Pantoprazole


Description

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...

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Pharmacology

Indication


**Pantoprazole Injection**:

**Treatment of gastroesophageal reflux disease associated with a hi...
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Pharmacodynamic

This drug acts to decrease gastric acid secretion, which reduces stomach acidity. Pantoprazole admin... Read more

Mechanismofaction

Hydrochloric acid (HCl) secretion into the gastric lumen is a process regulated mainly by the H(+)/K... Read more

Absorption

Pantoprazole is absorbed after oral administration as an enteric-coated tablet with maximum plasma c... Read more

Proteinbinding

Approximately 98%[FDA label]

Volumeofdistribution

The apparent volume of distribution of pantoprazole is approximately 11.0-23.6 L, distributing mainl... Read more

Clearance

*Adults**: With intravenous administration of pantoprazole to extensive metabolizers, total clearanc... Read more

Halflife

About 1 hour[ Read more

Routeofelimination

After a single oral or intravenous (IV) dose of 14C-labeled pantoprazole to healthy, normal metaboli... Read more

Toxicity

**Rat Oral LD 50** 747 mg/kg[ Read more


Adverse Effects

Effect Regions Age Groups Incidences Evidence Type
Headache US
  • adult
  • Kind: experimental
    • Percent: 12%
  • Kind: placebo
    • Percent: 9%
  • Clinical Trial
    Nausea US
    • adult
  • Kind: experimental
    • Percent: 7%
  • Kind: placebo
    • Percent: 10%
  • Clinical Trial
    Diarrhea US
    • adult
  • Kind: experimental
    • Percent: 9%
  • Kind: placebo
    • Percent: 5%
  • Clinical Trial
    Abdominal Pain US
    • adult
  • Kind: experimental
    • Percent: 6%
  • Kind: placebo
    • Percent: 6%
  • Clinical Trial
    Vomiting US
    • adult
  • Kind: experimental
    • Percent: 4%
  • Kind: placebo
    • Percent: 2%
  • Clinical Trial
    Constipation US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Flatulence US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Nausea US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Elevated Triglycerides US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Elevated Liver Enzymes US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Elevated creatine kinase US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Arthralgia US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Myalgia US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Dizziness US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Vertigo US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Urticaria US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Flatulence US
    • adult
  • Kind: experimental
    • Percent: 4%
  • Kind: placebo
    • Percent: 4%
  • Clinical Trial
    Upper Respiratory Infection US
    • pediatric
  • Kind: experimental
    • Percent: >4%
  • Clinical Trial
    Vomiting US
    • pediatric
  • Kind: experimental
    • Percent: >4%
  • Clinical Trial
    Diarrhea US
    • pediatric
  • Kind: experimental
    • Percent: >4%
  • Clinical Trial
    Fever US
    • pediatric
  • Kind: experimental
    • Percent: >4%
  • Clinical Trial
    Headache US
    • pediatric
  • Kind: experimental
    • Percent: >4%
  • Clinical Trial
    Facial edema US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Allergic Reaction US
  • Kind: experimental
    • Percent: ≤4%
  • Clinical Trial
    Abdominal Pain US
    • pediatric
  • Kind: experimental
    • Percent: >4%
  • Clinical Trial
    Rash US
    • pediatric
  • Kind: experimental
    • Percent: >4%
  • Clinical Trial
    Arthralgia US
    • adult
  • Kind: experimental
    • Percent: 3%
  • Kind: placebo
    • Percent: 1%
  • Clinical Trial
    Dizziness US
    • adult
  • Kind: experimental
    • Percent: 3%
  • Kind: placebo
    • Percent: 1%
  • Clinical Trial
    Allergic Reaction US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Facial edema US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Constipation US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Pyrexia US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Photosensitivity reaction US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Leukopenia US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Thrombocytopenia US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Dry Mouth US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Hepatitis US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Elevated Triglycerides US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Liver enzymes elevated US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Elevated creatine kinase US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Generalized edema US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Urticaria US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Vertigo US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Depression US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Myalgia US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Blurred vision US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Pruritus US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Rash US
    • adult
  • Kind: experimental
    • Percent: ≤2%
  • Clinical Trial
    Contusion Canada
  • Kind: experimental
    • Percent: 0.1-1
  • Clinical Trial
    Cystitis Canada
  • Kind: experimental
    • Percent: 0.1-1
  • Clinical Trial

    Contraindications

    • Regions: Canada
    • With Drugs:
        • Name: Saquinavir
        • Drugbank Id: DB01232
    • Regions: Canada
    • With Drugs:
        • Name: Nelfinavir
        • Drugbank Id: DB00220
    • Regions: Canada
    • With Drugs:
        • Name: Atazanavir
        • Drugbank Id: DB01072
    • Regions: Canada
    • With Drugs:
        • Name: Rilpivirine
        • Drugbank Id: DB08864
    • Regions: EU
    • Patient Conditions:
        • Name: Patients on an HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir
        • Drugbank Id: DBCOND0117231
    • Patient Conditions Associated With:
        • Name: HIV+
        • Drugbank Id: DBCOND0048079
    • Regions: US
    • Patient Conditions:
        • Name: Patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole
        • Drugbank Id: DBCOND0117161

    Food Interactions

    • Take without regard to meals.

    Interactions

    Type in a drug name to check for interaction with Pantoprazole

    The metabolism of (R)-warfarin can be decreased when combined with Pantoprazole.
    The metabolism of (S)-Warfarin can be decreased when combined with Pantoprazole.
    The metabolism of 3,5-diiodothyropropionic acid can be decreased when combined with Pantoprazole.
    The metabolism of 4-hydroxycoumarin can be decreased when combined with Pantoprazole.
    The metabolism of 5-androstenedione can be decreased when combined with Pantoprazole.
    The metabolism of Pantoprazole can be decreased when combined with 6-Deoxyerythronolide B.
    The metabolism of 6-O-benzylguanine can be decreased when combined with Pantoprazole.
    The metabolism of Pantoprazole can be decreased when combined with 7-ethyl-10-hydroxycamptothecin.
    The metabolism of 9-aminocamptothecin can be decreased when combined with Pantoprazole.
    Pantoprazole may decrease the excretion rate of Abacavir which could result in a higher serum level.
    The metabolism of Pantoprazole can be increased when combined with Abatacept.
    The serum concentration of Abemaciclib can be increased when it is combined with Pantoprazole.
    The metabolism of Abiraterone can be decreased when combined with Pantoprazole.
    The metabolism of Pantoprazole can be decreased when combined with Acalabrutinib.
    Pantoprazole may decrease the excretion rate of Acarbose which could result in a higher serum level.
    The serum concentration of Acebutolol can be increased when it is combined with Pantoprazole.
    Aceclofenac may decrease the excretion rate of Pantoprazole which could result in a higher serum level.
    Acemetacin may decrease the excretion rate of Pantoprazole which could result in a higher serum level.
    The metabolism of Acenocoumarol can be decreased when combined with Pantoprazole.
    The serum concentration of Acetaminophen can be increased when it is combined with Pantoprazole.

    References

    • 1 . Mathews S, Reid A, Tian C, Cai Q: An update on the use of pantoprazole as a treatment for gastroesophageal reflux disease. Clin Exp Gastroenterol. 2010;3:11-6. Epub 2010 Jan 20. [PubMed: 21694841]
    • 2 . Dabrowski A, Stabuc B, Lazebnik L: Meta-analysis of the efficacy and safety of pantoprazole in the treatment and symptom relief of patients with gastroesophageal reflux disease - PAN-STAR. Prz Gastroenterol. 2018;13(1):6-15. doi: 10.5114/pg.2018.74556. Epub 2018 Mar 26. [PubMed: 29657605]
    • 3 . Strand DS, Kim D, Peura DA: 25 Years of Proton Pump Inhibitors: A Comprehensive Review. Gut Liver. 2017 Jan 15;11(1):27-37. doi: 10.5009/gnl15502. [PubMed: 27840364]
    • 4 . Jungnickel PW: Pantoprazole: a new proton pump inhibitor. Clin Ther. 2000 Nov;22(11):1268-93. [PubMed: 11117653]
    • 5 . Shin JM, Kim N: Pharmacokinetics and pharmacodynamics of the proton pump inhibitors. J Neurogastroenterol Motil. 2013 Jan;19(1):25-35. doi: 10.5056/jnm.2013.19.1.25. Epub 2013 Jan 8. [PubMed: 23350044]
    • 6 . Bardou M, Martin J: Pantoprazole: from drug metabolism to clinical relevance. Expert Opin Drug Metab Toxicol. 2008 Apr;4(4):471-83. doi: 10.1517/17425255.4.4.471 . [PubMed: 18433349]
    • 7 . Shin JM, Sachs G: Differences in binding properties of two proton pump inhibitors on the gastric H+,K+-ATPase in vivo. Biochem Pharmacol. 2004 Dec 1;68(11):2117-27. doi: 10.1016/j.bcp.2004.07.035. [PubMed: 15498502]
    • 8 . Huber R, Hartmann M, Bliesath H, Luhmann R, Steinijans VW, Zech K: Pharmacokinetics of pantoprazole in man. Int J Clin Pharmacol Ther. 1996 May;34(1 Suppl):S7-16. [PubMed: 8793599]
    • 9 . Lewin MJ: Cellular mechanisms and inhibitors of gastric acid secretion. Drugs Today (Barc). 1999 Oct;35(10):743-52. [PubMed: 12973369]
    • 10 . Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK: The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016 Jul;151(1):51-69.e14. doi: 10.1053/j.gastro.2016.04.006. Epub 2016 Apr 19. [PubMed: 27102658]
    • 11 . Tanus-Santos JE, Pinheiro LC: Proton pump inhibitors: new mechanisms of action. Basic Clin Pharmacol Toxicol. 2019 Apr 13. doi: 10.1111/bcpt.13237. [PubMed: 30980783]
    • 12 . Haastrup PF, Thompson W, Sondergaard J, Jarbol DE: Side Effects of Long-Term Proton Pump Inhibitor Use: A Review. Basic Clin Pharmacol Toxicol. 2018 Aug;123(2):114-121. doi: 10.1111/bcpt.13023. Epub 2018 May 24. [PubMed: 29658189]
    • 13 . Reimer C, Sondergaard B, Hilsted L, Bytzer P: Proton-pump inhibitor therapy induces acid-related symptoms in healthy volunteers after withdrawal of therapy. Gastroenterology. 2009 Jul;137(1):80-7, 87.e1. doi: 10.1053/j.gastro.2009.03.058. Epub 2009 Apr 10. [PubMed: 19362552]
    • 14 . Ghebremariam YT, LePendu P, Lee JC, Erlanson DA, Slaviero A, Shah NH, Leiper J, Cooke JP: Unexpected effect of proton pump inhibitors: elevation of the cardiovascular risk factor asymmetric dimethylarginine. Circulation. 2013 Aug 20;128(8):845-53. doi: 10.1161/CIRCULATIONAHA.113.003602. Epub 2013 Jul 3. [PubMed: 23825361]
    • 15 . Tommasi S, Elliot DJ, Hulin JA, Lewis BC, McEvoy M, Mangoni AA: Human dimethylarginine dimethylaminohydrolase 1 inhibition by proton pump inhibitors and the cardiovascular risk marker asymmetric dimethylarginine: in vitro and in vivo significance. Sci Rep. 2017 Jun 6;7(1):2871. doi: 10.1038/s41598-017-03069-1. [PubMed: 28588208]
    • 16 . Pantoprazole Tablets, Monograph [File]
    • 17 . Pfizer Safety Data Sheet [File]
    • 18 . Assessment Report, Pantozol [File]
    • 19 . Protonix delayed release and oral suspension FDA label [File]
    • 20 . Pantoloc EMA label [File]
    • 21 . Sandoz Pantoprazole DRT Monograph [File]
    • 22 . Health Canada Label - Pantoprazole [File]
    • 23 . TOP Guidelines - H pylori [File]

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