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This study determined the total preparation time, cost, and contamination rate associated with preparing 50-mL admixtures of ranitidine 50 mg from each of the following commercial source vials: 50 mg/2 mL unit-dose vial (treatment A), 50 mg/2 mL 10 mL multidose vial (treatment B), and 50 mg/2 mL 40 mL multidose vial (treatment C). The study consisted of two separate phases: phase I extemporaneous compounding and phase II batch manufacturing. Twelve technicians prepared ten admixtures from each source vial during each phase. All admixtures were tested for sterility; bacterial contamination was not observed. Multidose vials saved approximately $197 per 200 admixtures. Drug and personnel costs were reduced when batch manufacturing with 40-mL multidose vials was compared with extemporaneous compounding with unit-dose vials. Our study showed that multidose vials decreased the total preparation time and cost for making ranitidine admixtures during both extemporaneous compounding and batch manufacturing by reducing setup time, preparation time, and drug procurement cost.
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The compatibility and stability of labetalol hydrochloride in combination with various critical care drugs was evaluated. Labetalol hydrochloride 1.0 mg/mL was combined in 5% dextrose injection with equal volumes of each of the following drugs: dobutamine 2.5 mg/mL (as the hydrochloride salt), dopamine hydrochloride 1.6 mg/mL, morphine sulfate 0.5 mg/mL, nitroglycerin 0.2 mg/mL, and ranitidine 0.6 mg/mL (as the hydrochloride salt). The mixtures were placed in duplicate Y-site administration sets. Visual inspection, pH determination, and high-performance liquid chromatography were performed in duplicate on samples removed at zero, two, and four hours. No change in pH or appearance occurred throughout the study. All drug concentrations remained above 90% of the initial concentration in each combination. Labetalol hydrochloride 1.0 mg/mL and dobutamine 2.5 mg/mL (as the hydrochloride salt), dopamine hydrochloride 1.6 mg/mL, morphine sulfate 0.5 mg/mL, nitroglycerin 0.2 mg/mL, or ranitidine 0.6 mg/mL (as the hydrochloride salt) in 5% dextrose injection were stable and compatible for up to four hours at 20-25 degrees C during simulated Y-site injection.
Of 84 initially treated patients, 73 entered the maintenance study. The percentage of asymptomatic patients after 90-day and 210-day treatment were 97% and 81.5%, for rabeprazole and 74.3% and 62.3%, for ranitidine, respectively. After 32 weeks, the relapse rates of esophagitis were 21.3% in the rabeprazole group and 62.9% in the ranitidine group (RR: 0.405, 95% CI: 0.215-0.766).
Ranitidine bismuth citrate (RBC) is a new chemical entity for the treatment of peptic ulcer disease.
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A total of 15,495 patients registered with eight general practitioners in seven general practices in Dundee, UK.
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Serum samples for measurement of ranitidine concentrations were collected at 2, 6, and 12 hrs after the fifth dose of oral ranitidine. Patients were monitored for upper gastrointestinal bleeding. All patients had therapeutic serum ranitidine concentrations at 2 and 6 hrs, while 88% of patients had therapeutic levels at 12 hrs.
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Fewer patients undergoing omeprazole therapy required redilatation compared with those on ranitidine (43 of 143 [30%] vs. 66 of 143 [46%] by 12 months; P < 0.01), and patients in the omeprazole group needed fewer redilatations during the year (0.48 vs. 1.08; P < 0.01). On completion, symptom relief favored omeprazole: 76% of patients in the omeprazole group were free of dysphagia (compared with 64% in the ranitidine group; P < 0.05); 83% were able to accept a normal diet (69%; P < 0.01); and 65% were completely asymptomatic (43%; P < 0.001).
A 56 year old female with acute pancreatitis and a known allergy to metronidazole and buscopan developed an anaphylaxis few minutes following the injection of ranitidine for epigastric discomfort. She went on to develop anaphylactic shock and a cardiorespiratory arrest.
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The effect of pretreatment with ranitidine, an antacid, on the absorption of AS-924, a novel prodrug-type cephem antibiotic derived from ceftizoxime (CTIZ), was examined in eight healthy adult male volunteers by the cross-over method, using cefteram-pivoxil (CTER-PI) as the control drug. The C(max) and area under the concentration (AUC) values and cumulative urinary excretion rate (0-24 h) of cefteram (CTER) after administration of CTER-PI decreased by 32, 38 and 37%, respectively, in the ranitidine pretreatment group whereas those of AS-924 were not affected by the antacid. The urinary levels of pivaloyl-carnitine determined to evaluate the solubility of these antibiotics in the gastrointestinal tract suggested that this was not affected by ranitidine. These results indicate that the absorption of CTER-PI was affected by pretreatment with ranitidine largely due to inactivation of this antibiotic in the gastrointestinal tract at high pH rather than to a decrease in solubility. In contrast, isomerization of AS-924 was hardly induced by the elevation of pH, thus demonstrating that AS-924 was less likely to be affected by pretreatment with antacids.
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A program in which pharmacists were authorized to change parenteral histamine H2-receptor antagonist (H2RA) therapy to the oral route without first contacting the prescriber was evaluated on cost and appropriateness of use of the parenteral route. Parenteral therapy was received by 264 and 244 patients in the study and comparison groups, respectively. Length of parenteral H2RA therapy was less in the study group (4.8 vs. 7.5 d) as was length of total (parenteral + oral) therapy (8.4 vs. 12.1 d). Parenteral H2RA drug acquisition savings were $6225 in the six-week study period or $53,950 when annualized. Decreased oral therapy contributed additional savings. There was a significant decrease in the number of inappropriate parenteral doses of ranitidine per patient, the drug used in more than 80 percent of the patients. In addition to the direct effect of pharmacists' interventions, there appeared to be an indirect effect of the program, as physicians initiated route of administration changes on their own.
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We evaluated 274 VLBW infants: 91 had taken ranitidine and 183 had not. The main clinical and demographic characteristics did not differ between the 2 groups. Thirty-four (37.4%) of the 91 children exposed to ranitidine and 18 (9.8%) of the 183 not exposed to ranitidine had contracted infections (odds ratio 5.5, 95% confidence interval 2.9-10.4, P < .001). The risk of NEC was 6.6-fold higher in ranitidine-treated VLBW infants (95% confidence interval 1.7-25.0, P = .003) than in control subjects. Mortality rate was significantly higher in newborns receiving ranitidine (9.9% vs 1.6%, P = .003).
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Colloidal bismuth subcitrate (CBS; DeNol) has been studied in clinical trials investigating the treatment of duodenal and gastric ulcer, non-ulcer dyspepsia, duodenitis, non-steroidal anti-inflammatory drug (NSAID)-induced disease, and Helicobacter pylori-induced gastroduodenitis. Healing rates for duodenal ulcer with CBS are significantly better than with placebo and are similar to results obtained with cimetidine or ranitidine. CBS is significantly better in the treatment of duodenal ulcer resistant to standard doses of H2 antagonists than increased doses of H2 antagonists. Duodenal ulcer relapse at 12 months after initial healing with CBS is significantly less than with H2-antagonist therapy. Ulcer healing with CBS is not influenced by smoking. H. pylori eradication with CBS appears to have little effect in ulcer healing but is of major importance in preventing ulcer relapse. CBS is effective in combination with antibiotics in eradicating H. pylori-associated gastritis. In gastric ulcer disease CBS therapy resulted in significant healing advantages over placebo and was comparable to treatment with cimetidine and sucralfate. CBS has been shown to be effective in the treatment of erosive duodenitis. The role of CBS in treatment of non-ulcer dyspepsia and NSAID-induced damage awaits further clinical studies.
To test the eradication rate of Helicobacter pylori by ranitidine bismuth citrate-based triple therapy, and evaluate the symptomatic response of Helicobacter pylori eradication therapy for non-ulcer dyspepsia.
To evaluate the effect of Bicitra (Willen Drug Company, Baltimore, Maryland), a commercial preparation of sodium citrate and metoclopramide, on gastric contents 150 elective outpatients allocated into six groups with 25 patients in each group were studied. Patients in Group 1 served as controls. Patients in Groups 2, 3, 5, and 6 received Bicitra, po, either 15 ml (Groups 2 and 5) or 30 ml (Groups 3 and 6). In addition, patients in Groups 5 and 6 also received metoclopramide 10 mg, iv; Group 4 patients received metoclopramide 10 mg, iv. Eighty-eight per cent of patients in the control group had a gastric pH less than or equal to 2.5, while 36% had a gastric content volume greater than or equal to 25 ml with pH less than or equal to 2.5. Bicitra, 15 ml and 30 ml, po, increased mean gastric pH and decreased the proportion of patients with a gastric pH less than or equal to 2.5 to 32 and 16%, respectively, in Groups 2 and 3. However, Bicitra 15 ml and 30 ml, increased the mean gastric volume in Group 3 and also increased the proportion of patients with a gastric volume greater than or equal to 25 ml to 56% in Group 2 and 84% in Group 3. The addition of metoclopramide 10 mg, iv, to Bicitra reduced the proportion of patients with a gastric volume greater than or equal to 25 ml in Groups 5 and 6 to 28 and 36%, respectively. Metoclopramide (Group 6) independently reduced mean gastric volume (15.6 ml vs. 32.7 ml) and the proportion of patients with a gastric volume greater than or equal to 25 ml (20% vs. 36%). Bicitra and metoclopramide combination significantly reduced the proportion of patients with gastric contents greater than or equal to 25 ml with pH less than or equal to 2.5.
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We report four chronically constipated female gastroesophageal reflux disease-patients with reflux symptoms and an increased number of reflux episodes in combined esophageal pH and multichannel impedance monitoring treated with prucalopride (2mg per day). Symptoms were persistent to proton pump inhibitors and ranitidine. Gastroesophageal reflux was detected by pH or multichannel impedance (MII) monitoring. Numbers of all reflux episodes as well as non-acid reflux episodes were reduced in all of our patients. The objective findings were concordant with subjective reports of symptom relief. There were no major adverse events in any patient during therapy with prucalopride.
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The results suggest that gastrin stimulates acid secretion by releasing histamine from ECL cells. Vagally induced acid secretion is also dependent on a histaminergic pathway but not on ECL-cell histamine.
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Famotidine and ranitidine in over-the-counter doses have a similar, sustained, effect on post-prandial nocturnal intragastric acidity in healthy subjects lasting up to 12 h after oral dosing.
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The overall unadjusted study odds ratio for VAP was 0.82 (P = .21) representing a trend toward less pneumonia with sucralfate compared with ranitidine. The odds ratio adjusted for adjudication pair was 0.85 (P = .27). The proportion of charts adjudicated as VAP positive among pairs ranged from 50% to 92%; crude agreement between readers in each pair varied from 50% to 82%. When adjudicators disagreed, the final consensus was split evenly between the two adjudicators' initial opinions in two pairs; in the other two pairs, the final decision reflected one dominant initial opinion. Personnel time to adjudicate all patients with a suspicion of VAP was 74 days.
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Cimetidine, an H2-receptor antagonist, is one of the most commonly prescribed drugs in the world. It has been reported to increase blood alcohol concentrations in drinking individuals. To determine if this increase could be due to inhibition of alcohol dehydrogenase activity, the effect of the drug on ethanol oxidation by gastric sigma sigma alcohol dehydrogenase and liver beta 2 beta 2, pi pi, and chi chi alcohol dehydrogenase isoenzymes was observed. Cimetidine inhibited all isoenzymes studied except chi chi; the chi chi isoenzyme showed no inhibition up to 5 mM cimetidine. Inhibition of the alcohol dehydrogenase isoenzymes by the H2-receptor antagonists nizatidine, ranitidine, and famotidine was negligible. Docking simulations with the beta 2.NAD+.4-iodopyrazole X-ray structure indicated that cimetidine fit well into the substrate binding site. The substitution on the thiazole ring of nizatidine, however, prevented docking into the binding site. Cimetidine inhibition of ethanol oxidation by sigma sigma and beta 2 beta 2 was competitive with varied ethanol, exhibiting Ki values of 2.8 +/- 0.4 mM and 0.77 +/- 0.07 mM, respectively. Cimetidine inhibition of ethanol oxidation by pi pi was noncompetitive with varied ethanol (Ki = 0.50 +/- 0.03 mM). Inhibition of ethanol oxidation by sigma sigma and beta 2 beta 2 with varied NAD+ was competitive. These results, together with the cimetidine inhibition kinetics of acetaldehyde reduction by sigma sigma and beta 2 beta 2, with either varied NADH or varied acetaldehyde, are consistent with cimetidine binding to two enzyme species. These species are free enzyme and the productive enzyme.NAD+ complex.
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The results of this pilot study revealed that among the outpatients suffering from rheumatic diseases, the number of females was double as high as the number of males, that these patients were of the mean age of 70 years, and that their diseases lasted longer than five years. Gastric complains such as nausea and gastric pain of mild intensity were the most often adverse effects of NSAIDs reported by our patients. It could be the consequence of the predominant use of diclofenac and ibuprofen, NSAIDs with mild to moderate ulcerogenic potential, as well as the concomitant use of H2-receptor antagonists.
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We have previously shown that sensory nerve peptides contribute to the pathogenesis of pulmonary hypersensitivity reactions (HSRs) to paclitaxel in rats. Moreover, pemirolast, an antiallergic agent, reverses the HSRs to paclitaxel, although the mechanism is considered to result from the blockade of paclitaxel-induced release of sensory peptides, rather than the inhibition of histamine release. In the present study, we investigated the preventive effect of pemirolast against acute HSRs in a total of 84 patients who undertook postoperative paclitaxel plus carboplatin chemotherapy every 4 weeks for ovarian cancer. Patients were assigned to receive oral lactose (placebo) or pemirolast (10 mg), 2 hr before paclitaxel infusion. All patients received conventional premedication, including oral diphenhydramine, intravenous ranitidine and intravenous dexamethasone, 30 min before paclitaxel infusion. The HSRs that led to the discontinuance of paclitaxel infusion (grade>or=2) occurred in 5 of 42 patients in placebo group, whereas none of pemirolast-treated 42 patients showed any signs of HSRs. Plasma histamine concentrations were not changed after paclitaxel infusion in either group. Our present findings suggest that pemirolast is potentially useful for prophylaxis of paclitaxel-induced HSRs. In this respect, the use of pemirolast as premedication is expected to be beneficial to the safety management in patients who undergo chemotherapy containing paclitaxel.
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We studied the effects of preanesthetic ranitidine on gastric contents in 60 outpatients scheduled for elective surgery, with random allocation into three groups of 20 patients each. Patients in group 1 did not receive ranitidine and served as controls. Patients in groups 2 and 3 received ranitidine orally, 150 and 300 mg, respectively, one to five hours before induction of anesthesia. In the control group, mean pH and volume of gastric contents were 1.90 and 27.7 ml respectively. Ninety percent of the control subjects had gastric pH less than or equal to 2.5, and 65% of the patients had pH less than or equal to 1.8; 65% of the patients had gastric volumes of 20 ml or greater. Ranitidine in 150 and 300 mg doses markedly raised mean gastric pH to 6.40 and 5.87 respectively and reduced the proportion of patients with gastric pH less than or equal to 2.5 to 10% in group 2 and 0% in group 3. Mean gastric volume and proportion of patients with volume greater than or equal to 20 ml were significantly reduced in both treatment groups. Proportions of patients with combination of pH less than or equal to 2.5 and volume greater than or equal to 20 ml were significantly low in both treatment groups, as there was only one patient in group 2 and none in group 3 with both low pH and high volume. With respect to reduction of gastric acidity and volume, 300 mg of ranitidine had no advantage over 150 mg.
Studies evaluating RBC plus two antibiotics were considered. For the meta-analysis, randomized controlled trials comparing PPI vs. RBC plus two antibiotics for 1 week were included.
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Thirteen percent of older veterans with a CrCl of 30 to 49 mL/min and 32% of those with a CrCl of 15 to 29 mL/min received one or more drugs that were contraindicated or prescribed at an excessive dose given the individual's level of renal function. The strongest risk factor for renally inappropriate prescribing was number of medications used; the risk of receiving renally inappropriate medications was 5.5 times as high (95% confidence interval = 5.1-5.9) in older adults taking 10 or more medications as in those taking one to three medications. Ranitidine, allopurinol, and metformin together accounted for 76% of renally misprescribed medications in individuals with a CrCl of 30 to 49 mL/min. Glyburide, ranitidine, gemfibrozil, carvedilol, and allopurinol accounted for 47% of renally misprescribed drugs for individuals with a CrCl of 15 to 29 mL/min.
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The present study was aimed to investigate the effects of microinjection of histamine and its H1, H2 and H3 receptor antagonists, mepyramine, ranitidine and thioperamide, respectively, into the anterior cingulate cortex (ACC) on pain-related behaviors induced by formalin in rats.
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Histamine is a potent mediator in allergic inflammatory processes and is released by basophils and mast cells. The aim of this study was to investigate the effect of histamine on in vitro migration of human fetal lung fibroblasts (HFL-1) to human plasma fibronectin (HFn), a chemoattractant. Using the blindwell chamber technique, histamine alone had no chemotactic activity. However, histamine augmented HFn-induced HFL-1 migration at concentrations ranging between 0 and 10(-7) M (290.6 +/- 20.8%) (P < 0.05). The concentration-response was bell-shaped. The effect of histamine increased with time. The stimulatory effect of histamine on HFL-1 migration was inhibited by an H4 receptor antagonist, JNJ7777120 (10(-5) M). Histamine's effect was also inhibited by pertussis toxin (50 ng/ml), showing that the effect was mediated by the H4 receptor. This study demonstrated that histamine has the potential to stimulate human lung fibroblast migration, and thus may contribute to regulation of wound healing and the development of fibrotic disorders of the lung.