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Konvomep Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Kit (pwd + diluent)—90mL, 150mL, 180mL
Manufacturer
Generic Availability
NO
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.
Konvomep Indications
Indications
Short-term treatment (4–8 weeks) of active benign gastric ulcer. To reduce risk of upper GI bleed in critically ill adult patients.
Konvomep Dosage and Administration
Adult
Gastric ulcer: 40mg once daily for 4–8 weeks. GI bleed risk reduction: initially 40mg, followed by 40mg 6–8hrs later, then 40mg once daily thereafter for 14 days.
Children
Not established.
Konvomep Contraindications
Contraindications
Concomitant rilpivirine-containing products.
Konvomep Boxed Warnings
Not Applicable
Konvomep Warnings/Precautions
Warnings/Precautions
Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Sodium-restricted diets. CHF. Avoid use in Bartter's syndrome, hypokalemia, hypocalcemia, acid-base imbalance abnormalities. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels prior to and during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (≥1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Pregnancy. Nursing mothers.
Konvomep Pharmacokinetics
Absorption
Median time to peak plasma concentration: 0.33 hour (range 0.17–1.3 hr). Mean peak plasma concentration (SD): 1250 ng/mL (470); AUC0-inf (SD): 1640 h*ng/mL (1050).
Distribution
Plasma protein bound: ~95%.
Elimination
Renal (~77%). Half-life: ~1 hour (range: 0.4–4.2 hours).
Konvomep Interactions
Interactions
Avoid concomitant clopidogrel, St. John's Wort, rifampin, atazanavir, nelfinavir. May potentiate citalopram, cilostazol, diazepam, digoxin, phenytoin, warfarin (monitor INR/PT), tacrolimus, saquinavir, methotrexate (esp. high-dose); monitor. Potentiated by voriconazole. May alter absorption of pH-dependent drugs (eg, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole, mycophenolate mofetil, iron salts). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). Long-term use of bicarbonate with calcium or milk may cause milk-alkali syndrome. Concomitant digoxin, diuretics may predispose patients to hypomagnesemia. May interfere with neuroendocrine tumor diagnostic investigations, secretin stimulation tests; interrupt therapy for ≥14 days. May result in false (+) urine tests for tetrahydrocannabinol.
Konvomep Adverse Reactions
Adverse Reactions
Headache, abdominal pain, nausea, diarrhea, vomiting, flatulence; bone fracture; possible C. difficile associated diarrhea; rare: hypomagnesemia and mineral metabolism.
Konvomep Clinical Trials
See Literature
Konvomep Note
Not Applicable
Konvomep Patient Counseling
See Literature
