Indications

IMPORTANT SAFETY INFORMATION

These highlights do not include all the information needed to use PRILOSEC safely and effectively. See full prescribing information for PRILOSEC.

INDICATIONS: PRILOSEC is a proton pump inhibitor (PPI) indicated for the treatment of active duodenal ulcer in adults, eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults, treatment of active benign gastric ulcer in adults, treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older, treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older, maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older, pathologic hypersecretory conditions in adults.

CONTRAINDICATIONS: Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation; patients receiving rilpivirine-containing products; refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with PRILOSEC.

WARNINGS AND PRECAUTIONS: Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing if there is suboptimal response or relapse. Consider endoscopy in elderly. Acute Interstitial Nephritis (AIN): Observed in patients taking PPIs; discontinue use if AIN develops. Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. 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. Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; avoid longer administration than medically indicated discontinue PRILOSEC and refer to specialist for evaluation if signs or symptoms consistent with cutaneous or systemic lupus erythematosus are noted. Interaction with Clopidogrel: Avoid concomitant use of PRILOSEC. Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. Interaction with St. John’s Wort or Rifampin: Avoid concomitant use of PRILOSEC. Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop PRILOSEC at least 14 days before assessing CgA levels. Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of PRILOSEC. Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy.

ADVERSE REACTIONS: Adults: Most common adverse reactions in adults (incidence ≥2%) are headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. Pediatric patients (1 to 16 years of age): Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.