Urinary Excretion of Ephedrine in Man without pH Control following Oral Administration of Three Commercial Ephedrine Sulfate Preparations

Welling, Peter G.; Lee, Kwang P.; Patel, Jayant A.; Walker, Jonathan E.; Wagner, John G.

doi:10.1002/jps.2600601107

Cited by 26 publications

(12 citation statements)

References 6 publications

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“…Pharmacokinetic assessment of data Drug body level data can, in most circumstances, be assigned to either a one-or two-compartment open model (Notari, 1971;Reigelman, Loo & Rowland, 1968;Welling et al, 1971). Pharmacokinetic assessment of the current data was carried out as described in the appendix, using both graphical and computer techniques.…”

Section: Plasma and Urine Collectionsmentioning

confidence: 99%

“…The pharmacokinetics of ephedrine in man have been deduced from urinary measurement made in normal subjects under controlled conditions (Wilkinson & Beckett, 1968a;Welling, Lee, Patel, Walker & Wagner, 1971). A specific assay has been developed (Pickup & Paterson, 1974) in order to monitor plasma levels and study the pharmacokinetics of ephedrine following oral dosing with ephedrine in asthmatic patients.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment.

Pickup¹,

May²,

Ssendagire³

et al. 1976

Brit J Clinical Pharma

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1 Ephedrine plasma levels have been measured in ten asthmatic patients given a singel dose of ephedrine hydrochloride (22 mg) along and in combination with theophylline and a barbiturate. 2 Pharmacokinetic assessment of the data indicated no significant intra‐subject changes in kinetic parameters before or after chronic treatment with ephedrine HCl (11 mg three times a day) alone or in combination. 3 Tolerance to these therapeutic doses, if it occurs, is therefore not disposition‐ related but rather to pharmacodynamic changes.

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Section: Plasma and Urine Collectionsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment.

Pickup¹,

May²,

Ssendagire³

et al. 1976

Brit J Clinical Pharma

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“…Several studies of synthetic ephedrine pharmacokinetics have been reported [16][17][18] and the distribution and elimination of naturally occurring ephedra products, containing ephedrine are similar except for slower absorption rates for the natural product [19,20]. Chiral separation is not carried out in our laboratory making it impossible to determine whether synthetic or naturally occurring ephedrine had been consumed ((þ)-ephedrine or (À)-pseudoephedrine do not occur naturally).…”

Section: Discussionmentioning

confidence: 84%

Demographic, pathologic, and toxicological profiles of 127 decedents testing positive for ephedrine alkaloids

Blechman

Karch

Stephens

2004

Forensic Science International

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“…Ephedrine was found to be moderately metabolised in humans through hepatic N-demethylation and oxidative deamination of the side-chain (Feller and Malspeis, 1977). In humans, 70 to 80 % of the dose was excreted as unchanged ephedrine in urine in 48 hours and this urinary excretion was shown to be pH-dependent (Welling et al, 1971). …”

Section: Discussionmentioning

confidence: 99%

“…The urinary excretion of ephedrine was studied in 3 male adults given three commercial ephedrine sulphate preparations orally (25 mg/person) either as syrup or capsules (Welling et al, 1971); the urine pH was not controlled in this study. There was an insufficient number of subjects to draw conclusions on the differences between dosage forms.…”

Section: Pharmacokinetic Studies Of Pseudoephedrine In Animalsmentioning

confidence: 99%

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2013

EFSA Journal

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The ANS Panel provides a scientific opinion evaluating the safety in use of Ephedra herb and its preparations originating from Ephedra species when used in food, e.g. in food supplements. Ephedra species contain alkaloids of biological relevance: ephedrine, pseudoephedrine, norephedrine, norpseudoephedrine (cathine), methylephedrine and methylpseudoephedrine. They have sympathomimetic activity and some of them are also used as active ingredients in medicinal products for which adverse effects are described. The use of Ephedra herb in food supplements is prohibited in several European countries, however food supplements containing Ephedra herb, also in combination with caffeine, are offered for sale via the internet. The Panel reviewed the available scientific data on a possible association between the intake of Ephedra herb, its preparations or its alkaloids and potential harmful effects on health. There is wide variation in the concentration of the individual ephedra alkaloids in different Ephedra species and in their preparations for use in food. No adequately specified individual preparations of Ephedra herb are known for which sufficient toxicological data for hazard characterisation exist. Due to the absence of adequate data on genotoxicity, short-term, long-term and reproductive and developmental toxicity the Panel could not provide advice on a daily intake of Ephedra herb and its preparations that do not give rise to concerns about harmful effects to health. Ephedra herb and its preparations in food supplements may result in exposure to total ephedra alkaloids or ephedrine which falls within or may exceed the therapeutic dose ranges for the individual ephedra alkaloids or ephedrine, respectively, in medicinal products. Such an exposure could lead to severe adverse effects, which may be enhanced by the combination with caffeine. The Panel concluded that Ephedra herb and its preparations containing ephedra alkaloids used as food supplements were of significant safety concern at the estimated use levels. In particular, EFSA was requested to review the existing scientific data on the possible link between the intake of Ephedra species and harmful effects on health, and to provide advice on a tolerable upper intake level (UL) for Ephedra species for the general population, and as appropriate, for vulnerable subgroups of the population. In the absence of a tolerable upper intake level, EFSA was asked to provide advice on a daily intake of Ephedra species that does not give rise to concerns about harmful effects to health.The risk assessment was performed by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in accordance with the 2009 EFSA Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements.In addressing the Terms of Reference of this request, the ANS Panel noted that the term -tolerable upper intake level‖, was used by EFSA so far only for nutrients, such as vitamins or minerals, to describe the maximum ...

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Urinary Excretion of Ephedrine in Man without pH Control following Oral Administration of Three Commercial Ephedrine Sulfate Preparations

Cited by 26 publications

References 6 publications

The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment.

The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment.

Demographic, pathologic, and toxicological profiles of 127 decedents testing positive for ephedrine alkaloids

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