{"id":10212,"date":"2010-04-02T11:57:19","date_gmt":"2010-04-02T11:57:19","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=10212"},"modified":"2013-08-08T12:25:10","modified_gmt":"2013-08-08T12:25:10","slug":"fda-label-change-for-lopinavirr-kaletra","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/10212","title":{"rendered":"FDA label change for lopinavir\/r (Kaletra)"},"content":{"rendered":"<p><strong>On 29 January 2010, the FDA revised\u00a0the Kaletra (lopinavir\/ritonavir) package insert to include drug-drug interaction information with inhaled medicines such as salmeterol or salmeterol in\u00a0combination with fluticasone propionate (Serevent, Advair) and sildenafil (Revatio).<\/strong><\/p>\n<p>Specifically, sildenafil (Revatio) when used for the treatment of pulmonary arterial hypertension is listed under Contraindications (Section 4, Table 3)\u00a0because a safe and effective dose has not been established when used with Kaletra. There is an increased potential for sildenafil-associated adverse\u00a0events, including visual abnormalities, hypotension, prolonged erections and syncope. Additionally, in Section 7 Drug Interactions, Table 9 was revised to\u00a0include this information and differentiate use of PDE5 inhibitors for pulmonary arterial hypertension and for erectile dysfunction<\/p>\n<p>Section 7 Drug Interactions Table 9 was revised to include the following information on salmeterol.\u00a0Concurrent administration of salmeterol and Kaletra is not recommended. The combination may result in increased risk of cardiovascular adverse events\u00a0associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.<\/p>\n<p>Section 17 Patient Counseling Information was revised to state:<br \/>\nIf they are receiving sildenafil, tadalafil, or vardenafil they may be at increased risk of associated adverse reactions including hypotension, visual\u00a0changes, and sustained erection, and should promptly report any symptoms to their doctor<\/p>\n<p>If they are taking or before they begin using Serevent (salmeterol) and Kaletra, they should talk with their doctor about problems these two medicines may\u00a0cause when taken together. The doctor may choose not to keep someone on Serevent (salmeterol)<\/p>\n<p>If they are taking or before they begin using Advair (salmeterol in combination with fluticasone propionate) and Kaletra, they should talk to their doctor\u00a0about problems these two medicines may cause when taken together. The doctor may choose not to keep someone on Advair (salmeterol in combination with\u00a0fluticasone propionate).<\/p>\n<p>The revised label will be posted to the FDA website (Kaletra):<br \/>\n<a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\">http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda<\/a><\/p>\n<p>Source: FDA list serve (29 January 2010)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 29 January 2010, the FDA revised\u00a0the Kaletra (lopinavir\/ritonavir) package insert to include drug-drug interaction information with inhaled medicines such as salmeterol or salmeterol in\u00a0combination with fluticasone propionate (Serevent, Advair) and sildenafil (Revatio). Specifically, sildenafil (Revatio) when used for the &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-10212","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/10212","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=10212"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/10212\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=10212"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=10212"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=10212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}