Tyramine Pressor Sensitivity During Treatment With the Selegiline Transdermal System 6 mg/24 h in Healthy Subjects

The oral tyramine pressor test was administered to healthy males during treatment with a selegiline transdermal system (STS; 6 mg/24 h). The tyramine sensitivity factor (TSF) was calculated from the ratio of baseline and on‐treatment tyramine pressor doses. The tyramine sensitivity factor value foll...

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Veröffentlicht in:Journal of clinical pharmacology 2006-08, Vol.46 (8), p.933-944
Hauptverfasser: Azzaro, Albert J., VanDenBerg, Chad M., Blob, Lawrence F., Kemper, Eva M., Sharoky, Melvin, Oren, Dan A., Campbell, Bryan J.
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container_end_page 944
container_issue 8
container_start_page 933
container_title Journal of clinical pharmacology
container_volume 46
creator Azzaro, Albert J.
VanDenBerg, Chad M.
Blob, Lawrence F.
Kemper, Eva M.
Sharoky, Melvin
Oren, Dan A.
Campbell, Bryan J.
description The oral tyramine pressor test was administered to healthy males during treatment with a selegiline transdermal system (STS; 6 mg/24 h). The tyramine sensitivity factor (TSF) was calculated from the ratio of baseline and on‐treatment tyramine pressor doses. The tyramine sensitivity factor value following 9 days of treatment with the selegiline transdermal system was 1.85 ± 0.10. Extended treatment, 33 days, produced a small, clinically nonmeaningful increase in this value. The tyramine sensitivity factor for the selegiline transdermal system was similar to that following treatment with 10 mg/d of oral selegiline capsules but more than 20 times less than observed during tranylcypromine treatment. A larger increase in the tyramine sensitivity factor was observed following extended selegiline transdermal system treatment at a higher dose (12 mg/24 h), which was significantly decreased following coadministration of tyramine capsules with a meal. These results suggest a wide tyramine safety margin for the selegiline transdermal system and provide evidence that the 6‐mg/24‐h selegiline transdermal system can be administered safely without dietary tyramine restrictions.
doi_str_mv 10.1177/0091270006289852
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The tyramine sensitivity factor (TSF) was calculated from the ratio of baseline and on‐treatment tyramine pressor doses. The tyramine sensitivity factor value following 9 days of treatment with the selegiline transdermal system was 1.85 ± 0.10. Extended treatment, 33 days, produced a small, clinically nonmeaningful increase in this value. The tyramine sensitivity factor for the selegiline transdermal system was similar to that following treatment with 10 mg/d of oral selegiline capsules but more than 20 times less than observed during tranylcypromine treatment. A larger increase in the tyramine sensitivity factor was observed following extended selegiline transdermal system treatment at a higher dose (12 mg/24 h), which was significantly decreased following coadministration of tyramine capsules with a meal. 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The tyramine sensitivity factor (TSF) was calculated from the ratio of baseline and on‐treatment tyramine pressor doses. The tyramine sensitivity factor value following 9 days of treatment with the selegiline transdermal system was 1.85 ± 0.10. Extended treatment, 33 days, produced a small, clinically nonmeaningful increase in this value. The tyramine sensitivity factor for the selegiline transdermal system was similar to that following treatment with 10 mg/d of oral selegiline capsules but more than 20 times less than observed during tranylcypromine treatment. A larger increase in the tyramine sensitivity factor was observed following extended selegiline transdermal system treatment at a higher dose (12 mg/24 h), which was significantly decreased following coadministration of tyramine capsules with a meal. 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dosage</subject><subject>Monoamine Oxidase Inhibitors - adverse effects</subject><subject>Reference Values</subject><subject>Selegiline</subject><subject>Selegiline - administration &amp; dosage</subject><subject>Selegiline - adverse effects</subject><subject>Testing</subject><subject>Time Factors</subject><subject>transdermal</subject><subject>Transdermal medication</subject><subject>Tranylcypromine - administration &amp; dosage</subject><subject>Tranylcypromine - adverse effects</subject><subject>Tyramine - administration &amp; dosage</subject><subject>Tyramine - adverse effects</subject><subject>tyramine pressor test</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU9v1DAQxSMEokvhzgn5C6QdO_6THKuFdqmqUmkXerTsZLJxm2Qr20vJt8dLVlTigizL8rz5PY-es-wjhTNKlToHqChTACBZWZWCvcoWVAiWcwn8dbY4yPlBP8nehfAAQCUX9G12QmUpBKhykfnN5M3gRiR3HkPYebLGMbjofro4kc9778Yt2Xg0ccAxknsXOxI7TF09bl1_ADfejKFBP5ierKcQcSCSDNtzxklH3EhWaPrYTWS9tw9Yx_A-e9OaPuCH43mafb_8slmu8ptvV1-XFzd5zaWAnFasVqJBw6ixTVG0knFprRGU1sArxRuksmK2bYQ1kGoWWctqaxuuACkvTrOz2XdretRubHfRmzqtBgdX70ZsXapfUF5yJoCrBMAM1H4XgsdWP3k3GD9pCvqQt_4374R8mpGnvR2weQGOAacGPjc87_qIPjz2-2f0uvuTSfKD9DBAzpIllOmWp00hYeKIpRmn_86hr5d3K6mKxOUz59I__PrLGf-ok6yEvr-90nKtriW7pPpH8RtZK6jK</recordid><startdate>200608</startdate><enddate>200608</enddate><creator>Azzaro, Albert J.</creator><creator>VanDenBerg, Chad M.</creator><creator>Blob, Lawrence F.</creator><creator>Kemper, Eva M.</creator><creator>Sharoky, Melvin</creator><creator>Oren, Dan A.</creator><creator>Campbell, Bryan J.</creator><general>Blackwell Publishing Ltd</general><general>SAGE Publications</general><general>Sage Publications, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>200608</creationdate><title>Tyramine Pressor Sensitivity During Treatment With the Selegiline Transdermal System 6 mg/24 h in Healthy Subjects</title><author>Azzaro, Albert J. ; VanDenBerg, Chad M. ; Blob, Lawrence F. ; Kemper, Eva M. ; Sharoky, Melvin ; Oren, Dan A. ; Campbell, Bryan J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4650-192c75dea21abd33f6246bba511c04974de1692bfd5ba01c0be2f2cbbd470e143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Administration, Cutaneous</topic><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Blood Pressure - drug effects</topic><topic>Complications and side effects</topic><topic>Cross-Over Studies</topic><topic>depression</topic><topic>Depression, Mental</topic><topic>Dosage and administration</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug therapy</topic><topic>Food-Drug Interactions</topic><topic>Heart Rate - drug effects</topic><topic>Humans</topic><topic>Hypertension - chemically induced</topic><topic>Hypertension - physiopathology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Monoamine oxidase</topic><topic>monoamine oxidase inhibitor</topic><topic>Monoamine Oxidase Inhibitors - administration &amp; dosage</topic><topic>Monoamine Oxidase Inhibitors - adverse effects</topic><topic>Reference Values</topic><topic>Selegiline</topic><topic>Selegiline - administration &amp; dosage</topic><topic>Selegiline - adverse effects</topic><topic>Testing</topic><topic>Time Factors</topic><topic>transdermal</topic><topic>Transdermal medication</topic><topic>Tranylcypromine - administration &amp; dosage</topic><topic>Tranylcypromine - adverse effects</topic><topic>Tyramine - administration &amp; dosage</topic><topic>Tyramine - adverse effects</topic><topic>tyramine pressor test</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Azzaro, Albert J.</creatorcontrib><creatorcontrib>VanDenBerg, Chad M.</creatorcontrib><creatorcontrib>Blob, Lawrence F.</creatorcontrib><creatorcontrib>Kemper, Eva M.</creatorcontrib><creatorcontrib>Sharoky, Melvin</creatorcontrib><creatorcontrib>Oren, Dan A.</creatorcontrib><creatorcontrib>Campbell, Bryan J.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Azzaro, Albert J.</au><au>VanDenBerg, Chad M.</au><au>Blob, Lawrence F.</au><au>Kemper, Eva M.</au><au>Sharoky, Melvin</au><au>Oren, Dan A.</au><au>Campbell, Bryan J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tyramine Pressor Sensitivity During Treatment With the Selegiline Transdermal System 6 mg/24 h in Healthy Subjects</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>2006-08</date><risdate>2006</risdate><volume>46</volume><issue>8</issue><spage>933</spage><epage>944</epage><pages>933-944</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><abstract>The oral tyramine pressor test was administered to healthy males during treatment with a selegiline transdermal system (STS; 6 mg/24 h). The tyramine sensitivity factor (TSF) was calculated from the ratio of baseline and on‐treatment tyramine pressor doses. The tyramine sensitivity factor value following 9 days of treatment with the selegiline transdermal system was 1.85 ± 0.10. Extended treatment, 33 days, produced a small, clinically nonmeaningful increase in this value. The tyramine sensitivity factor for the selegiline transdermal system was similar to that following treatment with 10 mg/d of oral selegiline capsules but more than 20 times less than observed during tranylcypromine treatment. A larger increase in the tyramine sensitivity factor was observed following extended selegiline transdermal system treatment at a higher dose (12 mg/24 h), which was significantly decreased following coadministration of tyramine capsules with a meal. These results suggest a wide tyramine safety margin for the selegiline transdermal system and provide evidence that the 6‐mg/24‐h selegiline transdermal system can be administered safely without dietary tyramine restrictions.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>16855078</pmid><doi>10.1177/0091270006289852</doi><tpages>12</tpages></addata></record>
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subjects Administration, Cutaneous
Administration, Oral
Adolescent
Adult
Blood Pressure - drug effects
Complications and side effects
Cross-Over Studies
depression
Depression, Mental
Dosage and administration
Dose-Response Relationship, Drug
Drug therapy
Food-Drug Interactions
Heart Rate - drug effects
Humans
Hypertension - chemically induced
Hypertension - physiopathology
Male
Middle Aged
Monoamine oxidase
monoamine oxidase inhibitor
Monoamine Oxidase Inhibitors - administration & dosage
Monoamine Oxidase Inhibitors - adverse effects
Reference Values
Selegiline
Selegiline - administration & dosage
Selegiline - adverse effects
Testing
Time Factors
transdermal
Transdermal medication
Tranylcypromine - administration & dosage
Tranylcypromine - adverse effects
Tyramine - administration & dosage
Tyramine - adverse effects
tyramine pressor test
title Tyramine Pressor Sensitivity During Treatment With the Selegiline Transdermal System 6 mg/24 h in Healthy Subjects
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