Buy Hirabesol capsules 20 mg 30 pcs
  • Buy Hirabesol capsules 20 mg 30 pcs

Rabeprazole

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2019-09-19
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Clinical Pharmacology

a remedy that decreases the secretion of the gastric glands - the proton pump inhibitor.

Indications

Peptic ulcer in the acute stage and ulcer anastomosis;
Duodenal ulcer in the acute stage;
Erosive and ulcerative gastroesophageal reflux disease or reflux esophagitis;
Supportive therapy for gastroesophageal reflux disease;
Non-erosive gastroesophageal reflux disease;
Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion;
In combination with appropriate antibiotic therapy for the eradication of Helicobacter pylori in patients with peptic ulcer.

Composition

Active ingredient: rabeprazole sodium - 20 mg.
Auxiliary ingredients: magnesium oxide 69 mg, mannitol 40 mg, corn starch 2.5 mg, povidon-K30 1.5 mg, low substituted hyprolosis 24 mg, sodium fumarate 2 mg.
Shell: 18 mg cellulose, 1.6 mg titanium dioxide, iron dye yellow oxide 0.16 mg.

Rabeprazole is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Hirabesol HiGlance Laboratories Pvt. Ltd India capsules
Rabeprazol-SZ North Star Russia capsules
Rabiet Obolensky OP Russia capsules
Razo Dr. Reddy`s India pills
Rabeloc® Cadilla India pills
Rabeloc® Cadilla India vials
Pariet Bush Pharmaceuticals Japan pills
Hirabesol HiGlance Laboratories Pvt. Ltd India pills
Zulbex Krka dd Novo mesto AO Slovenia pills

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Rabeprazole

Dosage and Administration

For oral use pills should be swallowed whole, not chewed or crushed. It is established that neither the time of day nor food intake affect the activity of rabeprazole.

When gastric ulcer in the acute stage and ulcer anastomosis: on 10 or 20 mg once a day. Usually, a cure occurs after 6 weeks of therapy, but in some cases the duration of treatment may be increased by another 6 weeks.

When duodenal ulcer in the acute stage: on 20 mg once a day. In some cases, the therapeutic effect occurs when taking 10 mg 1 time per day. The duration of treatment is from 2 to 4 weeks. If necessary, the duration of treatment can be increased by another 4 weeks.

In the treatment of erosive GERD or reflux esophagitis on 10 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 maintenance therapy of GERD on 10 or 20 mg once a day. The duration of treatment depends on the condition of the patient.

With non-erosive GERD (NERD) without esophagitis on 10 or 20 mg once a day.

If after 4 weeks of treatment the symptoms do not disappear, additional research should be carried out on the patient. 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 as required.

For the treatment of Zollinger-Alison syndrome and other conditions characterized by pathological hypersecretion, dose is selected individually. The initial dose is 60 mg per day, then the dose is increased and the drug is administered in a dose of up to 100 mg per day with a single dose or 60 mg 2 times a day. For some patients, fractional dosing of the drug is preferred. Treatment should continue as needed. In some patients with Zollinger-Alison syndrome, the duration of treatment with rabeprazole is up to one year.

For the treatment of duodenal ulcer or chronic gastritis associated with H. pylori infection, A treatment course of 7 days is recommended for one of the following combinations of drugs:

  • Hirabesol 20 mg 2 times a day + clarithromycin 500 mg 2 times a day and amoxicillin 1 g 2 times a day.
  • Hirabesol 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 insufficiency. Dose adjustment in patients with renal insufficiency is not required.

In patients with mild and moderate hepatic insufficiency, the concentration of rabeprazole in the blood is usually higher than in healthy patients.

Caution should be exercised in prescribing Hirabesol in patients with severe hepatic insufficiency.

Elderly patients. Dose adjustment is not required.

Children. The safety and efficacy of rabeprazole 20 mg for short-term (up to 8 weeks) treatment of GERD in children aged 12 years and more is confirmed by extrapolating the results of adequate and well-controlled studies that support the effectiveness of rabeprazole for adults in safety and pharmacokinetics for children of children. The recommended dose for children aged 12 years or 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 years has not been established. The safety and efficacy of rabeprazole for use in other indications has not been established for pediatric patients.

Adverse reactions

  • abdominal pain, nausea, loose stools or constipation
  • headache, dizziness
  • runny nose, cough
  • decrease in the number of leukocytes, blood platelets
  • allergic reactions.

Contraindications

WITHcaution It should be prescribed for severe liver failure, severe renal failure.

Drug interactions

The drug Hirabesol does not interact with liquid antacids.In the case of drowsiness, you should abandon driving a car and other activities that require high concentration of attention. When taken together, the drug Hirabesol reduces the effect.

Pregnancy and Lactation

Rabeprazole should not be given to pregnant women (there are no data on the safety of using rabeprazole during pregnancy). At the time of treatment should stop breastfeeding. It is not known whether rabeprazole is excreted in breast milk. Relevant studies in nursing women have not been conducted.

Special instructions

The patient's response to rabeprazole therapy does not exclude the presence of malignant tumors in the stomach. pills drug Hirabesol should not be chewed or crushed. pills should be swallowed whole. It is established that neither the time of day nor food intake affect the activity of rabeprazole.

In a special study in patients with mild or moderate liver dysfunction, there was no significant difference in the incidence of side effects of rabeprazole from that in healthy individuals matched by gender and age, but despite this it is recommended to use caution when first prescribing rabeprazole to patients with severely impaired liver function.

Patients with impaired renal or hepatic function do not need to adjust the dose of Hirabesol. AUC of rabeprazole in patients with severely impaired liver function is approximately 2 times higher than in healthy patients.

Hypomagnesemia. In the treatment of proton pump inhibitors for at least 3 months, in rare cases, there have been cases of symptomatic or asymptomatic hypomagnesemia. In most cases, these messages were received one year after the treatment. Serious side effects were tetany, arrhythmia, and seizures. Most patients required treatment for hypomagnesemia, including the replacement of magnesium and the abolition of therapy with proton pump inhibitors. For patients who will receive long-term treatment or who are taking proton pump inhibitors with drugs such as digoxin, or drugs that can cause hypomagnesemia (such as diuretics), medical professionals should monitor magnesium levels before starting treatment with proton pump inhibitors and during treatment.

Fractures. According to observational studies, it can be assumed that therapy with proton pump inhibitors may lead to an increase in the risk associated with osteoporosis of fractures of the hip, wrist, and spine. The risk of fractures was increased in patients who took high doses of proton pump inhibitors for a year or more.

Overdosage

Symptoms: data on intentional or accidental overdose is minimal. No cases of severe overdose with rabeprazole have been reported.

Treatment: The specific antidote for rabeprazole is unknown. Rabeprazole binds well to plasma proteins and is therefore poorly excreted during dialysis. In case of overdose, symptomatic and supportive treatment is necessary.

  • Brand name: Hirabesol
  • Active ingredient: Rabeprazole
  • Dosage form: Enteric-coated film capsules
  • Manufacturer: ResortMedservis

Studies and clinical trials of Rabeprazole (Click to expand)

  1. Liquid chromatographic–mass spectrometry analysis and pharmacokinetic studies of a novel rabeprazole formulation, sterile powder for injection, in dogs and rats
  2. Simultaneous estimation of four proton pump inhibitors—lansoprazole, omeprazole, pantoprazole and rabeprazole: development of a novel generic HPLC-UV method and its application to clinical pharmacokinetic study
  3. Enantioseparation of rabeprazole and omeprazole by nonaqueous capillary electrophoresis with an ephedrine-based ionic liquid as the chiral selector
  4. A New Furoxan NO-Donor Rabeprazole Derivative and Related Compounds
  5. Enantioselective Disposition of Lansoprazole and Rabeprazole in Human Plasma
  6. Synthetic Studies Connected with the Preparation of H+/K+-ATPase Inhibitors Rabeprazole and Lansoprazole.
  7. Synthetic studies connected with the preparation of h+/k+-ATPase inhibitors rabeprazole and lansoprazole
  8. Identification of degradation products in stressed tablets of Rabeprazole sodium by HPLC-hyphenated techniques
  9. Effect of pharmaceutical excipients on aqueous stability of rabeprazole sodium
  10. Application of instrumental evaluation of color for the pre-formulation and formulation of rabeprazole
  11. Quantification of rabeprazole in human plasma by liquid chromatography–tandem mass spectrometry
  12. Different dosage regimens of rabeprazole for nocturnal gastric acid inhibition in relation to cytochrome P450 2C19 genotype status
  13. Comparison of an increased dosage regimen of rabeprazole versus a concomitant dosage regimen of famotidine with rabeprazole for nocturnal gastric acid inhibition in relation to cytochrome P450 2C19 genotypes
  14. Acid-suppressive effects of rabeprazole, omeprazole, and lansoprazole at reduced and standard doses: A crossover comparative study in homozygous extensive metabolizers of cytochrome P450 2C19
  15. Direct injection, column switching–liquid chromatographic technique for the estimation of rabeprazole in bioequivalence study
  16. High-performance liquid chromatography method for the quantification of rabeprazole in human plasma using solid-phase extraction
  17. Determination of rabeprazole and its active metabolite, rabeprazole thioether in human plasma by column-switching high-performance liquid chromatography and its application to pharmacokinetic study
  18. Simple quantification of lansoprazole and rabeprazole concentrations in human serum by liquid chromatography/tandem mass spectrometry
  19. Determination of rabeprazole enantiomers and their metabolites by high-performance liquid chromatography with solid-phase extraction
  20. Development and validation of a dissolution test for rabeprazole sodium in coated tablets
  21. Identification and characterization of potential impurities of rabeprazole sodium
  22. Structural elucidation of rabeprazole sodium photodegradation products
  23. Identification, isolation and characterization of new impurity in rabeprazole sodium
  24. Spectrophotometric simultaneous determination of Rabeprazole Sodium and Itopride Hydrochloride in capsule dosage form

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