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U.S. Department of Health and Human Services

Safety

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Aptivus (tipranavir) capsules

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

 

Summary View

 

CONTRAINDICATIONS

Table 1 Drugs that are Contraindicated with Aptivus Co-Administered with Ritonavir
  • Alpha 1-adrenoreceptor antagonist- alfuzosin: Potentially increased alfuzosin concentrations can result in 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 Aptivus/ritonavir. There is an increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

PRECAUTIONS- DRUG INTERACTIONS

Table 4 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 Salmeterol/ritonavir 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 Aptivus/ritonavir.
  • 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 Aptivus/ritonavir. 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.