Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Contract Pharmacy Services-PA
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
Pantoprazole sodium delayed-release tablets are indicated for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD). Controlled studies did not extend beyond 12 months. Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation.
Pantoprazole sodium delayed-release tablets are supplied as 40 mg yellow oval biconvex delayed‑release tablets imprinted with PROTONIX (brown ink) on one side. They are available as follows: Store pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederle Division of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, Germany W10525C006 ET02 Rev 11/08 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--02/2010--NJW
New Drug Application
PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE CONTRACT PHARMACY SERVICES-PA ---------- PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS RX ONLY DESCRIPTION The active ingredient in 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 C H F N NaO S x 1.5 H 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. Pantoprazole sodium is supplied as a delayed-release tablet for oral administration, available in 2 strengths. Each delayed-release tablet contains 45.1 mg or 22.6 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. Pantoprazole Sodium Delayed Release tablets (40 mg and 20 mg) complies with USP dissolution test 2. CLINICAL PHARMACOLOGY PHARMACOKINETICS Pantoprazole sodium is prepared as an enteric-coated tablet so that absorption of pantoprazole begins only after the tablet leaves the stomach. Peak serum concentration (C ) and area under the serum concentration time curve (AUC) increase in a manner proportional to oral and intra Soma hati kamili