alprostadil

FDA Drug Profile — PROSTIN VR PEDIATRIC, Edex

Drug Details

Generic Name
alprostadil
Brand Names
PROSTIN VR PEDIATRIC, Edex
Application Number
NDA018484
Sponsor
Pharmacia & Upjohn Company LLC
NDC Codes
5
Dosage Forms
INJECTION, SOLUTION, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVASCULAR, INTRAVENOUS, INTRACAVERNOUS
Active Ingredients
ALPROSTADIL

Indications and Usage

INDICATIONS AND USAGE edex ® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Warnings

WARNINGS Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. The incidence of priapism (erections greater than 6 hours in duration) was <1% with long-term use for up to 24 months. In the majority of cases, spontaneous detumescence occurred. Pharmacologic intervention and/or aspiration of blood from the corpora was necessary in 1.6% of 311 patients with prolonged erections/priapism. To minimize the chances of prolonged erection or priapism, edex ® should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION ). The patient must be instructed to immediately report to his prescribing physician or, if unavailable, to seek immediate medical assistance for any erection that persists longer than six hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.