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Antacid preparations such as pantoprazole by suppressing acid mediated break down of proteins, leads to an elevated risk of developing food and drug allergies. This happens due to undigested proteins then passing into the gastrointestinal tract where sensitisation occurs. It is unclear whether this risk occurs with only long-term use or with short-term use as well.<ref name="pmid21121928">{{cite journal |author=Pali-Schöll I, Jensen-Jarolim E |title=Anti-acid medication as a risk factor for food allergy |journal=Allergy |volume=66 |issue=4 |pages=469–77 |year=2011 |month=April |pmid=21121928 |doi=10.1111/j.1398-9995.2010.02511.x |url=}}</ref>
Antacid preparations such as pantoprazole by suppressing acid mediated break down of proteins, leads to an elevated risk of developing food and drug allergies. This happens due to undigested proteins then passing into the gastrointestinal tract where sensitisation occurs. It is unclear whether this risk occurs with only long-term use or with short-term use as well.<ref name="pmid21121928">{{cite journal |author=Pali-Schöll I, Jensen-Jarolim E |title=Anti-acid medication as a risk factor for food allergy |journal=Allergy |volume=66 |issue=4 |pages=469–77 |year=2011 |month=April |pmid=21121928 |doi=10.1111/j.1398-9995.2010.02511.x |url=}}</ref>


===Common=== <ref name="DRUGDEX">{{url=}}</ref>
===Common===
■ Gastrointestinal: Abdominal pain (3% ), Diarrhea (4% ), Flatulence (4% )
* Gastrointestinal: Abdominal pain (3% ), Diarrhea (4% ), Flatulence (4% )
■ Neurologic: Headache (5% )
* Neurologic: Headache (5% )


===Serious===<ref name="DRUGDEX">{{url=}}</ref>
===Serious===
■ Gastrointestinal: Atrophic gastritis, Clostridium difficile diarrhea
* Gastrointestinal: Atrophic gastritis, Clostridium difficile diarrhea
■ Hematologic: Thrombocytopenia (less than 1% )
* Hematologic: Thrombocytopenia (less than 1% )
■ Immunologic: Stevens-Johnson syndrome, Toxic epidermal necrolysis
* Immunologic: Stevens-Johnson syndrome, Toxic epidermal necrolysis
■ Musculoskeletal: Disorder of muscle, Fracture of bone, Osteoporosis-related, Hip fracture, Rhabdomyolysis
* Musculoskeletal: Disorder of muscle, Fracture of bone, Osteoporosis-related, Hip fracture, Rhabdomyolysis
■ Renal: Interstitial nephritis, Acute (rare)
* Renal: Interstitial nephritis, Acute (rare)


==Pharmacology==
==Pharmacology==

Revision as of 17:09, 3 December 2012

Pantoprazole
Clinical data
Trade namesProtonix
AHFS/Drugs.comMonograph
MedlinePlusa601246
License data
Pregnancy
category
  • AU: B3
Routes of
administration		Oral and intravenous
ATC code
Legal status
Legal status
  • US: WARNING[1]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability77%
MetabolismHepatic (CYP3A4)
Elimination half-life1 hour
ExcretionRenal
Identifiers
  • (RS)-6-(Difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]-1H-benzo[d]imidazole
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.111.005 Edit this at Wikidata
Chemical and physical data
FormulaC16H15F2N3O4S
Molar mass383.371 g/mol g·mol−1
3D model (JSmol)
  • FC(F)Oc3cc1c(nc(n1)S(=O)Cc2nccc(OC)c2OC)cc3
  • InChI=1S/C16H15F2N3O4S/c1-23-13-5-6-19-12(14(13)24-2)8-26(22)16-20-10-4-3-9(25-15(17)18)7-11(10)21-16/h3-7,15H,8H2,1-2H3,(H,20,21) checkY
  • Key:IQPSEEYGBUAQFF-UHFFFAOYSA-N checkY
  (verify)

Pantoprazole (sold under various brand names including Somac, Tecta, Pantoloc, Protium, Protonix, Pantecta, Pantoheal, Pantpas, Ppi-40, and Neoppi) is a proton pump inhibitor drug that inhibits gastric acid secretion.

Use

Pantoprazole is used for short-term treatment of erosion and ulceration of the esophagus caused by gastroesophageal reflux disease. Initial treatment is generally of eight weeks' duration, after which another eight week course of treatment may be considered if necessary.[citation needed] It can be used as a maintenance therapy for long term use after initial response is obtained.

This medication may affect the results of certain lab tests, such as drug screenings (pantoprazole can cause a false positive for THC, the psychoactive component of cannabis.[2][3]

Adverse effects

Antacid preparations such as pantoprazole by suppressing acid mediated break down of proteins, leads to an elevated risk of developing food and drug allergies. This happens due to undigested proteins then passing into the gastrointestinal tract where sensitisation occurs. It is unclear whether this risk occurs with only long-term use or with short-term use as well.[4]

Common

  • Gastrointestinal: Abdominal pain (3% ), Diarrhea (4% ), Flatulence (4% )
  • Neurologic: Headache (5% )

Serious

  • Gastrointestinal: Atrophic gastritis, Clostridium difficile diarrhea
  • Hematologic: Thrombocytopenia (less than 1% )
  • Immunologic: Stevens-Johnson syndrome, Toxic epidermal necrolysis
  • Musculoskeletal: Disorder of muscle, Fracture of bone, Osteoporosis-related, Hip fracture, Rhabdomyolysis
  • Renal: Interstitial nephritis, Acute (rare)

Pharmacology

Pantoprazole is metabolized in the liver by the cytochrome P450 system.[5] Metabolism mainly consists of demethylation by CYP2C19 followed by sulfation. Another metabolic pathway is oxidation by CYP3A4. Pantoprazole metabolites are not thought to have any pharmacological significance. Pantoprazole is relatively free of drug interactions;[6] however, it may alter the absorption of other medications that depend on the amount of acid in the stomach, such as ketoconazole or digoxin. Generally inactive at acidic pH of stomach, thus it is usually given with a pro kinetic drug. Pantoprazole binds irreversibly to H+K+ATPase(Proton pumps) and suppresses the secretion of acid. As it binds irreversibly to the pumps, new pumps have to be made before acid production could be resumed. The drug's plasma half-life is about 2 hours.[7]

Availability

Pantoprazole was developed by Altana (owned by Nycomed) and was licensed in the USA to Wyeth (which was taken over by Pfizer) and is currently marketed under the brand name Protonix by Wyeth-Ayerst Laboratories, Pantec by Concept Pharmaceuticals, Somac by Pfizer, API by Vanguard Therapeutics, Astropan by Astron Lifesciences, Fenix by Bosnalijek, Pantecta by Novartis, Pantoloc or Somac by Nycomed, Tecta by Nycomed in Canada, Protium in the UK, Inipomp by Sanofi-Aventis or Eupantol by Nycomed in France, Pantozol by Nycomed in Germany, Pantodac, Perizole by Obsurge Biotech and Pansped in India, Zurcazol in Greece, Protonex by Abdi İbrahim in Turkey, Pantup in Ireland, Pantomed in Belgium, TopZole in South Africa, Nolpaza and Controloc in Romania and as UXL-D in India, Pantid by Opsonin in Bangladesh. Pantid is the first brand in the world which is providing in double Alu-Alu sachet packaging to prevent its degradation from moisture & light.The generic pantoprazole sodium is available in the U.S. from Kremers Urban, Teva, and Torrent Pharma. It is available by prescription in delayed-release tablets. It is also available for intravenous use.

On 24 December 2007, Teva Pharmaceutical released an AB-rated generic alternative to Protonix.[8] This was followed by generic equivalents from Sun Pharma and Kudco Pharma. Wyeth sued all three for patent infringement and launched its own generic version of Protonix with Nycomed.[9][10]

On October 18, 2010 the U.S. Food and Drug Administration (FDA) accepted the filing of an ANDA for a delayed release generic version of Protonix by Canadian company IntelliPharmaCeutics.[11] The combination of domperidone 10 mg and pantoprazole 40 mg is available in India under the brand name Pantazone, Pantop-D, Rantop-D. In Bangladesh Apex Pharma Limited markets pantoprazole under the brand name Pantrol. It is also available under the brand name Prazolin marketed by Rephco Pharmaceuticals Limited.It is also marketed by Chemist Laboratories Ltd. under the brand name Pantochem.

References

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  2. ^ Protonix package insert 12/07
  3. ^ "What causes false positives in marijuana drug testing?". LiveStrong.
  4. ^ Pali-Schöll I, Jensen-Jarolim E (2011). "Anti-acid medication as a risk factor for food allergy". Allergy. 66 (4): 469–77. doi:10.1111/j.1398-9995.2010.02511.x. PMID 21121928. {{cite journal}}: Unknown parameter |month= ignored (help)
  5. ^ Meyer, U A (1996). "Metabolic interactions of the proton-pump inhibitors lansoprazole, omeprazole and pantoprazole with other drugs". European journal of gastroenterology & hepatology. 8 (Suppl 1): S21–25. doi:10.1097/00042737-199610001-00005.
  6. ^ Steinijans, V. W.; Huber, R.; Hartmann, M.; Zech, K.; Bliesath, H.; Wurst, W.; Radtke, H. W. (1996). "Lack of pantoprazole drug interactions in man: An updated review". International Journal of Clinical Pharmacology and Therapeutics. 34 (6): 243–262. PMID 8793611.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  7. ^ Sachs G, Shin JM, Hunt R (2010). "Novel approaches to inhibition of gastric acid secretion". Curr Gastroenterol Rep. 12 (6): 437–47. doi:10.1007/s11894-010-0149-5. PMC 2974194. PMID 20924727. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  8. ^ Teva Announces Launch Of Generic Protonix Tablets
  9. ^ Rubenstein, Sarah (29 January 2008). "Wyeth Plans Generic Protonix; Litigation With Teva to Continue". The Wall Street Journal. p. D9. Retrieved 25 October 2009.
  10. ^ "Nycomed and Wyeth announce launch of an own generic version of PROTONIX - lawsuit to defend patent continues". Retrieved 25 October 2009. [dead link]
  11. ^ IntelliPharmaCeutics Press Release [1]

External links

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