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Pantoprazole_sodium: profile and news
Teva gets FDA approval for pantoprazole sodium DR tablets Apr 23, 2006 STABILITY OF OMEPRAZOLE SODIUM AND PANTOPRAZOLE SODIUM DILUTED FOR ... Apr 21, 2006 Teva Receives Tentative Approval for Generic Protonix(R) Delayed ... Apr 21, 2006 Teva Granted Tentative FDA Approval For Generic Protonix Delayed ... Apr 21, 2006 Teva OK'd on generic of Wyeth's Protonix Apr 21, 2006 Teva's generic Protonix gets FDA approval Apr 21, 2006 ADR Report: Latin America, Asia Lift Composite Index -2- Apr 21, 2006 Other information Indication Short-term (up to 16 weeks) treatment of erosive esophagitis. Pharmacology 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. 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. Drug Category Anti-ulcer Agents; Proton-pump Inhibitors; ATC:A02BC02 Brand Names/Synonyms BY 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 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 Chemical Formula C16H15F2N3O4S Half Life 1 hour Drug Type Approved Drug # Accession No APRD00073 CAS Registry Number 102625-70-7 |
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