Omeprazole and Sodium Bicarbonate

Warning

Acute tubulointerstitial nephritis, Clostridium difficile-associated diarrhea, bone fracture, cutaneous and systemic lupus erythematosus, cyanocobalamin (vitamin B-12) deficiency, hypomagnesemia, and fundic gland polyps.

Contraindications

• Known hypersensitivity to substituted benzimidazoles or any components of the formulation
• Patients receiving rilpivirine-containing products

Adverse Reactions

• Headache
• Abdominal pain
• Nausea
• Diarrhea
• Vomiting
• Flatulence

General Guidance

No dosage adjustment is necessary in the elderly.

Pregnancy

• There are no adequate and well-controlled studies with Omeprazole and Sodium Bicarbonate capsules in pregnant women
• Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use

Nursing Mothers

• It is not known if omeprazole is excreted in human milk

Pediatric Use

• Safety and effectiveness of Omeprazole and Sodium Bicarbonate capsules have not been established in pediatric patients

Geriatric Use

• Omeprazole was administered to over 2,000 elderly individuals (≥65 years of age) in clinical trials in the U.S. and Europe
• No dosage adjustment is necessary in the elderly