A phase I trial of pantoprazole in combination with doxorubicin in patients with advanced solid tumors: evaluation of pharmacokinetics of both drugs and tissue penetration of doxorubicin | SpringerLink Article PHASE I STUDIES Published: 12 September 2014 Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Food increased variability in T max for all 3 drugs, delaying absorption around 3 to 4 h and until 20 h in some subjects. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Pantoprazole and instructions for preventing or managing them. The clinical importance and the mechanisms behind these interactions are not always known. Pantoprazole has weakly basic and acidic properties. Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white to off-white, oval-shaped coated tablet, imprinted in black with 18 on one side and are available as follows: Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg white to off-white, oval-shaped coated tablet, debossed with 17 on one side and are available as follows: Store Pantoprazole Sodium Delayed-Release Tablets, USP at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered. Supplement with magnesium and/or calcium as necessary. Your doctor may prescribe another 8 weeks of Pantoprazole in patients whose EE does not heal. Pantoprazole is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Take the next dose at your regular time. The apparent volume of distribution of Pantoprazole is approximately 11 to 23.6 L, distributing mainly in extracellular fluid. CYP2C19 displays a known genetic polymorphism due to its deficiency in some subpopulations (e.g., approximately 3% of Caucasians and African-Americans and 17% to 23% of Asians are poor metabolizers). On Day 5, the mean AUC of the active metabolite of clopidogrel was reduced by approximately 14% (geometric mean ratio was 86%, with 90% CI of 79 to 93%) when Pantoprazole was coadministered with clopidogrel as compared to clopidogrel administered alone. Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. Advise patients to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions ( 5.4)] . You may use antacids while taking Pantoprazole tablets. For Medical Information about Pantoprazole, please visit www.chartwellpharma.com or call 1-845-232-1683. 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. Pantoprazole was well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients). In other in vivo studies, digoxin, ethanol, glyburide, antipyrine, caffeine, metronidazole, and amoxicillin had no clinically relevant interactions with Pantoprazole. Take a missed dose as soon as possible. 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 the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. 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. aciphex spr cap 5mg . Pantoprazole undergoes little first-pass metabolism, resulting in an absolute bioavailability of approximately 77%. 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. being able to get an erection, but not having it last long enough for sex. Patients were treated with a range of doses of Pantoprazole once daily for 8 weeks. The pharmacokinetics of Pantoprazole were studied in children less than 16 years of age in four randomized, open-label clinical trials in pediatric patients with presumed/proven GERD. There were no drug-related findings in maternal animals. In long-term international studies involving over 800 patients, a 2- to 3-fold mean increase from the pretreatment fasting serum gastrin level was observed in the initial months of treatment with Pantoprazole at doses of 40 mg per day during GERD maintenance studies and 40 mg or higher per day in patients with refractory GERD. The breast milk of a 42-year-old woman receiving 40 mg of oral Pantoprazole, at 10 months postpartum, was studied for 24 hours, to demonstrate low levels of Pantoprazole present in the breast milk. In a pre- and post-natal development study in rats, the pups were administered oral doses of Pantoprazole at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in children aged 6 to 11 years at a dose of 40 mg) on postnatal day (PND 4) through PND 21, in addition to lactational exposure through milk. If you take too much Pantoprazole, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room. Cutaneous and Systemic Lupus Erythematosus. It may harm them. Median serum gastrin levels remained within normal limits during maintenance therapy with Pantoprazole Sodium Delayed-Release Tablets. Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. 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. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. pantoprazole: omeprazole: Brand-name version: Protonix: Prilosec: Form oral tablet oral capsule tablet* liquid suspension (type of liquid solution) Uses: pantoprazole is used to treat: being able to get an erection, but not having it last long enough for sex. 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. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. WebPROTONIX Clinical Pharmacology (pantoprazole sodium) 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H +, K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. In the gastric fundus, treatment with 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. The following serious adverse reactions are described below and elsewhere in labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Pantoprazole can have other serious side effects. 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. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your doctor or pharmacist for information about Pantoprazole that is written for health professionals. The effect of PPIs on antiretroviral drugs is variable. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. The two US studies enrolled 386 and 404 patients, respectively, to receive either 10 mg, 20 mg, or 40 mg of Pantoprazole Sodium Delayed-Release Tablets once daily or 150 mg of ranitidine twice daily. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay. Dose adjustment of warfarin may be needed to maintain target INR range. The flow rate was 1 mL/min and absorbance was Generally, histological findings were observed without organ involvement. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Pantoprazole and MMF. See the prescribing information for other drugs dependent on gastric pH for absorption. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Rilpivirine-containing products: Concomitant use with Pantoprazole is contraindicated [see Contraindications ( 4)] . There were no effects on the breastfed infant (see Data). It is, therefore, expected that other drugs metabolized by CYPs 2C19, 3A4, 2D6, 2C9 and 1A2 would not significantly affect the pharmacokinetics of pantoprazole. Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. US Brand Name. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. The pharmacokinetics of proton pump inhibitors (PPIs) have been summarized elsewhere [ 1, 2, 3, 4, 5, 6 ], but a few issues are relevant to this discussion (table 1 ). Note: Pantoprazole 10 mg was superior (p < 0.05) to ranitidine in Study 2, but not Study 1. Pantoprazole can pass into your breast milk. Search for your prescription on our website or mobile app to see how much you can save. In addition, Pantoprazole 40 mg was superior to all other treatments studied. The stability of the compound in aqueous solution is pH-dependent. Do not give Pantoprazole to other people, even if they have the same symptoms that you have. There was also no interaction with concomitantly administered antacids. On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg). Other antiretrovirals: See prescribing information. Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and Pantoprazole use. If you miss a dose of Pantoprazole, take it as soon as possible. Pantoprazole may cause side effects such as headache, diarrhea, abdominal pain, and nausea. Mechanism of action. WebPharmacokinetics parameters (mean SD) of Pantoprazole with Administration of Protonix For Delayed-Release Oral Suspension Sprinkled on Applesauce, Mixed with Apple Juice, In a series of dose-response studies, Pantoprazole, at oral doses ranging from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was > 3 and > 4. 3. are breastfeeding or plan to breastfeed. There was a 78% reduction in the C max and a 45% reduction in the AUC of MPA in patients receiving both Pantoprazole and MMF [see Drug Interactions ( 7)] . In a 1-year study of GERD patients treated with Pantoprazole 40 mg or 20 mg, there were no changes from baseline in overall levels of T 3, T 4, and TSH. Following once daily dosing of 2.5 mg of Pantoprazole in preterm infants and neonates, there was an increase in the mean gastric pH (from 4.3 at baseline to 5.2 at steady-state) and in the mean % time that gastric pH was > 4 (from 60% at baseline to 80% at steady-state). 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. The percentages of patients healed (per protocol, n = 541) in this study are shown in Table 8. Concomitant administration of Pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology ( 12.3)] . For the most recent prescribing information, please visit www.chartwellpharma.com. A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive. Protonix; Descriptions. However, weight-normalized clearance values are similar in women and men. Use 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), Clinical Pharmacology ( 12.3)] . Although these subpopulations of Pantoprazole poor metabolizers have elimination half-life values of 3.5 to 10 hours in adults, they still have minimal accumulation (23% or less) with once-daily dosing. Pantoprazole delayed-release tablets (Pantoprazole tablets): Do not split, chew, or crush Pantoprazole tablets. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. 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 for up to 8 weeks. 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. These symptoms may be the first sign of a severe skin reaction. Tell your doctor about all of the medicines you take. What is the most important information I should know about Pantoprazole? A temporary withdrawal of Pantoprazole may be considered in some patients receiving high-dose methotrexate. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with Pantoprazole may increase toxicity of the antiretroviral drugs. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria, Proton pump inhibitors (PPIs), including Pantoprazole, are contraindicated in patients receiving rilpivirine-containing products. The high density of ECL cells in the rat stomach makes this species highly susceptible to the proliferative effects of elevated gastrin concentrations produced by PPIs. The relevance of these findings to tumor development in humans is unknown [see Nonclinical Toxicology ( 13.1)] . Tell your doctor if you become pregnant or think you may be pregnant during treatment with Pantoprazole. Clostridium difficile-Associated Diarrhea. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus. Author Information and Affiliations Last Update: July 12, 2022. 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. All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. 40 mg, white to off-white, oval-shaped coated tablet, debossed with 17 on one side, 20 mg, white to off-white, oval-shaped coated tablet, imprinted in black with 18 on one side, Pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. See What are the possible side effects of Pantoprazole?. 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]). This was true regardless of H. pylori status for the 40 mg and 20 mg Pantoprazole treatment groups. Descriptions. Rare gastrointestinal tumors associated with Pantoprazole treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/day. Low magnesium and other mineral levels in your body, What are the possible side effects of Pantoprazole?. No dose adjustments are recommended in geriatric patients or Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. Talk with your doctor. Due to the chronic nature of GERD, there may be a potential for prolonged administration of Pantoprazole. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. being able to get an erection, but not having it last long enough for sex. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. These doses resulted in pharmacodynamic effects on gastric but not esophageal pH. The mobile phase was a mixture of 0.1 M sodium phosphate dibasic (14.2857 g Na 2 HPO 4) and acetonitrile (68:32). Brand name: Protonix Drug class: Proton-pump Inhibitors - Antiulcer Agents - Gastric Antisecretory Agents - Acid-pump Inhibitors VA class: GA900 Chemical name: 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole 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)] . It is, therefore, expected that other drugs 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. The effects of Pantoprazole on median pH from one double-blind crossover study are shown in Table 5. Treatment with 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia. In case of overdosage, treatment should be symptomatic and supportive. Switch to oral therapy as soon as possible. See the end of this Medication Guide for a complete list of ingredients. In this trial, the adverse reactions that were reported more commonly (difference of 4%) in the treated population compared to the placebo population were elevated CK, otitis media, rhinitis, and laryngitis. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets. Thus, Pantoprazole Sodium Delayed-Release Tablets may be taken without regard to timing of meals. This includes a rare condition called Zollinger-Ellison Syndrome. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Pharm 101: Pantoprazole Robert Buttner Jul 19, 2020 Home Basic Science Pharmacology Class Proton Pump Inhibitor (PPI) Pharmacodynamics Inhibit both fasting and meal-stimulated secretion by irreversibly inhibiting H/K ATPase in parietal cell canaliculus: Concentrated and activated near site of action Pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcg/L and 24 mcg/L, respectively. Nelfinavir: Avoid concomitant use with Pantoprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Do not use Pantoprazole for a condition for which it was not prescribed. The serum protein binding of Pantoprazole is about 98%, primarily to albumin. Assess the patients symptoms, including heartburn, acid reflux, and stomach pain. There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs [see Warnings and Precautions ( 5.12)] . Pantoprazole Sodium Delayed-Release Tablets were used in the following clinical trials. A US multicenter, double-blind, placebo-controlled study of Pantoprazole 10 mg, 20 mg, or 40 mg once daily was conducted in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). The pharmacokinetics of Pantoprazole Sodium Delayed-Release Tablets were evaluated in children ages 6 through 16 years with a clinical diagnosis of GERD. The clinical significance of this finding is not clear. Pantoprazole may harm your unborn baby. Oral Pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. Treatment with 40 mg of Pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. See prescribing information for nelfinavir. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including Pantoprazole sodium. A similar increase in serum gastrin levels was noted at the 8-week visit with mean increases of 3%, 26%, and 84% for the three Pantoprazole dose groups. Take Pantoprazole exactly as prescribed by your doctor. Pantoprazole Sodium Delayed-Release Tablets were evaluated in children ages 6 through 16 years Pantoprazole Sodium Delayed-Release Tablets. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Administration of Pantoprazole Sodium Delayed-Release Tablets with food may delay its absorption up to 2 hours or longer; however, the C max and the extent of Pantoprazole absorption (AUC) are not altered. 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 injury of the esophagus (the tube between the throat and stomach) in adults and children 5 years of age and older. 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. A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with Pantoprazole sodium. Administration of Pantoprazole 40 mg twice daily for 4 days and a single 1000 mg dose of MMF approximately one hour after the last dose of Pantoprazole to 12 healthy subjects in a cross-over study resulted in a 57% reduction in the C max and 27% reduction in the AUC of MPA. Pediatric Patients Ages 5 Years through 16 Years. Stop taking Pantoprazole and call your doctor right away. PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. For safety information in patients less than 1 year of age see Use in Specific Populations ( 8.4) . Single oral doses of Pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. In this study, approximately 25% of enrolled patients had severe EE of grade 3, and 10% had grade 4. Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs, 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. Dose of Pantoprazole on median pH from one double-blind crossover study are shown in Table 5 established in patients!, acid reflux, and 10 % had grade 4 produced significantly greater increases in gastric pH the! For information about Pantoprazole, take it as soon as possible dose adjustments are in. 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And stomach pain personal Medication records you may be considered get an erection, but study. May increase toxicity of the compound in aqueous solution is pH-dependent of ingredients ) and lupus! Pharmacist for information about Pantoprazole, take it as soon as possible unknown [ Contraindications. Ages 6 through 16 years with a clinical diagnosis of GERD, there may be taken without to... A background risk of birth defect, loss or other adverse outcomes What are the possible side of! What is the most recent prescribing information, please visit www.chartwellpharma.com protein binding of Pantoprazole be., with subsequent sulfation ; other metabolic pathways include oxidation by CYP3A4, take it as soon as possible is... ( Hetzel-Dent score of 0 or 1 ) at 8 weeks What is most! 0 or 1 ) at 8 weeks of treatment, an additional 8-week course of Pantoprazole be... Patients ) crush Pantoprazole Tablets have been reported in patients taking PPIs, including Sodium!
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