KONVOMEP

AbsorptionThe bioavailability and pharmacokinetics of KONVOMEP was assessed in 57 healthy male and female volunteers following a 40 mg dose under fasted conditions. The absorption of omeprazole was rapid with a median time to peak plasma concentration of 0.33 hour (range 0.17 to 1.3 hr.). The mean peak plasma concentration (SD) was 1250 ng/mL (470) and the AUC (0-inf) (SD) was 1640 h*ng/mL (1050). Omeprazole is a time-dependent autoinhibitor of CYP2C19. The bioavailability of omeprazole from om...

14.1 Active Benign Gastric Ulcer 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. (see Table 8 .)

Table 8Treatment of Gastric Ulcer % of Patients Healed % of Patients Healed Omeprazole 40 mg once daily (n = 214) Placebo (n = 104) Week 4 55.6 p < 0.01 omeprazol...

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) Deficien...

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 K...

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 -Associ...

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 5Clinically Relevant Interactions Affecting Drugs Co-A...