Edex Generic Name & Formulations
Legal Class
Rx
General Description
Alprostadil (in alfadex inclusion complex) 10mcg, 20mcg, 40mcg; per cartridge; pwd for intracavernous inj after reconstitution.
Pharmacological Class
Prostaglandin.
How Supplied
2-cartridge pack (w. 1 inj device & supplies)—1; 6-cartridge pack (w. 1 inj device & supplies)—1
Manufacturer
Edex Indications
Indications
Erectile dysfunction.
Edex Dosage and Administration
Adult
Inject over 5–10 seconds into the lateral aspect of the proximal third of the penis, avoid visible veins; rotate injection side and site. Determine optimum dose in office. If no response occurs, may give next higher dose in 1 hour. If response occurs, must wait 24 hours before next dose. Vasculogenic, psychogenic, or mixed etiology: initially 2.5mcg. If partial response to initial dose, may give 2nd dose of 5mcg and then may increase by increments of 5–10mcg until desired response achieved. If no response to initial dose, may give 2nd dose of 7.5mcg and then may increase by increments of 5–10mcg until desired response achieved. Neurogenic etiology: initially 1.25mcg. May give 2nd dose of 2.5mcg, and 3rd dose of 5mcg, and then may increase by increments of 5mcg until desired response achieved. Max: 40mcg and 3 self-injections per week; allow at least 24 hours between doses. Reduce dose if erection lasts over 1 hour.
Children
Not indicated.
Edex Contraindications
Contraindications
Predisposition to priapism. Fibrotic conditions of the penis (eg, cavernosal fibrosis, Peyronie's disease). Penile implants.
Edex Boxed Warnings
Not Applicable
Edex Warnings/Precautions
Warnings/Precautions
Treat priapism immediately. Reevaluate every 3 months. Discontinue if penile fibrosis occurs. Preexisting cardiovascular disease. Renal impairment. Elderly. Pregnancy, nursing mothers: not indicated.
Edex Pharmacokinetics
See Literature
Edex Interactions
Interactions
Concomitant vasoactive agents: not recommended. Caution with concomitant heparin.
Edex Adverse Reactions
Adverse Reactions
Penile pain, priapism, inj site reactions, penile angulation or fibrosis, hypertension, headache, dizziness, upper respiratory infections, others.
Edex Clinical Trials
See Literature
Edex Note
Not Applicable
Edex Patient Counseling
See Literature