{"id":1765,"date":"2008-02-01T08:51:36","date_gmt":"2008-02-01T07:51:36","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=1765"},"modified":"2013-08-30T11:22:44","modified_gmt":"2013-08-30T11:22:44","slug":"changes-to-atazanavir-product-label-in-us","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/1765","title":{"rendered":"Changes to atazanavir product label in US"},"content":{"rendered":"<p><strong>The US atazanavir (Reyataz) package insert was revised to include information regarding the administration of atazanavir and\/or atazanavir\/ritonavir with food, proton pump inhibitors, H2 receptor antagonists, acetaminophen, and fluconazole. Additionally, dosing information in patients with renal impairment was included.<\/strong><\/p>\n<p>Major changes include:<\/p>\n<ul>\n<li>Drug Interaction Table 11<\/li>\n<\/ul>\n<p>For therapy-naive patients<\/p>\n<ul>\n<li>H2-receptor antagonist: The H2-receptor antagonist dose should not exceed a 40 mg dose equivalent of famotidine twice daily. Reyataz 300 mg and ritonavir 100 mg should be administered simultaneously with, and\/or at least 10 hours after, the dose of the H2-receptor antagonist.<\/li>\n<li>proton-pump inhibitors: The proton-pump inhibitor dose should not exceed a 20 mg dose equivalent of omeprazole and must be taken approximately 12 hours prior to the Reyataz 300 mg and ritonavir 100 mg dose.<\/li>\n<\/ul>\n<p>For therapy-experienced patients<\/p>\n<ul>\n<li>Whenever an H2-receptor antagonist is given to a patient receiving Reyataz with ritonavir, the H2-receptor antagonist dose should not exceed a dose equivalent to famotidine 20 mg twice daily, and the Reyataz and ritonavir doses should be administered simultaneously with, and\/or at least 10 hours after, the dose of the H2-receptor antagonist.<\/li>\n<li>Reyataz 300 mg (one 300-mg capsule or two 150-mg capsules) with ritonavir 100 mg once daily (all as a single dose with food) if taken with an H2-receptor antagonist.<\/li>\n<li>Reyataz 400 mg (two 200-mg capsules) with ritonavir 100 mg once daily (all as a single dose with food) if taken with both tenofovir and an H2-receptor antagonist.<\/li>\n<li>Proton-pump inhibitors should not be used in treatment-experienced patients receiving Reyataz.<\/li>\n<li>The Dosage and Administration section was updated to provide dosing information in patients with renal impairment as follows:<\/li>\n<\/ul>\n<p>For patients with renal impairment, including those with severe renal impairment who are not managed with hemodialysis, no dose adjustment is required for Reyataz. Treatment-naive patients with end stage renal disease managed with hemodialysis should receive Reyataz 300 mg with ritonavir 100 mg. Reyataz should not be administered to HIV-treatment experienced patients with end stage renal disease managed with hemodialysis.<\/p>\n<p>No dose adjustments are needed when Reyataz is co-administered with acetaminophen or fluconazole.<\/p>\n<ul>\n<li>The Clinical Pharmacology section was updated to include the following information:<\/li>\n<li>results of a food effect study with Reyataz 300 mg with ritonavir 100 mg with a light meal and high fat meal (see Clinical Pharmacology: Food Effect).<\/li>\n<li>results of a study in adult subjects with severe renal impairment, including those on hemodialysis is presented (see Clinical Pharmacology: Special Populations: Impaired Renal Function).<\/li>\n<li>results of drug-drug interaction studies with acetaminophen famotidine, fluconazole, and omperazole (See Clinical Pharmacology: Table 4: Drug Interactions: Pharmacokinetic Parameters for Atazanavir in the Presence of C administered Drugs and Table 5: Drug Interactions: Pharmacokinetic Parameters for Coadministered Drugs in the Presence of Reyataz.<\/li>\n<\/ul>\n<p><a href=\"http:\/\/www.fda.gov\/cder\/foi\/label\/2007\/021567s014lbl.pdf\">http:\/\/www.fda.gov\/cder\/foi\/label\/2007\/021567s014lbl.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The US atazanavir (Reyataz) package insert was revised to include information regarding the administration of atazanavir and\/or atazanavir\/ritonavir with food, proton pump inhibitors, H2 receptor antagonists, acetaminophen, and fluconazole. Additionally, dosing information in patients with renal impairment was included. Major &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-1765","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/1765","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=1765"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/1765\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=1765"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=1765"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=1765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}