Brand Name: Protonix
Active Ingredient: pantoprazole sodium
Indication: Short-term (up to 16 weeks) treatment of erosive esophagitis
Company Name: American Home Products Corporation
Availability: Tablet form approved by the FDA on February 3, 2000
Introduction
Nearly 60 million Americans experience symptoms of gastroesophageal reflux disease (GERD), a chronic condition in which stomach acids bubble up into the esophagus, causing the feeling more commonly known as heartburn. If left uncontrolled, GERD can progress to more serious complications, including bleeding, precancer, and esophageal cancer. A class of drugs called “proton pump inhibitors,” introduced in the late 1980s, has vastly improved the treatment of gastroesophageal reflux disease (GERD).
Protonix (pantoprazole sodium), the proton pump inhibitor, was approved by the FDA in February 2000. Manufactured by American Home Products Corporation, Protonix is used to promote healing and relieve symptoms in patients with erosive esophagitis, one of the most serious forms of gastroesophageal reflux disease (GERD), when taken for up to 16 weeks. Like many other drugs in its class, Protonix is easy to take: just one delayed-release tablet once a day.
How It Works
Protonix suppresses the final step in gastric acid production by binding 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. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists for longer than 24 hours.
Clinical Study Results
The efficacy of Protonix for the treatment of
Protonix (pantoprazole):
EE was established in more than 100 clinical trials worldwide in more than 11,000 patients. One multicenter study in the US compared 10 mg, 20 mg, or 40 mg Protonix once daily to placebo in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or higher. At both 4 and 8 weeks of follow-up, patients who took Protonix experienced significantly greater healing rates and relief of symptoms than those who took placebo.
For example, at week 4, healing rates in the 10 mg, 20 mg, and 40 mg Protonix groups were 45.6%, 58.4%, and 75.0%, respectively, compared to 14.3% for placebo. The corresponding rates for week 8 were 66.0%, 83.5%, and 92.6% for the Protonix groups, versus 39.7% for placebo. A significantly greater proportion of patients taking the 40 mg Protonix dose experienced relief of daytime and nighttime heartburn and the absence of regurgitation starting from the first day of treatment, compared to placebo. Moreover, patients taking Protonix consumed fewer antacid tablets each day.
Another multicenter US study compared Protonix (20 mg and 40 mg) with nizatidine (150 mg twice daily) in 243 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or higher. Protonix was significantly more effective for improving healing and relieving symptoms than nizatidine. At week 4, healing rates in the 20 mg and 40 mg Protonix groups were 61.4% and 64.0%, respectively, compared to 22.2% for nizatidine. The corresponding rates for week 8 were 79.2% and 82.9% for the Protonix groups, versus 41.4% for nizatidine. A significantly greater proportion of patients taking Protonix experienced complete relief of nighttime heartburn and regurgitation starting from the first day of treatment, compared to the nizatidine group. Moreover, patients taking Protonix consumed fewer antacid tablets each day than the nizatidine patients.
Protonix (pantoprazole sodium) has also been shown to be effective in healing duodenal ulcer (DU). A Brazilian study compared 40 mg Protonix to 300 mg ranitidine in 222 patients with DU. After two weeks of treatment, significantly more patients taking Protonix experienced ulcer healing (97.1% for Protonix, 74.5% for ranitidine) and remission of symptoms (97.6% for Protonix, 77.5% for ranitidine).
International Drug Names
The information about medications (pills, tablets, capsules, injection, creams) around the world.
Many medications are marketed under different names in different countries.
Proprietary drug names
Argentina: Gastromax; Pangest; Pantocas; Pantop; Pantus; Peptazol; Sipar; Supracam; Ulserch $; Zurcal $;
Australia: Somac;
Austria: Pantoloc; Zurcal;
Belgium: Pantozol; Zurcale;
Brazil: Gastropan; Noprop $; Pantocal; Pantopaz $; Pantozol; Pantrat; Peptovit $; Ziprol; Zurcal;
Canada: Panto; Pantoloc;
Chile: Singastril $; Ulcemex; Zurcal;
Czech Republic: Apo-Panto; Controloc; Nolpaza; Panogastin;
Denmark: Pantoloc;
Finland: Somac;
France: Eupantol; Inipomp;
Germany: Pantozol; Pantozol-Rifun $; Rifun;
Greece: Controloc; Pantosec; Zurcazol;
Hong Kong: Pantoloc;
Hungary: Controloc; Nolpaza; Pantacid; Zimpax;
India: Eracid $; Pantodac; Pantop; Pantosec; Pentaloc; Praize;
Indonesia: Pantozol;
Ireland: Protium;
Israel: Controloc;
Italy: Pantecta; Pantopan; Pantorc; Peptazol;
Malaysia: Controloc;
Mexico: Pantozol; Prazolan; Tecta; Zolpra; Zurcal;
Netherlands (Holland): Pantorc; Pantozol;
Norway: Somac;
New Zealand: Somac;
Philippines: Pantoloc; Ulcepraz;
Poland: Controloc;
Portugal: Apton; Pantoc; Praoz; Zurcal;
Russia: Sunpraz (Санпраз);
South Africa: Controloc; Pantocid; Pantoloc; Topzole;
Singapore: Controloc;
Spain: Anagastra; Pantecta; Pantocarm; Ulcotenal;
Sweden: Pantoloc;
Switzerland (Swiss): Pantozol; Zurcal;
Thailand: Controloc;
Turkey: Panthec; Panto; Pantpas; Pulcet;
UK (United Kingdom): Protium;
USA (United States of America): Protonix;
Venezuela: Pantop.
What You Should Know
The most common side effects reported by patients taking Protonix were headache, diarrhea, and feeling gassy – effects that are similar to those of other drugs in its class.
Jennifer is a clinical pharmacologist. She helps doctors of all medical specialties choose medications. Jennifer consults about drug dosage, interactions, and side effects.