alprostadil
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.