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ION The active ingredient in PROTONIX ® (pantoprazole sodium) Delayed- Release Tablets is a substituted benzimidazole, sodium 5-( difluoromethoxy)- 2- ( 3,4- dimethoxy- 2- pyridinyl) methyl sulfinyl - 1 H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16 H14 F2 N3 NaO4 S x 1.5 H2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate is a white to off- white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n- hexane. The stability of the compound in aqueous solution is pH- dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half- life is approximately 2.8 hours at pH 5.0 and approximately 220 hours at pH 7.8. PROTONIX is supplied as a delayed- release tab
pantoprazole S receiving pantoprazole for up to 8 weeks. Adverse Events in GERD Patients in Short-term International Trials % Incidence Study Event Pantoprazole Total (N=2805) Ranitidine 300 mg (N=594) Omeprazole 20 mg (N=474) Famotidine 40 mg (N=239) Headache 2 3 2 1 Diarrhea 2 2 2 <1 Abdominal pain 1 1 <1 <1 In two U. S. controlled clinical trials involving PROTONIX 10- pantoprazole, 20- pantoprazole, or 40- mg doses for up to 12 months pantoprazole, the following adverse events considered by investigators to be possibly pantoprazole, probably or definitely related to drug occurred in 1% or more of GERD patients on long- term therapy. Most Frequent Adverse Events Reported as Drug Related in Long- term Domestic Trials % Incidence Study Event PROTONIX (n = 536) Ranitidine (n = 185) Headache 5 2 Abdominal pain 3 1 Liver function tests abnormal 2 <1 Nausea 2 2 Vomiting 2 2 Note: Only adverse events with an incidence greater than or equal to the comparators are shown. In addition pantoprazole, in these short- and long- term domestic and international tr pantoprazole.
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E for adults is 40 mg daily for 4-8 weeks. It generally is recommended that tablets be taken approximately 30 minutes prior to meals for maximal effectiveness. Tablets should be swallowed whole and should not be crushed, split or chewed. DRUG INTERACTIONS: Pantoprazole is less likely than omeprazole to interact with other drugs. The absorption of certain drugs may be affected by stomach acidity, and, as a result, pantoprazole and other PPIs that reduce stomach acid also reduce the absorption and concentration in blood of ketoconazole (Nizoral) and increase the absorption and concentration in blood of digoxin (Lanoxin). This may lead to reduced effectiveness of ketoconazole or increased digoxin toxicity, respectively. PREGNANCY: Use of pantoprazole in pregnant women has not been adequately evaluated. NURSING MOTHERS: Pantoprazole has not been studied in nursing women. SIDE EFFECTS: Pantoprazole like other PPIs is well-tolerated. The most common side effects are diarrhea, nausea, vomitin
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