of the stomach. As a weak base, rabeprazole is rapidly absorbed in all dosages and accumulates in the acidic environment of the parietal cells of the stomach. Rabeprazole is converted to the sulfonamide form by protonation and then interacts with the available proton pump cysteine ​​molecules.

 

Antisecretory effect: after taking 20 mg of Zulbek, the antisecretory effect begins to develop within 1 hour, reaching a maximum after 2-4 hours. The suppression of basal and food-stimulated hydrochloric acid secretion in the stomach after 23 hours after the first dose of rabeprazole is 69% and 82% , respectively, and lasts up to 48 hours.The inhibitory effect of rabeprazole on the secretion of hydrochloric acid with repeated doses is slightly increased, reaching an equilibrium state after 3 days. After the drug is discontinued, the secretory activity of the stomach is restored after 2-3 days.

 

It was found that rabeprazole has a bactericidal action against Helicobacter pylori (Helicobacter). Eradication of Helicobacter pylori with rabeprazole and antimicrobial agents leads to a high degree of healing of mucosal lesions. Based on the results of clinical studies, it has been established that taking 20 mg of rabeprazole 2 times a day in combination with two antibiotics, for example, Clarithromycin and Amoxicillin or clarithromycin and Metronidazole for 1 week, allows Helicobacter pylori eradication more than 80% in patients with gastroduodenal ulcers. When choosing the appropriate combination for the eradication of Helicobacter pylori should be guided by approved standards of treatment. In patients with persistent infection (in the presence of initially sensitive strains of microorganisms), it is necessary to consider the possibility of developing secondary resistance to antibacterial drugs when choosing a dosage regimen.

 

Effect on serum gastrin: in clinical trials, patients received rabeprazole 10 or 20 mg once daily for up to 43 months. The concentration of gastrin in the serum increased in the first 2-8 weeks of administration, reflecting the suppressive effect on the secretion of hydrochloric acid, and then remained stable while continuing therapy. The gastrin concentrations returned to baseline values ​​usually within 1-2 weeks after the withdrawal of therapy.

 

The biopsy specimens from the Antral part and the bottom of the stomach obtained from more than 500 patients taking rabeprazole or comparative treatment for up to 8 weeks showed no changes in the ECL-cell and histological structure, the degree of gastritis, the incidence of atrophic gastritis, intestinal metaplasia or prevalence of H. pylori infection in more than 250 patients observed during 36 months of therapy, no significant changes in the initial conditions existed.

 

Other effects: the systemic effect of rabeprazole on the central nervous system, cardiovascular and respiratory systems has not been identified to date. Rabeprazole, used internally at a dose of 20 mg for 2 weeks,no effect on the function of the thyroid gland, carbohydrate metabolism or circulating concentrations of parathyroid hormone, cortisol, estrogens, testosterone, prolactin, cholecystokinin, secretin, glucagon, follicle stimulating hormone (FSH), luteinizing hormone (LH), renin, aldosterone or somatotropic hormone.

 

Clinical studies have shown that rabeprazole does not enter into a clinically significant interaction with amoxicillin, does not adversely affect the concentration of amoxicillin or clarithromycin in blood plasma, while using these drugs to eradicate Helicobacter pylori from the upper gastrointestinal tract.

 

Composition

 

Rabeprazole sodium + excipients.

 

Pharmacokinetics

 

The drug Zulbeks is a tablets of rabeprazole, coated with an enteric (resistant in the stomach) shell. This form is due to the instability of rabeprazole in an acidic environment. Therefore, the absorption of rabeprazole begins only after the tablet has left the stomach. Suction fast. There is no clinically significant interaction associated with ingestion. Neither the food nor the time of taking the drug does not affect the absorption of rabeprazole.In humans, rabeprazole binds approximately 97% to plasma proteins. Rabeprazole, like other representatives of the proton pump inhibitor class, is metabolized in the liver, with the participation of cytochrome P450 (CYP450). Studies with human hepatic microsomes have shown that rabeprazole is metabolized by CYP450 isoenzymes (CYP2C19 and CYP3A4). In these studies, rabeprazole in the expected plasma concentrations in humans did not suppress or stimulate CYP3A4. These results indicate that no interaction is expected between rabeprazole and cyclosporin. In humans, the main metabolites found in the plasma are thioether (M1) and carboxylic acid (M6), and sulfone (M2), desmethyl thioether (M4) and conjugate with mercapturic acid (M5) are determined in smaller amounts. Only desmethyl metabolite (M3) has low antisecretory activity, but it is not determined in plasma. After a single oral intake of 20 mg of 14C-labeled rabeprazole, unchanged rabeprazole is not excreted by the kidneys. Approximately 90% of the accepted dose is excreted by the kidneys in the form of two metabolites: conjugate with mercapturic acid (M5) and carboxylic acid (M6), and also in the form of two unknown metabolites. The rest of the injected drug is found in the contents of the intestine.

 

Sex: adjusted for growth and body weight, no sex differences in the pharmacokinetic parameters of rabeprazole at a dose of 20 mg were found.

 

Elderly patients: in elderly patients the removal of rabeprazole was slightly reduced. After using rabeprazole for 7 days in a daily dose of 20 mg, the AUC increased approximately 2-fold, and Cmax increased by 60%, T1 / 2 was increased by 30% compared to healthy young volunteers. No evidence of rabeprazole accumulation was noted.

 

Indications

  • peptic ulcer of the stomach and duodenum in the phase of exacerbation;
  • gastroesophageal reflux disease (GERD): erosive reflux-esophagitis (treatment), symptomatic treatment of GERD, incl. long-term maintenance therapy;
  • Zollinger-Ellison syndrome;
  • in the complex therapy: eradication of Helicobacter pylori in patients with peptic ulcer of stomach and duodenum or chronic gastritis;
  • treatment and prevention of recurrence of peptic ulcer associated with Helicobacter pylori.

 

Forms of release

 

Tablets coated with enteric coating 10 mg and 20 mg.

 

Instructions for use and dosing regimen

 

Tablets are taken orally, whole, not liquid and not breaking.

 

With gastric ulcer and duodenal ulcer in the phase of exacerbation, the drug is prescribed 20 mg once a day, in the morning. In most patients, active duodenal ulcer heals within 4 weeks. However, some patients may need another 4 weeks for complete healing of the ulcer. Active benign gastric ulcer in most patients heals within 6 weeks. However, in a small number of patients, it may take another 6 weeks for complete healing.

 

In gastroesophageal reflux disease (GERD): erosive reflux-esophagitis (treatment), symptomatic treatment of GERD drug is prescribed at 20 mg once a day for 4 to 8 weeks. With prolonged therapy, a maintenance dose of Zulbex can be used - 10-20 mg once a day, depending on the patient's response to treatment.

 

With symptomatic treatment of GERD - 10 mg once a day in patients without esophagitis. If the symptoms can not be controlled within 4 weeks, an additional examination of the patient is necessary. After the improvement of the patient's condition, further control of the symptoms can be performed with 10 mg once daily, on demand.

 

With the Zollinger-Ellison syndrome, the recommended starting dose for adults is 60 mg 1 time per day. The dose can be increased to 120 mg per day, depending on the individual needs of the patient. You can appoint a daily dose of up to 100 mg once a day. A dose of 120 mg may require a multiple admission, 60 mg twice a day. Therapy is performed as long as there are appropriate clinical indications.

 

Eradication of Helicobacter pylori in patients with peptic ulcer of stomach and duodenum or chronic gastritis: patients with Helicobacter pylori should undergo eradication therapy.

 

The following combinations of preparations are recommended for 7 days:

 

The drug Zulbeks 20 mg twice a day + clarithromycin 500 mg 2 times a day and amoxicillin 1 g 2 times a day.

 

In patients with impaired renal and / or liver function, dose adjustment of Zulbecks is not required.

 

Side effect

  • neutropenia, leukopenia, thrombocytopenia, leukocytosis;
  • reactions of hypersensitivity (includes facial edema, decreased blood pressure, dyspnea);
  • anorexia;
  • increase in body weight;
  • hyponatremia;
  • headache;
  • dizziness;
  • insomnia;
  • drowsiness;
  • nervousness;
  • depression;
  • confusion of consciousness;
  • visual impairment;
  • peripheral edema;
  • cough;
  • pharyngitis;
  • rhinitis;
  • bronchitis;
  • sinusitis;
  • diarrhea, constipation;
  • vomiting, nausea;
  • abdominal pain;
  • flatulence;
  • dyspepsia;
  • dryness of the oral mucosa;
  • eructation;
  • gastritis;
  • stomatitis;
  • change in taste;
  • hepatitis;
  • jaundice;
  • hepatic encephalopathy (rare reports on hepatic encephalopathy in patients with concomitant cirrhosis of the liver have been obtained.) When prescribing Zulbex for the first time, patients with severe impairment of liver function are advised to exercise caution);
  • rash;
  • erythema;
  • itching;
  • sweating;
  • bullous rash;
  • erythema multiforme;
  • toxic epidermal necrolysis;
  • Stevens-Johnson syndrome (erythema, bullous reactions and hypersensitivity reactions usually pass on their own after discontinuation of the drug);
  • nonspecific pain;
  • backache;
  • myalgia;
  • cramps of the calf muscles;
  • arthralgia;
  • urinary tract infections;
  • interstitial nephritis;
  • gynecomastia;
  • asthenia;
  • influenza-like disease.

 

Contraindications

  • pregnancy (no experience of use);
  • period of breastfeeding (no experience of use);
  • children's age (no experience of application);
  • hypersensitivity to the active ingredient or auxiliary components of the drug.

 

Application in pregnancy and lactation

 

Pregnancy

 

There is no data on the safety of rabeprazole during pregnancy in humans. Reproductive studies in rats and rabbits showed no signs of impaired fertility or the harmful effects of rabeprazole on the fetus.

 

Zulbecks is not used in pregnancy.

 

Lactation

 

It is not known whether rabeprazole is secreted into human milk, but secreted into the milk of rats. Studies in women during lactation were not conducted.

 

If you need Zulbeks during lactation, breastfeeding should be discontinued.

 

Use in children

 

Due to the lack of data on the efficacy and safety of rabeprazole, Zulbecks is not used in children.

 

Application in elderly patients

 

In elderly patients, removal of rabeprazole was slightly reduced. No evidence of rabeprazole accumulation was noted. Correction of the dose of the drug is not required.

 

special instructions

 

Reducing the severity of symptoms on the background of therapy with Zulbeks does not exclude the presence of malignant tumors in the stomach or esophagus, therefore, before the start of therapy it is necessary to conduct a checkup, in order to exclude the growth of the gastrointestinal tract.

 

Patients receiving long-term therapy with Zulbecks (especially more than one year) should undergo a regular examination.

 

It is impossible to exclude the risk of cross-reactions with other proton pump inhibitors or with substituted benzimidazoles.

 

The patient should be warned that the pill must be swallowed whole, not chewing and not breaking.

 

There are reports of post-marketing research on the development of blood dyscrasias (cases of thrombocytopenia and neutropenia) on the background of the use of rabeprazole. In most cases, when it was not possible to find out the alternative causes of these conditions, they did not give complications and passed after the abolition of rabeprazole.

 

Against the background of the use of Zulbex, a change in the activity of liver enzymes that occur after the drug has been withdrawn is possible.

 

In a study in patients with mild or moderate impairment of liver function, no significant problems were noted,related to the safety of rabeprazole in comparison with the control group of healthy patients corresponding to sex and age. Due to the lack of clinical data on the use of rabeprazole in patients with severe impairment of liver function, caution should be exercised when using Zulbex in this group of patients.

 

Impact on the ability to drive vehicles

 

Based on the properties of rabeprazole, it is unlikely that the Zulbex product may interfere with the ability to drive vehicles or affect the operation of technical devices. In case of side effects (drowsiness, dizziness, confusion), you should give up driving and work, which requires an increased concentration of attention and speed of psychomotor reactions.

 

Drug Interactions

 

Zulbecks causes persistent and prolonged suppression of the secretion of hydrochloric acid in the stomach. There may be interaction with drugs, the absorption of which depends on the pH.

 

The simultaneous use of rabeprazole with Ketoconazole or Itraconazole may lead to a significant decrease in their concentration in the blood plasma, which may require a dose adjustment of these drugs.

 

Proton pump inhibitors, including rabeprazole, should not be used concomitantly with atazanavir.

 

Rabeprazole does not have a clinically significant interaction with amoxicillin and with other drugs metabolized by cytochrome CYP450 enzymes such as warfarin, phenytoin, theophylline and diazepam.

 

Zulbex slows the excretion of certain drugs metabolized in the liver by microsomal oxidation (diazepam, phenytoin, indirect anticoagulants).

 

The concentrations of rabeprazole and the active metabolite of clarithromycin in plasma with simultaneous admission are increased by 24% and 50%, respectively.

 

Rabeprazole with simultaneous application reduces the concentration of ketoconazole by 33%, Digoxin by 22%.

 

Analogues of the drug Zulbeks

 

Structural analogs for the active substance:

  • Beret;
  • Zolispan;
  • Нофлюкс;
  • Ontime;
  • Parries;
  • Rabelock;
  • Rabeprazole;
  • Rabeprazole sodium;
  • Razo;
  • Hyrabezole.

 

Analogues for the pharmacological group (proton pump inhibitors):

  • Acrylase;
  • Vimovo;
  • Gastrozole;
  • Demeprazole;
  • A zerocide;
  • Zipantola;
  • Zolser;
  • Controllers;
  • Lanzabel;
  • Lanzap;
  • Lansoprazole;
  • Lansofed;
  • Lancid;
  • Losek;
  • Nexium;
  • Nolpaz;
  • Omesol;
  • Omez;
  • Omez Insta;
  • Omeprazole;
  • Omepros;
  • Omeface;
  • Omitox;
  • Ortanol;
  • Pantaz;
  • Pantoprazole;
  • Pepazol;
  • Pepticum;
  • Pylobact;
  • Puloreph;
  • Romesque;
  • Sunpras;
  • Ulzol;
  • Ulcozol;
  • Ulter;
  • Ultop;
  • Helithrix;
  • Helicid;
  • Cisagast;
  • Esomeprazole;
  • Emanera;
  • Epicurus.

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