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Label Changes for:

Kaletra (lopinavir/ritonavir) capsules, tablets, and oral solution

April 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) – April 2010

CONTRAINDICATIONS

Table 10 (Capsules) : Drugs That Are Contraindicated With Kaletra (Table 3- Tablets and Oral Solution)
  • Alpha 1-adrenoreceptor antagonist- alfuzosin: Potential for serious and/or life-threatening reactions such as hypotension.
  • PDE5 Inhibitors: Sildenafil for treatment of pulmonary arterial hypertension; A safe and effective dose for the treatment of pulmonary arterial hypertension has not been established with Kaletra. There is an increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

PRECAUTIONS- DRUG INTERACTIONS

Table 11 (Capsules) and Table 9(Tablets and Oral Solution): Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
  • Inhaled beta agonist-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. 
  • Endothelin receptor antagonists-Bosentan: new dosing recommendations for bosentan when prescribed with Kaletra.
  • PDE5 inhibitors: Use of PDE5 inhibitors for pulmonary arterial hypertension (PAH): Use of Revatio, (sildenafil) for the treatment of pulmonary hypertension dosing recommendations in table.
  • Colchicine (Antigout): Patients with renal or hepatic impairment should not be given colchicine with Kaletra. Addition of new dosing recommendations for colchicine when prescribed for the prophylaxis of gout and for for the treatment of familial Mediterranean fever or gout.
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