Rabeprazole Sodium

What it is and how it works

Mechanism of Action Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress 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. Rabeprazole blocks the final step of gastric acid secretion. In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide.

Indications

Rabeprazole Sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: • Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) . • Maintenance of Healing of Erosive or Ulcerative GERD . • Treatment of Symptomatic GERD . • Healing of Duodenal Ulcers . • Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence . • Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome . In adolescent patients 12 years of age and older for: • Short-term Treatment of Symptomatic GERD . Healing of Erosive or Ulcerative GERD in Adults Rabeprazole Sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabeprazole Sodium delayed-release tablets may be considered.

Dosage and administration (summary)

Table 1 shows the recommended dosage of Rabeprazole Sodium delayed-release tablets in adults and adolescent patients 12 years of age and older. The use of Rabeprazole Sodium delayed-release tablets is not recommended for use in pediatric patients 1 year to less than 12 years of age because the lowest available tablet strength (20 mg) exceeds the recommended dose for these patients. Use another rabeprazole formulation for pediatric patients 1 year to less than 12 years of age.

Contraindications

• Rabeprazole Sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria . • PPIs, including Rabeprazole Sodium delayed-release tablets, are contraindicated with rilpivirine-containing products .

Warnings and precautions

• Gastric Malignancy : In adults, symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing . • Use with Warfarin : Monitor for increases in INR and prothrombin time ( 5.2 , 7 ). • Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients . • Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk of ( Error! Hyperlink reference not valid. ).

Pregnancy

Pregnancy Risk Summary There are no available human data on Rabeprazole Sodium delayed-release tablets use in pregnant women to inform the drug associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S.

Storage and supply

Rabeprazole Sodium delayed-release tablets 20 mg are supplied as light yellow colored round, biconvex tablets with beveled edges and B683 printed on one side with black ink and plain on the other side. Bottles of 30 NDC# 71205-603-30 Bottles of 60 NDC# 71205-603-60 Bottles of 90 NDC# 71205-603-90 Store at 25°C (77°F).

Source: Rabeprazole Sodium (Rabeprazole Sodium) — US FDA prescribing information, 2022-04-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.