Themipan 40mg Injection

Pantoprazole for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (Pantoprazole) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Pantoprazole for Injection is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Gastric Malignancy: In adults, symptomatic response to therapy with Pantoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. Injection Site Reactions: Thrombophlebitis is associated with the administration of intravenous Pantoprazole. Assess the patient and remove the catheter if clinically indicated. Potential Exacerbation of Zinc Deficiency: Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. Clostridioides difficile -Associated Diarrhea: PPI therapy may be associated with increased risk. Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue treatment and refer to specialist for evaluation. Hepatic Effects: Elevations of transaminases observed. Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. Fundic Gland Polyp s: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. Presence of Gastric Malignancy In adults, symptomatic response to therapy with Pantoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy. Injection Site Reactions Thrombophlebitis was associated with the administration of Pantoprazole. Potential for Exacerbation of Zinc Deficiency Pantoprazole for injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients treated with Pantoprazole for injection who are prone to zinc deficiency. Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following serious adverse reactions are described below and elsewhere in labeling: Injection Site Reactions Potential for Exacerbation of Zinc Deficiency Acute Tubulointerstitial Nephritis Clostridioides difficile -Associated Diarrhea Bone Fracture Severe Cutaneous Adverse Reactions Cutaneous and Systemic Lupus Erythematosus Hepatic Effects Hypomagnesemia and Mineral Metabolism Fundic Gland Polyps Most common adverse reactions (> 2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Gastroesophageal Reflux Disease (GERD) Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole (20 mg or 40 mg), 299 patients on an H 2 -receptor antagonist, 46 patients on another PPI, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 2. The number of patients treated in comparative studies with Pantoprazole for injection is limited; however, the adverse reactions seen were similar to those seen in the oral studies. Thrombophlebitis was the only new adverse reaction identified with Pantoprazole for injection. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.