Konvomep (omeprazole and sodium bicarbonate for oral suspension) - 2 indications

Scroll down for more information in each indication:

• for the treatment of active benign gastric ulcer; approved September 2022
• for reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients; approved September 2022

General Information

Konvomep is a combination of omeprazole, a proton pump inhibitor (PPI) and sodium bicarbonate.

Konvomep is specifically indicated for:

• the short-term treatment (4 to 8 weeks) of active benign gastric ulcer
• reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients

Konvomep is supplied as an oral suspension. 

Konvomep is a kit of two bottles: one bottle containing omeprazole powder and one bottle of diluent containing sodium bicarbonate. Konvomep needs to be reconstituted by a healthcare provider for use in adults. After reconstitution, each mL of Konvomep contains 2 mg of omeprazole and 84 mg of sodium bicarbonate. Recommended doses throughout the labeling are based upon the omeprazole component of Konvomep.

Scroll down for the recommended dosing/administration for each indication.

Mechanism of Action

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

Side Effects

Adverse effects associated with Konvomep may include, but are not limited to, the following:

• headache
• abdominal pain
• nausea
• diarrhea
• vomiting
• flatulence

Take the sodium content of Konvomep into consideration when prescribing this product.

Indication 1 - for the short-term treatment of active benign gastric ulcer

approved September 2022

Dosing/Administration

40 mg once daily for 4 to 8 weeks.

Clinical Trial Results

The effectiveness of Konvomep has been established, in part, based on studies of an oral delayed-release omeprazole product for the treatment of active benign gastric ulcer. In a U.S. multicenter, double-blind study of two doses of omeprazole and placebo in 520 patients with endoscopically diagnosed gastric ulcer, the following results were obtained with 40 mg omeprazole and placebo, respectively:

Percent (%) of patients healed:

• Week 4: 55.6% versus 30.8%
• Week 8: 82.7% versus 48.1%

Indication 2  - for reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients

approved September 2022

Dosing/Administration

40 mg initially; followed by 40 mg 6 to 8 hours later; and 40 mg once daily thereafter for 14 days

Clinical Trial Results

The effectiveness of Konvomep has been established, in part, based on studies of another omeprazole and sodium bicarbonate oral suspension product for the reduction of risk of upper GI bleeding in critically ill adult patients. 

A double-blind, multicenter, randomized, non-inferiority clinical trial was conducted to compare omeprazole and sodium bicarbonate oral suspension 40 mg/1680 mg versus intravenous cimetidine for the reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients. The primary endpoint was significant upper GI bleeding defined as bright red blood which did not clear after adjustment of the nasogastric tube and a 5 to 10 minutes lavage, or persistent Gastroccult positive coffee grounds for 8 consecutive hours which did not clear with 100 mL lavage.

Omeprazole and sodium bicarbonate oral suspension was administered as two doses of 40 mg omeprazole and 1680 mg sodium bicarbonate 6 to 8 hours apart on the first day via orogastric or nasogastric tube, followed by 40 mg omeprazole and 1680 mg sodium bicarbonate once daily thereafter. Cimetidine was administered intravenously as a 300 mg bolus, followed by 50 to 100 mg/hour continuously thereafter. Treatment was administered for up to 14 days (mean = 6.8 days). A total of 359 patients were studied.

The results of the study showed that omeprazole and sodium bicarbonate oral suspension was non-inferior to intravenous cimetidine, 7/178 (3.9%) patients in the omeprazole and sodium bicarbonate oral suspension group vs. 10/181 (5.5%) patients in the cimetidine group experienced clinically significant upper GI bleeding.