All 4 patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks.Two independent, multicenter, randomized, double-blind, comparator-controlled trials of identical design were conducted in adult GERD patients with endoscopically confirmed healed EE to demonstrate efficacy of Pantoprazole sodium delayed-release tablets in long-term maintenance of healing. Peak serum concentration (CIn extensive metabolizers with normal liver function receiving an oral dose of the enteric-coated 40 mg Pantoprazole tablet, the peak concentration (CAfter administration of a single or multiple oral 40 mg doses of Pantoprazole sodium delayed-release tablets, the peak plasma concentration of Pantoprazole was achieved in approximately 2.5 hours, and CAdministration of Pantoprazole sodium delayed-release tablets with food may delay its absorption up to 2 hours or longer; however, the CThe apparent volume of distribution of Pantoprazole is approximately 11 to 23.6 L, distributing mainly in extracellular fluid.
The effects of Pantoprazole on median pH from one double-blind crossover study are shown in Table 5.Fasting serum gastrin levels were assessed in two double-blind studies of the acute healing of EE in which 682 patients with gastroesophageal reflux disease (GERD) received 10, 20, or 40 mg of Pantoprazole sodium for up to 8 weeks. The relevance of these findings to tumor development in humans is unknown PPI use is associated with an increased risk of fundic gland Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. Dosage of the HIV protease inhibitor may need to be adjusted.Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or INR. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. The increase in gastrin is reversible. Healthcare providers should temporarily stop Pantoprazole sodium delayed-release tablets treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. Reproduction studies have been performed in rats at oral doses up to 450 mg/kg/day (about 88 times the recommended human dose) and rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose) with administration of Pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to Pantoprazole in this study A pre-and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with Pantoprazole sodium. It allows continued monitoring of the benefit/risk balance of the medicinal product. Pantoprazole 20 mg is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group (see section 5.2).The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients listed in section 6.1.In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use.
There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to Pantoprazole in 549 live births. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature.