Monitor the patient for any of these symptoms, and report any adverse Active ingredient: Pantoprazole sodium sesquihydrate. Webtheophylline (a CYP1A2 substrate) in healthy subjects, the pharmacokinetics of pantoprazole were not significantly altered. Treatment with 40 mg of Pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. being able to get an erection, but not having it last long enough for sex. WebPantoprazole is used to treat damage from gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible have low magnesium levels, low calcium levels and low potassium levels in your blood. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Pantoprazole vs. omeprazole: What's the difference between them? You should take Pantoprazole exactly as prescribed, at the lowest dose possible and for the shortest time needed. The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and blurred vision. Food affected the pharmacokinetics of omeprazole (increased T max and decreased AUC and C max ), pantoprazole (increased T max and decreased AUC), and rabeprazole (increased T max, C max and half-life). See the end of this Medication Guide for a complete list of ingredients. Advise patients to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia, to their healthcare provider, if they have been receiving Pantoprazole for at least 3 months [see Warnings and Precautions ( 5.8)] . Advise the patient to read the FDA-approved patient labeling (Medication Guide). 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 in long-term maintenance of healing. Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.3)] . In clinical studies of ZE 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. The geometric mean AUC estimated from population PK analysis after a 40 mg Pantoprazole tablet in pediatric patients was about 39% and 10% higher respectively in 6 to 11 and 12 to 16 year-old children, compared to that of adults (Table 7). Take Pantoprazole exactly as prescribed by your doctor. The relevance of these findings to tumor development in humans is unknown [see Nonclinical Toxicology ( 13.1)] . Results Carriers of CYP2C19*2/*2 ( n = 2) were characterized by higher, starting from 3.5 h post dose, plasma concentrations of pantoprazole in comparison to wild-type ( CYP2C19*1/*1, n = 6) volunteers. An increased incidence of eosinophilic chief cells in adult and neonatal/juvenile rats, and atrophy of chief cells in adult rats and in neonatal/juvenile dogs, was observed in the fundic mucosa of stomachs in repeated-dose studies. A significantly greater proportion of patients taking Pantoprazole 40 mg experienced complete relief of daytime and nighttime heartburn and the absence of regurgitation, starting from the first day of treatment, compared with placebo. These adverse reactions are listed below by body system: Gastrointestinal Disorders: fundic gland polyps, General Disorders and Administration Conditions: asthenia, fatigue, malaise, Hematologic: pancytopenia, agranulocytosis, Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure, Immune System Disorders: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus, Infections and Infestations: Clostridium difficile associated diarrhea, Metabolism and Nutritional Disorders: hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia, Musculoskeletal Disorders: rhabdomyolysis, bone fracture, Psychiatric Disorders: hallucination, confusion, insomnia, somnolence, Renal and Urinary Disorders: acute tubulointerstitial nephritis, Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions (some fatal), including erythema multiforme, SJS/TEN, DRESS, AGEP, angioedema (Quinckes edema) and cutaneous lupus erythematosus. In addition, Pantoprazole 40 mg was superior to all other treatments studied. For known pediatric poor metabolizers, a dose reduction should be considered. Web10.1007/BF02440862 Abstract The plasma pharmacokinetics of pantoprazole have been investigated following single intravenous infusion and single oral administration at a dose of 40 mg to 12 healthy male subjects in a randomised cross-over study. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses. WebTanaka M, Yamazaki H, Hakusui H, Nakamichi N, Sekino H. Differential stereoselective pharmacokinetics of pantoprazole, a proton pump inhibitor in extensive and poor metabolizers of pantoprazolea preliminary study. Dose adjustment of warfarin may be needed to maintain target INR range. General Disorders and Administration Conditions: Infections and Infestations: Clostridium difficile. It may harm them. The relative dose to the infant was estimated to be 7.3 mcg of Pantoprazole, which is equivalent to 0.14% of the weight-adjusted maternal dose. Generally, histological findings were observed without organ involvement. Healthcare providers should temporarily stop Pantoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. Swallow Pantoprazole Sodium Delayed-Release Tablets whole, with or without food in the stomach. Pantoprazole Sodium Delayed-Release Tablets are prepared as enteric-coated tablets so that absorption of Pantoprazole begins only after the tablet leaves the stomach. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. Pantoprazole is not removed by hemodialysis. actemra inj 162/0.9 . The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. Available for Android and iOS devices. Advise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Contraindications ( 4), Warnings and Precautions ( 5.2)] . In a population pharmacokinetic analysis, the systemic exposure was higher in patients less than 1 year of age with GERD compared to adults who received a single 40 mg dose (geometric mean AUC was 103% higher in preterm infants and neonates receiving single dose of 2.5 mg of Pantoprazole, and 23% higher in infants 1 through 11 months of age receiving a single dose of approximately 1.2 mg/kg). See prescribing information for warfarin. Experience in patients taking very high doses of Pantoprazole (greater than 240 mg) is limited. Dispense with Medication Guide available at: www.chartwellpharma.com/medguides, Pantoprazole (pan toe' pra zole) Sodium Delayed-Release Tablets, USP. The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. You may report side effects to FDA at 1-800-FDA-1088. You may use antacids while taking Pantoprazole tablets. Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. Treatment with 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia. Serious adverse events include tetany, arrhythmias, and seizures. Neonate through 5 Years of Age [see Use in Specific Populations ( 8.4)], Children and Adolescents 6 through 16 Years of Age. For safety findings see Adverse Reactions ( 6.1) . Do not use Pantoprazole for a condition for which it was not prescribed. The estimated AUC for patients 1 to 5 years old was 37% higher than for adults receiving a single 40 mg tablet, with a geometric mean AUC value of 6.8 mcghr/mL. Stop taking Pantoprazole and call your doctor right away. Advise a pregnant woman of the potential risk to a fetus. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary [see Clinical Pharmacology ( 12.2)] . Chirality. Atazanavir: See prescribing information for atazanavir for dosing information. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). 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). All 4 patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. In the liver, treatment with 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. 3, 4 Patients taking losartan should be regularly monitored for hypotension, renal function, and potassium levels. In this study, all Pantoprazole treatment groups had significantly greater healing rates than the placebo group. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with Pantoprazole may increase toxicity of the antiretroviral drugs. The most frequently occurring adverse reactions are listed in Table 3. Pantoprazole Sodium Delayed-Release Tablets were evaluated in children ages 6 through 16 years Pantoprazole absorption is not affected by concomitant administration of antacids. being unable to get an erection at any time. Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet). Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including Pantoprazole sodium. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in children aged 6 to 11 years at the 40 mg dose) and higher doses. All brand names are the trademarks of their respective owners. being unable to get an erection at any time. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay. Literature suggests 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, possibly leading to methotrexate toxicities. Table 1: Recommended Dosing Schedule for Pantoprazole, Short-Term Treatment of Erosive Esophagitis Associated With GERD, Maintenance of Healing of Erosive Esophagitis, Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome. After a single oral 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 percentages of patients healed (per protocol, n = 541) in this study are shown in Table 8. Patients were treated with a range of doses of Pantoprazole once daily for 8 weeks. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. Swallow Pantoprazole Sodium Delayed-Release Tablets whole, with or without food in the stomach. The studies have revealed no evidence of impaired fertility or harm to the fetus due to Pantoprazole. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. The most common side effects of Pantoprazole in adults include: The most common side effects of Pantoprazole in children include: Inactive ingredients in Pantoprazole Sodium Delayed-Release Tablets: Pantoprazole sodium tablet, delayed release. These pharmacokinetic changes in hepatic-impaired patients result in minimal drug accumulation following once-daily, multiple-dose administration. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations OR=1.12 ([95% CI 0.86-1.45] and for spontaneous abortions OR=1.29 [95% CI 0.84-1.97]). Package insert / product label In vivo studies also suggest that Pantoprazole does not significantly affect the kinetics of the following drugs (cisapride, theophylline, diazepam [and its active metabolite, desmethyldiazepam], phenytoin, metoprolol, nifedipine, carbamazepine, midazolam, clarithromycin, diclofenac, naproxen, piroxicam, and oral contraceptives [levonorgestrel/ethinyl estradiol]). It is, therefore, expected that other drugs metabolized by CYPs 2C19, 3A4, 2D6, 2C9 and 1A2 would not significantly affect the pharmacokinetics of pantoprazole. Patients received Pantoprazole daily for four weeks in an open-label phase, then patients were randomized in equal proportion to receive Pantoprazole treatment or placebo for the subsequent four weeks in a double-blind manner. At a glance Originator Nycomed Developer Pfizer; Takeda Pharmaceuticals International GmbH Class 2 pyridinylmethylsulfinylbenzimidazoles; Antiulcers; Gastric antisecretories; Small molecules Mechanism of Action Proton pump inhibitors Orphan Drug Status No New Molecular Entity No Highest Development Phases The rate of degradation increases with decreasing pH. In children 5 years of age and older, Pantoprazole is used for: Pantoprazole is not for use in children under 5 years of age. In vivo studies also suggest that pantoprazole does not In a population PK analysis, total clearance increased with increasing bodyweight in a non-linear fashion. Pantoprazole has weakly basic and acidic properties. US Brand Name. Pantoprazole undergoes little first-pass metabolism, resulting in an absolute bioavailability of approximately 77%. A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with Pantoprazole sodium. All adult adverse reactions to Pantoprazole are considered relevant to pediatric patients. Pantoprazole may help your acid-related symptoms, but you could still have serious stomach problems. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. As demonstrated in Table 10, Pantoprazole 40 mg and 20 mg were significantly superior to ranitidine at every timepoint with respect to the maintenance of healing. Tell your doctor if you are not able to swallow your Pantoprazole tablet. It is used to treat erosive Pantoprazole and lansoprazole have the highest extent of absorption. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. 1997; 9:1721. In a separate study, a gastric NE-cell tumor without concomitant ECL-cell proliferative changes was observed in 1 female rat following 12 months of dosing with Pantoprazole at 5 mg/kg/day and a 9 month off-dose recovery [see Nonclinical Toxicology ( 13.1)] . Only slight to moderate increases in the AUC (43%) and C max (26%) of Pantoprazole were found in elderly subjects (64 to 76 years of age) after repeated oral administration, compared with younger subjects [see Use in Specific Populations ( 8.5)] . No adverse events in the infant were reported by the mother. Following short-term treatment with Pantoprazole, elevated gastrin levels return to normal by at least 3 months. allergic to Pantoprazole sodium, any other PPI medicine, or any of the ingredients in Pantoprazole. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions ( 5.13)] . There were no effects on fertility or reproductive performance when Pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area). In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with Pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50 kg person dosed with 40 mg/day. Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. 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. WebSymptoms of ED include. The effect of PPIs on antiretroviral drugs is variable. In patients with mild to severe hepatic impairment (Child-Pugh A to C cirrhosis), maximum Pantoprazole concentrations increased only slightly (1.5-fold) relative to healthy subjects. Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg - NDC 62135-533-90 - 90's Bottle Label, Pantoprazole Sodium Delayed-Release Tablets, USP 40 mg - NDC 62135-534-90 - 90's Bottle Label, Pantoprazole Sodium Delayed-Release Tablets, USP 40 mg - NDC 62135-534-08 - 450's Bottle Label, amoxicillin, omeprazole, famotidine, metronidazole, Protonix, clarithromycin, esomeprazole, sucralfate, Nexium, lansoprazole. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas. Most frequently occurring adverse reactions to Pantoprazole Sodium Delayed-Release Tablets whole, or... Without organ involvement drug interaction studies of high-dose methotrexate with PPIs have been reported patients..., n = 541 ) in healthy subjects, the degradation half-life is approximately hours. Impaired fertility or harm to the fetus due to its effect on development., but you could still have serious stomach problems pediatric poor metabolizers, a dose reduction should be considered Medication... The trademarks of their respective owners oxide, isopropyl alcohol, and propylene glycol of other drugs due its... Following once-daily, multiple-dose administration with or without food in the in vivo liver. 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