Famotidine

Kraus, G.; Krishna, D. R.; Chmelarsch, D.; Schmid, Markus; Klotz, Ulrich

doi:10.2165/00003088-199018010-00005

Cited by 25 publications

(12 citation statements)

References 14 publications

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“…The limit of quantification in plasma is improved to 0.5 ng ml 1 using 100 µl of plasma sample, which represents a 20-fold increase in comparison with . Representative famotidine plasma profiles from subject A, a 35-day-old neonate weighing 3.1 kg, following intravenous administration, of famotidine at 0.5 mg kg 1 and subject B, a 6-day-old neonate weighing 2.8 kg, following oral suspension administration of famotidine at 0.5 mg kg 1 .…”

Section: Resultsmentioning

confidence: 99%

“…The weighted least-squares regression Calibration curve was linear over the concentration ranges 0.5-500 ng ml 1 and 0.05-50 µg ml 1 for plasma and urine assay, respectively. Replicate standards (n D 5) were analyzed to assess the within-day variability of the assay.…”

Section: Linearity Precision and Accuracymentioning

confidence: 94%

“…These solutions were stable at 4°C and prepared weekly. A standard solution of the internal standard was prepared in methanol at 125 and 500 ng ml 1 for the plasma and urine assay, respectively. The solutions were stored at 4°C until required.…”

Section: Preparation Of Working Standard Solutions and Calibration Cumentioning

confidence: 99%

“…This yielded calibration curve concentrations of famotidine in the range 0.5-500 ng ml 1 . A daily urine calibration curve was prepared by mixing 50 µl of control urine, 50 µl of each of the famotidine working standard solutions and 500 µl of internal standard solution into glass culture tubes.…”

Section: Preparation Of Working Standard Solutions and Calibration Cumentioning

confidence: 99%

“…A daily urine calibration curve was prepared by mixing 50 µl of control urine, 50 µl of each of the famotidine working standard solutions and 500 µl of internal standard solution into glass culture tubes. This yielded calibration curve concentrations of famotidine in the range 0.05-50 µg ml 1 . These standard samples were subjected to further sample preparation as described in the next section.…”

Section: Preparation Of Working Standard Solutions and Calibration Cumentioning

confidence: 99%

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Determination of famotidine in low‐volume human plasma by normal‐phase liquid chromatography/tandem mass spectrometry

2001

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A rapid, sensitive and robust assay procedure using liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) for the determination of famotidine in human plasma and urine is described. Famotidine and the internal standard were isolated from plasma samples by cation-exchange solid-phase extraction with benzenesulfonic acid (SCX) cartridges. The urine assay used direct injection of a diluted urine sample. The chromatographic separation was accomplished by using a BDS Hypersil silica column with a mobile phase of acetonitrile-water containing trifluoroacetic acid. The MS/MS detection of the analytes was set in the positive ionization mode using electrospray ionization for sample introduction. The analyte and internal standard precursor-product ion combinations were monitored in the multiple-reaction monitoring mode. Assay calibration curves were linear in the concentration range 0.5--500 ng ml(-1) and 0.05--50 microg ml(-1) in plasma and urine, respectively. For the plasma assay, a 100 microl sample aliquot was subjected to extraction. To perform the urine assay, a 50 microl sample aliquot was used. The intra-day relative standard deviations at all concentration levels were <10%. The inter-day consistency was assessed by running quality control samples during each daily run. The limit of quantification was 0.5 ng ml(-1) in plasma and 0.05 microg ml(-1) in urine. The methods were utilized to support clinical pharmacokinetic studies in infants aged 0-12 months.

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Section: Resultsmentioning

confidence: 99%

Section: Linearity Precision and Accuracymentioning

confidence: 94%

Section: Preparation Of Working Standard Solutions and Calibration Cumentioning

confidence: 99%

Section: Preparation Of Working Standard Solutions and Calibration Cumentioning

confidence: 99%

Section: Preparation Of Working Standard Solutions and Calibration Cumentioning

confidence: 99%

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Determination of famotidine in low‐volume human plasma by normal‐phase liquid chromatography/tandem mass spectrometry

2001

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Pharmacokinetics and Pharmacodynamics of Famotidine in Children

James

Marshall

Heulitt

et al. 1996

The Journal of Clinical Pharma

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The pharmacokinetics and pharmacodynamics of intravenous famotidine were studied in 12 children (1.1-12.9 years of age; mean weight +/- standard deviation = 27.6 +/- 21.2 kg) who were given the drug for prophylactic management of stress ulceration. After a 0.5-mg/kg infusion of famotidine, timed blood (n = 10) and urine (n = 6) samples and repeated evaluations of intragastric pH (n = 13) were obtained from each subject. Pharmacokinetic parameters were determined from curve fitting of serum concentration data. The mean (+/- SD) maximum serum concentration (Cmax) was 527.6 +/- 281.2 ng/mL, the elimination half-life (t1/2) was 3.2 +/- 3.0 hours, and the apparent steady-state volume of distribution (Vdss) was 2.4 +/- 1.7 L/kg. Plasma clearance (Cl) and renal clearance (ClR) were 0.70 +/- 0.34 L/hr/kg and 0.43 +/- 0.24 L/hr/kg, respectively. Over 24 hours, 73.0 +/- 27.3% of the dose was excreted unchanged in the urine (Fel). Pharmacodynamic analysis of gastric pH data using the sigmoid Emax model predicted that 50% of the maximal effect of famotidine (EC50) occurs at a serum concentration of 26.0 +/- 13.2 ng/mL. Children who did not have an initial intragastric pH < or = 4 did not have a significant response in pH after receiving famotidine. Although Vdss and Cl were higher in these children than those seen in adults, statistically significant relationships between these parameters and age were not observed in the study population. The pharmacodynamics and pharmacokinetics of famotidine in children older than one year of age appear to be similar to those noted in adults.

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Pharmacokinetics and pharmacodynamics of famotidine and ranitidine in critically ill children

Madani

Kauffman

Simpson

et al. 2013

The Journal of Clinical Pharmacology

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To characterize and compare acid suppression (pharmacodynamics) and pharmacokinetics of IV famotidine and ranitidine in critically ill children at risk for stress gastritis. Single-blind, randomized study in PICU patients 6 months to 18 years requiring mechanical ventilation with continuous gastric pH monitoring, randomized to IV famotidine 12 mg/m(2) or ranitidine 60 mg/m(2) when gastric pH < 4.0 >1 hour with serial blood sampling following first dose. Twenty-four children randomized to either famotidine (n = 12) or ranitidine (n = 12). Sixteen out of twenty-four completed both PK and PD study arms (7/12 famotidine; 4.7 ± 3.4 years; 9/12 ranitidine; 6.6 ± 4.7 years; p = 0.38). Time to gastric pH 4.0 and total time pH above 4.0 similar with no difference in pH at 6 and 12 hours (p > 0.2). No difference between drugs in clearance, volume of distribution and half-life (p > 0.05). Ratio of AUC pH to AUC drug concentration 0-12 hours after first dose was significantly greater for famotidine (0.06849 ± 0.01460 SD) than ranitidine (0.02453 ± 0.01448; p < 0.001) demonstrating greater potency of famotidine. pH lowering efficacy of both drugs is similar. Greater potency of famotidine may offer clinical advantage due to lower drug exposure and less frequent dosing to achieve same pH lowering effect.

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Famotidine

Cited by 25 publications

References 14 publications

Determination of famotidine in low‐volume human plasma by normal‐phase liquid chromatography/tandem mass spectrometry

Determination of famotidine in low‐volume human plasma by normal‐phase liquid chromatography/tandem mass spectrometry

Pharmacokinetics and Pharmacodynamics of Famotidine in Children

Pharmacokinetics and pharmacodynamics of famotidine and ranitidine in critically ill children

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