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The area under the plasma concentration-time curves (AUC) of (R)-rabeprazole in homEMs, hetEMs and PMs were 1.8-, 2.2- and 2.4-fold, respectively, greater than those of (S)-rabeprazole; the relative AUC ratios of (R)- and (S)-rabeprazole in homEMs, hetEMs and PMs were 1:1.1:2.1 and 1:0.9:1.5, respectively. The mean maximum plasma concentrations (Cmax) of (R)-rabeprazole in homEMs, hetEMs and PMs were 1.7-, 1.9- and 1.8-fold higher, respectively, than those of the corresponding (S)-enantiomer (P<0.05). There was no difference between homEMs and PMs in the elimination half-life of (S)-rabeprazole, whereas the elimination half-life of (R)-rabeprazole was significantly longer in PMs than in homEMs [1.7 h (1.4, 2.0) (mean (95% confidence interval)]vs. 0.8 h (0.6, 1.0), respectively, P<0.0001).
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In 4 male cases, 3 cases had no obvious symptoms of stomach and esophagus and 1 case had symptoms of bloating and acid reflux. Additionally, 4 cases in which lesions were all located to the left side were diagnosed by trial therapy with proton pump inhibitors (PPIs) with good responding. 2 of 4 cases were relapsed after operations. Meanwhile 4 patients were treated by Rabeprazole for acid suppression therapy and 3 cases were cured and 1 invalid case was cured by Pantoprazole. All patients were followed up for 4-48 months with no recurrence.
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Relevant articles in the English-language literature were identified through a MEDLINE search (1968-2003) using the key words stress-related mucosal disease, stress-related injury, ulcer, prophylaxis, intensive care unit, and upper gastrointestinal bleeding.
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This was a randomized, open-label study enrolling 279 patients with erosive esophagitis A or B (Los Angeles classification) and typical gastroesophageal reflux disease symptoms. Patients who showed complete endoscopic and symptomatic healing after 8 weeks of proton pump inhibitor treatment were randomly allocated to maintenance treatment with omeprazole 10 mg once daily or rabeprazole 10 mg once daily for 42 weeks. The primary efficacy endpoint was the proportion of patients with symptomatic remission at 42 weeks.
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The present review will verify by intra-study rank orders, and their comparison between studies, that the different gastric proton pump inhibitors (PPIs) display similar dose-response relationships with similar potencies and efficacies on a milligram basis, i.e., at the same milligram doses. This is in line with their basic pharmacology which suggests that, primarily, the serum AUCs of the free pro-drugs and their chemical activation half lives at pH 1 relative to their serum elimination half lives determine the efficacies of PPIs. According to the literature, these drug characteristics are similar for all PPIs. Although PPIs have been introduced into the therapy of acute peptic ulcer disease at different daily, oral doses of 20 mg (omeprazole and rabeprazole), 30 mg (lansoprazole) and 40 mg (pantoprazole), the data suggest that the optimal dose of lansoprazole, omeprazole and pantoprazole, with respect to the acute treatment of peptic ulcers and moderate to severe gastroesophageal reflux disease (GERD), is about 30-40 mg daily. The data base of rabeprazole appears to be too small at present to make any definite statement. Lower daily doses of the PPIs of about 15-20 mg are sufficient in less severe cases of GERD and in maintenance therapy. It appears that different dose recommendations were based on different strategies to balance optimal drug dosage and safety, rather than on real differences in milligram-related efficacies.
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Gastroesophageal reflux disease (GERD) is a well-recognized cause of impaired sleep in patients with frequent GERD symptoms, as well as those with sleep apnea. GERD's role in sleep disturbance of minimally symptomatic patients with poor sleep quality is less clear.
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NAB in studies a, b, c, and d was observed in 9, 1, 4, and 4 subjects, respectively, and the longest periods of nocturnal gastric pH at less than 4.0 were 102.5, 14.0, 37.5, and 52.5 min, respectively (study b vs study c, P<0.05).
Forty-seven patients completed the study (three were excluded from the analysis for breaching the study protocol). The patients included 18 males and 29 females within the age range of 13-80 years (mean 43.7, SD 16.8). The clinical features of the study subjects were dyspepsia, reflux symptoms and features of gastrointestinal bleeding. The average eradication rate was 87.2%. Eighteen subjects were enrolled in the 7-d arm, while 29 were in the 10-d arm. There was no statistically significant difference in the age or sex distributions of the two arms. There was no significant advantage of the 10-d treatment duration over the 7-d duration (P = 0.78), and the eradication outcomes were not influenced by the gender or age of the subjects. No adverse effects were reported in either arm.
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We previously reported that H2-antagonist medication given for longer than 4 wk may produce complete tolerance to preanesthetic H2 antagonist therapy. In this study, we evaluated the efficacy of preanesthetic proton pump inhibitor (PPI; oral rabeprazol) use in patients receiving regular H2-antagonist (oral famotidine) therapy for more than 4 wk. Forty-eight patients with assumed complete tolerance to H2 antagonists undergoing elective surgery were recruited and randomly assigned to receive either a preanesthetic PPI (rabeprazol 20 mg; n = 24) or H2-antagonist (H2 group; roxatidine 75 mg; n = 24) at 9:00 pm on the day before surgery and 2 h before the induction of anesthesia. Volume of gastric contents and pH values were measured after the induction of anesthesia. Gastric pH value in the PPI group (5.38 +/- 2.42) was significantly higher than in the H2 group (3.27 +/- 1.98; P < 0.01). Gastric volume in the PPI group (8.6 +/- 1.5 mL) was significantly smaller than in the H2 group (15.4 +/- 2.8 mL; P < 0.05; cf. PPI). Fourteen patients in the H2 group were at risk of acid aspiration pneumonia (gastric pH <2.5 or volume >25 mL), whereas only four patients in the PPI group (P < 0.05) were at risk. These data suggest that in patients receiving H2-antagonist therapy for longer than 4 wk, prophylaxis for acid aspiration pneumonia should include preanesthetic PPI medication.
To evaluate the relative bioavailability of a new formulation containing 5 mg mosapride and 10 mg rabeprazole (T) and compare it with the branded formulations of both drugs co-administered in separate tablets (R) to meet the regulatory requirements of bioequivalence in Argentina.
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Proton-pump inhibitors (PPIs) have been proved as safe and effective ways to treat patients with non-erosive reflux disease (NERD). However, less is known about the comparisons among different PPIs and their best dosage. We aimed to synthesize the available evidence through network meta-analysis to investigate the efficacy and safety of different PPIs in treating patients with NERD. Fifteen studies with 6309 patients were included in the meta-analyses. For the rate of symptomatic relief, compared with control groups, all interventions except rabeprazole 5 mg significantly increased rate of symptomatic relief. Among the comparisons of different interventions, omeprazole 20 mg group was associated with a higher rate of symptomatic relief in contrast to omeprazole 10 mg group (odds ratio, OR: 1.89, 95% confidence interval, CI: 1.34, 2.67; p-value: 0.0005) or rabeprazole 5 mg group (OR: 2.51, 95%CI: 1.16, 5.42; p-value: 0.019); dexlansoprazole 30 mg therapy significantly improved the rate of symptomatic relief compared with rabeprazole 5 mg group (OR: 2.64, 95%CI: 1.08, 6.43; p-value: 0.03). For the rate of adverse events, there was no significant difference among all interventions.
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Helicobacter pylori treatment failure is a growing problem in daily practice.
We prospectively studied 95 consecutive patients with cirrhosis and H. pylori-infected active peptic ulcers. H. pylori infection was confirmed if any 2 of the following were positive: H. pylori DNA, histology, and rapid urease test. Patients were assigned to an open-label 2-week course of oral amoxicillin 1,000 mg b.i.d., rabeprazole 20 mg b.i.d. and clarithromycin 500 mg b.i.d. Subsequently, all patients received oral rabeprazole 20 mg once daily until week 8. Three months and 1 year after therapy, all patients with cirrhosis were followed up endoscopically for peptic ulcer, rapid urease test, and (13)C-urea breath test. The CYP2C19 genotype status for 2 mutations associated with the extensive metabolizer phenotype was determined by polymerase chain reaction and restriction fragment length polymorphism analysis.
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Prospective uncontrolled trial.
307 patients, from 2 endoscopic centers in Greece, were randomized to receive Rabeprazole 20 mg bid, Clarithromycin 500 mg bid, and Amoxycillin 1gr bid for 7-days, for 10-days or for 14-days. Cure rates were assessed by CLO-test and histology. Clarithromycin sensitivity tests were carried out in the cultured pre-treatment H.pylori strains. The success rates were calculated by both intention-to-treat (ITT) and per protocol (PP) analyses.
Gastroesophageal reflux disease (GERD) is a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Its pathophysiology, diagnosis and treatment have frequently been analyzed but it is interesting to review some aspects of the GERD refractory patients to the proton pump inhibitors treatment. The treatment encompasses behavioral measures and pharmacological therapy. The majority of the patients respond well to proton pump inhibitors treatment but 20%-42% of them may not do so well. Patients who are unresponsible to 4-8 weeks' treatment with proton pump inhibitors (omeprazole, pantoprazole, rabeprazole, lansoprazole, esomeprazole, pantoprazole-Mg) might have so-called refractory GERD.
Four-week, rabeprazole 10 mg/day acid suppression therapy was effective in resolving symptoms in Japanese GERD patients. This therapy was more effective in erosive GERD than in NERD patients, and in those with severe RO than in those with mild RO.
The two-week high dose PPI treatment was not effective for early satiation, postprandial abdominal fullness, regurgitation or belching symptoms in patients with overlapping NERD and FD. Acid exposure in the distal esophagus could not predict the response of symptoms to PPI. In addition, the 2-week PPI test provided limited value for gastroesophageal reflux disease diagnosis in patients with overlapping NERD and FD.
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Rabeprazole has been demonstrated to be a potent antisecretory agent and has been shown to be clinically effective in the treatment of acid-related diseases.
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A reliable method to assess in vitro metabolic stability of rabeprazole and its modulation by Generally Recognized As Safe (GRAS)-listed pharmaceutical excipients was established in human liver microsomes. The metabolic stability of rabeprazole decreased as a function of incubation time, resulting in the formation of thioether rabeprazole via nonenzymatic degradation and enzymatic metabolism. Buffer type was also a determining factor for the degree of both nonenzymatic degradation and enzymatic metabolism. The net extent of enzymatic drug metabolism, obtained by calculating the difference in drug degradation between a microsome-present reaction system and a microsome-free solution, was about 9.20 +/- 0.67% in phosphate buffer and 2.27 +/- 1.76% in Tris buffer, respectively. Rabeprazole exhibited first-order kinetics in microsome-free solution but showed non-linear kinetics in the microsome-present reaction system. The maximal velocity, Vmax, in phosphate buffer was 5.07 microg mL(-1) h(-1) and the Michaelis-Menten constant, Km, was 10.39 microg mL(-1) by computer-fitting to the classical Michaelis-Menten equation for pattern of time-dependent change in the substrate concentration. The intact drug and its thioether form were well resolved and successfully identified by HPLC chromatography and liquid chromatography mass spectroscopy (LC/MS). The metabolic stability of rabeprazole was also modulated by the presence of pharmaceutical excipients. Among the five pharmaceutical excipients tested, poloxamer 188 and Gelucire 44/14 had potentially inhibitory effects on rabeprazole metabolism in human liver microsomes (p < 0.05). A greater understanding of metabolic stability and its modulation by pharmaceutical excipients would be useful for optimizing the bioavailability of rabeprazole at the early formulation stages.
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To evaluate the effect of efflux pump inhibitors (EPIs) on multidrug resistance of Helicobacter pylori (H. pylori).