MedPath

Pantoprazole

Generic Name
Pantoprazole
Brand Names
Protonix, Somac Control, Tecta, Pantozol Control, Controloc Control
Drug Type
Small Molecule
Chemical Formula
C16H15F2N3O4S
CAS Number
102625-70-7
Unique Ingredient Identifier
D8TST4O562
Background

Pantoprazole is a first-generation 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 Zollinger-Ellison (ZE) Syndrome. It can also be found in quadruple regimens for the treatment of H. pylori infections along with other antibiotics including amoxicillin, clarithromycin, and metronidazole, for example. Its efficacy is considered similar to other medications within the PPI class including omeprazole, esomeprazole, lansoprazole, dexlansoprazole, and rabeprazole.

Pantoprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of pantoprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, pantoprazole's duration of antisecretory effect persists longer than 24 hours.

Due to their good safety profile and as several PPIs are available over the counter without a prescription, their current use in North America is widespread. Long term use of PPIs such as pantoprazole have been associated with possible adverse effects, however, including increased susceptibility to bacterial infections (including gastrointestinal C. difficile), reduced absorption of micronutrients including iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia which may contribute to osteoporosis and bone fractures later in life.

PPIs such as pantoprazole have also been shown to inhibit the activity of dimethylarginine dimethylaminohydrolase (DDAH), an enzyme necessary for cardiovascular health. DDAH inhibition causes a consequent accumulation of the nitric oxide synthase inhibitor asymmetric dimethylarginie (ADMA), which is thought to cause the association of PPIs with increased risk of cardiovascular events in patients with unstable coronary syndromes.

Pantoprazole doses should be slowly lowered, or tapered, before discontinuing as rapid discontinuation of PPIs such as pantoprazole may cause a rebound effect and a short term increase in hypersecretion.

Indication

Pantoprazole Injection:

Treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis

Pantoprazole for injection is indicated for short-term treatment (7-10 days) of patients having gastroesophageal reflux disease (GERD) with a history of erosive esophagitis, as an alternative to oral medication in patients who are unable to continue taking pantoprazole delayed-release tablets. Safety and efficacy of pantoprazole injection as the initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated at this time.

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome

Pantoprazole for injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions.

Pantoprazole delayed-release oral suspension:

Short-Term Treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD)

Indicated in adults and pediatric patients five years of age and above for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been determined.

Maintenance of healing of erosive esophagitis

Indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD.

Pathological hypersecretory conditions including Zollinger-Ellison syndrome

Indicated for the long-term treatment of the above conditions.

Associated Conditions
Erosive Esophagitis, GERD With Erosive Esophagitis, Gastro-esophageal Reflux Disease (GERD), Healing, Heartburn, Helicobacter Pylori Infection, Stress Ulcers, Zollinger-Ellison Syndrome, Conditions where a reduction of gastric acid secretion is required, Pathological hypersecretory conditions
Associated Therapies
-

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

Not Applicable
Completed
Conditions
Helicobacter Pylori Infection
Interventions
First Posted Date
2014-06-10
Last Posted Date
2019-05-13
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
390
Registration Number
NCT02159976
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of

Histamine Glutamate Antagonism in Stroke

Phase 2
Completed
Conditions
Acute Cerebrovascular Accident
Cerebral Edema
Interventions
First Posted Date
2014-05-20
Last Posted Date
2015-12-15
Lead Sponsor
University of Florida
Target Recruit Count
3
Registration Number
NCT02142712
Locations
🇺🇸

Shands Hospital at University of Florida, Gainesville, Florida, United States

The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

Phase 4
Withdrawn
Conditions
Eustachian Tube Dysfunction
Laryngopharyngeal Reflux
Interventions
Drug: Omeprazole
Drug: Ranitidine
Drug: Pantoprazole
Procedure: 24-Hour Diagnostic pH-Probe Test
Procedure: Laryngoscopy
First Posted Date
2014-04-25
Last Posted Date
2016-09-26
Lead Sponsor
Loma Linda University
Registration Number
NCT02123498
Locations
🇺🇸

1895 Orange Tree Lane, Suite 102, Redlands, California, United States

🇺🇸

11234 Anderson Street, Loma Linda, California, United States

Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment

Phase 3
Completed
Conditions
Peptic Ulcer
Interventions
First Posted Date
2014-03-12
Last Posted Date
2014-06-03
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
323
Registration Number
NCT02084420
Locations
🇰🇷

Kangbuk Samsung Hospital, Seoul, Korea, Republic of

🇰🇷

Seoul Asan hoapital, Seoul, Korea, Republic of

🇰🇷

Inje Busan Paik Hospital, Busan, Korea, Republic of

and more 15 locations

Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study

Phase 1
Completed
Conditions
Obesity
GERD
Interventions
First Posted Date
2013-06-27
Last Posted Date
2021-12-03
Lead Sponsor
Children's Mercy Hospital Kansas City
Target Recruit Count
71
Registration Number
NCT01887743
Locations
🇺🇸

Children's Mercy Hospital and Clinics, Kansas City, Missouri, United States

Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy

Phase 2
Completed
Conditions
Nephrotoxicity
Ototoxicity
Osteosarcoma
Interventions
Drug: Pantoprazole
Drug: High-dose methotrexate infusion duration
First Posted Date
2013-05-07
Last Posted Date
2020-03-16
Lead Sponsor
Children's Hospital of Philadelphia
Target Recruit Count
13
Registration Number
NCT01848457
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

Phase 4
Completed
Conditions
Immunosuppression
Transplantation
Drug Interaction
Interventions
First Posted Date
2013-02-28
Last Posted Date
2019-02-21
Lead Sponsor
Klemens Budde
Target Recruit Count
20
Registration Number
NCT01801280
Locations
🇩🇪

Charité Hospital Campus Mitte, Berlin, Germany

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

First Posted Date
2013-01-28
Last Posted Date
2022-11-28
Lead Sponsor
Bayer
Target Recruit Count
27395
Registration Number
NCT01776424

Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2012-12-12
Last Posted Date
2021-03-23
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
21
Registration Number
NCT01748500
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Comparison of Pantoprazole and Ranitidine in Dyspepsia

Phase 4
Completed
Conditions
Dyspepsia
Interventions
First Posted Date
2012-11-30
Last Posted Date
2015-07-23
Lead Sponsor
Akdeniz University
Target Recruit Count
66
Registration Number
NCT01737840
Locations
🇹🇷

Akdeniz University, Antalya, Turkey

© Copyright 2025. All Rights Reserved by MedPath