BAROLE Capsule

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD):

Rabeprazole is indicated for short-term (4-8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD).

Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD):

Rabeprazole is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance).

Healing of Duodenal Ulcers:

Rabeprazole is indicated for short-term (up to 4 weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within 4 weeks. It is highly effective in the presence of H.Pylori.

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

Rabeprazole is indicated for the long-term treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome.

Dosage and Administration

BAROLE should be administered before meals.

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD):

The recommended adult oral dose is 20mg to be taken daily for 4-8 weeks.

Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance):

The recommended adult oral dose is 20mg to be taken daily.

Healing of Duodenal Ulcers:

The recommended adult oral dose is 20mg to be taken daily after the morning meal for a period up to 4 weeks. Most patients with duodenal ulcer heal within 4 weeks.

Treatment of Pathological hypersecretory Conditions, including Zollinger-Ellison Syndrome:

The dosage in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 100mg QD and 60mg BID have been administered.

No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of Rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on Rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.

Barole capsules should be swallowed whole. The capsules should not be chewed, crushed or split.

In patients with known hypersensitivity to Rabeprazole, substituted benzimidazole or to any component of the formulation.

Adverse effects with Rabeprazole are mild to moderate in intensity and include malaise, diarrhea, nausea, skin eruptions, headache and dizziness.

Abnormal laboratory findings (increased hepatic enzymes, LDH, blood urea nitrogen) observed with Rabeprazole were similar in incidence and severity with comparator agents and reversible with cessation of therapy. Inform your doctor in case of any adverse reactions related to drug use.

Rabeprazole is metabolized by the CYP450 drug metabolizing enzyme system. Rabeprazole does not rave clinically significant interactions with other drugs metabolized by the CYP450 system, such as warfarin, theophylline, diazepam and phenytoin.

Rabeprazole produces sustained inhibition of gastric acid secretion. An interaction with compounds which are dependent on gastric pH for absorption like ketoconazole may occur due to the magnitude of acid suppression observed with Rabeprazole. Therefore, patients may need to be monitored when such drugs are taken concomitantly with Rabeprazole. Co-administration of Rabeprazole and antacids produced no clinically relevant changes in plasma Rabeprazole concentration.

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Since many drugs are excreted in milk, caution should be exercised when Rabeprazole is administered to a nursing mother.

General

Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric malignancy.

See the package insert about the details below:

- Pediatric use

- Geriatric use

Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that to not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+,K+ ATPase at the secretory surface of the gastric parietal cell. Because this enzyme if regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor. In gastric parietal cells, Rabeprazole is protonated, accumulates, and is transformed to an active sulfonamide.