FDA核准靜脈注射Sildenafil用於治療肺動脈高壓

作者：Yael Waknine  
出處：WebMD醫學新聞

　　November 23, 2009 —美國食品藥物管理局(FDA)核准靜脈注射型sildenafil(商品名Revatio，Pfizer藥廠)，用於無法口服藥物之肺動脈高壓病患的連續治療。
　　
　　肺動脈高壓是一種罕見、漸進型的疾病，特徵是肺動脈長期高血壓，通常會導致心衰竭和早產兒死亡。暫時無法服用錠劑的病患使用注射型sildenafil可以維持治療，這對改善運動能力和延緩疾病惡化相當重要。
　　
　　注射型sildenafil的建議劑量是10 mg (12.5 mL)，相當於口服劑量20 mg，每天3次、靜脈快速注入；副作用可能包括鼻出血、頭痛、消化不良、潮紅與失眠。


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.