Monograph Details
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Urogenital System
> Erectile dysfunction
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EDEX |
| Manufacturer |
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Schwarz Pharma, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Prostaglandin. |
| Generic Name |
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Alprostadil (in alfadex inclusion complex) 10 micrograms, 20 micrograms, 40 micrograms; per cartridge; pwd for intracavernous inj after reconstitution. |
| Indications |
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Erectile dysfunction. |
| Children |
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Not recommended; see Contraindications. |
| Adults |
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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 partial response occurs, must wait 24 hours before next higher dose. Vasculogenic, psychogenic, or mixed etiology: initially 2.5 micrograms. If partial response to initial dose, may give 2nd dose of 5 micrograms and then may increase by increments of 5–10 micrograms until desired response achieved. If no response to initial dose, may give 2nd dose of 7.5 micrograms and then may increase by increments of 5–10 micrograms until desired response achieved. Neurogenic etiology: initially 1.25 micrograms. May give 2nd dose of 2.5 micrograms, and 3rd dose of 5 micrograms, and then may increase by increments of 5 micrograms until desired response achieved. Max: 40 micrograms and 3 self-injections per week; allow at least 24 hours between doses. Reduce dose if erection lasts over 1 hour. |
| Contraindications |
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Predisposition to priapism. Anatomical penile deformation. Penile implants. Patients for whom sexual activity is inadvisable or contraindicated. Women. Children. Newborns. |
| Precautions |
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Treat priapism immediately. Reevaluate every 3 months. Discontinue if penile fibrosis occurs. Renal dysfunction. |
| Interactions |
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Concomitant vasoactive agents: not recommended. Caution with anticoagulants. |
| Adverse Reactions |
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Penile pain, priapism, injection site reactions, penile angulation or fibrosis, hypertension, headache, dizziness, upper respiratory infections, increased risk of blood-borne diseases, others. |
| How Supplied |
2-cartridge pack (w. 1 inj device & supplies)—1
6-cartridge pack (w. 1 inj device & supplies)—1 |
| Additional Resources |
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• Related Prescribing Note |
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