EDEX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for EDEX (EDEX).

How it works

Prostaglandin E1 (alprostadil) acts as a vasodilator and smooth muscle relaxant by binding to prostaglandin E1 receptors, increasing intracellular cAMP levels, which leads to relaxation of the corpus cavernosum and penile arteries, thereby increasing blood flow and inducing erection.

What the body does with it

Metabolism	Primarily metabolized in the lungs via oxidation (15-hydroxydehydrogenase) and reduction (13,14-reductase). Also undergoes beta and omega oxidation. Metabolites are excreted in urine and feces.
Excretion	Renal: approximately 60% (mostly as metabolites); biliary/fecal: approximately 20%; remainder unaccounted for.
Half-life	Terminal elimination half-life is 4-6 hours in patients with normal renal function, prolonged in renal impairment (up to 12 hours or more).
Protein binding	80-94% bound to plasma proteins (primarily albumin).
Volume of Distribution	0.7-1.2 L/kg, indicating distribution into total body water and some tissue binding.
Bioavailability	Intracavernosal: 100% (systemic absorption minimal); oral: not applicable (administered only via intracavernosal injection).
Onset of Action	Intracavernosal injection: 5-20 minutes; peak effect at 10-30 minutes.
Duration of Action	Erection lasting 30-60 minutes depending on dose and individual response; clinical effect can persist up to 2 hours.

Classification & Brands

Dosing & administration

Erectile dysfunction: 10 to 20 mcg intracavernosal injection, with a maximum of 60 mcg per dose; usual frequency is once daily with at least 24 hours between doses. The dose is titrated based on response and tolerability.

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustments are recommended for renal impairment based on GFR, as the drug is locally administered. However, use with caution in severe renal impairment due to limited data.
Liver impairment	No specific dose adjustments are recommended for hepatic impairment based on Child-Pugh score. Use with caution in severe hepatic impairment (Child-Pugh class C) due to potential for altered hemodynamics.
Pediatric use	Not approved for use in pediatric patients; safety and efficacy have not been established. No pediatric dosing guidelines are available.
Geriatric use	No specific dose adjustment is required for elderly patients, but initiate at the lowest effective dose (e.g., 10 mcg) and titrate cautiously due to potential increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for EDEX (EDEX).

Breastfeeding	Unknown if distributed in human milk. Caution advised; no M/P ratio available. Use only if potential benefit justifies risk to infant.
Teratogenic Risk	FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; no adequate human studies. Risk to fetus cannot be ruled out; use only if clearly needed.
Fetal Monitoring	Monitor blood pressure and heart rate due to vasodilatory effects; assess for priapism or prolonged erection.

Warnings & precautions

■ FDA Black Box Warning

Priapism: Prolonged erections (lasting >4 hours) may occur. Patients should be instructed to seek immediate medical attention. In clinical trials, priapism was reported in 4% of patients.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to alprostadil or any component of the formulation","Conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia)","Penile anatomical deformities (e.g., angulation, cavernosal fibrosis, Peyronie's disease)","Penile implants","Concurrent use of anticoagulants (relative contraindication due to increased risk of hematoma)"]

Clinical Precautions

Precautions

["Risk of priapism: Instruct patient to report erections lasting >4 hours.","Penile fibrosis: Use with caution in patients with penile anatomical deformities.","Hypotension: May cause transient hypotension, especially in patients with cardiovascular risk.","Syncope: Episodes of dizziness or fainting have been reported.","Not for use in neonates: EDEX is contraindicated in neonates due to risk of apnea."]

Clinical Tips & Counseling

Drug interactions

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EDEX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for EDEX (EDEX).

How it works

What the body does with it

Metabolism	Primarily metabolized in the lungs via oxidation (15-hydroxydehydrogenase) and reduction (13,14-reductase). Also undergoes beta and omega oxidation. Metabolites are excreted in urine and feces.
Excretion	Renal: approximately 60% (mostly as metabolites); biliary/fecal: approximately 20%; remainder unaccounted for.
Half-life	Terminal elimination half-life is 4-6 hours in patients with normal renal function, prolonged in renal impairment (up to 12 hours or more).
Protein binding	80-94% bound to plasma proteins (primarily albumin).
Volume of Distribution	0.7-1.2 L/kg, indicating distribution into total body water and some tissue binding.
Bioavailability	Intracavernosal: 100% (systemic absorption minimal); oral: not applicable (administered only via intracavernosal injection).
Onset of Action	Intracavernosal injection: 5-20 minutes; peak effect at 10-30 minutes.
Duration of Action	Erection lasting 30-60 minutes depending on dose and individual response; clinical effect can persist up to 2 hours.

Classification & Brands

Dosing & administration

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustments are recommended for renal impairment based on GFR, as the drug is locally administered. However, use with caution in severe renal impairment due to limited data.
Liver impairment	No specific dose adjustments are recommended for hepatic impairment based on Child-Pugh score. Use with caution in severe hepatic impairment (Child-Pugh class C) due to potential for altered hemodynamics.
Pediatric use	Not approved for use in pediatric patients; safety and efficacy have not been established. No pediatric dosing guidelines are available.
Geriatric use	No specific dose adjustment is required for elderly patients, but initiate at the lowest effective dose (e.g., 10 mcg) and titrate cautiously due to potential increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for EDEX (EDEX).

Breastfeeding	Unknown if distributed in human milk. Caution advised; no M/P ratio available. Use only if potential benefit justifies risk to infant.
Teratogenic Risk	FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; no adequate human studies. Risk to fetus cannot be ruled out; use only if clearly needed.
Fetal Monitoring	Monitor blood pressure and heart rate due to vasodilatory effects; assess for priapism or prolonged erection.

Warnings & precautions

■ FDA Black Box Warning

Priapism: Prolonged erections (lasting >4 hours) may occur. Patients should be instructed to seek immediate medical attention. In clinical trials, priapism was reported in 4% of patients.