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Omeprazole

OMEPRAZOLE

Manufacturer: Quallent Pharmaceuticals Health LLC

Score: 145.0

Quick Summary

Omeprazole is a proton pump inhibitor (PPI) used for the treatment of various conditions such as active duodenal ulcer, Helicobacter pylori eradication, active benign gastric ulcer, symptomatic gastroesophageal reflux disease (GERD), erosive esophagitis (EE), and pathological hypersecretory conditions. The drug works by reducing stomach acid production and is available in delayed-release capsules. Important safety information includes the risk of acute tubulointerstitial nephritis, Clostridium difficile-associated diarrhea, and bone fractures. Contraindications include known hypersensitivity to the drug and use in patients receiving rilpivirine-containing products. The main dosing recommendations vary by condition, with typical adult doses ranging from 20 to 40 mg once daily. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific recommendations and precautions for each group.

Key Clinical Findings and Indications

  • Treatment of active duodenal ulcer
  • Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence
  • Treatment of active benign gastric ulcer
  • Treatment of symptomatic gastroesophageal reflux disease (GERD)
  • Treatment of erosive esophagitis (EE) due to acid-mediated GERD
  • Maintenance of healing of EE due to acid-mediated GERD
  • Pathological hypersecretory conditions

Important Safety Information

Warning

Acute tubulointerstitial nephritis, Clostridium difficile-associated diarrhea, and bone fractures have been reported with the use of omeprazole.

Contraindications

  • Known hypersensitivity to the drug
  • Use in patients receiving rilpivirine-containing products

Adverse Reactions

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

Dosing Recommendations

General Guidance

Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child-Pugh Class A, B, or C) and Asian patients.

Active duodenal ulcer

Adult Dose

20 mg once daily for 4 weeks

Pediatric Dose

Not recommended for pediatric patients

Helicobacter pylori eradication

Adult Dose

20 mg twice daily for 10 days

Pediatric Dose

Not recommended for pediatric patients

Active benign gastric ulcer

Adult Dose

40 mg once daily for 4 to 8 weeks

Pediatric Dose

Not recommended for pediatric patients

Symptomatic GERD

Adult Dose

20 mg once daily for up to 4 weeks

Pediatric Dose

10 to less than 20 kg: 10 mg once daily for up to 4 weeks; 20 kg and greater: 20 mg once daily for up to 4 weeks

EE due to acid-mediated GERD

Adult Dose

20 mg once daily for 4 to 8 weeks

Pediatric Dose

10 to less than 20 kg: 10 mg once daily for 4 to 8 weeks; 20 kg and greater: 20 mg once daily for 4 to 8 weeks

Special Population Considerations

Pregnancy

  • There are no adequate and well-controlled studies with omeprazole 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

  • Limited data suggest omeprazole may be present in human milk.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omeprazole and any potential adverse effects on the breastfed infant from omeprazole or from the underlying maternal condition.

Pediatric Use

  • The safety and effectiveness of omeprazole have been established in pediatric patients 2 to 16 years for the treatment of symptomatic GERD, treatment of EE due to acid-mediated GERD, and maintenance of healing of EE due to acid-mediated GERD.
  • Use of omeprazole in this age group is supported by adequate and well-controlled studies in adults and uncontrolled safety, efficacy, and pharmacokinetic studies performed in pediatric and adolescent patients.

Geriatric Use

  • Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the U.S. and Europe.
  • There were no differences in safety and effectiveness between the elderly and younger subjects.

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