Generic

Rabeprazole Sodium

Indications

Rabeprazole Gastro-resistant pills are used to treat the following conditions: Active duodenal ulcers

Gastric ulcer that is active and benign

Gastroesophageal reflux disease (GERD) that is symptomatic, erosive, or ulcerative (GERD).

Gastro-esophageal Reflux Disease (GERD) is a disease that affects the esophagus and Long-term planning (GERD Maintenance)

Symptomatic therapy for gastroesophageal reflux disease (GERD) ranging from mild to severe (symptomatic GERD)

Syndrome of Zollinger-Ellison

Helicobacter pylori eradication in patients with peptic ulcer disease in conjunction with suitable antimicrobial treatment regimens.

Pharmacology

Rabeprazole inhibits the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell, which reduces gastric acid production. Rabeprazole has been classified as a gastric proton-pump inhibitor since this enzyme is thought to be the acid (proton) pump within the parietal cell.

Dosage & Administration

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

Interaction

Gastric acid secretion is profoundly and long-lastingly inhibited by respite. It’s possible that you’ll come into contact with a chemical whose absorption is pH-dependent. When rabeprazole sodium is used with ketoconazole or itraconazole, antifungal plasma levels may be significantly reduced. When ketoconazole or itraconazole are used along with Respite, individual patients may need to be evaluated to see whether a dose change is necessary. There was no interaction with liquid antacids. Atazanavir’s absorption is pH-dependent. As a result, PPIs, such as rabeprazole, should not be used with atazanavir.

Contraindications

Hypersensitivity to the active ingredient or any excipient. Rabeprazole is not recommended during pregnancy or nursing.

Side Effect

Rabeprazole is generally well tolerated in both short and long-term trials. Headache, diarrhoea, stomach discomfort, vomiting, constipation, dry mouth, increased or decreased hunger, muscular soreness, sleepiness, and dizziness are all possible side effects of rabeprazole.

Pregnancy & Lactation

Pregnancy category ‘C’ according to the US Food and Drug Administration. Rabeprazole has been studied in animals, and there has been no indication of reduced fertility or damage to the fetus as a result of its use. However, no appropriate and well-controlled trials in pregnant women have been conducted. Because rabeprazole is likely to be excreted in human milk, a choice should be taken on whether to stop breastfeeding or stop taking the medication, taking into account the drug’s value to the mother.

Precautions & Warnings

The symptom response of rabeprazole treatment cannot exclude the presence of gastric or esophageal malignancies, so the possibility of malignant tumors should be ruled out before starting treatment with rabeprazole 20 mg gastric-resistant tablets.

Long-term patients (especially those who have been treated for more than one year) should be monitored regularly.

Proton pump inhibitors, especially if used in high doses and for a long time (> 1 year), may moderately increase the risk of hip, wrist and spine fractures, mainly in the elderly or those with other known risk factors Case. Observational studies have shown that proton pump inhibitors may increase the overall risk of fracture by 10% to 40%. Part of the reason for this increase may be other risk factors. Patients at risk for osteoporosis should be cared for and should get enough vitamin D and calcium.

The risk of allergic cross-reactions with other proton pump inhibitors or substituted benzimidazoles cannot be ruled out.

Patients should be advised that rabeprazole enteric-coated tablets should not be chewed or crushed, but should be swallowed whole.

There are post-marketing reports of blood cachexia (thrombocytopenia and neutropenia). In most cases where an alternative cause cannot be determined, the event is not complicated and will resolve after stopping rabeprazole.

Abnormal liver enzymes have been found in clinical trials and have also been reported from the market. In most cases where an alternative cause cannot be determined, the event is not complicated and will resolve after stopping rabeprazole.

In a study of patients with mild to moderate liver damage and normal age- and sex-matched controls, no evidence of significant drug-related safety concerns was found. However, since there are no clinical data on the use of rabeprazole in patients with severe hepatic dysfunction, it is recommended that prescribers be cautious when using rabeprazole 20 mg for gastro-resistant therapy. The tablets were used for the first time in these patients.

Co-administration of atazanavir and rabeprazole is not recommended.

Treatment with proton pump inhibitors (including rabeprazole) may increase the risk of gastrointestinal infections, such as Salmonella, Campylobacter, and Clostridium difficile.

Hypomagnesaemia: Reportedly, patients receiving rabeprazole and other PPI treatment for at least three months and, in most cases, patients aged 1 year have severe hypomagnesaemia. Severe manifestations of hypomagnesemia, such as fatigue, hand and foot spasms, delirium, seizures, dizziness, and ventricular arrhythmia can occur, but can begin during the incubation period and be ignored. In most affected patients, hypomagnesemia improved after magnesium replacement and discontinuation of PPIs. For patients expected to require long-term treatment or taking PPIs and digoxin or medications that can cause hypomagnesemia (such as diuretics), healthcare professionals should consider regularly measuring magnesium levels before and during PPI treatment. .

Effect on vitamin B12 absorption: Like all acid blockers, rabeprazole sodium can reduce the absorption of vitamin B12 (cyanocobalamin) due to insufficient gastric acid or hyperacidity. This should be taken into account if the patient’s body storage is reduced or risk factors for reduced vitamin B12 absorption during long-term treatment or corresponding clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very rare cases of SCLE. If injuries occur, especially to areas of the skin exposed to the sun, accompanied by joint pain, the patient should seek medical help immediately and health professionals should consider discontinuing rabeprazole. SCLE after previous treatment with proton pump inhibitors may increase the risk of SCLE after the use of other proton pump inhibitors.

Interference with laboratory testing: Elevated levels of chromogranin A (CgA) may interfere with neuroendocrine tumor research. To avoid this interference, the treatment with rabeprazole 20 mg gastric anti-pill should be stopped for at least 5 days before the CgA measurement. If the CgA and gastrin levels do not return to the reference range after the initial measurement, the measurement should be repeated 14 days after stopping treatment with proton pump inhibitors.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Pharmaceutical Name

Drug International Ltd.