Pantoprazole
Encyclopedia
Pantoprazole is a proton pump inhibitor
drug that inhibits gastric acid
secretion.
. Initial treatment is generally of eight weeks' duration, after which another eight week course of treatment may be considered if necessary. 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
).
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; 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. Half life of the drug is approx 24 hours.
(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, and as UXL-D in India and Pantid in Bangladesh. The generic pantoprazole sodium is available in the U.S. from Kremers Urban. 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. 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
.
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
. 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 also marketed pantoprazole under the brand name Pantrol.
Proton pump inhibitor
Proton-pump inhibitors are a group of drugs whose main action is a pronounced and long-lasting reduction of gastric acid production. They are the most potent inhibitors of acid secretion available today. The group followed and has largely superseded another group of pharmaceuticals with similar...
drug that inhibits gastric acid
Gastric acid
Gastric acid is a digestive fluid, formed in the stomach. It has a pH of 1 to 2 and is composed of hydrochloric acid , and large quantities of potassium chloride and sodium chloride...
secretion.
Use
Pantoprazole is used for short-term treatment of erosion and ulceration of the esophagus caused by gastroesophageal reflux diseaseGastroesophageal reflux disease
Gastroesophageal reflux disease , gastro-oesophageal reflux disease , gastric reflux disease, or acid reflux disease is chronic symptoms or mucosal damage caused by stomach acid coming up from the stomach into the esophagus...
. Initial treatment is generally of eight weeks' duration, after which another eight week course of treatment may be considered if necessary. 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
Tetrahydrocannabinol
Tetrahydrocannabinol , also known as delta-9-tetrahydrocannabinol , Δ1-THC , or dronabinol, is the main chemical psychoactive substance found in the cannabis plant. It was first isolated in 1964. In pure form, it is a glassy solid when cold, and becomes viscous and sticky if warmed...
, the psychoactive component of cannabis
Cannabis
Cannabis is a genus of flowering plants that includes three putative species, Cannabis sativa, Cannabis indica, and Cannabis ruderalis. These three taxa are indigenous to Central Asia, and South Asia. Cannabis has long been used for fibre , for seed and seed oils, for medicinal purposes, and as a...
).
Pharmacology
Pantoprazole is metabolized in the liver by the cytochrome P450 system. Metabolism mainly consists of demethylationDemethylation
Demethylation is the chemical process resulting in the removal a of methyl group from a molecule.A common way of demethylation is the replacement of a methyl group by a hydrogen atom, resulting in a net loss of one carbon and two hydrogen atoms....
by CYP2C19
CYP2C19
Cytochrome P450 2C19 , a member of the cytochrome P450 mixed-function oxidase system, is involved in the metabolism of xenobiotics in the body. It is involved in the metabolism of several...
followed by sulfation
Sulfation
Sulfation in biochemistry is the enzyme-catalyzed addition of sulfate to another molecule. It often refers to a phase II enzyme reaction. This biotransformation process uses its cosubstrate 3'-phosphoadenosine-5'-phosphosulfate to transfer sulfate to a xenobiotic...
. Another metabolic pathway is oxidation by CYP3A4
CYP3A4
Cytochrome P450 3A4 , a member of the cytochrome P450 mixed-function oxidase system, is one of the most important enzymes involved in the metabolism of xenobiotics in the body. CYP3A4 is involved in the oxidation of the largest range of substrates of all the CYPs. As a result, CYP3A4 is present in...
. Pantoprazole metabolites are not thought to have any pharmacological significance. Pantoprazole is relatively free of drug interactions; however, it may alter the absorption of other medications that depend on the amount of acid in the stomach, such as ketoconazole
Ketoconazole
Ketoconazole is a synthetic antifungal drug used to prevent and treat fungal skin infections, especially in immunocompromised patients such as those with AIDS or those on chemotherapy. Ketoconazole is sold commercially as an anti-dandruff shampoo, topical cream, and oral tablet.Ketoconazole is...
or digoxin
Digoxin
Digoxin INN , also known as digitalis, is a purified cardiac glycoside and extracted from the foxglove plant, Digitalis lanata. Its corresponding aglycone is digoxigenin, and its acetyl derivative is acetyldigoxin...
. 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. Half life of the drug is approx 24 hours.
Availability
Pantoprazole was developed by AltanaAltana
The Altana AG is a German chemical company based in Wesel. Altana develops and produces products in the specialty chemicals business. The ALTANA Group, with headquarters in Wesel/Germany, sells 85% of its products overseas...
(owned by Nycomed
Nycomed
Nycomed is a European pharmaceutical company. Nycomed is privately owned primarily by the two private equity investors Nordic Capital and CSFB Alternative Capital. Production is located in Norway, Denmark, Poland, Austria, Belgium, Germany, Estonia India, Mexico, Brazil and Argentina. Head office...
) and was licensed in the USA to Wyeth
Wyeth
Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...
(which was taken over by Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
) and is currently marketed under the brand name Protonix by Wyeth-Ayerst Laboratories
Wyeth
Wyeth, formerly one of the companies owned by American Home Products Corporation , was a pharmaceutical company. The company was based in Madison, New Jersey, USA...
, Pantec by Concept Pharmaceuticals, Somac by Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
, API by Vanguard Therapeutics, Astropan by Astron Lifesciences, Fenix by Bosnalijek
Bosnalijek
Bosnalijek is the largest pharmaceutical company in Bosnia and Herzegovina. The organisation was established in 1951 and employs ~620 workers, out of which more than 50% have university level or higher qualifications. Its product portfolio consists of ~180 products. The company continues investment...
, Pantecta by Novartis
Novartis
Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland, ranking number three in sales among the world-wide industry...
, Pantoloc or Somac by Nycomed, Tecta by Nycomed in Canada, Protium in the UK, Inipomp by Sanofi-Aventis
Sanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
or Eupantol by Nycomed in France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
, Pantozol by Nycomed in Germany, Pantodac, Perizole by Obsurge Biotech and Pansped in India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
, Zurcazol in Greece
Greece
Greece , officially the Hellenic Republic , and historically Hellas or the Republic of Greece in English, is a country in southeastern Europe....
, Protonex by Abdi İbrahim in Turkey
Turkey
Turkey , known officially as the Republic of Turkey , is a Eurasian country located in Western Asia and in East Thrace in Southeastern Europe...
, Pantup in Ireland
Ireland
Ireland is an island to the northwest of continental Europe. It is the third-largest island in Europe and the twentieth-largest island on Earth...
, Pantomed in Belgium
Belgium
Belgium , officially the Kingdom of Belgium, is a federal state in Western Europe. It is a founding member of the European Union and hosts the EU's headquarters, and those of several other major international organisations such as NATO.Belgium is also a member of, or affiliated to, many...
, TopZole in South Africa, and as UXL-D in India and Pantid in Bangladesh. The generic pantoprazole sodium is available in the U.S. from Kremers Urban. It is available by prescription in delayed-release tablets. It is also available for intravenous use.
On 24 December 2007, Teva Pharmaceutical
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd. , is an international pharmaceutical company headquartered in Petah Tikva, Israel. It specializes in generic and proprietary pharmaceuticals and active pharmaceutical ingredients...
released an AB-rated generic alternative to Protonix. 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
Nycomed
Nycomed is a European pharmaceutical company. Nycomed is privately owned primarily by the two private equity investors Nordic Capital and CSFB Alternative Capital. Production is located in Norway, Denmark, Poland, Austria, Belgium, Germany, Estonia India, Mexico, Brazil and Argentina. Head office...
.
On October 18, 2010 the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) accepted the filing of an ANDA
ANDA
An Abbreviated New Drug Application is an application for a U.S. generic drug approval for an existing licensed medication or approved drug....
for a delayed release generic version of Protonix by Canadian company IntelliPharmaCeutics
IntelliPharmaCeutics
IntelliPharmaCeutics is a Canadian specialty pharmaceutical company, operating internationally and primarily engaged in the research, development, and commercialization of controlled-release and targeted pharmaceutical products.-Focalin XR:...
. 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 also marketed pantoprazole under the brand name Pantrol.