Antaxid Special Precautions

General: Symptomatic response to therapy with pantoprazole does not produce the presence of gastric malignancy.
Dosing to the chronic nature of erosive esophagitis, there may be a potential for prolonged administration of pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown.
Generally, daily treatment with any acid-suppressing medications over a long period of time (eg. Longer than 3 years) may lead to malabsorption of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This possibility should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole, particularly in patients who were H. pylori positive.
Information for Patients: Patients should be cautioned that pantoprazole delayed-release tablets should not be split, crushed or chewed. The tablets should be swallowed whole, with or without food in the stomach. Concomitant administration of antacids does not affect the absorption of pantoprazole.
Use in Women: Erosive esophagitis healing rates in the 221 women treated with pantoprazole delayed-release tablets in U.S clinical trials were similar to those found in men. In the 122 women treated long-term with pantoprazole delayed-release 40 mg or 20 mg tablets, healing was maintenance at a rate similar to that in men. The incidence rates of adverse events were also similar for 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: Teratogenic effects: Pregnancy Category B: Teratology studies have been performed in rats at oral doses up to 450 mg/kg/day (88 times the recommended human dose based on body surface area) and rabbits at oral doses up to 40 mg/kg/day (16 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use in Lactation: Pantoprazole and its metabolite are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: In short-term U.S clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥65 years old) treated with pantoprazole sodium delayed-release tablets were similar to those found in patients under the age of 65. 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.