Generic

Rabeprazole Sodium

Indications

Prompton® capsule is a proton pump inhibitor (PPI) indicated in adults for:
• Healing of erosive or ulcerative GERD
• Maintenance of healing of erosive or ulcerative GERD
• Treatment of symptomatic GERD
• Healing of duodenal ulcer
• Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence
• Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome

In adolescent patients 12 years of age and older for:
• Short-term treatment of symptomatic GERD

Pharmacology

Prompton® suppresses gastric acid secretion by inhibiting the gastric H+/K+ ATPase at the secretary surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Prompton® has been characterized as a gastric proton-pump inhibitor.

Dosage & Administration

Route of administration: Oral 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 4 – 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8 weeks 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 Ulcer

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.

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome

The dose 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 patient’s 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.

Short-term Treatment of Symptomatic GERDin Adolescents of 12 Years of Age and Older

The recommended oral dose is one Prompton® capsule once daily up to 8 weeks.

Interaction

a) With medicine: 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 Cytochrome 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.

b) With food & others: In studies no interaction with liquid antacid or foods was observed.

Contraindications

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

Side Effects

a) Common: 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.

b) Rare: The less common adverse effects are abdominal pain, asthenia, flatulence, rash, dry mouth etc.

Pregnancy & Lactation

Pregnancy category ‘C’ according to the US Food and Drug Administration. Rabeprazole has been studied in animals, and there has been no indication of decreased fertility or fetal damage as a result of its use. However, no appropriate and well-controlled trials in pregnant women exist. Because rabeprazole is likely to be excreted in human milk, a choice should be taken whether to cease breastfeeding or the medication, taking into consideration the risks of both.

Precautions & Warnings

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.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Store in cool & dry place below 30ºC, protect from light & moisture.
Keep out of reach of children.

Pharmaceutical Name

Radiant Pharmaceuticals Ltd.