RABEPRAZOLE  20 MG cap E.C.

Category: Proton Pump Inhibitor.

INDICATIONS: Healing, Maintenance of Healing, of Erosive or Ulcerative GERD, Treatment of Symptomatic GERD, Healing of Duodenal Ulcers, Treatment of Pathological Hypersecretory Conditions.

DOSAGE AND ADMINISTRATION: Rabeprazole tablets should be swallowed whole. The tablets should not be chewed, crushed, or split. Rabeprazole can be taken with or without food.

Healing of Erosive or Ulcerative GERD: The recommended adult oral dose is one rabeprazole 20 mg tablet 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 may be considered.

Maintenance of Healing of Erosive or Ulcerative GERD: The recommended adult oral dose is one Rabeprazole 20 mg tablet to be taken once daily.

Treatment of Symptomatic GERD: The recommended adult oral dose is one Rabeprazole 20 mg tablet to be taken 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 Rabeprazole 20 mg tablet to be taken 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.

Treatment of Pathological Hypersecretory Conditions: The dosage of Rabeprazole 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-Ellison syndrome have been treated continuously for up to one year.

Short-term Treatment of GERD in Adolescent Patients 12 Years of Age and Above: The recommended oral dose for adolescents 12 years of age and above is 20 mg once daily for up to 8 weeks.

CLINICAL PHARMACOLOGY: Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do 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. Rabeprazole is extensively metabolized. The thioether and sulphone are the primary metabolites measured in human plasma. These metabolites were not observed to have significant antisecretory activity.Studies have demonstrated that rabeprazole is metabolized in the liver primarily by cytochromes.approximately 90% of the drug was eliminated in the urine, primarily as thioether carboxylic acid; its glucuronide, and mercapturic acid metabolites. The remainder of the dose was recovered in the feces.

CONTRAINDICATIONS: Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation.

PRECAUTIONS:

Pregnancy: Pregnancy Category B.

Nursing Mothers: a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of RABEPRAZOLE-NAJO® for the treatment of GERD patients < 12 years of age have not been established.

No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.

SIDE EFFECTS: Rare but important: Apnea, Convulsions, Anemia, Agranulocytosis, Leukopenia, Neutropenia, thrombocytopenia, Hematuria and Hepatitis.

DRUG INTERACTION: Cyclosporine, Digoxin, ketoconazole and Warfarin.

How Supplied: Each Package of Rabeprazole-Najo contains 2 Blisters and 28 Tablets.

storage: Store at controlled room temperature to 30°C. Protect from light and moisture.

For more information please refer to:

USPDI for Professional Health Care, 2007, page: 2481.

IRAN NAJO PHARMACEUTICAL COMPANY

www.irannajo.com
Address: No. 153, West Hoveiseh, Sabounchi St., Sohrevardi Ave., Tehran 1533693317, Iran
Tel: +9821-88747363   Fax: +9821-88740644   info@irannajo.com