Pantoprazole is administered orally or intravenously. Protonix pantoprazole sodium tablets, drug label fda. Protonix pantoprazole sodium for delayedrelease oral suspension is a substituted benzimidazole, sodium 5difluoromethoxy23,4dimethoxy2pyridinylmethyl sulfinyl 1hbenzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. It shares the same core structure as other currently available protonpump inhibitors ppis. Pantoprazole is a substituted benzimidazole and proton pump inhibitor with antacid activity. Naproxen, a nonsteroidal antiinflammatory drug suggested for the long term treatment of disease conditions such as rheumatoid arthritis and osteoarthritis poses an immediate risk of stomach ulceration. Lackofeffect of pantoprazole the pharmacodynamics and. Cyp2c19, cyp2c9, cyp3a4 pantoprazole is extensively metabolized in the liver to inactive metabolites by the cytochrome p450 cyp system. Drugs for which gastric ph can affect bioavailability 7. It decrease the amount of acid produced in stomach drug information, 2005. Pantoprazole drug information indications, dosage, side. In one study, pantoprazole was present in human breast milk only at 2 and 4 h postdose, and the levels achieved were unlikely to have any effect on the fetus. Formulation development and evaluation of pantoprazole enteric coated tablets sumit chakraborty.
Profiles of drug substances, excipients and related methodology. Most adverse events have been mild and transient showing no. Pantoprazole, sold under the brand name protonix among others, is a medication used for the treatment of stomach ulcers, shortterm treatment of erosive esophagitis due to gastroesophageal reflux disease gerd, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including zollingerellison syndrome. Aspirinpantoprazole glaxosmithkline latest information update. Chemists at byk gulden, a subsidiary of altana a german chemical company, are credited with the synthesis of pantoprazole in 1985 whereas swedish chemists at the. Dailymed pantoprazole sodium tablet, delayed release. Route onset peak duration pantoprazole pantoeprazole. Asingle oral dose of 25 mgwarfarin sodium was coadministered with pantoprazole or placebo on day 2 of each treatment period. Pantoprazole was not detectable pantoprazole na and pantoprazole mg are different salts of the same molecule, their drug interaction profiles are expected to be similar.
Pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcgl and 24 mcgl, respectively. Pharmacokinetic drug interaction profiles of proton pump. Pantoprazole is a proton pump inhibitor ppi and a potent inhibitor of gastric acidity which is widely used in the therapy of gastroesophageal reflux and peptic ulcer disease. Pantoprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach pantoprazole is used to treat erosive esophagitis damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or gerd in adults and children who are at least 5 years old. Literature suggests that concomitant use of ppis with methotrexate primarily at. It works by decreasing the amount of acid your stomach makes. Its low potential for drug interactions may give it an advantage in patients taking other drugs. The formulation containing f1 pantoprazole drug layer has shown good result with 97. Tablets, delayedrelease 40 mg suspension, delayedrelease, oral 40 mg. To avoid this risk, a proton pump inhibitor is often prescribed along with it. Pharmacokinetic drug interaction profiles of proton pump inhibitors. Pantoprazole is an irreversible proton pump inhibitor that was marketed for acute treatment of gastric and duodenal ulcers and gastroesophageal reflux disease. Instruct patient to report bothersome or prolonged side effects, including headache or gi effects diarrhea, flatulence, belching, abdominal pain.
Pantoprazole is used to treat certain stomach and esophagus problems such as acid reflux. Pantoprazole is the third proton pump inhibitor to be launched for the treatment of peptic acid diseases. See what the interactions are and for which people. Pantoprazole was not detectable pantoprazole greater than 240 mg is limited. Experience in patients taking very high doses of pantoprazole greater than 240 mg is limited. The sodium salt of pantoprazole is obtained as an almost white to off white, crystalline powder. Several studies have shown that omeprazole carries a considerable potential for drug interactions because of its high af. It is extensively metabolised, and renal clearance accounts for only 4% of total drug clearance. Advise patient to avoid alcohol and foods that may cause an increase in gi irritation. In controlled clinical trials, pantoprazole 40mg once daily has proved superior to ranitidine 300mg once daily or 150mg twice daily and equivalent to omeprazole 20mg once daily in the short term. Drug interactions with rabeprazole are less well studied than those with omeprazole or pantoprazolena, as evidenced by the large number of unknown results in table 1.
It is 99% bound to human plasma proteins, primarily to albumin. Pantoprazole has weakly basic and acidic properties. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is. Pantoprazole oral interactions with other medication. To retrieve all information, including data published postapproval, use the all studies containing pantoprazole query. Pantoprazole is used to treat corrosive esophagitis damage to the esophagus from the stomach acid, and other conditions involving excess stomach acid such as zollingerellison syndrome drug information. Racaemic pantoprazole takeda next previous table of contents at a glance development overview introduction company agreements key development milestones. Pdf this chapter focuses on the drug pantoprazole sodium. The molecule contains an azabicyclooctyl group which confers special properties on the basic sulphonylurea moiety. The relative infant dose is estimated to be about 1%.
Gliclazide is a sulphonylurea drug with an intermediate halflife of around 11 hours. Pantoprazole sodium usp is freely soluble in water, very slightly soluble in phosphate buffer at ph 7. Us7550153b2 us11731,474 us73147407a us7550153b2 us 7550153 b2 us7550153 b2 us 7550153b2 us 73147407 a us73147407 a us 73147407a us 7550153 b2 us7550153 b2 us 7550153b2 authority us united states prior art keywords multiparticulates method according pantoprazole mg coat prior art date 20031001 legal status the legal status is an assumption and is. Thereby reducing gastric acid secretions dosage tablets, delayedrelease 20 mg.
Contraindicationshypersensitivity to drug or class. Like other drugs in this class, pantoprazole binds irreversibly and specifically to the proton pump, thereby reducing gastric acid secretion and causing longlasting inhibition of acid. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Although no significant drugdrug interactions have been observed in clinical. Pantoprazole comes as a delayedrelease releases the medication in the intestine to prevent breakdown of the medication by stomach acids tablet and as delayedrelease granules to take by mouth. Mechanism of actiondrug inhibits h k atpase pump function.
The active ingredient in protonix pantoprazole sodium for delayedrelease oral suspension and protonix pantoprazole sodium delayedrelease tablets, a ppi, is a substituted benzimidazole, sodium 5difluoromethoxy23,4dimethoxy2 pyridinylmethyl. Protonix pantoprazole sodium delayedrelease tablets. Comparison profile between c 2t 5 and innovator 0 10 20 30 40 50 60 70 80 90 100 0 100 200 300. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated.
Oct 24, 2018 protonix pantoprazole sodium delayedrelease tablets. Pantoprazole shows to have minimal interactions with other drugs because of a lower. Pantoprazole is a firstgeneration proton pump inhibitor ppi used for the management of gastroesophageal reflux disease gerd, for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of nsaids, and for the treatment of pathological hypersecretory conditions including zollingerellison ze syndrome. If you are allergic to medicines containing other proton pump inhibitors. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate. Pantoprazole and omeprazole are medications classified as protonpump inhibitors ppis and are commonly prescribed for the management of medical conditions in which stomach acid reduction is of therapeutic benefit.
Po gerd 2040 mg day in the morning for 4 to 8 weeks if needed. Protonix pantoprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach protonix is used to treat erosive esophagitis damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or gerd in adults and children who are at least 5 years old. Nonprescription medicines for relief from heartburn include antacids, alginates, histamine2receptor antagonist and proton pump inhibitors ppis. In the present study, naproxen 500mg is prepared in combination with pantoprazole, a proton pump. Protonix pantoprazole sodium for delayedrelease oral suspension. Protonix pantoprazole sodium clinical pharmacology pfizer. Ppi have minimal side effects and few slight drug interactions and are. Pantoprazole more rapidly heals ulcer, and has far greater efficacy than omeprazole and ranitidinein esophageal reflux disease. Affected cytochrome p450 isoenzymes and drug transporters. This chapter focuses on the drug pantoprazole sodium. Us7550153b2 pantoprazole multiparticulate formulations. Introduction 23, 24, 25 drug name pantoprazole sodium sesquihydrate. This contrast shows high sensitivity to the lipid hydrocarbon chains and the protein profile in the bulk. May 07, 2020 pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcgl and 24 mcgl, respectively.
Pantoprazole indications, dosage, side effects and precautions. Information for the user pantoprazole 40 mg gastroresistant tablets. Fda label due to their good safety profile and as several ppis are available over the. Pantoprazole protonix side effects, dosage, interactions. There are no wellcontrolled studies in nursing women. Pantoprazole sodium is the sodium salt form of a substituted benzimidazole with proton pump inhibitor activity. Feb 19, 2014 drug interactions with rabeprazole are less well studied than those with omeprazole or pantoprazole na, as evidenced by the large number of unknown results in table 1. The packets of delayedrelease granules must be mixed with applesauce or apple juice and taken by mouth or given through a feeding tube. Following the initial oral dose of 40 mg pantoprazole, a 51% mean inhibition was.
Allopurinol and pantoprazole drug interactions a study of. However, a study performed in caco2 cells did not show a significant efflux of pantoprazole by pgp. Maypabsorption of drugs requiring acid ph, including ketocona. Cyp2c19, cyp2c9, cyp3a4 pantoprazole is extensively metabolized in the liver to inactive metabolites by. Pantoprazole sodium pantoprazole is a prescription drug used to treat conditions such as pathological hypersecretory diseases, gastroesophageal reflux disease gerd, and erosive esophagitis.
Generic drugs usually cost less than the brandname version. Oct 31, 2012 pantoprazole is an irreversible proton pump inhibitor which, at the therapeutic dose of 40mg, effectively reduces gastric acid secretion. A link to download a pdf version of the drug profile will be included in your email receipt. Pantoprazole is a firstgeneration proton pump inhibitor ppi used for the. Pdf pharmacokinetic drug interaction profiles of proton. Pantoprazole is a lipophilic, weak base that crosses the parietal cell membrane and enters the acidic parietal cell canaliculus where it becomes protonated, producing the active metabolite sulfenamide, which forms an irreversible. The adverse reaction profiles for protonix pantoprazole sodium for delayedrelease oral. Pantoprazole appears to have a lower potential for interactions with other medications, and has been used in more than 100 different countries worldwide 1051.
Prpantoprazole for injection pantoprazole sodium sesquihydrate for injection. Esomeprazoledrug interaction or lansoprazoledrug interaction or pantoprazoledrug interaction or rabeprazoledrug interaction or protonpumpinhibitor drug interaction. Compare pantoprazole vs prilosec headtohead with other drugs for uses, ratings, cost, side effects, interactions and more. The 90% confidence intervals for the testreference mean ratios of the excess auc0,168h of. Assessment of dissolution profile of pantoprazole tablets. Feb 01, 2020 pantoprazole sodium usp is a white to offwhite powder and is racemic. Formulation development and evaluation of pantoprazole. Capitals indicate lifethreatening, underlines indicate most frequent. Medscape gastric ulcer, gerd, heartburnspecific dosing for protonix pantoprazole, frequencybased adverse effects, comprehensive interactions. Pantoprazole therapy is associated with a low rate of transient and asymptomatic serum aminotransferase elevations and is a rare cause of clinically apparent liver injury. The medication works by reducing the amount of acid in your stomach.
It belongs to a class of drugs known as proton pump inhibitors ppis. This drug has an excellent safety profile and a low incidence of drug interactions. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole. Adverse drug reaction overview pantoprazole sodium is well tolerated. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help. Longterm management of gerd in the elderly with pantoprazole. The drug content of both naproxen and pantoprazole in multilayered tablets optimized formulation d 1 was found to be 96. Talk to your doctor, pharmacist or nurse before taking. Pantoprazole is metabolized mainly by cyp2c19 and to minor extents by cyps 3a4, 2d6 and 2c9. Protonix pantoprazole dosing, indications, interactions, adverse. The stability of the compound in aqueous solution is phdependent.
This study is created by ehealthme based on reports of 7,059 people who take allopurinol and pantoprazole from food and drug administration fda, and is updated regularly. Pantoprazole is a prescription drug used as a shortterm treatment for gastroesophageal reflux disease gerd its part of a class of medications known as protonpump inhibitors ppis and is. Pantoprazole sodium sesquihydrate is a white to offwhite crystalline powder and is racemic. Pantoprazole competitively inhibits cyp2c19 activity in human liver microsomes with a ki of 69. Pantoprazole is usually given for up to 8 weeks at a time while your esophagus heals. Ruben vardanyan, victor hruby, in synthesis of bestseller drugs, 2016. Drug interactions are reported among people who take allopurinol and pantoprazole together. Dailymed pantoprazole sodium dr pantoprazole sodium. Pantoprazole fda prescribing information, side effects and uses. Pantoprazole is a group of drugs called proton pump inhibitor. Most studies report interactions attributed to the group effect of all ppis on gastric ph e. Protonix pantoprazole dosing, indications, interactions.
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