Pantopraz IV Special Precautions

Implications of symptomatic response: Symptomatic response to therapy with Pantoprazole does not preclude the presence of gastric malignancy.
Injection site reaction: Thrombophlebitis was associated with the administration of Pantoprazole Injection.
Hypersensitivity and severe skin reactions: Anaphylaxis and other serious reactions such as erythema multiforme, Steven-Johnson's syndrome, and toxic epidermal necrolysis (TEN) have been reported with use of Pantoprazole injection. These may require emergency medical treatment.
Potential for exacerbation of zinc deficiency: Pantoprazole 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 injection who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously.
Acute interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs including Pantoprazole injection. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Pantoprazole injection if acute interstitial nephritis develops.
Clostridium difficile associated diarrhea: Published observational studies suggest that PPI therapy like pantoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.
Patient should use the lowest dose and shortest duration of PPI therapy appropriated to the condition being treated.
Bone fracture: Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk of osteoporosis-related fractures should be managed according to the established treatment guidelines.
Hepatic effects: Mild, transient transaminase elevations have been observed in clinical studies. The clinical significance of this finding in a large population of subjects administered intravenous pantoprazole is unknown.
Hypomagnesemia: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Interference with urine screen for tetrahydrocannabinol may produce false-positive urine screen for THC (tetrahydrocannabinol).
Concomitant use with methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
Use in Children: Safety and effectiveness in pediatric (under 18 years old) patients have not been established.
Use in Elderly: No age-related differences in the safety profile of intravenous pantoprazole were seen in international trials involving under 65 years old and over 65 years old patients with erosive esophagitis associated with GERD.