Universidad Peruana Cayetano Heredia

Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis

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dc.contributor.author Ravis, William R.
dc.contributor.author Llanos Cuentas, Elmer Alejandro
dc.contributor.author Sosa, Nestor
dc.contributor.author Kreishman-Deitrick, Mara
dc.contributor.author Kopydlowski, Karen M.
dc.contributor.author Nielsen, Carl
dc.contributor.author Smith, Kristen S.
dc.contributor.author Smith, Philip L.
dc.contributor.author Ransom, Janet H.
dc.contributor.author Lin, Yuh-Jing
dc.contributor.author Grogl, Max
dc.date.accessioned 2022-01-04T20:29:54Z
dc.date.available 2022-01-04T20:29:54Z
dc.date.issued 2013
dc.identifier.uri https://hdl.handle.net/20.500.12866/10376
dc.description.abstract This study evaluated the pharmacokinetics of topical creams containing 15% paromomycin (“paromomycin alone”) and 15% paromomycin plus 0.5% gentamicin (WR 279,396) in patients with cutaneous leishmaniasis. The investigational creams were applied topically to all lesions once daily for 20 days. Plasma samples were analyzed for simultaneous quantitation of paromomycin and gentamicin isomers and total gentamicin. Pharmacokinetic parameters for gentamicin could not be calculated because detectable levels were rarely evident. After one application, the paromomycin area under the concentration-time curve from 0 to 24 h (AUC0–24) was 2,180 ± 2,621 ng · h/ml (mean ± standard deviation [SD]) for the paromomycin-alone group and 975.6 ± 1,078 ng · h/ml for the WR 279,396 group. After 20 days of application, the paromomycin AUC0–24 and maximum concentration of drug (Cmax) were 5 to 6 times greater than those on day 1 for both treatment groups. For the paromomycin-alone group, the AUC0–24 was 8,575 ± 7,268 ng · h/ml and the Cmax was 1,000 ± 750 ng/ml, compared with 6,037 ± 3,956 ng · h/ml and 660 ± 486 ng/ml for the WR 279,396 group, respectively. Possibly due to large intersubject variability, no differences (P ≥ 0.05) in the AUC0–24 or Cmax were noted between treatment or between sites on day 1 or 20. The percentage of dose absorbed on day 20 was 12.0% ± 6.26% and 9.68% ± 6.05% for paromomycin alone and WR 279,396, respectively. Paromomycin concentrations in plasma after 20 days of application were 5 to 9% of those after intramuscular administration of 15 mg/kg of body weight/day to adults for the systemic treatment of visceral leishmaniasis. Effective topical treatment of cutaneous leishmaniasis appears to be possible with limited paromomycin and gentamicin systemic absorption, thus avoiding drug accumulation and toxicity. (The work described here has been registered at ClinicalTrials.gov under registration no. NCT01032382 and NCT01083576.) en_US
dc.language.iso eng
dc.publisher American Society for Microbiology
dc.relation.ispartofseries Antimicrobial Agents and Chemotherapy
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject human en_US
dc.subject controlled study en_US
dc.subject area under the curve en_US
dc.subject maximum plasma concentration en_US
dc.subject randomized controlled trial en_US
dc.subject double blind procedure en_US
dc.subject Leishmaniasis, Cutaneous en_US
dc.subject skin leishmaniasis en_US
dc.subject gentamicin en_US
dc.subject isomer en_US
dc.subject cream en_US
dc.subject drug absorption en_US
dc.subject drug accumulation en_US
dc.subject Gentamicins en_US
dc.subject paromomycin en_US
dc.subject Paromomycin en_US
dc.subject plasma en_US
dc.subject time to maximum plasma concentration en_US
dc.title Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1128/AAC.00628-13
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.21
dc.relation.issn 1098-6596


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