{"id":4290,"date":"2001-04-17T21:05:35","date_gmt":"2001-04-17T20:05:35","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=4290"},"modified":"2014-06-12T14:02:16","modified_gmt":"2014-06-12T14:02:16","slug":"european-marketing-approval-granted-for-lopinavirr-kaletra","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/4290","title":{"rendered":"European marketing approval granted for lopinavir\/r (Kaletra)"},"content":{"rendered":"

Abbott Laboratories have announced that it has received approval from the European Agency for the Evaluation of Medicinal Products (EMEA) to market its second-generation protease inhibitor (PI), lopinavir\/ritonavir (lopinavir\/r), previously known as ABT-378\/r, for the treatment of HIV-infection. Lopinavir\/r is to be marketed under the tradename Kaletra\u2122.<\/strong><\/p>\n

The approval of lopinavir\/r was based on extensive clinical data from studies conducted around the world. Phase II and Phase III clinical trials included more than 800 patients from a broad range of patient groups, including those not previously treated with HIV therapy and those who have failed other HIV treatment regimens.<\/p>\n

Lopinavir\/r is a co-formulation of lopinavir (133.3mg) plus ritonavir (33.3mg). At the recommended dosage (400\/100mg twice daily in adults) ritonavir has no antiviral activity, but acts as a pharmacokinetic enhancer – slowing the clearance of lopinavir from the blood. This novel formulation ensures high and sustained levels of lopinavir, which result in effective viral suppression.<\/p>\n

The safety of lopinavir\/r has been investigated in 612 patients in phase II\/III clinical trials.<\/p>\n

The following adverse reactions of moderate to severe intensity with possible or probable relationship to lopinavir\/r have been reported in >2 % of patients: diarrhoea 14 %, nausea 6 %, vomiting 2 %, abdominal pain 2.5 %, asthenia 4 % and headache 3 %.<\/p>\n

Marked clinical laboratory abnormalities (Grade 3 or 4) reported in > 2 % of patients included: increased glucose (2.5 %), increased SGOT\/AST (2 %), increased SGPT\/ALT (2 %) increased GGT (9 %), increased total cholesterol (8.5 %) and increased triglycerides (8 %). Importantly, discontinuations due to study drug were low in both na\u2022ve (2-3%)2, 3 and experienced patients (approximately 3-8%).<\/p>\n

Lopinavir\/r will be available as soft capsules or as an oral solution (400mg lopinavir\/100mg ritonavir per 5 ml).<\/p>\n

The recommended dosage of lopinavir\/r, in adults is 3 capsules twice daily or 5ml oral solution twice daily taken with food. The dosage for children is based on body weight. Lopinavir\/r soft capsules and oral solution should be stored under refrigeration between +2\u00bcC to + 8\u00bcC until they are dispensed to the patient. Refrigeration by the patient is not required if the product is used within 42 days (6 weeks) and stored below 25\u00bcC.<\/p>\n

A fact sheets on lopinavir\/r can be found at:
\nhttp:\/\/www.aidsmeds.com\/drugs\/Kaletra.htm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Abbott Laboratories have announced that it has received approval from the European Agency for the Evaluation of Medicinal Products (EMEA) to market its second-generation protease inhibitor (PI), lopinavir\/ritonavir (lopinavir\/r), previously known as ABT-378\/r, for the treatment of HIV-infection. Lopinavir\/r is …<\/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-4290","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/4290","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=4290"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/4290\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=4290"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=4290"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=4290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}