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Omeprazole, Sodium bicarbonate

OMEPRAZOLE, SODIUM BICARBONATE

Manufacturer: Bryant Ranch Prepack

Score: 141.0

Quick Summary

Omeprazole and Sodium Bicarbonate capsules are a proton pump inhibitor (PPI) indicated for the short-term treatment of active duodenal ulcer, active benign gastric ulcer, treatment of heartburn and other symptoms associated with GERD, and the treatment of erosive esophagitis (EE) due to acid-mediated GERD. The capsules contain 20 mg or 40 mg of omeprazole and 1100 mg of sodium bicarbonate. The recommended dosage regimen is based on the indication and ranges from 20 mg to 40 mg once daily. Important safety information includes contraindications such as known hypersensitivity to substituted benzimidazoles or any components of the formulation, and patients receiving rilpivirine-containing products. Adverse reactions include headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. Special population considerations include use in pregnancy, pediatric use, geriatric use, and patients with renal or hepatic impairment.

Key Clinical Findings and Indications

  • Short-term treatment of active duodenal ulcer
  • Short-term treatment of active benign gastric ulcer
  • Treatment of heartburn and other symptoms associated with GERD
  • Treatment of erosive esophagitis (EE) due to acid-mediated GERD
  • Maintenance of healing of EE due to acid-mediated GERD

Important Safety Information

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

Dosing Recommendations

General Guidance

No dosage adjustment is necessary in the elderly.

Active duodenal ulcer

Adult Dose

20 mg once daily for 4 weeks

Pediatric Dose

Not established

Active benign gastric ulcer

Adult Dose

40 mg once daily for 4 to 8 weeks

Pediatric Dose

Not established

GERD

Adult Dose

20 mg once daily for up to 4 weeks

Pediatric Dose

Not established

EE due to acid-mediated GERD

Adult Dose

20 mg once daily for 4 to 8 weeks

Pediatric Dose

Not established

Special Population Considerations

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