{"id":546,"date":"2008-08-30T16:55:00","date_gmt":"2008-08-30T15:55:00","guid":{"rendered":"http:\/\/localhost\/new\/htb\/?p=546"},"modified":"2013-08-27T16:13:24","modified_gmt":"2013-08-27T16:13:24","slug":"us-label-changes-for-nevirapine-paediatric-solution","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/546","title":{"rendered":"US label changes for nevirapine paediatric solution"},"content":{"rendered":"<p><strong>On 24 June 2008, FDA approved labeling changes to the Viramune (nevirapine) oral solution and tablets to reflect various updates, including:<\/strong><\/p>\n<ul>\n<li>Dosing recommendations for paediatric patients 15 days to 2 months of age.<\/li>\n<li>Dose recommendations for all pediatric age groups are now based on body surface area (BSA) instead of weight-based dosing. Studies were conducted comparing weight-based dosing and BSA-based dosing. While comparable drug concentrations are achieved with either method, BSA dosing allows for smoother dose transitions between pediatric age groups and is therefore preferred.<\/li>\n<li>Addition of data from a pharmacokinetic hepatic impairment study<\/li>\n<li>Revision of the recommendation that nevirapine not be administered to patients with severe hepatic impairment to a recommendation that nevirapine not be administered to patients with moderate (Childs Pugh B) or severe (Childs Pugh C) hepatic impairment.<\/li>\n<li>Revision of recommendations for the occurrence of rash during the once daily lead-in phase of dosing. The label now states that lead-in dosing should not be extended beyond 28 days of dosing.<\/li>\n<\/ul>\n<p>Source: FDA list serve (27 June 2008).<br \/>\n<a href=\"http:\/\/www.fda.gov\/oashi\/aids\/listserve\/listserve2008.html#62708\">http:\/\/www.fda.gov\/oashi\/aids\/listserve\/listserve2008.html#62708<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 24 June 2008, FDA approved labeling changes to the Viramune (nevirapine) oral solution and tablets to reflect various updates, including: Dosing recommendations for paediatric patients 15 days to 2 months of age. Dose recommendations for all pediatric age groups &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-546","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/546","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=546"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/546\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=546"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=546"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=546"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}