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Rubee

Generic Name: Rabeprazole Sodium

Therapeutic Class: ANTI-ULCERANTS


Dosage Form: Tablet


View Prescribing


  • Presentation
  • Description
  • Indications
  • Dosage & Administration
  • Side Effect
  • Precautions
  • Contraindications
  • Drug Interaction
  • Storage

Presentation

Rubee

Rubee 20 Tablet  Each enteric coated tablet contains Rabeprazole Sodium INN 20 mg.

Description

Rabeprazole Sodium is an antiulcerant drug in the class of Proton Pump Inhibitors. Rabeprazole Sodium is a substituted benzimidazole which suppresses gastric acid secretion by inhibiting the gastric H+/K+ ATPase enzyme at the secretory surface of the gastric parietal cell. It is an enteric coated tablet, because of its coated formulation it is highly stable in stomach and because of higher pKa value of Rabeprazole Sodium it provides faster onset of action. It blocks the final step of gastric acid secretion. After oral administration of 20 mg, Rabeprazole is absorbed and can be detected in plasma by 1 hour. The effects of food on the absorption of Rabeprazole have not been evaluated. Rabeprazole is 96.3% bound to human plasma proteins. Rabeprazole is primarily metabolized in the liver by Cytochrome P-450 3A (Sulphone metabolite) and 2C19 (Desmethyl Rabeprazole). Following a single 20 mg oral dose of Rabeprazole, approximately 90% of the drug is eliminated in the urine. The remainder of the dose is excreted in the feaces.

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Indication

  • Short-term treatment in healing and symptomatic relief of duodenal ulcers and erosive or ulcerative Gastroesophageal Reflux Disease (GERD).
  • Maintaining healing and reducing relapse rates of heartburn symptoms in patients with GERD.
  • Treatment of daytime and night time heartburn and other symptoms associated with GERD.
  • Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
In combination with Amoxicillin and Clarithromycin to eradicate Helicobacter pylori.

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Dosage & Administration

  • Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): 20 mg to be taken once daily for 4 to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course may be considered.
  • Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance): The recommended adult oral dose is 20 mg once daily.
  • Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose 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.
  • Healing of Duodenal Ulcers: The recommended adult oral dose is 20 mg once daily after the morning meal for a period up to four weeks. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.
  • Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence:

Rabeprazole Sodium

20 mg

Twice Daily for 7 Days

Amoxicillin

1000 mg

Twice Daily for 7 Days

Clarithromycin

500 mg

Twice Daily for 7 Days

All three medications should be taken twice daily with the morning and evening meals. It is important that patients comply with the full 7-day regimen.

Treatment of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome: The dosage of Rabeprazole Sodium in patients with pathologic hypersecretory conditions varies with the individual patient. 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 QD and 60 mg BID have been administered. Some patients with Zollinger-Ellision syndrome have been treated continuously with Rabeprazole Sodium for up to one year.

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Side Effect

Rabeprazole Sodium may some times cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness and dizziness.

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Precautions

Pregnant women: Rabeprazole is FDA pregnancy category B. No data are available on administration of Rabeprazole to pregnant women. However this drug should be used during pregnancy, only if clearly needed. Lactating mother: There are no data on the excretion of Rabeprazole into the breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother. Pediatric use: The safety and effectiveness of Rabeprazole in pediatric patients have not been established.

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Contraindications

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

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Drug Interaction

No drug interaction is reported.

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Storage

Store in cool & dry place, away from children.

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