Rablet 20

Generic

Rabeprazole Sodium

 

Indications

Rabeprazole antigastric tablets are suitable for the treatment of: 
 *active duodenal ulcer 
 *active benign gastric ulcer 
 *symptomatic erosive or ulcerative gastroesophageal reflux disease (GERD). 
 *Long-term treatment of gastroesophageal reflux disease (GERD maintenance) 
 *Symptomatic treatment of moderate to very severe gastroesophageal reflux disease (symptomatic GERD) 
 *Zollinger-Ellison syndrome 
 *Combine with appropriate antibacterial therapy to eradicate Helicobacter pylori Helicobacter pylori patients.

 

Pharmacology

Rabeprazole inhibits gastric acid secretion by inhibiting the secretion of gastric ATPase H + / K + on the surface of gastric parietal cells. Because this enzyme is considered to be an acid (proton) pump in parietal cells, rabeprazole is classified as a gastric proton pump inhibitor.

 

Dosage & Administration

1) Duodenal ulcer: Rablet 20 mg tablet in the morning is indicated for 4 weeks treatment in the healing and symptomatic relief of duodenal ulcer. Most patients heal within 4 weeks.

2) Healing of erosive or ulcerative Gastroesophageal Reflux Disease (GERD): Rablet 20 mg daily in the morning for 4 to 8 weeks. Those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rablet may be considered.

3) Treatment of symptomatic GERD: The recommended adult oral dose of Rablet is 20 mg once daily in the morning for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.

4) Zollinger-Ellison Syndrome: The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted according to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg once daily and 60 mg twice daily have been administered.

5) Maintenance of healing of erosive or ulcerative GERD: Rablet is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative GERD maintenance. Controlled studies do not extend beyond 12 months.

 

Interactions

Rabeprazole is metabolized by the cytochrome P-450 (CYP-450) enzyme system. Studies in healthy subjects have shown that Rabeprazole does not have clinically significant interactions with other drugs metabolized by the CYP-450 system, such as warfarin and theophylline given as single oral doses, diazepam as a single intravenous dose, and phenytoin given as a single intravenous dose.

 

Contraindications

Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, other PPIs or to any component of the formulation.

 

Side Effects

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

 

Pregnancy

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

Rablet tablets should not be splited, chewed or crushed.

 

Therapeutic Class

Proton Pump Inhibitor

 

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

 

Pharmaceutical Name

NIPRO JMI Pharma Ltd.