Alprostadil

Alprostadil injection is used to treat men who have erectile dysfunction (also called sexual impotence). Alprostadil should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Product dosage: 500mcg
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Alprostadil is a synthetic prostaglandin E1 (PGE1) analog, representing a cornerstone in the pharmacological management of erectile dysfunction (ED) and certain critical neonatal and adult cardiovascular conditions. As a potent vasodilator and antiplatelet agent, it functions by directly relaxing smooth muscle tissue in the arteries, increasing blood flow, and inhibiting platelet aggregation. Its clinical utility spans urology, neonatology, and vascular medicine, offering a targeted mechanism of action that bypasses neural pathways, making it effective even in cases of neurogenic impotence or where other therapies have failed. This profile provides a comprehensive, evidence-based overview for healthcare professionals.

Features

• Synthetic analog of prostaglandin E1.
• Available in multiple formulations: intracavernosal injection, intraurethral pellet (medicated urethral system for erection, MUSE), and intravenous infusion.
• Potent vasodilator with direct action on vascular smooth muscle.
• Exhibits antiplatelet aggregation properties.
• Onset of action is formulation-dependent, typically within 5-15 minutes for urological applications.
• Half-life is extremely short (minutes) due to rapid metabolism in the lungs and liver.

Benefits

• Direct Mechanism: Bypasses neurological and hormonal pathways, offering a reliable option for patients with diverse etiologies of ED, including post-prostatectomy, diabetic, and vasculogenic causes.
• High Efficacy Rates: Demonstrated success in facilitating erections sufficient for intercourse in a significant majority of patients who respond to dose titration.
• On-Demand Use: Provides predictable, patient-controlled treatment that is not tied to daily dosing, allowing for spontaneity.
• Treatment for Critical Conditions: As a continuous IV infusion, it maintains patency of the ductus arteriosus in neonates with congenital heart defects until corrective surgery can be performed.
• Alternative for PDE5 Inhibitor Non-Responders: Serves as an effective second-line therapy for patients who cannot use or do not respond to oral phosphodiesterase type 5 inhibitors.

Common use

Alprostadil is primarily indicated for the diagnosis and treatment of erectile dysfunction of vasculogenic, neurogenic, and psychogenic origin. It is a second-line therapy typically employed after or in conjunction with oral agents like sildenafil. In a completely different therapeutic arena, it is used in neonatal intensive care to maintain patency of the ductus arteriosus in neonates with ductal-dependent congenital heart disease, preserving systemic or pulmonary blood flow until surgical intervention is possible. Off-label, it is sometimes used intra-arterially to treat severe peripheral vascular disease and vasculitic ulcers.

Dosage and direction

For Erectile Dysfunction (Injection):

• Treatment must be initiated under medical supervision for proper dose titration and training.
• The initial recommended dose is 2.5 mcg. If the response is inadequate, the dose may be increased in 2.5 mcg increments to a dose of 5 mcg, then 10 mcg, and then 20 mcg.
• The maximum dose is 60 mcg, and dosing should not exceed once daily or more than three times per week.
• Administration: Inject directly into the lateral aspect of the proximal third of the penis, alternating sides and sites to minimize fibrosis.

For Erectile Dysfunction (Intraurethral Pellet, MUSE):

• The initial dose is 125 mcg. If this is ineffective, doses of 250 mcg, 500 mcg, and 1000 mcg may be tried.
• Administration: The pellet is inserted into the urethra using a dedicated applicator. The patient should roll the penis between their hands for 10 seconds to dissolve the pellet and then stand upright for several minutes.

For Neonatal Ductal Patency (IV Infusion):

• Administration is strictly within a hospital setting.
• The initial infusion rate is typically 0.05 to 0.1 mcg/kg/minute. The rate may be increased gradually until the desired therapeutic effect is achieved.
• The maximum recommended dose is 0.4 mcg/kg/minute.
• The solution must be prepared in a specific dilution (e.g., dextrose or saline) and administered via a continuous infusion pump.

Precautions

• Priapism: Patients must be thoroughly counseled on the risk of priapism (an erection lasting more than 4 hours). This is a urological emergency requiring immediate treatment to prevent permanent tissue damage and impotence.
• Penile Fibrosis: Repeated injections can lead to fibrotic nodules or plaques at the injection site. Careful site rotation and adherence to frequency limits are mandatory. Patients should report any penile curvature, pain, or nodules.
• Hypotension: Due to its vasodilatory effects, systemic absorption can cause hypotension, dizziness, and syncope. Patients should remain supine or seated during and immediately after administration of the intraurethral formulation.
• Urethral Bleeding: The intraurethral applicator may cause minor urethral abrasion and bleeding, especially in patients with anatomical abnormalities.
• Sterile Technique: Meticulous aseptic technique is required for intracavernosal injections to prevent infection.

Contraindications

• Known hypersensitivity to alprostadil or any component of the formulation.
• Conditions that predispose patients to priapism, such as sickle cell anemia or trait, leukemia, multiple myeloma, or anatomical penile deformation (e.g., angulation, cavernosal fibrosis, Peyronie’s disease).
• Use in men for whom sexual activity is inadvisable or contraindicated due to underlying cardiovascular disease.
• The intravenous formulation is contraindicated in neonates with respiratory distress syndrome due to the risk of apnea.

Possible side effect

• Very Common (>10%): Penile pain (up to 37% with injection, 32% with MUSE), localized burning or pain in the urethra (MUSE).
• Common (1-10%):
  • Local: Penile erythema, minor urethral bleeding/spotting (MUSE), penile edema, hematoma/ecchymosis at injection site, fibrotic nodules.
  • Systemic: Dizziness, headache, hypotension.
• Uncommon (<1%): Priapism, urinary tract infection, syncope, vasovagal response, penile rash, warmth in the pelvic region.
• IV-specific: Apnea (in neonates), fever, flushing, bradycardia, hyperostosis (with long-term use).

Drug interaction

• Anticoagulants/Antiplatelets (e.g., Warfarin, Clopidogrel, Aspirin): Alprostadil has antiplatelet effects. Concomitant use may theoretically increase the risk of bleeding or bruising, particularly with the intraurethral formulation. Caution is advised.
• Antihypertensives: The vasodilatory effects of alprostadil may be additive with other antihypertensive medications, potentially increasing the risk of symptomatic hypotension.
• Other Agents for Erectile Dysfunction: Concomitant use with PDE5 inhibitors (e.g., sildenafil, tadalafil) is not recommended due to a significantly increased risk of priapism and profound hypotension.

Missed dose

Alprostadil for erectile dysfunction is used on an as-needed basis; the concept of a “missed dose” does not apply. Simply administer it when needed, ensuring adherence to the frequency limits (no more than once daily or three times per week). For the continuous IV infusion in neonates, any interruption must be managed immediately by clinical staff to maintain ductal patency.

Overdose

Symptoms: The primary manifestation of an alprostadil overdose in the urological context is priapism (a prolonged and painful erection). Systemic overdose from urological formulations is rare but could manifest as severe hypotension, dizziness, syncope, tachycardia, or palpitations. In neonates on IV infusion, overdose can cause profound apnea, hypotension, bradycardia, and fever. Management: Priapism is a medical emergency requiring immediate urological intervention, typically with aspiration and irrigation of the corpora cavernosa with a sympathomimetic agent (e.g., phenylephrine). Systemic hypotension should be managed with standard supportive care, including placing the patient in the Trendelenburg position and administering IV fluids. Vasopressors may be required in severe cases. For neonatal IV overdose, the infusion must be stopped immediately and supportive measures for apnea and cardiovascular instability instituted.

Storage

• Store the unopened vials, pellets, and injection kits at controlled room temperature (20°-25°C or 68°-77°F). Some formulations may require refrigeration; always check the manufacturer’s prescribing information.
• Protect from light and moisture.
• Do not freeze.
• Once a multi-dose vial is opened, note the expiration date provided by the manufacturer (often 30 days). Do not use beyond this date.
• Keep all medicines out of the reach of children and pets.

Disclaimer

This information is intended for educational and informational purposes exclusively for qualified healthcare professionals. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or before starting, stopping, or modifying any treatment regimen. Never disregard professional medical advice or delay in seeking it because of something you have read here. The author and publisher are not responsible for any errors or omissions or for any consequences from the application of this information.

Reviews

“Alprostadil intracavernosal injection remains a gold-standard second-line therapy in our andrology clinic. Its efficacy is predictable and independent of neural function, which is invaluable for our post-radical prostatectomy patients. The main challenge is patient education to mitigate injection anxiety and ensure adherence to site rotation to prevent fibrosis.” – Urologist, Male Health Center

“In the NICU, alprostadil is a literal lifeline for neonates with ductal-dependent circulation. It reliably keeps the ductus open, buying us crucial time to stabilize the infant for surgery. Vigilant monitoring for apnea is an absolute necessity, but its benefit overwhelmingly outweighs the risk in this specific population.” – Neonatologist, Tertiary Care Hospital

“While effective, the side effect profile, particularly penile pain, leads to a significant discontinuation rate among my patients. Those who persist through the titration phase, however, often achieve excellent results. It’s a powerful tool, but patient selection and comprehensive counseling are paramount to its successful use.” – Clinical Pharmacist, Sexual Medicine Clinic