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RABEPRAZOLE SODIUM
RABEPRAZOLE ORAL (ACIPHEX)
ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.
ISSUE: FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels
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DIARRHEA; LIVER PROBLEMS. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use.
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Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Swallow TABLETS whole; DO NOT cut, crush or chew. Take with plenty of water or other appropriate fluids. * Take ANTACIDS as needed for pain relief, but not within 30 minutes of taking this medicine. * Use this medicine for the full prescribed treatment period.
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* There are no adequate or well-controlled safety studies in pregnant women. NOTIFY YOUR DOCTOR IF PREGNANT or intend to become pregnant. * NOTIFY YOUR DOCTOR AS SOON AS POSSIBLE IF YOU FEEL ANY MALAISE, FATIGUE, OR DARK DISCOLORATION OF THE URINE. * If DIARRHEA develops/persists and is severe or lasts more than 2 or 3 days, call your doctor.
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Headache; Nausea; Feeling of general discomfort; Dizziness; Diarrhea; High cholesterol level; Liver problems; Low magnesium level; Increased sensitivity to sunlight; Muscle weakness.
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If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY.
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients.
Copyright © CliniDATA Source, Inc. 03/14. All rights reserved
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