Each Vial contains:
Pantoprazole sodium …. 40 mg
Pantoprazole sodium for injection is a specific inhibitor of the gastric H+, K+-ATPase enzyme (the proton pump) that is responsible for acid secretion by the parietal cells of the stomach.
Indications and Clinical Use
Pantoprazole for Injection is indicated for the short-term treatment (up to 7 days) of conditions where a rapid reduction of gastric acid secretion is required, such as the following:
Reflux esophagitis, in hospitalized patients who cannot tolerate oral medication
Pathological hypersecretion associated with Zollinger-Ellison Syndrome, in hospitalized patients who cannot tolerate oral medication
WARNINGS AND PRECAUTIONS
In the presence of any alarm symptom (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, or melena) and when gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with pantoprazole for injection is instituted since treatment with pantoprazole sodium may alleviate symptoms and delay diagnosis.
Further investigation should be considered if symptoms persist despite adequate treatment. As with any other intravenous product containing edetate tetrasodium (the salt form of EDTA), which is a potent chelator of metal ions including zinc, zinc supplementation should be considered in patients treated with pantoprazole for injection who are prone to zinc deficiency. Caution should be used when other EDTA-containing products are also co-administered intravenously.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
DOSAGE AND ADMINISTRATION
40 mg intravenous injection: Inject 10 mL of physiological sodium chloride solution into the vial containing the dry substance. The resulting potency of the solution is 4 mg. Patients should be switched to pantoprazole sodium tablets when feasible. Pantoprazole for injection should be administered for up to 7 days in clinical trials.
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