FDA Approves Intravenous Sildenafil for Pulmonary Arterial Hypertension
By Yael Waknine
Medscape Medical News
November 23, 2009 — The US Food and Drug Administration (FDA) has approved an intravenous formulation of sildenafil (Revatio, Pfizer, Inc) for the continued treatment of patients with pulmonary arterial hypertension who are unable to take oral medication.
Pulmonary arterial hypertension is a rare, progressive disease that is characterized by chronic high blood pressure in the pulmonary arteries, often leading to heart failure and premature death. Use of injectable sildenafil in patients temporarily unable to ingest tablets allows maintenance of therapy, which is important for improving exercise ability and delaying disease progression.
The recommended dose of sildenafil injection is 10 mg (12.5 mL), corresponding to an oral dose of 20 mg, administered as an intravenous bolus 3 times daily. Adverse events may include epistaxis, headache, dyspepsia, flushing, and insomnia.