rabeprazole sodium 20 mg
1 INDICATIONS AND USAGE Rabeprazole Sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults 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 Risk of Duodenal Ulcer Recurrence ( 1.5 ). Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6 ). In adolescent patients 12 years of age and older for: Short-term Treatment of Symptomatic GERD ( 1.7 ). 1.1 Healing of Erosive or Ulcerative GERD in Adults Rabeprazole Sodium delayed-release tablets are 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 Rabeprazole Sodium delayed-release tablets may be considered. 1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults Rabeprazole Sodium delayed-release tablets are 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 in Adults Rabeprazole Sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks. 1.4 Healing of Duodenal Ulcers in Adults Rabeprazole Sodium delayed-release tablets are 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 in Adults Rabeprazole Sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are 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. 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 (12.2) and the full prescribing information for clarithromycin]. 1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults Rabeprazole Sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. 1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older Rabeprazole Sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
advagen pharma limited
ROUND YELLOW B 683
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING
RABEPRAZOLE SODIUM delayed-release tablets 20 mg are supplied as light yellow colored round, biconvex tablets with beveled edges and B683 printed on one side with black ink and plain on the other side. Bottles of 30 NDC#72888-059-30 Bottles of 90 NDC#72888-059-90 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature] . Protect from moisture.
More pills like ROUND B 683