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 treatment 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 combination with appropriate antimicrobial treatment regimens.

Pharmacology

Rabeprazole inhibits the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell, which decreases gastric acid secretion. 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 substance 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 together with Respite, individual patients may need to be watched to see if a dosage adjustment 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 taken with atazanavir.

Contraindications

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

Side Effects

Rabeprazole is generally well-tolerated in both short and long-term studies. Headache, diarrhoea, abdominal discomfort, vomiting, constipation, dry mouth, increased or decreased hunger, muscle 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 evidence of reduced fertility or injury to the fetus as a result of its use. However, no suitable and well-controlled studies 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 importance to the mother.

Precautions & Warnings

Because a symptomatic response to Rabeprazole therapy does not rule out the presence of stomach or esophageal cancer, the potential of cancer should be ruled out before starting treatment with Rabeprazole 20 mg Gastro-resistant Tablets.Patients on long-term treatment (especially those who have been on it for more than a year) should be monitored on a frequent basis.

Proton pump inhibitors, especially when used in high dosages and for long periods of time (>1 year), can raise the risk of hip, wrist, and spine fractures, especially in the elderly or in the presence of other known risk factors. Proton pump inhibitors may increase total blood pressure, according to observational studies.

It’s impossible to rule out the possibility of cross-hypersensitivity interactions with other proton pump inhibitors or substituted benzimidazoles.

Rabeprazole gastro-resistant pills should not be chewed or mashed, but rather eaten whole.

Post-marketing reports of blood dyscrasias have been reported (thrombocytopenia and neutropenia). When an alternate aetiology could not be found, the occurrences were usually straightforward and resolved after the rabeprazole was stopped.

It’s impossible to rule out the possibility of cross-hypersensitivity interactions with other proton pump inhibitors or substituted benzimidazoles.

Rabeprazole gastro-resistant pills should not be chewed or mashed, but rather eaten whole.

Post-marketing reports of blood dyscrasias have been reported (thrombocytopenia and neutropenia). When an alternate aetiology could not be found, the occurrences were usually straightforward and resolved after the rabeprazole was stopped.

A study of patients with mild to moderate hepatic impairment compared to normal age and sex matched controls found no evidence of substantial drug-related safety issues. However, because there is no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction, prescribers should be cautious while using Rabeprazole 20mg Gastro-resistant. In such patients, tablet therapy is started first. It is not suggested to take atazanavir and Rabeprazole together. Proton pump inhibitors, such as rabeprazole, have been linked to an increased risk of gastrointestinal infections such Salmonella, Campylobacter, and Clostridium difficile.

Hypomagnesaemia: Patients on PPIs like rabeprazole for at least three months, and in most cases for a year, have been documented to have severe hypomagnesaemia. Hypomagnesaemia can cause serious symptoms like weariness, tetany, delirium, convulsions, dizziness, and cardiac arrhythmia, although it can start slowly and go unnoticed. After magnesium replenishment and termination of the PPI, hypomagnesaemia improved in the majority of affected patients. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children’s reach.

Pharmaceutical Name

General Pharmaceuticals Ltd.