Omeprazole/sodium Bicarbonate
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FDA Labeling Changes
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Uses
Omeprazole/Sodium Bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)]
Omeprazole/Sodium Bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2)]
Symptomatic GERD
Omeprazole/Sodium Bicarbonate is indicated for the treatment of heartburn and other symptoms associated with GERD. [See Clinical Studies (14.3)]
Erosive Esophagitis
Omeprazole/Sodium Bicarbonate is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of Omeprazole/Sodium Bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of Omeprazole/Sodium Bicarbonate may be considered. [See Clinical Studies (14.3)]
Omeprazole/Sodium Bicarbonate is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)]
Omeprazole/Sodium Bicarbonate Powder for Oral Suspension 40 mg/1680 mg is indicated for the reduction of risk of upper GI bleeding in critically ill patients. [See CLINICAL STUDIES, Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (14.5)]
History
There is currently no drug history available for this drug.
Other Information
Omeprazole/Sodium Bicarbonate is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:
Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
Omeprazole/Sodium Bicarbonate is supplied as immediate-release capsules and unit-dose packets as powder for oral suspension. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole and 1680 mg of sodium bicarbonate with the following excipients: xylitol, sucrose, sucralose, xanthan gum, and flavorings.
Sources
Omeprazole/sodium Bicarbonate Manufacturers
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Prasco, Laboratories
![Omeprazole/sodium Bicarbonate (Omeprazole, Sodium Bicarbonate) Capsule [Prasco, Laboratories]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Omeprazole/sodium Bicarbonate | Prasco, Laboratories
Omeprazole/Sodium Bicarbonate is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 1. All recommended doses throughout the labeling are based upon omeprazole.
Since both the 20 mg and 40 mg oral suspension packets contain the same amount of sodium bicarbonate (1680 mg), two packets of 20 mg are not equivalent to one packet of Omeprazole/Sodium Bicarbonate 40 mg; therefore, two 20 mg packets of Omeprazole/Sodium Bicarbonate should not be substituted for one packet of Omeprazole/Sodium Bicarbonate 40 mg.
Since both the 20 mg and 40 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are not equivalent to one capsule of Omeprazole/Sodium Bicarbonate 40 mg; therefore, two 20 mg capsules of Omeprazole/Sodium Bicarbonate should not be substituted for one capsule of Omeprazole/Sodium Bicarbonate 40 mg.
Omeprazole/Sodium Bicarbonate should be taken on an empty stomach at least one hour before a meal.
For patients receiving continuous Nasogastric (NG)/ Orogastric (OG) tube feeding, enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of Omeprazole/Sodium Bicarbonate Powder for Oral Suspension.
Table 1: Recommended Doses of Omeprazole/Sodium Bicarbonate by Indication for Adults 18 Years and Older* Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [See Clinical Studies (14.1)]
** For additional information, [See Clinical Studies (14)]
+ For additional information, [See Indications and Usage (1)]
Indication Recommended Dose Frequency Short-Term Treatment of Active Duodenal Ulcer 20 mg Once daily for 4 weeks*,+ Benign Gastric Ulcer 40 mg Once daily for 4-8 weeks **,+ Gastroesophageal Reflux Disease (GERD) Symptomatic GERD (with no esophageal erosions) 20 mg Once daily for up to 4 weeks+ Erosive Esophagitis 20 mg Once daily for 4-8 weeks+ Maintenance of Healing of Erosive Esophagitis 20 mg Once daily** Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients
(40 mg oral suspension only) 40 mg 40 mg initially followed by
40mg 6-8 hours later and
40mg daily thereafter for 14 days**Special Populations
Hepatic Insufficiency
Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology (12.3)]
Administration of Capsules
Omeprazole/Sodium Bicarbonate Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.
Preparation and Administration of Suspension
Directions for use: Empty packet contents into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.
If Omeprazole/Sodium Bicarbonate is to be administered through a nasogastric (NG) or orogastric (OG) tube, the suspension should be constituted with approximately 20 mL of water. DO NOT USE OTHER LIQUIDS OR FOODS. 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.
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