Pantoprazole purpose pantoprazole sodium

The most frequently occurring adverse reactions are listed in Table 3.Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Pantoprazole (n=1473)%Comparators(n=345)%Placebo(n=82)%Headache12.212.88.5Diarrhea8.89.64.9Nausea75.29.8Abdominal pain6.24.16.1Vomiting4.33.52.4Flatulence3.92.93.7Dizziness32.91.2Arthralgia2.81.41.2Additional adverse reactions that were reported for pantoprazole in clinical trials with a frequency of ≤ 2% are listed below by body system: Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edemaGastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia, thrombocytopenia Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Pediatric Patients  Adverse reaction information in pediatric patients with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. If patients are unable to swallow a 40 mg tablet, ass ratiopharm aspirin two 20 mg tablets may be taken. StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. Following oral administration, the serum concentration of pantoprazole declines biexponentially, with a terminal elimination half-life of approximately one hour.In extensive metabolizers with normal liver function receiving an oral dose of the enteric-coated 40 mg pantoprazole tablet, the peak concentration (Cmax) is 2.5 mcg/mL; the time to reach the peak concentration (tmax) is 2.5 h, and the mean total area under the plasma concentration versus time curve (AUC) is 4.8 mcg∙h/mL (range 1.4 to 13.3 mcg∙h/mL). Zollinger-Ellison Syndrome In clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients taking pantoprazole 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium. A significantly greater proportion of the patients in the pantoprazole sodium delayed-release tablets treatment groups experienced complete relief of nighttime heartburn and regurgitation, starting on the first day and of daytime heartburn on the second day, compared with those taking nizatidine 150 mg twice daily. Dosage adjustment of these drugs is not necessary when they are coadministered with pantoprazole. There is no evidence that any of the pantoprazole metabolites have significant pharmacologic activity.ExcretionAfter a single oral or intravenous dose of 14C-labeled pantoprazole to healthy, normal metabolizer subjects, approximately 71% of the dose was excreted in the urine, with 18% excreted in the feces through biliary excretion. The effectiveness of pantoprazole sodium for treating symptomatic GERD in pediatric patients has not been established.Although the data from the clinical trials support use of pantoprazole sodium for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see Dosage and Administration (2)].In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of 2.4 L/h. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. Due to the chronic nature of GERD, there may be a potential for prolonged administration of pantoprazole sodium  delayed-release tablets. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)] Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of pantoprazole sodium for symptomatic GERD in the pediatric population. In pediatric patients ages 1 through 16 years there were no clinically relevant effects of gender on clearance of pantoprazole, as shown by population pharmacokinetic analysis.Renal Impairment In patients with severe renal impairment, pharmacokinetic parameters for pantoprazole were similar to those of healthy subjects. In other in vivo studies, digoxin, ethanol, glyburide, antipyrine, caffeine, metronidazole, and amoxicillin had no clinically relevant interactions with pantoprazole. Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of pantoprazole sodium delayed-release tablets for symptomatic GERD in the pediatric population. Due to the chronic nature of GERD, there may be a potential for prolonged administration of pantoprazole sodium. Renal ImpairmentIn patients with severe renal impairment, pharmacokinetic parameters for pantoprazole were similar to those of healthy subjects. Pantoprazole 40 mg and 20 mg once daily were also compared with nizatidine 150 mg twice daily in a US multicenter, double-blind study of 243 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7)]. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Pantoprazole sodium is supplied as delayed-release tablets. A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive.

Pantoprazole injection

The safety and effectiveness of pantoprazole sodium delayed-release tablets for short-term treatment (up to eight weeks) of  EE associated with GERD have been established in pediatric patients 1 year through 16 years of age. The product's dosage form is tablet, delayed release and is administered via oral form. Rare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum at 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus at 200 mg/kg/day. Treatment with 40 mg of pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. With once-a-day dosing for 7 days, the mean inhibition was increased to 85%. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)] . In other in vivo studies, digoxin, ethanol, glyburide, antipyrine, caffeine, metronidazole, and amoxicillin had no clinically relevant interactions with pantoprazole.Although no significant drug-drug interactions have been observed in clinical studies, the potential for significant drug-drug interactions with more than once-daily dosing with high doses of pantoprazole has not been studied in poor metabolizers or individuals who are hepatically impaired.AntacidsThere was also no interaction with concomitantly administered antacids. If overexposure to Pantoprazole sodium delayed-release tablets occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium  delayed-release tablets may be considered. The relevance of these findings to tumor development in humans is unknown [see Nonclinical Toxicology (13.1)]. The information in this website is intended for healthcare providers and consumers in the United States. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole. Patients received pantoprazole sodium delayed-release tablets daily for four weeks in an open-label phase, digitoxin 0 07 then patients were randomized in equal proportion to receive pantoprazole sodium delayed-release tablets treatment or placebo for the subsequent four weeks in a double-blind manner. Pantoprazole sodium was well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients). Pantoprazole sodium delayed-release tablets were well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients). Published observational studies suggest that PPI therapy like pantoprazole sodium delayed-release tablets may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole sodium.A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. In pediatric patients ages 1 through 16 years there were no clinically relevant effects of gender on clearance of pantoprazole, as shown by population pharmacokinetic analysis. Other EffectsIn a clinical pharmacology study, Pantoprazole 40 mg given once daily for 2 weeks had no effect on the levels of the following hormones: cortisol, testosterone, triiodothyronine (T3), thyroxine (T4), thyroid-stimulating hormone (TSH), thyronine-binding protein, parathyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimulating hormone, luteinizing hormone, prolactin, and growth hormone. In short-term US clinical trials, EE healing rates in the 107 elderly patients (≥ 65 years old) treated with pantoprazole were similar to those found in patients under the age of 65. The effectiveness of pantoprazole sodium delayed-release tablets for treating symptomatic GERD in pediatric patients has not been established.Although the data from the clinical trials support use of pantoprazole sodium delayed-release tablets for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see Dosage and Administration (2)].In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of 2.4 L/h. Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses. 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 safety and effectiveness of Pantoprazole for pediatric uses other than EE have not been established.1 year through 16 years of ageUse of Pantoprazole in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of Pantoprazole for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies (14.1), and Clinical Pharmacology (12.3)].Safety of Pantoprazole in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel- treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years).

What is the drug pantoprazole used for

Pantoprazole has weakly basic and acidic properties. 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 [see Adverse Reactions (6.2)] . The safety and effectiveness of pantoprazole for short-term treatment (up to eight weeks) of EE associated with GERD have been established in pediatric patients 1 year through 16 years of age. In adults, symptomatic response to therapy with pantoprazole sodium delayed-release tablets does not preclude the presence of gastric malignancy. PPI use is associated with an increased risk of fundic gland  that increases with longterm use, especially beyond one year. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH. Use of pantoprazole sodium delayed-release tablets in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of pantoprazole sodium delayed-release tablets for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see Clinical Studies (14.1), Clinical Pharmacology (12.3)]. Doses higher than 40 mg per day of pantoprazole sodium have not been studied in hepatically impaired patients.Drug Interaction StudiesEffect of Other Drugs on PantoprazolePantoprazole is metabolized mainly by CYP2C19 and to minor extents by CYPs 3A4, 2D6, and 2C9. Administration of pantoprazole sodium delayed-release tablets with food may delay its absorption up to 2 hours or longer; however, the Cmax and the extent of pantoprazole absorption (AUC) are not altered. If  it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Pantoprazole sodium delayed-release tablets are prepared as enteric-coated tablets so that absorption of pantoprazole begins only after the tablet leaves the stomach. Children with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of pantoprazole sodium (20 mg or 40 mg). The serum protein binding of pantoprazole is about 98%, primarily to albumin. In the liver, treatment with 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. However, due to Wyeth Pharmaceuticals Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.Pediatric PatientsSafety of Pantoprazole in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials. Although the data from the clinical trials support use of pantoprazole sodium delayed-release tablets for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see Dosage and Administration (2)]. Pantoprazole undergoes little first-pass metabolism, resulting in an absolute bioavailability of approximately 77%. Avoid administration of PPIs for longer than medically indicated. Due to the chronic nature of GERD, there may be a potential for prolonged administration of pantoprazole sodium delayed-release tablets. Based on the potential for tumorigenicity shown for pantoprazole sodium 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. Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Pantoprazole drug interactions

How SuppliedPantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white, oval biconvex delayed-release tablets imprinted in black ink with "KU" on one side and "180" on the other side and are available as follows:Overbagged with 10 tablets per bag, NDC 55154-4330-0Dispensed in Blister Punch Material. Fasting serum gastrin levels generally remained at approximately 2 to 3 times baseline for up to 4 years of periodic follow-up in clinical trials.Following short-term treatment with pantoprazole sodium, elevated gastrin levels return to normal by at least 3 months.Enterochromaffin-Like (ECL) Cell Effects In 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was a moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau after 4 years.In a nonclinical study in Sprague-Dawley rats, lifetime exposure (24 months) to pantoprazole at doses of 0.5 to 200 mg/kg/day resulted in dose-related increases in gastric ECL cell proliferation and gastric neuroendocrine (NE)-cell tumors. In clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients taking pantoprazole sodium delayed-release tablets 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD.