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Label in Design HIGHLIGHTS OF PRESCRIBING INFORMATION • Bone Fracture: Long-term and multiple daily dose PPI therapy may be These highlights do not include all the information needed to use associated with an increased risk for osteoporosis-related fractures of the PRILOSEC safely and effectively. See full prescribing information for hip, wrist or spine. (5.4) PRILOSEC. • Diminished anti-platelet activity of clopidogrel due to impaired CYP2C19 function by 80 mg omeprazole (5.5) PRILOSEC (omeprazole) Delayed-Release Capsules and PRILOSEC • Hypomagnesemia has been reported rarely with prolonged treatment (omeprazole magnesium) For Delayed-Release Oral Suspension with PPIs (5.6) INITIAL U.S. APPROVAL: 1989 • Avoid concomitant use of PRILOSEC with St John’s Wort or rifampin due to the potential reduction in omeprazole concentrations (5.7, 7.3) -------------------------RECENT MAJOR CHANGES----------------------------­ • Interactions with diagnostic investigations for Neuroendocrine Tumors: Warnings and Precautions, Clostridium difficile associated 09/2012 Increases in intragastric pH may result in hypergastrinemia and diarrhea (5.3) enterochromaffin-like cell hyperplasia and increased Choromogranin A Warnings and Precautions, Concomitant use of PRILOSEC 01/2012 levels which may interfere with diagnostic investigations for with Methotrexate (5.9) neuroendocrine tumors. (5.8, 12.2) --------------------------INDICATIONS AND USAGE----------------------------­ -------------------------------ADVERSE REACTIONS--------------------------­ PRILOSEC is a proton pump inhibitor indicated for: Adults: Most common adverse reactions in adults (incidence ≥ 2%) are • Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2) • Headache, abdominal pain, nausea, diarrhea, vomiting, and • Treatment in adults and children of gastroesophageal reflux disease flatulence (6) (GERD) (1.3) and maintenance of healing of erosive esophagitis (1.4) Pediatric patients (1 to 16 years of age): The safety and effectiveness of PRILOSEC in pediatric patients <1 year of Safety profile similar to that in adults, except that respiratory system age have not been established. (8.4) events and fever were the most frequently reported reactions in pediatric studies (8.4) -----------------------DOSAGE AND ADMINISTRATION----------------------­ To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca Indication Omeprazole Dose Frequency at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Treatment of Active 20 mg Once daily for 4 weeks. Some Duodenal Ulcer (2.1) patients may require an --------------------------------DRUG INTERACTIONS--------------------------­ additional 4 weeks • Atazanavir and nelfinavir: PRILOSEC reduces plasma levels of H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (2.2) atazanavir and nelfinavir. Concomitant use is not recommended (7.1) Triple Therapy: • Saquinavir: PRILOSEC increases plasma levels of saquinavir. Monitor PRILOSEC 20 mg Each drug twice daily for 10 for toxicity and consider dose reduction of saquinavir (7.1) Amoxicillin 1000 mg days • May interfere with drugs for which gastric pH affects bioavailability Clarithromycin 500 mg (e.g., ketoconazole, iron salts, ampicillin esters, and digoxin). Patients Dual Therapy: treated with PRILOSEC and digoxin may need to be monitored for PRILOSEC 40 mg Once daily for 14 days increases in digoxin toxicity (7.2) Clarithromycin 500 mg Three times daily for 14 days • Co-administration of clopidogrel with 80 mg omeprazole may reduce the Gastric Ulcer (2.3) 40 mg Once daily for 4 to 8 weeks pharmacological activity of clopidogrel if given concomitantly or if GERD (2.4) 20 mg Once daily for 4 to 8 weeks given 12 hours apart (7) Maintenance of Healing of 20 mg Once daily • Cilostazol: PRILOSEC increases systemic exposure of cilostazol and Erosive Esophagitis (2.5) one of its active metabolites. Consider dose reduction of cilostazol.(7.3) Pathological Hypersecretory 60 mg (varies with Once daily • Drugs metabolized by cytochrome P450 (e.g., diazepam, warfarin, Conditions (2.6) individual patient) phenytoin, cyclosporine, disulfiram, benzodiazepines): PRILOSEC can Pediatric Patients prolong their elimination. Monitor and determine need for dose (1 to 16 years of age) (2.7) Weight Dose adjustments (7.3) GERD And Maintenance 5 < 10 kg 5 mg Once daily • Patients treated with proton pump inhibitors and warfarin may need to of Healing of Erosive 10< 20 kg 10 mg be monitored for increases in INR and prothrombin time (7.3) Esophagitis > 20 kg 20 mg • Combined inhibitor of CYP 2C19 and 3A4 (e.g. voriconazole) may raise omeprazole levels (7.3) ----------------------DOSAGE FORMS AND STRENGTHS--------------------­ • Tacrolimus: PRILOSEC may increase serum levels of tacrolimus (7.4) • PRILOSEC Delayed-Release Capsules, 10 mg, 20 mg and 40 mg (3) • Methotrexate: PRILOSEC may increase serum levels of methotrexate • PRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg (3) (7.7) ---------------------------CONTRAINDICATIONS-------------------------------­ ------------------------USE IN SPECIFIC POPULATIONS----------------------­ Known hypersensitivity to any component of the formulation or substituted Patients with hepatic impairment: benzimidazoles (angioedema and anaphylaxis have occurred) (4) Consider dose reduction, particularly for maintenance of healing of erosive esophagitis (12.3) -----------------------WARNINGS AND PRECAUTIONS-----------------------­ • Symptomatic response does not preclude the presence of gastric -----See 17 for Patient Counseling Information and FDA approved malignancy (5.1) medication guide----­ • Atrophic gastritis: has been noted with long-term therapy (5.2) REVISED 09/2012 • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. (5.3) _______________________________________________________________________________________________________________________ Reference ID: 3196017 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 1.1 Duodenal Ulcer (adults) 7.1 Interference with Antiretroviral Therapy 1.2 Gastric Ulcer (adults) 7.2 Drugs for Which Gastric pH Can Affect Bioavailability 1.3 Treatment of Gastroesophageal Reflux Disease (GERD) 7.3 Effects on Hepatic Metabolism/Cytochrome P-450 Pathways (adults and pediatric patients) 7.4 Tacrolimus 1.4 Maintenance of Healing of Erosive Esophagitis (adults) 7.5 Interactions with Investigations of Neuroendocrine Tumors 1.5 Pathological Hypersecretory Conditions 7.6 Combination Therapy with Clarithromycin 2 DOSAGE AND ADMINISTRATION 7.7 Methotrexate 2.1 Short-Term Treatment of Active Duodenal Ulcer 8 USE IN SPECIFIC POPULATIONS 2.2 H. pylori Eradication for the Reduction of the Risk of 8.1 Pregnancy Duodenal Ulcer Recurrence 8.3 Nursing Mothers 2.3 Gastric Ulcer 8.4 Pediatric Use 2.4 Gastroesophageal Reflux Disease (GERD) 8.5 Geriatric Use 2.5 Maintenance of Healing of Erosive Esophagitis 8.6 Hepatic Impairment 2.6 Pathological Hypersecretory Conditions 8.7 Renal Impairment 2.7 Pediatric Patients 8.8 Asian Population 2.8 Alternative Administration Options 10 OVERDOSAGE 2.9 Use with clopidogrel 11 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics 5.1 Concomitant Gastric Malignancy 12.3 Pharmacokinetics 5.2 Atrophic Gastritis 12.4 Microbiology 5.3 Clostridium difficile associated diarrhea 13 NONCLINICAL TOXICOLOGY 5.4 Bone Fracture 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.5 Diminished anti-platelet activity of clopidogrel due to 13.2 Animal Toxicology and/or Pharmacology impaired CYP2C19 function by omeprazole 14 CLINICAL STUDIES 5.6 Hypomagnesemia 14.1 Duodenal Ulcer Disease 5.7 Comcomitant Use of PRILOSEC with St John’s Wort or 14.2 Gastric Ulcer rifampin 14.3 Gastroesophageal Reflux Disease (GERD) 5.8 Interactions with Diagnostic Investigations for 14.4 Erosive Esophagitis Neuroendocrine Tumors 14.5 Pathological Hypersecretory Conditions 5.9 Concomitant use of PRILOSEC with Methotrexate 14.6 Pediatric GERD 6 ADVERSE REACTIONS 15 REFERENCES 6.1 Clinical Trials Experience with PRILOSEC Monotherapy 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Clinical Trials Experience with PRILOSEC in Combination 17 PATIENT COUNSELING INFORMATION Therapy for H. pylori Eradication *Sections or subsections omitted from the full prescribing information are 6.3 Post-marketing Experience not listed. _______________________________________________________________________________________________________________________ Reference ID: 3196017 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Duodenal Ulcer (adults) PRILOSEC is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. PRILOSEC in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. PRILOSEC in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)]. Among patients who fail therapy, PRILOSEC with clarithromycin is more likely to be associated with the development
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