Generic Aciphex

What it is used for

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 reduc

How it is taken

2 DOSAGE AND ADMINISTRATION Indication Recommended Dosage ( 2 ) Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) 20 mg once daily for 4 to 8 weeks Maintenance of Healing of Erosive or Ulcerative GERD* studied for 12 months 20 mg once daily* Symptomatic GERD in Adults 20 mg once daily for 4 weeks Healing of Duodenal Ulcers 20 mg once daily after morning meal for up to 4 weeks Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Three Drug Regimen: Rabeprazole sodium delayed-release tablets 20 mg Amoxicillin 1,000 mg Clarithromycin 500 mg All three medications should be taken twice daily with morning and evening meals for 7 days. Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome Starting dose 60 mg once daily then adjust to patient needs Symptomatic GERD in Adolescents 12 Years of Age and Older 20 mg once daily for up to 8 weeks Administration Instructions ( 2 ) : Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush or split the tablets. For the treatment of duodenal ulcers take rabeprazole sodium delayed-release tablets after a meal. For Helicobacter pylori eradication take rabeprazo

Warnings

5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing ( 5.1 ). Use with Warfarin : Monitor for increases in INR and prothrombin time ( 5.2 , 7 ). Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients ( 5.3 ). Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk of ( 5.4 ). Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine ( 5.5 ). Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutatneous adverse reactions or other signs of hypersensitivity and consider further evaluation ( 5.6 ). Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous, new onset or exacerbation of existing disease; discontinue rabeprazole sodium delayed-release tablets and refer to specialist for evaluation ( 5.7 ). Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorpt

Source: openFDA / DailyMed. Provided for information only — always follow the directions given by your own prescriber.