2016
DOI: 10.1002/jcph.799
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Population Pharmacokinetics of an Intranasally Administered Combination of Oxymetazoline and Tetracaine in Healthy Volunteers

Abstract: The primary objective of the current investigation was to establish the pharmacokinetic characteristics of oxymetazoline and tetracaine's primary metabolite, para-butylaminobenzoic acid (PBBA), after the intranasal administration of oxymetazoline/tetracaine. Thirty-six subjects contributing a total of 1791 plasma concentration results from 2 open-label trials were utilized. Model development was achieved using data from the second trial (N = 24) in which 0.3 mg oxymetazoline/18 mg tetracaine was administered. … Show more

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Cited by 7 publications
(6 citation statements)
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“…We postulate that the absorption from the nasal mucosa may be slowed by the drug's local vasoconstrictor effect on the vasculature of the nasal mucosa. This may reduce systemic absorption and contribute to hemodynamic stability and observed serum concentrations similar to those reported in other studies, despite larger and repeated oxymetazoline dosing and a higher bioavailability with the current pledget administration …”
Section: Discussionsupporting
confidence: 77%
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“…We postulate that the absorption from the nasal mucosa may be slowed by the drug's local vasoconstrictor effect on the vasculature of the nasal mucosa. This may reduce systemic absorption and contribute to hemodynamic stability and observed serum concentrations similar to those reported in other studies, despite larger and repeated oxymetazoline dosing and a higher bioavailability with the current pledget administration …”
Section: Discussionsupporting
confidence: 77%
“…This may reduce systemic absorption and contribute to hemodynamic stability and observed serum concentrations similar to those reported in other studies, despite larger and repeated oxymetazoline dosing and a higher bioavailability with the current pledget administration. 8,13 Although oxymetazoline is readily available as an over-the-counter medication, its hemodynamic profile may be concerning especially when higher than recommended doses are administered. The impetus for this study was the concern of the safety of the drug, given anecdotal reports of cardiovascular collapse.…”
Section: Discussionmentioning
confidence: 99%
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“…Kovanaze se emplea en el dispositivo descartable BD Acusspray [32][33][34][35]37,38 , el cual crea una pulverización al forzar el líquido a través de un atomizador de remolino de presión cuando se acciona la barra que contiene al émbolo 39 (Fig.5). Cada pulverización de 0.2 mL contiene 6 mg de clorhidrato de tetracaína y 0.1mg de clorhidrato de oximetazolina, equivalente a 5.27 mg de tetracaína y 0.08mg de oximetazolina.…”
Section: Dosificación Del Anestésico Intranasalunclassified