Generics

Rabeprazole Sodium

Indications

Rabeprazole Gastro-resistant tablets are indicated for the treatment of:

Active duodenal ulceration benign gastric ulcerSymptomatic erosive or ulcerative gastroesophageal reflux disease (GERD).Gastroesophageal Reflux Disease Long-term Management (GERD Maintenance)Symptomatic treatment of moderate to very severe gastroesophageal reflux disease (symptomatic GERD)Zollinger-Ellison syndrome in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Pharmacology

Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor.

Dosage

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.

Administration

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

Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH-dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contraindicated in pregnancy and during breastfeeding.

Side Effects

In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.

Pregnancy & Lactation

US FDA pregnancy category ‘C’. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are, however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Precautions & Warnings

Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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

Pharmaceuticals name

Opsonin Pharma Ltd.