{"id":30001,"date":"2016-06-01T09:06:51","date_gmt":"2016-06-01T09:06:51","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=30001"},"modified":"2016-06-07T15:37:42","modified_gmt":"2016-06-07T15:37:42","slug":"paediatric-labeling-expanded-and-additional-tablet-strengths-for-ftctdf","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/30001","title":{"rendered":"Paediatric labeling expanded, and additional tablet strengths for FTC\/TDF"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>The combined formulation of emtricitabine\/tenofovir disoproxil fumerate (FTC\/TDF) tablet label was recently updated to expand the indication to include paediatric patients weighing at least 17 kilograms.<\/strong><\/p>\n<p>New strength tablets are available: 100\/150 mg, 133\/200 mg and 167\/250 mg.<\/p>\n<p>A summary of the changes is included below but please see prescribing information for full details.<\/p>\n<h2>Recommended dose<\/h2>\n<p>The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet, is one low strength FTC\/TDF tablet (167 mg\/250 mg, 133 mg\/200 mg, or 100 mg\/150 mg based on body weight) taken orally once daily with or without food.<\/p>\n<p>The recommended oral dosage of TRUVADA low strength tablets is presented in Table 1. Weight should be monitored periodically and the dose adjusted accordingly.<\/p>\n<table>\n<caption>Table 1. Dosing for paediatric patients weighing 17 kg to less than 35 kg using FTC\/TDF low strength tablets<\/caption>\n<tbody>\n<tr>\n<th scope=\"col\">Body weight (kg)<\/th>\n<th scope=\"col\">Dosing of FTC (mg)\/TDF (mg)<\/th>\n<\/tr>\n<tr>\n<td>17 to less than 22<\/td>\n<td>one 100\/150 tablet once daily<\/td>\n<\/tr>\n<tr>\n<td>22 to less than 28<\/td>\n<td>one 133\/200 tablet once daily<\/td>\n<\/tr>\n<tr>\n<td>28 to less than 35<\/td>\n<td>one 167\/250 tablet once daily<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Dose forms and strengths<\/h2>\n<p>TRUVADA tablets are available in three new dose strengths:<\/p>\n<ul>\n<li>Tablet: 100 mg of FTC and 150 mg of TDF (equivalent to 123 mg of tenofovir disoproxil): blue, oval-shaped, film-coated, debossed with &#8220;GSI&#8221; on one side and with &#8220;703&#8221; on the other side.<\/li>\n<li>Tablet: 133 mg of FTC and 200 mg of TDF (equivalent to 163 mg of tenofovir disoproxil): blue, rectangular-shaped, film-coated, debossed with &#8220;GSI&#8221; on one side and with &#8220;704&#8221; on the other side.<\/li>\n<li>Tablet: 167 mg of FTC and 250 mg of TDF (equivalent to 204 mg of tenofovir disoproxil): blue, modified capsule-shaped, film-coated, debossed with &#8220;GSI&#8221; on one side and with &#8220;705&#8221; on the other side.<\/li>\n<\/ul>\n<p>Reference:<\/p>\n<p>Truvada (emtricitabine\/tenofovir disoproxil fumarate) pediatric labeling expanded, &amp; additional tablet strengths added.<br \/>\n<a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/021752s047lbl.pdf\">http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/021752s047lbl.pdf<\/a>\u00a0(PDF)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base The combined formulation of emtricitabine\/tenofovir disoproxil fumerate (FTC\/TDF) tablet label was recently updated to expand the indication to include paediatric patients weighing at least 17 kilograms. New strength tablets are available: 100\/150 mg, 133\/200 mg and &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-30001","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30001","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=30001"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30001\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=30001"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=30001"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=30001"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}