Generic

Rabeprazole

Therapeutic Class

Antiulcerant

Pack Size

Prompton 20 mg capsule: Each box contains 60 capsules (6 x 10's) in Alu-Alu blister pack.

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

Therapeutic Class

Antiulcerant

Dosage & Administration

Prompton® capsule should be swallowed whole. Prompton® capsule can be taken with or without food. Healing of Erosive or Ulcerative GERD The recommended adult oral dose is Prompton® capsule to be taken once daily for four to eight weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Prompton® capsule may be considered. Maintenance of Healing of Erosive or Ulcerative GERD The recommended adult oral dose is one Prompton® capsule once daily. Treatment of Symptomatic GERD The recommended adult oral dose is one Prompton® 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 Ulcers The recommended adult oral dose is one Prompton® 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 Prompton® 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 Prompton® 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 needs 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 Prompton® capsule for up to one year.

Contraindications

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

Side Effects

Rabeprazole capsules are generally well tolerated. The observed undesirable effects have been generally mild/moderate and transient in nature. The most common adverse events are headache, diarrhoea and nausea. The less common adverse effects are abdominal pain, asthenia, flatulence, rash, dry mouth etc.

Pregnancy & Lactation

Pregnancy: Pregnancy category B. 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 becasue 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.

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.

Storage Conditions

high air pressure DTH bit below 30ºC, away from light & moisture.Keep out of reach of children.