Konvomep

omeprazole and sodium bicarbonate · KIT · Azurity Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Konvomep is a kit containing omeprazole and sodium bicarbonate. Manufactured by Azurity Pharmaceuticals, Inc..

Key Facts

Brand Name: Konvomep
Generic Name: omeprazole and sodium bicarbonate
NDC Code (Product): 65628-272
Manufacturer: Azurity Pharmaceuticals, Inc.
Dosage Form: KIT
Marketing Status
Application #: NDA213593
Marketing Start: 02/15/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease108 reports

drug ineffective67 reports

acute kidney injury50 reports

renal failure44 reports

incorrect product administration duration39 reports

nausea33 reports

product use issue32 reports

headache26 reports

inappropriate schedule of product administration26 reports

off label use25 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & 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 …

Contraindications

4 CONTRAINDICATIONS KONVOMEP is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Proton pump inhibitors (PPIs), including KONVOMEP, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions ( 7 )] . Known hypersensitivity to any components of the formulation ( 4 ) Patients receiving rilpivirine‑containing products ( 4 , 7 )

Drug Interactions

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. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology ( 12.3 )] . Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology ( 12.3 )] . There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: Rilpivirine-conta…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] . Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] . Bone Fracture [see Warnings and Precautions ( 5.5 )] . Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.6 )] . Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.7 )] . Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.9 )] . Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.10 )] . Fundic Gland Polyps [see Warnings and Precautions ( 5.14 )] . Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of …

Frequently Asked Questions

What is Konvomep used for?

Konvomep contains omeprazole and sodium bicarbonate. It is a kit taken as directed. Consult your doctor for specific uses.

Is Konvomep a controlled substance?

Konvomep is not classified as a controlled substance by the DEA.

What is the generic name for Konvomep?

The generic name for Konvomep is omeprazole and sodium bicarbonate. There are 11 other brand versions of omeprazole and sodium bicarbonate.

What is the NDC code for Konvomep ?

The NDC (National Drug Code) for Konvomep is 65628-272, listed by Azurity Pharmaceuticals, Inc..

Product NDC

65628-272

Package NDC

65628-272-03

Other Omeprazole Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)