Zur Pharmakokinetik von Ethambutol bei Gesunden und Patienten mit terminaler Niereninsuffizienz

Dume, Th.; Cl, Wagner; Wetzels, E

doi:10.1055/s-0028-1110155

Cited by 17 publications

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“…1. [3][4][5] Our data over the first 12 hr postdosing favor longer tVz values (see Table IV) than those previously reported. Previous studies may have underestimated the tVz of EMB by calculating tlh from the distribution phase rather than the terminal phases since detection of the latter phases requires prolonged plasma sampling and a sensitive, specific assay.…”

Section: Clinical Pharmacology and Therapeuticssupporting

confidence: 47%

“…1. 4,10 Our results indicate only minor variation among individuals. For the oral solution, the peak concentrations ranged from 3.35 to 6.0 mcg/ml (4.45 ± 0.88) and for tablets, 3.25 to 5.62 mcg/ml (4.01 ± 0.84).…”

Section: Discussionmentioning

confidence: 44%

“…3 , 4, 10 Half-life values have similarly varied from 1.5 hr to 4.2 hr. 1, [3][4][5] The assay procedures used in the different studies may account for some of the discrepancies observed in determining the pharmacokinetics of this drug. The various studies have used microbiological, chemical, and radiochemical assays, some of which may be measuring metabolites of EMB as well as unchanged drug.…”

mentioning

confidence: 99%

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Kinetics of oral ethambutol in the normal subject

Lee

Gambertoglio

Brater

et al. 1977

Clin Pharma and Therapeutics

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Section: Clinical Pharmacology and Therapeuticssupporting

confidence: 47%

Section: Discussionmentioning

confidence: 44%

mentioning

confidence: 99%

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Kinetics of oral ethambutol in the normal subject

Lee

Gambertoglio

Brater

et al. 1977

Clin Pharma and Therapeutics

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“…EMB (277.2 Daltons, protein binding 20-30%, volume of distribution 1.6-3.2 l/kg) is primarily bacteriostatic at a minimum inhibitory concentration (MIC) of 0.4-1.8 mg/ml, but can be bactericidal at higher concentrations. 2,3 First-line therapy of new-onset TB includes a combination of isoniazid (INH), RIF, pyrazinamide (PZA), and EMB for (at least) the first 2 months, with these showing additive and synergistic effects. Although having less potent bactericidal activity against mycobacteria compared to other agents, EMB decreases antibiotic resistance.…”

mentioning

confidence: 99%

Single- and multiple-dose pharmacokinetics of ethambutol and rifampicin in a tuberculosis patient with acute respiratory distress syndrome undergoing extended daily dialysis and ECMO treatment

Strunk

Ciesek

Schmidt

et al. 2016

International Journal of Infectious Diseases

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The dosing of drugs in critically ill patients undergoing renal replacement therapy is based on limited data. We report for the first time single- and multiple-dose pharmacokinetics of ethambutol (EMB), which is cleared renally to 80%, and rifampicin (RIF), which is cleared renally to <30%, in a patient requiring both extracorporeal membrane oxygenation (ECMO) and renal replacement therapy. Extended dialysis removed a considerable amount of both EMB and RIF, with a dialyser plasma clearance ranging between 37 and 95 ml/min for EMB and between 39 and 53 ml/min for RIF. The EMB peak level (3h after a 2-h infusion) using a dose of 1000 mg/day on the first day of treatment was 2.3mg/l, which is in the low therapeutic range (2-5mg/l). Doubling the dose to 2000 mg/day resulted in peak levels slightly to markedly above the recommended range. There was no detectable effect of the ECMO membrane on the removal of both drugs. After an initial dose as for patients without renal impairment (15 mg/kg/day), therapeutic drug monitoring should be used to guide EMB dosing in patients undergoing extended daily dialysis.

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Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ethambutol DihydrochlorideThis paper reflects the scientific opinion of the authors and not the policies of regulating agencies.A project of the International Pharmaceutical Federation FIP, Groupe BCS, http://www.fip.org/bcs.

Becker

Dressman

Amidon

et al. 2008

Journal of Pharmaceutical Sciences

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Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing ethambutol dihydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ethambutol dihydrochloride is a Biopharmaceutics Classification System (BCS) Class III drug with permeability properties approaching the border between BCS Class I and III. BE problems of ethambutol formulations containing different excipients and different dosages forms have not been reported and hence the risk of bioinequivalence caused by excipients is low. Ethambutol has a narrow therapeutic index related to ocular toxicity. However, as long as the prescribers' information of the test product stipulates the need for regular monitoring of ocular toxicity, the additional patient risk is deemed acceptable. It is concluded that a biowaiver can be recommended for IR solid oral dosage forms provided that the test product (a) contains only excipients present in ethambutol IR solid oral drug products approved in ICH or associated countries, for instance as presented in this paper, (b) complies with the criteria for "very rapidly dissolving" and (c) has a prescribers' information indicating the need for testing the patient's vision prior to initiating ethambutol therapy and regularly during therapy.

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Zur Pharmakokinetik von Ethambutol bei Gesunden und Patienten mit terminaler Niereninsuffizienz

Cited by 17 publications

References 0 publications

Kinetics of oral ethambutol in the normal subject

Kinetics of oral ethambutol in the normal subject

Single- and multiple-dose pharmacokinetics of ethambutol and rifampicin in a tuberculosis patient with acute respiratory distress syndrome undergoing extended daily dialysis and ECMO treatment

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ethambutol DihydrochlorideThis paper reflects the scientific opinion of the authors and not the policies of regulating agencies.A project of the International Pharmaceutical Federation FIP, Groupe BCS, http://www.fip.org/bcs.

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Zur Pharmakokinetik von Ethambutol bei Gesunden und Patienten mit terminaler Niereninsuffizienz

Cited by 17 publications

References 0 publications

Kinetics of oral ethambutol in the normal subject

Kinetics of oral ethambutol in the normal subject

Single- and multiple-dose pharmacokinetics of ethambutol and rifampicin in a tuberculosis patient with acute respiratory distress syndrome undergoing extended daily dialysis and ECMO treatment

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ethambutol Dihydrochloride**This paper reflects the scientific opinion of the authors and not the policies of regulating agencies.**A project of the International Pharmaceutical Federation FIP, Groupe BCS, http://www.fip.org/bcs.

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Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ethambutol DihydrochlorideThis paper reflects the scientific opinion of the authors and not the policies of regulating agencies.A project of the International Pharmaceutical Federation FIP, Groupe BCS, http://www.fip.org/bcs.