Rabe Tablet 20mg

Presentation:

Rabe-20 Tablet: Each enteric coated tablet contains Rabeprazole Sodium BP 20 mg.

Rabe-20 Capsule: Each vegetable capsule shell contains Rabeprazole Sodium BP 20 mg as enteric coated pellets.

Indications:

- Healing of Erosive or Ulcerative GERD

- Maintenance of Healing of Erosive or Ulcerative GERD

- Treatment of Symptomatic GERD

- Healing of Duodenal Ulcers

- Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

- Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome

Dosage & Administration:

Rabe-20 Tablet or Capsule should be swallowed whole. Rabe-20 Tablet or Capsule can be taken with or without food.

Healing of Erosive or Ulcerative GERD:

The recommended adult oral dose of Rabe-20 Tablet or Capsule is once daily for four to eight weeks. For those patients who have

not healed after 8 weeks of treatment, an additional 8-weeks course of Rabe-20 Tablet or Capsule may be considered.

Maintenance of Healing of Erosive or Ulcerative GERD:

The recommended adult oral dose is one Rabe-20 Tablet or Capsule once daily.

Treatment of Symptomatic GERD:

The recommended adult oral dose is one Rabe-20 Tablet or Capsule 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 Ulcer:

The recommended adult oral dose is one Rabe-20 Tablet or Capsule once daily after the morning meal for a period up to 4 weeks.

Most patients with duodenal ulcer heal within 4 weeks. A few patients may require additional therapy to achieve healing.

Helicobacter pylori eradication to reduce the risk of Duodenal Ulcer Recurrence:

Rabe-20 (20 mg), Amoxicillin (1000 mg) & Clarithromycin (500 mg) twice daily with the morning and evening meals for 7 days.

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome:

The dosage of Rabe-20 Tablet or Capsule in patients with pathological 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 patients need and

should continue for as long as clinically indicated. Some patients may require divided doses. Some patients with Zollinger-Ellison

Syndrome have been treated continuously with Rabe-20 Tablet or Capsule for up to one year.

Contrainidications:

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

Warning & Precautions:

Administration of Rabeprazole to patients with mild to moderate liver impairment results in increased exposure and decreased

elimination. Caution should be exercised in patients with severe hepatic impairment.

Side effects:

Rabeprazole is generally well tolerated. The observed undesirable effects have been generally mild/moderate and transient in

nature. The most common adverse events are headache, diarrhea and nausea. The less common adverse effects are abdominal pain,

asthenia, flatulence, rash, dry mouth etc.

Drug interaction:

Rabeprazole like other PPIs is metabolized through Cytochrome P450 drug metabolizing enzyme system. But Rabeprazole does not have

clinically significant interaction with other drugs metabolized by CYP P450 system, such as warfarin, theophylline, diazepam and

phenytoin. Rabeprazole inhibits gastric acid secretion and may interfere with absorption of drugs where gastric pH is an important

determinant of bioavailability e.g. ketoconazole, iron salts and digoxin. In studies no interaction with liquid antacid or foods

was observed.

Use in special groups:

Use in Pregnancy:

Pregnancy:

Pregnancy category C. There are no adequate well-controlled studies in pregnant women. This drug should be used during pregnancy

only if clearly needed.

Nursing mother:

Since many drugs are excreted in milk and because of the potential for adverse reactions to nursing infants from Rabeprazole, a

decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the

mother.

Geriatric patients:

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater

sensitivity of some older individuals can not be ruled out.

Packing:

Rabe-20 Tablet:Each box contains 140\'s tablet in Alu-Alu blister within Alu-Alu pillow pack.

Rabe-20 Capsule: Each box contains 60 capsules in Alu-Alu blister within Alu-Alu pillow pack.