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RABENEX-20/DSR (RABEPRAZOLE CAPSULES)
DESCRIPTION
The active ingredient in ACIPHEX (rabeprazole sodium) Delayed-Release Tablets and in ACIPHEX Sprinkle (rabeprazole sodium) Delayed-Release Capsules is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1H–benzimidazole sodium salt. It has an empirical formula of C18H20N3NaO3S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid.
DOSAGE
20 mg orally once a day, after the morning meal. The usual duration of therapy is four weeks in most patients, however, some patients may require additional therapy to achieve ulcer healing.
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. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor.
INDICATIONS
Short-term treatment in healing and symptomatic relief of duodenal ulcers and erosive or gastroesophageal reflux disease (GERD); maintaining healing and reducing relapse rates of heartburn symptoms in patients with GERD; treatment of daytime and nighttime heartburn and other symptoms associated with GERD; long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome and in combination with amoxicillin and clarithromycin to eradicate Helicobacter pylori.
CONTRA INDICATIONS
hypersensitivity to rabeprazole, substituted benzimidazoles or any of components of its pharmaceutical forms. lactation: Thomson Lactation Ratings: Infant risk cannot be ruled out.
SIDE EFFECTS
abdominal pains, anxiety, arthralgia, asthenia, constipation, diarrhea ,dry mouth, erythema, granulocytopenia, headache, increased or decreased appetite, insomnia, leukocytopenia, meteorism, muscle or bone pain, myalgia, nausea, skin eruption, thrombocytopenia, vertigo, vomiting.
DRUG INTERACTIONS
Rabeprazole decreases the concentration of ketoconazole in the plasma (in 33%), increases the concentration of digoxin (in 22%), and does not interact with liquid antacids. Rabeprazole is compatible with any medicine metabolized by the CYP450 (theophylline, warfarin, diazepam, phenytoin).
AVAILABILITY
RABENEX-20/DSR is available in strips of ten capsules containing RABEPRAZOLE CAPSULES.