Aciphex 20 MG Enteric Coated Tablet
1 INDICATIONS AND USAGE Enter section text here ACIPHEX is a proton-pump inhibitor indicated for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1 ) Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2 ) Treatment of Symptomatic GERD ( 1.3 ) Healing of Duodenal Ulcers ( 1.4 ) Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 1.5 ) Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6 ) ACIPHEX is a proton-pump inhibitor indicated for adolescent patients 12 years of age and above for: Short-term treatment of Symptomatic GERD ( 1.3 ) 1.1 Healing of Erosive or Ulcerative GERD ACIPHEX is indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered. 1.2 Maintenance of Healing of Erosive of Ulcerative GERD ACIPHEX is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months. 1.3 Treatment of Symptomatic GERD ACIPHEX is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults and adolescents 12 years of age and above. 1.4 Healing of Duodenal Ulcers ACIPHEX is indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks. 1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ACIPHEX in combination with amoxicillin and clarithromycin as a three drug regimen, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. {See CLINICAL STUDIES ( 14.5 ) and DOSAGE AND ADMINISTRATION ( 2.5 )} In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. {See CLINICAL PHARMACOLOGY, Microbiology ( 12.2 ) and the clarithromycin package insert, CLINICAL PHARMACOLOGY, Microbiology } 1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ACIPHEX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Physicians Total Care, Inc.
ROUND YELLOW ACIPHEX 20
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16 HOW SUPPLIED/STORAGE AND HANDLING ACIPHEX 20 mg is supplied as delayed-release light yellow enteric-coated tablets. The name and strength, in mg, (ACIPHEX 20) is imprinted on one side. Bottles of 30 NDC 54868-4185-0 Bottles of 60 NDC 54868-4185-2 Bottles of 90 NDC 54868-4185-1 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature] Protect from moisture.
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