Omeprazole

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

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H + /K + ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

Indication Recommended Adult and Pediatric Dosage. Treatment of Active Duodenal Ulcer 20 mg once daily for 4 weeks, some patients may require an additional 4 weeks. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: PRILOSEC Amoxicillin Clarithromycin 20 mg 1000 mg 500 mg Each drug twice daily for 10 days * Dual Therapy: PRILOSEC Clarithromycin 40 mg once daily for 14 days** 500 mg three times daily for 14 days. Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks. Symptomatic GERD 20 mg once daily for up to 4 weeks. See full prescribing information for weight based dosing in pediatric patients 1 year of age and older. EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks *** See full prescribing information for weight based dosing in pediatric patients 1 month of age and older.

• PRILOSEC is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria. • Proton pump inhibitors (PPIs), including PRILOSEC, are contraindicated in patients receiving rilpivirine-containing products. • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PRILOSEC, refer to the CONTRAINDICATIONS section of their package inserts.

• Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. • Acute Tubulointerstital Nephritis: Discontinue treatment and evaluate patients. • 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. • Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous, new onset or exacerbation of existing disease, discontinue PRILOSEC and refer to specialist for evaluation.

The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis • Clostridium difficile -Associated Diarrhea • Bone Fracture • Severe Cutaneous Adverse Reactions • Cutaneous and Systemic Lupus Erythematosus • Cyanocobalamin (Vitamin B-12) Deficiency • Hypomagnesemia and Mineral Metabolism • Fundic Gland Polyps 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.

Table 3 and Table 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance.

Storage Store PRILOSEC for delayed-release oral suspension at 25°C (77°F), excursions permitted to 15 – 30°C (59 – 86°F).