Centrapraz Special Precautions

General: 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. Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy. As with any other intravenous product containing edetate disodium (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 who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously.
Use in Women: No gender-related differences in the safety profile of intravenous Pantoprazole were seen in international trials involving 166 men and 120 women with erosive esophagitis associated with GERD. Erosive esophagitis healing rates in the 221 women treated with oral Pantoprazole in U.S. clinical trials were similar to those found in men. The incidence rates of adverse events were also similar between men and women.
Laboratory Tests: There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving most proton pump inhibitors, including Pantoprazole. An alternative confirmatory method should be considered to verify positive results.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in the Elderly: No age-related differences in the safety profile of intravenous Pantoprazole were seen in international trials involving 86 elderly (≥65 years old) and 200 younger (<65 years old) patients with erosive esophagitis associated with GERD. Erosive esophagitis healing rates in the 107 elderly patients (≥65 years old) treated with oral Pantoprazole in U.S. Clinical trials were similar to those found in patients under the age of 65. The incidence rates of adverse events and laboratory abnormalities in patients under the age of 65 years and older were similar to those associated with patients younger than 65 years of age.