Omeprazole and Sodium bicarbonate

ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for the: • short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. • short-term treatment (4 to 8 weeks) of active benign gastric ulcer. • treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. • short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. o The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered. • maintenance of healing of EE due to acid-mediated GERD.

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 Dosage ZEGERID for oral suspension or ZEGERID capsules Active Duodenal Ulcer 20 mg once daily for 4 weeks, some patients may require an additional 4 weeks Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily for up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks* Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily** 40 mg ZEGERID for oral suspension Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days * an additional 4 weeks of treatment may be given if no response, if recurrence, additional 4 to 8-week courses may be considered. ** studied for 12 months.

ZEGERID 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 ZEGERID, are contraindicated in patients receiving rilpivirine containing products. • Known hypersensitivity to any components of the formulation. • Patients receiving rilpivirine-containing products

• Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. • Sodium Bicarbonate Buffer Content: Take sodium content into consideration in patients on a sodium-restricted diet. Avoid in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. • 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.

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 Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.

Tables 6 and 7 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 6: 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and moisture.