Konvomep FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 3, 2022.
FDA Approved: Yes (First approved August 30, 2022)
Brand name: Konvomep
Generic name: omeprazole and sodium bicarbonate
Dosage form: Powder for Oral Suspension
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Stomach Ulcer, Gastrointestinal Hemorrhage
Konvomep (omeprazole and sodium bicarbonate) is an oral liquid formulation of the proton pump inhibitor (PPI) omeprazole and sodium bicarbonate combination indicated for the treatment of active benign gastric ulcer, and reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients.
- Omeprazole is a proton pump inhibitor that works to reduce acid production in the stomach. Sodium bicarbonate is an antacid that raises the gastric pH and protects the omeprazole from acid degradation.
- In the treatment of active benign gastric ulcer, Konvomep is administered orally once daily for 4 to 8 weeks. For the reduction of risk of upper GI bleeding in critically ill patients, Konvomep is administered orally as an initial dose, followed by a dose 6 to 8 hours later, then once daily thereafter for 14 days.
- Konvomep contains 2 mg omeprazole and 84 mg sodium bicarbonate per mL after reconstitution.
- Konvomep is associated with the following warnings and precautions: gastric malignancy; acute tubulointerstitial nephritis; sodium content; clostridium difficile-associated diarrhea; bone fracture; severe cutaneous adverse reactions; cutaneous and systemic lupus erythematosus; interaction with clopidogrel; cyanocobalamin (vitamin B-12) deficiency; hypomagnesemia and mineral metabolism; interaction with St. John’s Wort or rifampin; interactions with diagnostic investigations for neuroendocrine tumors; interaction with methotrexate; and fundic gland polyps.
- Common adverse reactions include headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
Development timeline for Konvomep
Further information
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