Omeprazole / Sodium Bicarbonate Dosage

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Usual Adult Dose for Duodenal Ulcer

Short-term treatment of active duodenal ulcer: 20 mg orally once daily for 4 weeks.

Usual Adult Dose for Gastric Ulcer

Benign gastric ulcer: 40 mg orally once daily for 4 to 8 weeks.

Usual Adult Dose for Gastroesophageal Reflux Disease

Symptomatic GERD without esophageal erosions: 20 mg orally once daily for up to 4 weeks.

Usual Adult Dose for Erosive Esophagitis

Endoscopically diagnosed erosive esophagitis: 20 mg orally once daily for 4 to 8 weeks.

Maintenance of healing of erosive esophagitis: 20 mg orally once daily.

Usual Adult Dose for Gastrointestinal Hemorrhage

Reduction of risk of upper gastrointestinal bleeding in critically ill patients (40 mg oral suspension only): 40 mg orally followed by 40 mg six to eight hours later, and 40 mg daily thereafter for 14 days.

Usual Pediatric Dose for Duodenal Ulcer

Omeprazole-sodium bicarbonate has not received FDA approval for use in children despite an approved dosage for omeprazole in children and considering that omeprazole has been used safely in children as an extemporaneous formulation with sodium bicarbonate. Although not FDA approved, the following dosage is recommended for GERD, ulcers, and esophagitis:

5 kg to less than 10 kg: 5 mg once daily

10 kg to less than or equal to 20 kg: 10 mg once daily

greater than or equal to 20 kg: 20 mg once daily

Alternate dosing: 1 mg/kg/day once or twice daily; range of effective doses in the literature: 0.2 to 3.5 mg/kg/day. Higher doses may be necessary for children between 1 to 6 years of age due to increased metabolic clearance. To maintain gastric pH greater than 5 in critically ill children, administration every 6 to 8 hours may be necessary (1.5 to 2 mg/kg/day).

Usual Pediatric Dose for Gastric Ulcer

Omeprazole-sodium bicarbonate has not received FDA approval for use in children despite an approved dosage for omeprazole in children and considering that omeprazole has been used safely in children as an extemporaneous formulation with sodium bicarbonate. Although not FDA approved, the following dosage is recommended for GERD, ulcers, and esophagitis:

5 kg to less than 10 kg: 5 mg once daily

10 kg to less than or equal to 20 kg: 10 mg once daily

greater than or equal to 20 kg: 20 mg once daily

Alternate dosing: 1 mg/kg/day once or twice daily; range of effective doses in the literature: 0.2 to 3.5 mg/kg/day. Higher doses may be necessary for children between 1 to 6 years of age due to increased metabolic clearance. To maintain gastric pH greater than 5 in critically ill children, administration every 6 to 8 hours may be necessary (1.5 to 2 mg/kg/day).

Usual Pediatric Dose for Gastroesophageal Reflux Disease

Omeprazole-sodium bicarbonate has not received FDA approval for use in children despite an approved dosage for omeprazole in children and considering that omeprazole has been used safely in children as an extemporaneous formulation with sodium bicarbonate. Although not FDA approved, the following dosage is recommended for GERD, ulcers, and esophagitis:

5 kg to less than 10 kg: 5 mg once daily

10 kg to less than or equal to 20 kg: 10 mg once daily

greater than or equal to 20 kg: 20 mg once daily

Alternate dosing: 1 mg/kg/day once or twice daily; range of effective doses in the literature: 0.2 to 3.5 mg/kg/day. Higher doses may be necessary for children between 1 to 6 years of age due to increased metabolic clearance. To maintain gastric pH greater than 5 in critically ill children, administration every 6 to 8 hours may be necessary (1.5 to 2 mg/kg/day).

Renal Dose Adjustments

CrCl <10 mL/min: data not available

Liver Dose Adjustments

Dosage adjustment should be considered in hepatically impaired patients.

Dose Adjustments

Short-term treatment of active duodenal ulcer: some patients may require an additional 4 weeks of therapy.

Dosage adjustment should be considered in Asian subjects. A fourfold increase in the area under the plasma concentration versus time curve (AUC) has been reported in Asian patients compared to Caucasians following the administration of a similar dosage.

Precautions

The sodium content should be taken into consideration when administering omeprazole-sodium bicarbonate to patients on a sodium restricted diet. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate. Each packet of powder for oral suspension contains either 40 mg or 20 mg of omeprazole and 1680 mg of sodium bicarbonate.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Because omeprazole is highly protein bound, little is expected to be removed by hemodialysis. Sodium bicarbonate is removed by hemodialysis and by continuous ambulatory peritoneal dialysis.

Other Comments

Omeprazole-sodium bicarbonate should be taken on an empty stomach at least one hour before a meal.

For patients receiving continuous nasogastric or orogastric tube feeding, the enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of the omeprazole-sodium bicarbonate powder for oral suspension.

If the drug needs to be administered through a nasogastric or orogastric tube, the powder for oral suspension should be reconstituted with approximately 20 mL of water. Stir well and administer immediately. An appropriately-sized syringe should be used to instill the suspension in the tube. The suspension should be washed through the tube with 20 mL of water.

Preparation and administration of powder for oral suspension: Empty packet contents into a small cup containing 15 mL to 30 mL of water. Stir well and drink immediately. Refill cup with water and drink.

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