About Rabeprazole Sodium (Amorphous & Form Y) API
Therapeutic CategoryGastrointestinal (GI)
CAS Number
117976-90-6
API Technology
Sintética
Dose Form
Cápsula/ Tableta
Dr Reddy's Development Status
Disponible
Available Regulatory Filing
USDMF, CEP Enviado, DMF de Brasil, EUDMF, DMF de Canadá, DMF de Rusia, DMF de China
Mechanism of Action
"Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-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. When studied in vitro, rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds. It inhibits acid transport in porcine gastric vesicles with a half-life of 90 seconds."
Indication
ACIPHEX 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
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