{"id":306619,"date":"2010-02-11T09:21:29","date_gmt":"2010-02-11T14:21:29","guid":{"rendered":"http:\/\/blogs.jwatch.org\/hiv-id-observations\/?p=718"},"modified":"2010-02-11T09:21:29","modified_gmt":"2010-02-11T14:21:29","slug":"ritonavir-tablet%c2%a0approved","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/306619","title":{"rendered":"Ritonavir Tablet\u00a0Approved"},"content":{"rendered":"

\"norvirIt’s not on Abbott’s web site yet<\/a> (update:\u00a0 now it’s here<\/a>), but the FDA has approved a new formulation of ritonavir — a heat-stable 100 mg tablet.\u00a0 From an e-mail release by the FDA:<\/p>\n

\n

On February 10, 2010, FDA approved Norvir (ritonavir) 100 mg Tablets. These tablets do not require refrigeration.\u00a0 Unlike the capsule formulation [pictured], Norvir tablets must be taken with meals<\/span>.
\n–snip–<\/em>
\nNORVIR tablets are not bioequivalent to NORVIR capsules. Under moderate fat conditions (857 kcal; 31% fat, 13% protein, 56% carbohydrates), when a single 100 mg NORVIR dose was administered as a tablet compared with a capsule, AUC(0- \u221e)<\/sub> met equivalence criteria but mean Cmax <\/sub>was increased by 26% (92.8% confidence intervals: \u219115 -\u219139%).<\/p>\n<\/blockquote>\n

This is obviously an advance — the Norvir soft-gel capsule is much-despised for a variety of reasons, one of the most notable being the glob of melted capsules that results if the medication is left in the car, in a warm room in the summertime, near a radiator, etc.\u00a0 When Kaletra switched from capsule to tablet, the heat-stability was a big improvement in convenience, and also made treatment in resource-limited settings much easier.<\/p>\n

Time will tell if the increase in peak levels has any effect on tolerability, a potential concern since much of ritonavir’s toxicity is dose-related.\u00a0\u00a0 I suspect Abbott will have both formulations available for a while until this is sorted out.<\/p>\n

And for those who still have patients still on 600 mg twice-daily — it’s time to switch to something else!<\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

It’s not on Abbott’s web site yet (update:\u00a0 now it’s here), but the FDA has approved a new formulation of ritonavir — a heat-stable 100 mg tablet.\u00a0 From an e-mail release by the FDA: On February 10, 2010, FDA approved Norvir (ritonavir) 100 mg Tablets. These tablets do not require refrigeration.\u00a0 Unlike the capsule formulation […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-306619","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/306619","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=306619"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/306619\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=306619"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=306619"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=306619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}