Kaletra (Lopinavir/Ritonavir) Package Insert Revision Regarding Drug-Drug Interaction Information
January 29, 2010
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 (Section 4, Table 3) 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. Additionally, in Section 7 Drug Interactions, Table 9 was revised to include this information and differentiate use of PDE5 inhibitors for pulmonary arterial hypertension and for erectile dysfunction
Section 7 Drug Interactions Table 9 was revised to include the following information on salmeterol:
Section 17 Patient Counseling Information was revised to state:
Similar changes were made to the Medication Guide.
Kaletra is a product of Abbott Laboratories.
New Kaletra (Lopinavir/Ritonavir) Tablets and Oral Solution Once Daily Dosing Regimen in Certain Adult Patients
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