Label Changes for:

Kaletra (lopinavir/ritonavir) oral solution and tablets

January 2010

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010

CONTRAINDICATIONS

  • Table 3 Updated with PDE5 enzyme inhibitor/ Sildenafil (Revatio) when used for the treatment of pulmonary arterial hypertension
    • 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 erection, and syncope

DRUG INTERACTIONS

  • Table 9 was revised to include the information on salmeterol: 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.

PATIENT COUNSELING INFORMATION

Patients or parents of patients should be informed of Drug Interactions:
  • If they are receiving sildenafil, tadalafil, or vardenafil they may be at increased risk of associated adverse reactions including hypotension, visual changes, and sustained erection, and should promptly report any symptoms to their doctor
  • 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 cause when taken together. The doctor may choose not to keep someone on Serevent (salmeterol)
  • If they are taking or before they begin using Advair (salmeterol in combination with fluticasone propionate) and Kaletra, they should talk to their doctor about problems these two medicines may cause when taken together. The doctor may choose not to keep someone on Advair (salmeterol in combination with fluticasone propionate).
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