"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
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Axid (nizatidine) is indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with Axid (nizatidine) for longer than 1 year are not known.
Axid (nizatidine) is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
DOSAGE AND ADMINISTRATION
Active Duodenal Ulcer — The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.
Maintenance of Healed Duodenal Ulcer — The recommended oral dosage for adults is 150 mg once daily at bedtime.
Gastroesophageal Reflux Disease — The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150mg twice daily.
Active Benign Gastric Ulcer — The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
Active Duodenal Ulcer, GERD and Benign Gastric Ulcer
150 mg daily
150 mg every other day
150 mg every other day
150 mg every 3 days
Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.
Axid (nizatidine) ® Pulvules®* are available in:
The 150-mg Pulvules are imprinted with "150" on the opaque dark yellow cap and "AXID (nizatidine) " and "Reliant" on the opaque pale yellow body, using black ink. They are available as follows:
|Bottles of 60Â||NDC 65726-144-15|
The 300-mg Pulvules are imprinted with "300" on the opaque brown cap and "AXID (nizatidine) " and "Reliant" on the opaque pale yellow body, using black ink. They are available as follows:
|Bottles of 30||NDC 65726-145-10|
*Pulvules® (filled gelatin capsules, Lilly)
Store at controlled room temperature 20° to 25°C (68° to 77°F) in a tightly closed container [see USP].
The USP defines controlled room temperature as: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.
Distributed by: Reliant Pharmaceuticals, Inc. Liberty Corner, NJ 07938, USA
Address Medical Inquiries to: Reliant Pharmaceuticals, Inc.
Medical Affairs 110 Allen Road
Liberty Corner, NJ 07938, USA © 2005 Reliant Pharmaceuticals, Inc., 214R400, PRINTED IN U.S.A.
FDA revision date:12/23/05
Last reviewed on RxList: 2/14/2006
This monograph has been modified to include the generic and brand name in many instances.
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