Axepron Special Precautions

Implications of Symptomatic Response: Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy.
Hypersensitivity and Severe Skin Reactions: Anaphylaxis and other serious reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN) have been reported with use of intravenous pantoprazole. These may require emergency medical treatment.
Injection Site Reactions: Thrombophlebitis was associated with administration of intravenous pantoprazole.
Clostridium difficile Associated Diarrhea: Published observational studies suggest that PPI therapy like pantoprazole maybe 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.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate 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 receive high-dose, define as multiple daily doses, and long-term PPI therapy (a year longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to 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 THC: May produce false-positive urine screen for THC (tetrahydrocannabinol).
Concomitant Use of Pantoprazole with Methotrexate: Literature suggest 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, possible leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
Gender: No gender-related differences in the safety profile of intravenous pantoprazole were seen involving men and women with erosive esophagitis associated with GERD. The incidence rates of adverse reactions were also similar to men and women.
Hepatic Impairment: Doses higher than 40 mg/day have not been studied in patients with hepatic impairment.
Use in Children: Safety and effectiveness of pantoprazole in pediatric patients have been established.
Use in Elderly: The incidence rates of adverse events and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.