Rabeprazole Sodium : Uses,Dosage,Side Effects

Generic Name

Rabeprazole Sodium

Therapeutic Class: Gastro-Intestinal Disorders/Proton Pump Inhibitor

Indications:

Rabeprazole is indicated in-

• Duodenal ulcer
• Benign gastric ulcer
• Duodenal ulcer and benign gastric ulcer associated with H. pylori infection
• Healing of erosive or ulcerative Gastroesophageal Reflux Disease (GERD
• Treatment of symptomatic GERD
• Maintenance of healing of erosive or ulcerative GERD
• Prevention or treatment of NSAID-induced ulcers
• Zollinger-Ellison Syndrome.

Presentation:

Rabeprazole Sodium 20 tablet: Each enteric-coated tablet contains Rabeprazole Sodium INN 20 mg.
Rabeprazole Sodium 10 capsule: Each sprinkle capsule contains Rabeprazole Sodium INN 10 mg.

Description:
The active ingredient in Rasonix is Rabeprazole sodium, a rapid-acting proton pump inhibitor (PPI). Rabeprazole is a substituted benzimidazole that suppresses gastric acid secretion by inhibiting the gastric H+/ K+ ATPase at the secretory surface of the gastric parietal cell. This enzyme is regarded as the acid (proton) pump within the parietal cell. Rabeprazole blocks the final step of gastric acid secretion. The stability of Rabeprazole sodium depends on pH; it is rapidly degraded in acid media and is more stable under alkaline conditions. Because of its enteric-coated formulation, Rasonix is highly stable in the stomach and a higher pKa value of Rabeprazole provides faster action compared to other PPIs.

Dosage & Administration:

• Duodenal ulcer: Rasonix 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.
• Benign gastric ulcer: 20 mg daily in the morning for 6 weeks, followed by a further 6 weeks if not fully cured.
• Duodenal ulcer and benign gastric ulcer associated with H. pylori infection: Rasonix in combination with Amoxicillin and Clarithromycin as a three-drug regimen is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease. Rabeprazole offers a faster therapy option than other PPIs, up to 10 to 14 days 20 mg once daily.
• Healing of erosive or ulcerative Gastroesophageal Reflux Disease (GERD): 20 mg daily in the morning 4 to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rasonix may be considered.
•  Treatment of symptomatic GERD: The recommended adult oral dose of Rasonix is 20 mg once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
•  Maintenance of healing of erosive or ulcerative GERD: Rasonix 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.
• Prevention or treatment of NSAID-induced ulcers: Rasonix 20 mg tablet once daily, in patients receiving treatment with NSAIDs.
• Zollinger-Ellison Syndrome: The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted 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.
• Treatment of GERD in Pediatric Patients 1 to 11 Years of Age: The recommended dosage for pediatric patients 1 to 11 years of age by body weight is:

-Less than 15 kg: 5 mg once daily for up to 12 weeks with the option to increase to 10 mg if inadequate response.
-15 kg or more: 10 mg once daily for up to 12 weeks.

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

Contraindications:
Rabeprazole is contraindicated in patients with hypersensitivity to rabeprazole, other PPIs, or any of the ingredients in the formula.

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

Pregnancy & Lactation:
U.S. FDA Pregnancy Division ‘C’. Studies have been done in animals and no evidence of impaired fertility or loss of fetus due to rabeprazole has been revealed. However, there are no adequate and controlled studies of pregnant women. Rabeprazole is likely to be excreted in human milk, so the mother should decide whether to stop nursing or stop the drug, considering the importance of the drug.

Precautions:
Rabeprazole Sodium tablets should not be split, chewed or crushed.

Overdose:
There is no experience with large overdoses with Rabeprazole. The maximum reported overdose is 80 mg. There are not any clinical signs or symptoms related to any reported overdose. Patients with Zollinger-Ellison syndrome are treated with up to 120 mg Rabeprazole once daily. No specific antidote for Rabeprazole is known.

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