Pantoprazole sodium

This page contains recent news articles, when available, and an overview of Pantoprazole sodium but does not offer medical advice. You should contact your physician with regard to any health issues or concerns.


Overview:

Pantoprazole sodium
(when available)

Pharmacology and use:
Pantoprazole is a substituted benzimidazole indicated for the short-term treatment (up to 16 weeks) in the healing and symptomatic relief of erosive esophagitis. Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production. Short-term (up to 16 weeks) treatment of erosive esophagitis.

Mechanism Of Action:
Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by forming a covalent bond to two sites of the (H+,K+ )- ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect is dose- related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

News Articles on Pantoprazole

Acute allergic interstitial nephritis after use of pantoprazole  -  ‎Mar 4, 2009‎
4 , 6 In the 2008 Canadian drug monograph for pantoprazole sodium, interstitial nephritis was listed as a reported adverse event in postmarketing use for CMAJ

MoH suspends use, sales of Yixin Pharma injection  -  ‎Mar 8, 2009‎
INTERFAX-CHINA - The Ministry of Health (MoH) has suspended the use and sales of pantoprazole sodium injections manufactured by Jilin Yixin Pharmaceutical Interfax China

Canada: Canada: The IP Year 2008 In Review: Patents (Part 1 of 3)  -  Dec 23, 2008
Inc. and Altana Pharma AG ("Solvay") sought an order prohibiting the issuance of a NOC for Apotex's enteric coated tablets of pantoprazole sodium. Mondaq News Alerts (registration),

China Sky One Medical, Inc. Announces 26 New Drugs in Clinical Trials  -  Sep 10, 2008
Doxofylline injection is for the treatment of asthma; -- Pantoprazole sodium injection is for the treatment of canker sores; -- Calcium Folinate Earthtimes (press release),

US Attorney Subpoenas Protonix Marketing and Pricing Documents  -  Aug 6, 2008
...for Protonix (pantoprazole sodium), as well as pricing practices for both the IV and tablet formulations of the drug, according to SEC filings. FDA news (subscription),

Wyeth Reports Earnings Results for the 2008 Second Quarter and ...  -  Jul 23, 2008
Sales of PROTONIX(R) (pantoprazole sodium), Wyeth's branded proton pump inhibitor indicated for gastroesophageal reflux disease, continued to be adversely FOXBusiness

Wyeth, Nycomed Take Teva to Court Over Heartburn Drug  -  Jun 25, 2008
Teva notified Nycomed and Wyeth in a letter dated April 25 that it had filed an ANDA for injectable Protonix (pantoprazole sodium) that included a Paragraph FDA news (subscription),

Positive Clinical Data with Santarus' ZEGERID Capsules in ...  -  May 24, 2008
The clinical study evaluated the effect of morning dosing of immediate-release ZEGERID Capsules, Protonix (pantoprazole sodium) Delayed-Release Tablets 40 Stockhouse,

Positive Clinical Data with Santarus' ZEGERID Capsules in ...  -  May 19, 2008
The clinical study evaluated the effect of morning dosing of immediate-release ZEGERID Capsules, Protonix(R) (pantoprazole sodium) Delayed-Release Tablets PR-Inside.com (Pressemitteilung),

Santarus' study reveals ZEGERID produces notably greater and ...  -  May 19, 2008
ZEGERID capsules were compared with 40 mg of Protonix or pantoprazole sodium delayed-release tablets, and 30 mg of Prevacid or lansoprazole delayed-release RTT News,

Santarus Reports First Quarter 2008 Financial Results  -  May 7, 2008
...two other marketed PPIs, Prevacid ® (lansoprazole) delayed release capsules 30 mg and Protonix ® (pantoprazole sodium) delayed-release tablets 40 mg. Earthtimes (press release),

Wyeth Reports Earnings Results for the 2008 First Quarter  -  Apr 22, 2008
Sales in the 2008 first quarter of PROTONIX(R) (pantoprazole sodium), Wyeth's branded proton pump inhibitor indicated for gastroesophageal reflux disease, MSN Money

Sun Pharma launches generic protonix tablets  -  Feb 21, 2008
Sun Pharmaceutical announced that it has commercially launched generic pantoprazole sodium delayed release (DR) tablets, 40 mg, which is AB-rated to Wyeth's Express Pharma,

Santarus Reports Fourth Quarter and Full Year 2007 Financial Results  -  Mar 3, 2008
...mg and two leading PPIs, Protonix ® (pantoprazole sodium) delayed-release tablets 40 mg and Prevacid ® (lansoprazole) delayed-release capsules 30 mg. Business Wire (press release),

Santarus Q4 2007 Earnings Call Transcript  -  Mar 3, 2008
...or pantoprazole sodium was launched, followed in late January of this year by an authorized generic and a third generic pantoprazole sodium entry. Seeking Alpha,

Teva Introduces Pantoprazole Sodium Delayed-Release Tablets  -  Jan 31, 2008
NORTH WALES, Pa., January 31, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Pantoprazole Sodium Delayed-Release PharmaLive.com (press release),

Caraco Pharmaceutical Laboratories launches Pantoprazole Sodium ...  -  Jan 31, 2008
Pantoprazole Sodium DR is indicated for short-term treatment for erosive esophagitis, for the maintenance of healing erosive esophagitis and reduction in Trading Markets (press release),

Sun Pharma launches Pantoprazole tablets  -  Jan 30, 2008
Sun Pharma had received a US FDA approval for these tablets in September 2007 and this strength of Pantoprazole Sodium has annual sales of around 2.3 Hindu,

Caraco Pharmaceutical Laboratories Ltd. to Market Generic Protonix(R)  -  Jan 30, 2008
Pantoprazole Sodium DR is indicated for the short-term treatment (up to eight weeks) in the healing and symptomatic relief of erosive esophagitis, CNNMoney.com

Sun Pharma launches generic Protonix tablets  -  Jan 30, 2008
MUMBAI: Sun Pharmaceutical Industries Ltd on Wednesday commercially launched generic Pantoprazole Sodium Delayed Release tablets, 40 mg, which is AB-rated Economic Times,

Sun Pharmaceuticals launches “Pantoprazole SDR Tabâ€?; Stock up 9%  -  Jan 30, 2008
Drug Major Sun Pharmaceuticals has announced the commercial launch of generic Pantoprazole Sodium Delayed Release (DR) Tablets, 40 mg in the market. TopNews,

MG Strategies: Has added Caraco Pharmaceutical Laboratories Ltd ...  -  Jan 30, 2008
Wednesday, January 30 2008, Caraco Pharmaceutical Laboratories, Ltd. announced that it has launched Pantoprazole Sodium Delayed-Release Tablets, Trading Markets (press release),

Prasco to Distribute Wyeth's Own Generic Versions of Protonix(R ...  -  Jan 30, 2008
Prasco, as ESI's agent and on ESI's behalf, will solicit orders for and distribute the 20 mg and 40 mg formulations of Pantoprazole Sodium Delayed-Release Centre Daily Times,

Sun Pharma launches generic version of Wyeth's Protonix  -  Jan 30, 2008
Sun Pharmaceutical Industries Ltd. announced today that it has commercially launched generic pantoprazole sodium delayed release (DR) tablets, 40mg, domain-B,

Sun Pharma launches Protonix DR Tablets  -  Jan 29, 2008
Sun Pharmaceutical Industries Ltd on January 30, 2008 announced that it has commercially launched generic Pantoprazole Sodium Delayed Release (DR) Tablets, India Infoline.com,

Teva will not market generic Protonix  -  Feb 3, 2008
Friday announced, "The company has not relaunched and does not intend to ship additional units of generic Protonix (Pantoprazole Sodium) at this time. Globes,

Market Report -- In Play (TEVA)  -  Jan 29, 2008
...additional shipments by Teva of generic Protonix (Pantoprazole Sodium) has terminated as a result of Wyeth's launch of an authorized generic product. MSN Money

Teva Doesn't Intend To Relaunch Generic Protonix  -  Feb 1, 2008
Teva Pharamaceutical Industries Ltd. (TEVA) said it hasn't relaunched and doesn't intend to ship additional units of generic Protonix (pantoprazole sodium) CNNMoney.com

Caraco Pharmaceutical Laboratories To Market Generic Protonix [CPD]  -  Jan 30, 2008
1/30/2008 1:36:31 PM Caraco Pharmaceutical Laboratories Ltd. (CPD) announced that it has launched Pantoprazole Sodium Delayed-Release Tablets, RTT News,

Prasco, ESI Lederle ink deal to distribute Protonix generic  -  Jan 30, 2008
Prasco said Wednesday it will solicit orders for and distribute 20 mg and 40 mg formulations of pantoprazole sodium delayed-release tablets, Bizjournals.com,

Wyeth announces launch of own generic version of Protonix  -  Jan 30, 2008
...of new information, future developments or otherwise. Drugs PANTOPRAZOLE SODIUM Companies: ALTANA AG WYETH NYCOMED TEVA PHARMACEUTICAL INDUSTRIES LTD. Lifescience-online,

McKesson Reports Fiscal 2008 Third-Quarter Results  -  Feb 1, 2008
McKesson was selected by Teva Pharmaceuticals as a strategic launch partner for the generic version of Protonix(R) (pantoprazole sodium), one of the leading FOXBusiness

Sun Pharma Q3 net profit up 60 pct; launches generic Protonix in ...  -  Jan 30, 2008
Separately, the company said it has commercially launched pantoprazole sodium delayed-release tablets, 40 mg dose, which is the bio-equivalent to Wyeth's CNNMoney.com

Medtronic Gets FDA Approval For Endeavor Zotarolimus-Eluting ...  -  Feb 1, 2008
Ltd. (TEVA) on Friday said it has not relaunched and does not intend to ship additional units of generic Protonix or Pantoprazole Sodium at this time. RTT News,

Wyeth's Authorized Generic Launch Ends Protonix Standstill Agreement  -  Jan 31, 2008
Teva would not comment on the status of its generic Protonix (pantoprazole sodium) launch. Teva sold its product only briefly before entering into a FDA news (subscription),

Wyeth Gets FDA Approval Of Protonix For Delayed-Release Oral ...  -  Nov 15, 2007
...announced on Thursday that the US Food and Drug Administration has approved Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension, Trading Markets (press release),

Nacco Industries To Repurchase Up To $100 Mln Of Shares Of Its ...  -  Nov 15, 2007
...announced on Thursday that the US Food and Drug Administration has approved Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension, RTT News,

Wyeth And Nycomed Says Court Rejects Preliminary Injunction ...  -  07 Sep 2007
PK) seeking to prevent the launch of a generic version of PROTONIX or pantoprazole sodium prior to resolution of ongoing patent litigation between the RTT News,

Teva Gets Favorable Court Decision Regarding Generic Protonix ...  -  07 Sep 2007
...and Altana for a preliminary injunction related to Teva's Pantoprazole Sodium Delayed Release or DR Tablets, AB-rated to Wyeth's Protonix DR Tablets. Trading Markets,

Wyeth, Nycomed File for Injunction to Block Generic Protonix Launch  -  Aug 8, 2007
The court has obtained a commitment from Teva and Sun that they will not launch generic Protonix (pantoprazole sodium) before Sept. FDA news (subscription),

Adnexus Therapeutics Announces Appointment of Timothy J. Rink, MD ...  -  Aug 21, 2007
...scientists in multiple therapeutic areas, which resulted in the marketed drugs Requip(R) (ropinirole HCl) and Protonix(R) (pantoprazole sodium). PharmaLive.com (press release),

Allied Waste Industries Q2 Profit Rises, Revenues Up - Quick Facts  -  Aug 2, 2007
RTT News,Pantoprazole Sodium DR Tablets are the AB-rated equivalent of Protonix DR Tablets, indicated in the short-term treatment of erosive esophagitis in GERD,

Court Takes Matter Of Wyeth's Preliminary Injunction Against Teva ...  -  Jul 31, 2007
RTT News,PK) regarding a potential launch of a generic version of Protonix or pantoprazole sodium under advisement. The Court obtained a commitment from both Teva

Pristiq gets double whammy  -  Jul 24, 2007
US-PharmaTechnologist.com,Already home to production of major Wyeth products such as Effexor (venlafaxine), Protonix (pantoprazole sodium) and Rapamune (sirolimus), the site will

Wyeth (WYE) Files Preliminary Injunction Against Teva Pharma (TEVA ...  -  Jun 25, 2007
StreetInsider.com (subscription),Pantoprazole sodium is the active ingredient in Protonix. As a result of the filing of that suit, final FDA approval of Teva\'s ANDA was automatically

Broadway Actress/HIV Advocate, Sheryl Lee Ralph, Unveils Winning ...  -  Apr 16, 2007
Drug Newswire (press release),Prevacid(R) (lansoprazole), Prilosec(R) (omeprazole), or Protonix(R) (pantoprazole sodium). Viagra(R) (sildenafil citrate), Levitra(R) (vardenafil HCl),

Nycomed officially launched as combined group  -  Jan 16, 2007
CNW Telbec (Communiqués de presse),In 2006 most Nycomed products showed growth, with Pantoloc(R) (pantoprazole sodium), remaining the largest single product by revenue.



Teva gets FDA approval for pantoprazole sodium DR tablets  Apr 23, 2006
...approval for the company's abbreviated new drug application (ANDA) to market its generic version of Wyeth's Protonix (pantoprazole sodium) delayed release (DR ... - Globes

STABILITY OF OMEPRAZOLE SODIUM AND PANTOPRAZOLE SODIUM DILUTED FOR ...  Apr 21, 2006
BACKGROUND: Proton-pump inhibitors are often administered by intravenous infusion to raise intragastric pH and prevent rebleeding following endoscopic ... - The Journal of Pharmacy Technology

Teva Receives Tentative Approval for Generic Protonix(R) Delayed ...  Apr 21, 2006
...approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Wyeth's Protonix(R) (Pantoprazole Sodium) Delayed Release ... - International News Service

Teva Granted Tentative FDA Approval For Generic Protonix Delayed ...  Apr 21, 2006
New Drug Application to market its generic version of Wyeth's Protonix Delayed Release Tablets, 20 mg and 40 mg.Teva's Pantoprazole Sodium DR Tablets will be ... - Trading Markets

Teva OK'd on generic of Wyeth's Protonix  Apr 21, 2006
Food and Drug Administration has given tentative approval to its generic version of Wyeth's Protonix Sodium Delayed Release Tablets (pantoprazole sodium) in 20 ... - United Press International

Teva's generic Protonix gets FDA approval  Apr 21, 2006
Teva's pantoprazole sodium DR (delayed release) tablets are the equivalent of Wyeth's Protonix DR tablets. The brand name had 2005 sales of about $2.4 billion. ... - BusinessWeek

ADR Report: Latin America, Asia Lift Composite Index -2-  Apr 21, 2006
...hypersecretory conditions. Israel's Teva is currently involved in a patent-litigation lawsuit over its pantoprazole sodium tablets. The ... - Yahoo! News



Brand Names/Synonyms:
Pantoprazole sodium is also known by the following brand names and/or synonymsBY 1023; CHEMBANK1787; Pantoloc; Pantoprazol [Inn-Spanish]; Pantoprazole; Pantoprazole Na; Pantoprazole Sodium; Pantoprazole [Usan:Ban:Inn]; Pantoprazolum [Inn-Latin]; Pantoprozole; Protonix; Protonix I.V.; Protonix Iv

Drug Category:
Pantoprazole sodium is categorized under the following by the FDA: Anti-ulcer Agents; Proton-pump Inhibitors; ATC:A02BC02

Dosage Forms:
TABLET (ENTERIC-COATED)

Absorption:
Pantoprazole is well absorbed; it undergoes little first- pass metabolism resulting in an absolute bioavailability of approximately 77%.

Interactions:
Interactions for Pantoprazole:

Pantoprazole is metabolized through the cytochrome P450 system, primarily the CYP2C19 and CYP3A4 isozymes, and subsequently undergoes Phase II conjugation.

Based on studies evaluating possible interactions of pantoprazole with other drugs, no dosage adjustment is needed with concomitant use of the following: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and its active metabolite, desmethyldiazepam), diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, an oral contraceptive (levonorgestrel/ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin, midazolam, clarithromycin, metronidazole, or amoxicillin. Clinically relevant interactions of pantoprazole with other drugs with the same metabolic pathways are not expected. Therefore, when coadministered with pantoprazole, adjustment of the dosage of pantoprazole or of such drugs may not be necessary. There was also no interaction with concomitantly administered antacids. There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (eg, ketoconazole, ampicillin esters, and iron salts).

Laboratory Tests

There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving most proton pump inhibitors, including pantoprazole. An alternative confirmatory method should be considered to verify positive results.





Chemical IUPAC Name:
5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]-3H-benzoimidazole

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