General MedicationsOralHigh Alert

Konvomep

OMEPRAZOLE AND SODIUM BICARBONATE

Standard Dose

2 DOSAGE AND ADMINISTRATION Recommended doses of KONVOMEP in the table below are based upon the omeprazole content. ( 2.2 ) Indication Recommended Adult Dosage ( 2.2 ) Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days 2.1 Important Administration Instructions •KONVOMEP is a kit of two bottles: one bottle containing omeprazole powder and one bottle of diluent containing sodium bicarbonate. •KONVOMEP is for reconstitution 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. •Take the sodium content of KONVOMEP into consideration when prescribing this product [see Warnings and Precautions ( 5.3 )] . •Recommended doses throughout the labeling are based upon the omeprazole component of KONVOMEP. 2.2 Dosage Regimen The recommended dosage regimen in adults of KONVOMEP by indication is summarized in Table 1 . Recommended dosage is based upon the omeprazole content of KONVOMEP. Table 1: Recommended Dosage Regimen of KONVOMEP for Adults by Indication Indication Recommended Dosage Treatment Duration Treatment of Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially; followed by 40 mg 6 to 8 hours later; and 40 mg once daily thereafter 14 days 2.3 Preparation and Administration Preparation of Reconstituted Suspension by a Healthcare Provider Prior to Dispensing 1.Hold the neck of the bottle containing the omeprazole powder and tap all four of the bottom edges on a hard surface to loosen the powder.2.Shake the diluent containing sodium bicarbonate for a few seconds. Open the diluent bottle and transfer about one-third of the contents into the bottle containing omeprazole powder, replace the omeprazole powder cap, and shake the bottle vertically for approximately 30 seconds.3.Add a second one-third of the diluent into the omeprazole powder bottle and shake the bottle vigorously for approximately 30 seconds.4.Add the remaining diluent into the omeprazole powder bottle. Allow diluent to drain into the omeprazole powder bottle for 10 seconds and shake the omeprazole bottle vigorously for approximately 30 seconds.5.The reconstituted suspension contains 40 mg of omeprazole per 20 mL and should be pink to red and hazy.6.Instruct the patient to shake the reconstituted suspension well before each use. Use an oral dosing device that measures the appropriate volume. Nasogastric or Orogastric Tube Administration (8 French or larger) If KONVOMEP is administered via nasogastric or orogastric tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of KONVOMEP. 1.Reconstitute KONVOMEP according to the steps for preparation provided above.2.Use a catheter or oral tip syringe to administer KONVOMEP through the nasogastric or orogastric tube.3.Shake the bottle well prior to dispensing 20 mL of KONVOMEP into the syringe.4.Immediately inject the medication through the nasogastric or orogastric tube into the stomach.5.Refill the syringe with 20 mL of water.6.Flush any remaining medication from the nasogastric or orogastric tube into the stomach. Storage of Reconstituted Suspension Store the reconstituted KONVOMEP suspension under refrigerated conditions 2°C to 8°C (36°F to 46°F) for up to 30 days.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE KONVOMEP is indicated in adults for: short-term treatment (4 to 8 weeks) of active benign gastric ulcer.

Summary

KONVOMEP is a combination of omeprazole, a proton pump inhibitor (PPI) and sodium bicarbonate, indicated in adults for: •Treatment of active benign gastric ulcer ( 1 ) •Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended doses of KONVOMEP in the table below are based upon the omeprazole content. ( 2.2 ) Indication Recommended Adult Dosage ( 2.2 ) Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days 2.1 Important Administration Instructions •KONVOMEP is a kit of two bottles: one bottle containing omeprazole powder and one bottle of diluent containing sodium bicarbonate. •KONVOMEP is for reconstitution 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. •Take the sodium content of KONVOMEP into consideration when prescribing this product [see Warnings and Precautions ( 5.3 )] . •Recommended doses throughout the labeling are based upon the omeprazole component of KONVOMEP. 2.2 Dosage Regimen The recommended dosage regimen in adults of KONVOMEP by indication is summarized in Table 1 .

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE KONVOMEP is indicated in adults for: 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 a combination of omeprazole, a proton pump inhibitor (PPI) and sodium bicarbonate, indicated in adults for: •Treatment of active benign gastric ulcer ( 1 ) •Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended doses of KONVOMEP in the table below are based upon the omeprazole content. ( 2.2 ) Indication Recommended Adult Dosage ( 2.2 ) Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days 2.1 Important Administration Instructions •KONVOMEP is a kit of two bottles: one bottle containing omeprazole powder and one bottle of diluent containing sodium bicarbonate. •KONVOMEP is for reconstitution 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. •Take the sodium content of KONVOMEP into consideration when prescribing this product [see Warnings and Precautions ( 5.3 )] . •Recommended doses throughout the labeling are based upon the omeprazole component of KONVOMEP. 2.2 Dosage Regimen The recommended dosage regimen in adults of KONVOMEP by indication is summarized in Table 1 . Recommended dosage is based upon the omeprazole content of KONVOMEP. Table 1: Recommended Dosage Regimen of KONVOMEP for Adults by Indication Indication Recommended Dosage Treatment Duration Treatment of Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially; followed by 40 mg 6 to 8 hours later; and 40 mg once daily thereafter 14 days 2.3 Preparation and Administration Preparation of Reconstituted Suspension by a Healthcare Provider Prior to Dispensing 1.Hold the neck of the bottle containing the omeprazole powder and tap all four of the bottom edges on a hard surface to loosen the powder.2.Shake the diluent containing sodium bicarbonate for a few seconds. Open the diluent bottle and transfer about one-third of the contents into the bottle containing omeprazole powder, replace the omeprazole powder cap, and shake the bottle vertically for approximately 30 seconds.3.Add a second one-third of the diluent into the omeprazole powder bottle and shake the bottle vigorously for approximately 30 seconds.4.Add the remaining diluent into the omeprazole powder bottle. Allow diluent to drain into the omeprazole powder bottle for 10 seconds and shake the omeprazole bottle vigorously for approximately 30 seconds.5.The reconstituted suspension contains 40 mg of omeprazole per 20 mL and should be pink to red and hazy.6.Instruct the patient to shake the reconstituted suspension well before each use. Use an oral dosing device that measures the appropriate volume. Nasogastric or Orogastric Tube Administration (8 French or larger) If KONVOMEP is administered via nasogastric or orogastric tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of KONVOMEP. 1.Reconstitute KONVOMEP according to the steps for preparation provided above.2.Use a catheter or oral tip syringe to administer KONVOMEP through the nasogastric or orogastric tube.3.Shake the bottle well prior to dispensing 20 mL of KONVOMEP into the syringe.4.Immediately inject the medication through the nasogastric or orogastric tube into the stomach.5.Refill the syringe with 20 mL of water.6.Flush any remaining medication from the nasogastric or orogastric tube into the stomach. Storage of Reconstituted Suspension Store the reconstituted KONVOMEP suspension under refrigerated conditions 2°C to 8°C (36°F to 46°F) for up to 30 days. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) Sodium Content : Take sodium content into consideration in patients on a sodium-restricted diet. Avoid in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. ( 5.3 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.4 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. ( 5.5 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider

Monitoring

• 5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy.
• Consider additional follow-up and diagnostic testing.
• ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients.
• ( 5.2 ) Sodium Content : Take sodium content into consideration in patients on a sodium-restricted diet.

Interaction Notes

• 7 DRUG INTERACTIONS Table 5 and Table 6 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them.
• Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
• Table 5: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable.
• The clinical importance and the mechanisms behind these interactions are not always known.