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PRILOSEC Delayed-Release Capsules: 10 Mg, 20 Mg and 40 Mg (3) PRILOSEC Safely and Effectively

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PRILOSEC Delayed-Release Capsules: 10 Mg, 20 Mg and 40 Mg (3) PRILOSEC Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------- DOSAGE FORMS AND STRENGTHS -------------------­ These highlights do not include all the information needed to use PRILOSEC delayed-release capsules: 10 mg, 20 mg and 40 mg (3) PRILOSEC safely and effectively. See full prescribing information for PRILOSEC for delayed-release oral suspension: 2.5 mg and 10 mg unit PRILOSEC. dose packets (3) ® PRILOSEC (omeprazole) delayed-release capsules ----- --------------------------CONTRAINDICATIONS ---------------------------­ ® PRILOSEC (omeprazole magnesium) for delayed-release oral Patients with known hypersensitivity to substituted benzimidazoles or suspension any component of the formulation. (4) Initial U.S. Approval: 1989 Patients receiving rilpivirine-containing products. (4, 7) Refer to the Contraindications section of the prescribing information for -------------------------- RECENT MAJOR CHANGES -------------------------­ clarithromycin and amoxicillin, when administered in combination with Warnings and Precautions, Fundic Gland Polyps (5.12) 06/2018 PRILOSEC. (4) --------------------------- INDICATIONS AND USAGE -------------------------­ ----------------------- WARNINGS AND PRECAUTIONS ---------------------­ PRILOSEC is a proton pump inhibitor (PPI) indicated for the: Gastric Malignancy: In adults, symptomatic response does not preclude Treatment of active duodenal ulcer in adults (1.1) the presence of gastric malignancy. Consider additional follow-up and Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer diagnostic testing. (5.1) recurrence in adults (1.2) Acute Interstitial Nephritis: Observed in patients taking PPIs. (5.2) Treatment of active benign gastric ulcer in adults (1.3) Clostridium difficile-Associated Diarrhea: PPI therapy may be Treatment of symptomatic gastroesophageal reflux disease (GERD) in associated with increased risk. (5.3) patients 1 year of age and older (1.4) Bone Fracture: Long-term and multiple daily dose PPI therapy may be Treatment of erosive esophagitis (EE) due to acid-mediated GERD in associated with an increased risk for osteoporosis-related fractures of the patients 1 month of age and older (1.5) hip, wrist or spine. (5.4) Maintenance of healing of EE due to acid-mediated GERD in patients 1 Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new year of age and older (1.6) onset or exacerbation of existing disease; discontinue PRILOSEC and Pathologic hypersecretory conditions in adults (1.7) refer to specialist for evaluation. (5.5) Interaction with Clopidogrel: Avoid concomitant use of PRILOSEC. ---------------------- DOSAGE AND ADMINISTRATION ---------------------­ (5.6, 7) Indication Recommended Adult (2.1) and Pediatric Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., Dosage (2.2) longer than 3 years) may lead to malabsorption or a deficiency of Treatment of Active 20 mg once daily for 4 weeks; some patients cyanocobalamin. (5.7) Duodenal Ulcer may require an additional 4 weeks (2.1) Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (5.8) Triple Therapy: Interaction with St. John’s Wort or Rifampin: Avoid concomitant use of PRILOSEC 20 mg Each drug twice daily for 10 PRILOSEC. (5.9, 7) Amoxicillin 1000 mg days (2.1)* Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Clarithromycin 500 mg Increased Chromogranin A (CgA) levels may interfere with diagnostic Dual Therapy: investigations for neuroendocrine tumors; temporarily stop PRILOSEC PRILOSEC 40 mg once daily for 14 days** at least 14 days before assessing CgA levels. (5.10, 7) Clarithromycin 500 mg three times daily for 14 days (2.1) Interaction with Methotrexate: Concomitant use with PPIs may elevate Active Benign Gastric 40 mg once daily for 4 to 8 weeks (2.1) and/or prolong serum concentrations of methotrexate and/or its Ulcer metabolite, possibly leading to toxicity. With high dose methotrexate Symptomatic GERD 20 mg once daily for up to 4 weeks (2.1) administration, consider a temporary withdrawal of PRILOSEC. (5.11, See full prescribing information for weight 7) based dosing in pediatric patients 1 year of Fundic Gland Polyps: Risk increases with long-term use, especially age and older (2.2) beyond one year. Use the shortest duration of therapy. (5.12) EE due to Acid-Mediated 20 mg once daily for 4 to 8 weeks (2.1)*** ------------------------------ ADVERSE REACTIONS ----------------------------­ GERD See full prescribing information for weight Adults: Most common adverse reactions in adults (incidence ≥2%) are based dosing in pediatric patients 1 month of age and older (2.2) Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. (6) Maintenance of Healing 20 mg once daily (2.1)**** Pediatric patients (1 to 16 years of age): of EE due to Acid- See full prescribing information for weight Safety profile similar to that in adults, except that respiratory system Mediated GERD based dosing in pediatric patients 1 year of events and fever were the most frequently reported reactions in pediatric age and older (2.2) studies. (8.4) Pathological Starting dose is 60 mg once daily (varies Hypersecretory with individual patient, see full prescribing To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma Conditions information) as long as clinically indicated at 1--866-488-4423 or FDA at 1-800-FDA-1088 or (2.1) www.fda.gov/medwatch. * if ulcer present, continue PRILOSEC 20 mg once daily for an additional 18 days. ------------------------------ DRUG INTERACTIONS ----------------------------­ ** if ulcer present, continue PRILOSEC 20 mg once daily for an additional 14 See full prescribing information for a list of clinically important drug days. interactions. (7) *** an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered. See 17 for PATIENT COUNSELING INFORMATION and Medication **** studied for 12 months. Reduce the dosage to 10 mg once daily for Guide. patients with hepatic impairment (Child-Pugh Class A, B, or C) and Asian Revised: 06/2018 patients (8.6, 8.7) Reference ID: 4274291 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 1.1 Treatment of Active Duodenal Ulcer 8 USE IN SPECIFIC POPULATIONS 1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer 8.1 Pregnancy Recurrence 8.2 Lactation 1.3 Treatment of Active Benign Gastric Ulcer 8.4 Pediatric Use 1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) 8.5 Geriatric Use 1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD 8.6 Hepatic Impairment 1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD 8.7 Asian Population 1.7 Pathological Hypersecretory Conditions 10 OVERDOSAGE 2 DOSAGE AND ADMINISTRATION 11 DESCRIPTION 2.1 Recommended Adult Dosage Regimen by Indication 12 CLINICAL PHARMACOLOGY 2.2 Recommended Pediatric Dosage Regimen by Indication 12.1 Mechanism of Action 2.3 Administration Instructions 12.2 Pharmacodynamics 3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics 4 CONTRAINDICATIONS 12.4 Microbiology 5 WARNINGS AND PRECAUTIONS 12.5 Pharmacogenomics 5.1 Presence of Gastric Malignancy 13 NONCLINICAL TOXICOLOGY 5.2 Acute Interstitial Nephritis 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.3 Clostridium difficile-Associated Diarrhea 14 CLINICAL STUDIES 5.4 Bone Fracture 14.1 Active Duodenal Ulcer 5.5 Cutaneous and Systemic Lupus Erythematosus 14.2 H. pylori Eradication in Patients with Duodenal Ulcer Disease 5.6 Interaction with Clopidogrel 14.3 Active Benign Gastric Ulcer 5.7 Cyanocobalamin (Vitamin B-12) Deficiency 14.4 Symptomatic GERD 5.8 Hypomagnesemia 14.5 EE due to Acid-Mediated GERD 5.9 Interaction with St. John’s Wort or Rifampin 14.6 Maintenance of Healing of EE due to Acid-Mediated GERD 5.10 Interactions with Diagnostic Investigations for Neuroendocrine 14.7 Pathological Hypersecretory Conditions Tumors 14.8 Pediatric Studies for the Treatment of Symptomatic GERD, 5.11 Interaction with Methotrexate Treatment of EE due to Acid-Mediated GERD, and Maintenance of 5.12 Fundic Gland Polyps Healing of EE due to Acid-Mediated GERD 6 ADVERSE REACTIONS 15 REFERENCES 6.1 Clinical Trials Experience with PRILOSEC 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Clinical Trials Experience with PRILOSEC in Combination Therapy 17 PATIENT COUNSELING INFORMATION for H. pylori Eradication 6.3 Postmarketing Experience *Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Treatment of Active Duodenal Ulcer 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. 1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple 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. Dual Therapy 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. Among patients who fail therapy, PRILOSEC with clarithromycin is more
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