Alprostadil Approved
for Treatment of Impotence

Alprostadil is a naturally occurring form of the hormone prostaglandin E-1. It usually induces an erection within 5 to 20 minutes after injection into the dorsolateral aspect of the proximal third of the penis by relaxing smooth muscle and dilating the major arteries. In clinical trials, 70% to 80% of patients experienced erections sufficient for sexual intercourse after injection with alprostadil.

Doses should be individualized for each patient and titrated under a physician's supervision. Initial doses must be monitored carefully. The lowest possible effective dose should always be used, and doses exceeding 60 æg are not recommended. Alprostadil should not be administered more than three times a week and no more than once in 24 hours. The first injections must be done in the physician's office by medically trained personnel. Each patient must be instructed and trained in the self-injection procedure and then carefully assessed by the physician before self-injection is attempted outside the medical setting.

Adverse events include mild to moderate pain at the injection site, local formation of excessive fibrous tissue, and priapism. Patients must be instructed to contact their physicians immediately or seek other emergency assistance if an erection persists for more than 6 hours.

Injectable alprostadil should not be used by patients who have sickle cell anemia or trait, multiple myeloma, leukemia, anatomical deformation of the penis, or penile implants. Underlying treatable causes of impotence should be diagnosed and treated before initiating therapy with alprostadil.

For further prescribing information and precautions regarding alprostadil, please refer to the package insert.