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Prazole Forte/Prazole IV

Prazole Forte/Prazole IV Mechanism of Action

pantoprazole

Manufacturer:

Multicare

Distributor:

Zuellig
Full Prescribing Info
Action
Pharmacology: Mechanism of Action: Pantoprazole is a proton-pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the H+/K+-ATPase results in a duration of antisecretory effect that persists longer than 24 hrs of all doses tested.
Pharmacokinetics: Prazole Forte: Peak plasma of Pantoprazole concentrations are achieved about 2 to 2.5 hours after a dose by mouth. The oral bioavailability is about 77% with the enteric-coated tablet formulation, and does not vary after single or multiple doses. Pantoprazole is 98% bound to plasma proteins. It is extensively metabolized in the liver, primarily by cytochrome P450 isoenzyme CYP2C19, to desmethylpantoprazole; small amounts are also metabolized by CYP3A4, CYP2D6, and CYP2C9. Metabolites are excreted principally about 80% in the urine, with the remainder being excreted in bile. The terminal elimination half-life is about 1 hour, and is prolonged in hepatic impairment; the half-life in patients with cirrhosis was 3 to 6 hours.
Prazole IV: Pantoprazole does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following the administration of pantoprazole sodium for injection, the serum concentration of pantoprazole declines bioexponentially with a terminal elimination t½ of approximately 1 hr. In extensive metabolizers with normal liver function receiving a dose of Prazole IV 40 mg for injection by constant rate over 15 min, the peak concentration (Cmax) is 5.52 mcg/mL and the total area under the plasma concentration versus time curve (AUC) is 5.4 mcg hr/mL. The total clearance is 7.6-14 L/hr and apparent volume of distribution is 11-23.6 mL.
The serum protein-binding of pantoprazole is about 98% primarily to albumin. Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP450) system.
After administration of a single IV dose of pantoprazole to healthy, normal stabilizer subjects, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion. There was no renal excretion of unchanged pantoprazole.
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