Kaletra (Lopinavir/Ritonavir) Product Label Updated to Revise Drug-Drug Interactions

Written by AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Service of the U.S. Department of Health and Human Services (DHHS) on February 5, 2010 – 12:00 am -

“On January 29, 2009, FDA approved revisions to the Kaletra (lopinavir/ritonavir) package insert to include drug-drug interaction information for concurrent Kaletra administration with inhaled medicines such as salmeterol or salmeterol in combination with fluticasone propionate (Serevent, Advair) and sildenafil (Revatio).

“Specifically, sildenafil (Revatio) when used for the treatment of pulmonary arterial hypertension is listed under Contraindications … because a safe and effective dose has not been established when used with Kaletra. There is an increased potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erections and syncope. …

“Concurrent administration of salmeterol and Kaletra is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.”

The complete revised labeling will be available at the FDA Web site.

More information is available:


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