Medication Guide App

Label Changes for:

Norvir (ritonavir) capsule and solution

November 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

CONTRAINDICATIONS

Table updated: Drugs that are Contraindicated with Norvir
  • PDE5 enzyme inhibitor: Sildenafil (Revatio) only when used for the treatment of pulmonary arterial hypertension (PAH)

WARNINGS

Drug Interactions
  • See Contraindications- Table 4 for a listing of drugs that are contraindicated with Norvir due to potentially life-threatening adverse events, significant drug interactions, or loss of virologic activity.
  • Also, see Precautions - Table 5 and Table 6 for drugs that should not be co-administered with Norvir and for a listing of drugs with established and other significant drug interactions.

PRECAUTIONS

Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen Recommended Based on Drug Interaction Studies or Predicted Interaction
  • Concomitant use of fluticasone propionate and Norvir. Norvir increases plasma concentrations of fluticasone propionate, resulting in significantly reduced serum cortisol concentrations. Co-administration of fluticasone propionate and Norvir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
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