HD Pharmaceuticals


POMIV Injection

POMIV

PRESENTATION:
Pantoprazole IP 40 mg

PACKING AVAILABLE:
SHRINK=24 1`S WFI
Pantoprazole is a selective "proton pump inhibitor", a medicine which reduces the amount of acid produced in stomach. It is used for treating acid-related diseases of the stomach and intestine.

Therapeutic Indication



Pantoprazole tablet is indicated for the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD).

Pantoprazole is used for treating:
Adults and adolescents 12 years of age and above:
⇒ Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
Adults:
⇒ Stomach and duodenal ulcers.
⇒ Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.

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 enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

Pharmacokinetics



Pantoprazole sodium delayed-release tablets are prepared as enteric-coated tablets so that absorption of Pantoprazole begins only after the tablet leaves the stomach. Peak serum concentration (Cmax) and area under the serum concentration time curve (AUC) increase in a manner proportional to oral. Pantoprazole does not accumulate, and its pharmacokinetics is unaltered with multiple daily dosing.
In extensive metabolizers with normal liver function receiving an oral dose of the gastro resitant-coated 40 mg Pantoprazole tablet, the peak concentration (Cmax) is 2.5 mcg/mL; the time to reach the peak concentration (tmax) is 2.5 h, and the mean total area under the plasma concentration versus time curve (AUC) is 4.8 mcg•h/mL (range 1.4 to 13.3 mcg•h/mL).

Absorption: After administration of a single or multiple oral 40 mg doses of Pantoprazole sodium delayed-release tablets, the peak plasma concentration of Pantoprazole was achieved in approximately 2.5 hours, and Cmax was 2.5 mcg/mL. Pantoprazole undergoes little first-pass metabolism, resulting in an absolute bioavailability of approximately 77%. Pantoprazole absorption is not affected by concomitant administration of antacids. Administration of Pantoprazole sodium delayed-release tablets with food may delay its absorption up to 2 hours or longer; however, the Cmax and the extent of Pantoprazole absorption (AUC) are not altered. Thus, Pantoprazole sodium tablets may be taken without regard to timing of meals.
Distribution: The apparent volume of distribution of Pantoprazole is approximately 11.0 to 23.6 L, distributing mainly in extracellular fluid. The serum protein binding of Pantoprazole is about 98%, primarily to albumin.
Metabolism: Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. Pantoprazole metabolism is independent of the route of administration (intravenous or oral). The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. There is no evidence that any of the Pantoprazole metabolites have significant pharmacologic activity.
Elimination: After a single oral dose of Pantoprazole to healthy, normal metabolizer volunteers, 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.

Pharmacodynamics



Pantoprazole sodium gastro resistant tablet, 40 mg in suppressing pentagastrin-stimulated MAO in patients (n = 49) with GERD and a history of EE. In this multicenter, pharmacodynamic crossover study, a 40 mg oral dose of this tablet administered. Tablets after administration of each formulation once daily for 7 days and administered thirty minutes before breakfast. Pentagastrin-stimulated (MAO) was assessed from hour 23 to 24 at steady state.

Contraindications



Contraindicated in patients with known hypersensitivity to any component of the formulation.

Drug Interactions



Increases risk of digoxin-induced cardiotoxic effects. Increases risk of hypomagnesaemia with diuretics. It may increase prothrombin time of warfarin. Delayed absorption and decreased bioavailability with sucralfate. Decreases the absorption of ketoconazole, itraconazole.

Pregnancy & Lactation: Please ask the doctor if you are pregnant and lactating women.
Driving and using machines Pantoprazole has no or negligible influence on the ability to drive and use machines. If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.

Warning and Precautions



⇒ This has been prescribed for the patient's specific condition only.
⇒ Children and adolescents Pantoprazole is not recommended for use in children as it has not been proven to work in children below 12 years of age.

Adverse Drug Reactions



⇒ headache
⇒ dizziness
⇒ nausea
⇒ vomiting
⇒ flatulence
⇒ insomnia etc.

Storage



Store in a cool & dry place. Protect from light and moisture.

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