EZERAB

Each enteric coated tablets contains:

(Rabeprazole Sodium IP 20 mg)

Tablet for Oral Use

Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that suppress gastric acid secretion by inhibiting the gastric H⁺/K⁺ATPase (hydrogen-potassium adenosine triphosphatase) 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.

Absorption: Rabeprazole has an absolute bioavailability upon oral administration of approximately 52%. Maximal plasma concentrations are reached after approximately 3-4 hr. Concentrations increase proportionally with the dose.

Distribution: Rabeprazole is extensively distributed in a variety of tissues, including the gastric mucosa, stomach, kidney, bladder, liver, intestine, and thyroid (volume of distribution, 0.34 L/kg) Protein Binding: The plasma protein binding of Rabeprazole varies in humans ranging from 94.8% to 97.5%

Metabolism &Excretion: Rabeprazole is metabolized through the hepatic cytochrome P (CYP) 450 enzyme system (CYP3A4 and CYP2C19). Following oral administration of 20 mg of radiolabelled Rabeprazole, about 90% of the dose is excreted in urine, mainly as two inactive metabolites and their glucuronides, mercapturic acid and carboxylic acid. The remainder of the dose is recovered in faeces

Half Life: The terminal elimination half-life (t_½) was up to 1hr

• To prevent injury to the esophagus or stomach in patients with gastroesophageal reflux disease (GERD)
• Peptic Ulcer Disease
• Zollinger Ellision Syndrome
• H. Pylori Infection
• Gastritis

ADVERSE REACTION:

The more common side effects of Rabeprazole include: headache, pain in the abdomen (stomach area), sore throat, gas, infection, constipation, and diarrhea

Serious side effects and their symptoms include: Low levels of magnesium (a mineral). Severe diarrhea (caused by infection with C. difficile), Cutaneous lupus erythematosus (CLE), Systemic lupus erythematosus (SLE).