Omeprazole And Sodium Bicarbonate

Omeprazole and sodium bicarbonate is available as a capsule 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 capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are not equivalent to one capsule of omeprazole and sodium bicarbonate 40 mg; therefore, two 20 mg capsules of omeprazole and sodium bicarbonate should not be substituted for one capsule of omeprazole and sodium bicarbonate 40 mg.

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

Table 1: Recommended Doses of Omeprazole and 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 section (1)]

I ndication

R ecommended Dose

F requency

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 40 mg 6-8 hours later and 40 mg 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 and Sodium Bicarbonate Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.

Use with clopidogrel

Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80mg omeprazole, a proton pump inhibitor that is an inhibitor if CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see WARNINGS AND PRECAUTIONS (5.6) and Drug Interactions (7) ].

Omeprazole and 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 and Sodium Bicarbonate 40 mg; therefore, two 20 mg packets of Omeprazole and Sodium Bicarbonate should not be substituted for one packet of Omeprazole and 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 and Sodium Bicarbonate 40 mg; therefore, two 20 mg capsules of Omeprazole and Sodium Bicarbonate should not be substituted for one capsule of Omeprazole and Sodium Bicarbonate 40 mg.

Omeprazole and 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 and Sodium Bicarbonate Powder for Oral Suspension.

Table 1:   Recommended Doses of Omeprazole and Sodium Bicarbonateby Indication for Adults 18 Years and Older

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 40 mg 6-8 hours later and 40 mg daily thereafter for 14 days**

* Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [See Clinical Studies (14.1)]

** Controlled studies do not extend beyond 12 months. [See Clinical Studies (14)]

+ For additional information, [See Indications and Usage (1)]

Special Populations

Hepatic Insufficiency

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology (12.3)]

Administration of Capsules

Omeprazole and 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 and 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.