Prostaglandin E1


Article Author:
Melanie Hew


Article Editor:
Valerie Gerriets


Editors In Chief:
David Wood
Andrew Wilt
Hajira Basit


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Heba Mahdy
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Abbey Smiley
Sarosh Vaqar
Mark Pellegrini
James Hughes
Beenish Sohail
Hajira Basit
Phillip Hynes
Sandeep Sekhon


Updated:
10/15/2019 2:09:15 PM

Indications

Prostaglandin E1 (PGE1) is an endogenous prostaglandin used as a medication. Its synthetic form, alprostadil, is a vasodilator and smooth muscle relaxant used for several different medical purposes.[1]

  • Labeled indications
    • Temporary patency of ductus arteriosus in ductal-dependent congenital heart disease obstructing pulmonary circulation in neonates. The patent ductus arteriosus allows the neonate to adequately oxygenated blood.[2]
    • Diagnosis and second-line treatment of erectile dysfunction due to vascular, psychological, or neurological etiologies.[3]
  • Off-label indications
    • Treatment of Raynaud phenomenon due to systemic sclerosis after standard oral therapies such as calcium-channel blockers and phosphodiesterase (PDE-5) inhibitors have proven insufficient. However, some studies indicate alprostadil has the same efficacy as a placebo.[4]
    • Prevention of contrast-induced nephropathy.[5]
    • Treatment for stenosis of the lumbar spinal canal.[6]

Mechanism of Action

In the treatment of erectile dysfunction, prostaglandin E1 (PGE1) works by increasing cAMP production and thus reduces the influx of calcium within the penile vascular smooth muscle. The result is a relaxation of trabecular smooth muscle by arterial dilation. Blood becomes entrapped in the penis that eventually leads to an erection. PGE1 can also serve as a treatment for maintaining the patency of ductus arteriosus heart defects in neonates by a similar mechanism. PGE1 dilates the ductus smooth muscle so that it remains open and blood flow may be maintained. Ductal patency allows for oxygenated blood flow until the congenital anomaly can be surgically corrected.[3]

Administration

For erectile dysfunction (adult administration):

Prostaglandin E1 (PGE1) can be administered via intracavernous or intraurethral routes. Dosages for individual persons require titration to achieve the most efficacious results.

Intracavernous administration involves injection directly into the penis using a 27- to 30-gauge 1/2-inch needle syringe. Strong recommendations are that a healthcare professional administers the first dose; afterward, self-administration is permissible. After sterilization of the injection site, the penis should be held firmly away from the body in preparation for injection. The injection should be given perpendicular to the base of the penis, avoiding any visible veins. Repeated administrations should be on alternate sides of the penis. Pressure should be applied to the injection site to cease bleeding if any. Studies have shown that efficacy is dose-dependent.[7]

When utilizing MUSE (Medicated System for Erection) via the intraurethral route, the pellet must be inserted immediately following urination. The applicator stem will get inserted into the urethra to deposit the medicinal pellet. To deposit the pellet, a user would press the button at the top of the applicator. Following administration, the user removes the applicator. A study on the drug’s efficacy indicated that an increase in dosage (ranging between the lowest effective dose of 125 mcg and a maximum of 1000 mcg) also increased the maximum response. For this reason, the recommended initial starting dose is 500 mcg. There are no reported instances of an increase in adverse effects with increasing dosage.[8][9]

For ductus arteriosus (pediatric administration):

PGE1 administration for pediatric patients is via continuous IV infusion through a vein or at the site of the ductal opening using a catheter placed in the umbilical artery. The typical concentration of the infusion is 10 to 20 mcg/mL.  Initial dosing requires titration by micrograms per kilogram of body weight per minute.[10]

Adverse Effects

Prostaglandin E1 (PGE1) is used as a second-line treatment for erectile dysfunction when oral therapies are not the most effective option. Overall, it is both safe and effective. The side effects are listed below by route of administration.[11]

Following intracavernosal injection:

Penile pain (greater than 10%), hypertension, dizziness, headache, penile disease, penile rash or swelling, Peyronie disease (1 to 10%), erection lasting more than four hours (4%), localized injection site bruising or hematoma (less than 1%), balanitis, hemorrhage at the site of injection, priapism (0.4%).

Following intraurethral injection:

Penile pain, urethral burning (greater than 10%), dizziness, headache, central nervous system-related pain, testicular pain, minor urethral bleeding, vulvovaginal pruritus in female partners (2 to 10%), leg pain, perineal pain, tachycardia (less than 2%). 

Following intravenous injection:

Flushing, apnea, fever (greater than 10%), bradycardia/tachycardia, cardiac episode, edema, hypertension/hypotension, seizure, headache, dizziness, hypokalemia, diarrhea, disseminated intravascular coagulation (DIC), sepsis, local pain not at injection site, back pain, upper respiratory tract infection, flu-like symptoms, cough, congestion, sinusitis (1-10%), anemia, bradypnea, cardiac failure, gastroesophageal reflux disease (GERD), hemorrhage (cerebral hemorrhage), hyperbilirubinemia, stiffness, shock, lethargy, jitteriness, hyperemia, irritability, hyperkalemia, thrombocytopenia, hypoglycemia, neck hyperextension, hypothermia, peritonitis, second degree atrioventricular block, supraventricular tachycardia, ventricular fibrillation, hematuria or anuria, bronchial wheezing (less than 1%). 

U.S. Boxed Warnings:

With the use of pediatric IV formulation, infants born with congenital heart defects and weighing less than two kilograms at birth may experience apnea. Symptoms are most likely to be seen within an hour of the initial infusion. The recommendation is that infants who meet these criteria receive careful monitoring and treatment where emergency respiratory assistance can are readily available for rapid deployment.[12]  

Other concerns:

  • Hypotension/syncope
  • Penile fibrosis
  • Priapism/prolonged erection
  • Cardiovascular disease

Contraindications

For intracavernosal injection:

Documented hypersensitivity to the drug or any of its ingredients, predisposing conditions related to priapism or penile deformities, and penile implants.

For intraurethral injection:

Documented hypersensitivity to the drug or any of its ingredients, urethral deformities, urethritis, predisposing hematological conditions such as thrombosis or hyper-viscosity syndrome that could cause priapism, warning against sexual activity, sexual intercourse with a pregnant woman without using a condom.

For intravenous injection:

None listed.

Monitoring

When starting prostaglandin E1 (PGE1) as well as during treatment with PGE1, vital signs such as blood pressure, heart rate, temperature, and respirations should be monitored in addition to signs of penile pain or fibrosis, infection, effectiveness after dosing, and duration of an erection.

Toxicity

Phosphodiesterase 5 inhibitors in combination with prostaglandin E1 (PGE1) may enhance the toxic effects of PGE1. Two common side effects of taking PGE1 are prolonged erection or priapism, both of which require emergent treatment. There are dosage forms that contain benzyl alcohol, which can potentially cause fatal toxicity in infants known as “gasping syndrome” when introduced in high amounts.

Enhancing Healthcare Team Outcomes

Use of prostaglandin E1 (PGE1) for erectile dysfunction and its side effects requires thorough discussion with patients. There are relatively common pre-existing conditions such as cardiovascular disease that are contraindicated or cautioned with PGE1, and the healthcare team should be aware of all up-to-date information about PGE1 to prescribe the medication to the appropriate patient population. While some brands of PGE1 used for erectile dysfunction can be self-administered, the first dose should be administered by a healthcare professional. In particular, patient education about intracavernosal injection requires an interprofessional team of healthcare providers, including physicians, nurses, and pharmacists. Additionally, physicians and pharmacists need to discuss their patient's sexual health before prescribing sexual performance-enhancing medications. Finally, because dosing may require titration, the healthcare team may need to adjust the dose repeatedly to obtain the most effective dose. Though the efficacy appears to be dose-dependent, the recommended maximum dosages should not be surpassed. Nursing can play a vital role in monitoring patient compliance, administration technique, and watching for adverse events. The pharmacist should also perform complete medication reconciliation and report back to the rest of the healthcare team

For pediatric patients, the use of PGE1 for congenital heart defects comes with a U.S. Boxed Warning. Neonates receiving this medication should be monitored closely by an interdisciplinary healthcare team, as symptoms are not always immediately apparent. Neonatal nursing is crucial in the administration and monitoring of these patients and will alert the treating physician promptly regarding any concerns.

In summary, PGE-1 therapy requires an interprofessional team approach, including physicians, specialists, specialty-trained nurses, and pharmacists, all collaborating across disciplines to achieve optimal patient results. [Level V]


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Prostaglandin E1 - Questions

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An underweight, cyanotic newborn requires emergency prostaglandin infusion following premature birth. All vitals are within normal limits except for O2 saturation, which is 75% while on supportive oxygen. A chest X-ray shows clear bilateral lung fields. No heart murmur is detected on auscultation. For which respiratory complication is this infant most at risk?



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A 65-year-old man with a history significant for a spinal cord injury six years ago is taking a medication for erectile dysfunction that is administered via intracavernosal injection. Prior to injection, all vitals are within normal limits. Physical exam yields no significant findings. Prior to receiving the injectable medication, the patient was previously taking sildenafil for erectile dysfunction, which proved insufficient. Which of the following effects is associated with the medication most likely given to this patient?



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A newborn infant becomes cyanotic soon after delivery and remains cyanotic despite being given increased oxygen support. There is no audible murmur detected on auscultation. Breath sounds are clear and equal bilaterally. While on a fraction of inspired oxygen of 1.0, an arterial blood gas reveals a partial pressure of oxygen of 24 mmHg. What medication should be initiated immediately to alleviate the newborn's symptoms?



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A 65-year-old man is seeking the injectable medication alprostadil for erectile dysfunction after his experience with sildenafil caused an emergent case of priapism a few months ago. The patient’s past medical history is significant for a spinal cord injury for which he is receiving physical therapy, diabetes mellitus, and gout. He has been a pack-per-day smoker for over twenty years. His blood pressure is 150/95 mmHg, heart rate is 106 beats per minute, respirations are 12 per minute, the temperature is 37 C, and oxygen saturation is 98% on room air. Which of the following details in the patient’s medical history contraindicates treatment with alprostadil?



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A 65-year-old man is taking medication for erectile dysfunction. He was previously taking sildenafil citrate for the treatment of his condition, but he was not satisfied with the results. His clinician recommended a medication that would be administered via the intraurethral route. The patient is otherwise healthy, with nothing in his medical history that would contraindicate the use of this medication. The clinician warns the patient that a side effect of this medication is vulvovaginal pruritus in female partners and condoms should be worn during sexual activity. What is the mechanism of action of this medication?



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Prostaglandin E1 - References

References

Kirtland SJ, Prostaglandin E1: a review. Prostaglandins, leukotrienes, and essential fatty acids. 1988;     [PubMed]
Singh Y,Mikrou P, Use of prostaglandins in duct-dependent congenital heart conditions. Archives of disease in childhood. Education and practice edition. 2018 Jun;     [PubMed]
Hanchanale V,Eardley I, Alprostadil for the treatment of impotence. Expert opinion on pharmacotherapy. 2014 Feb;     [PubMed]
Mohrland JS,Porter JM,Smith EA,Belch J,Simms MH, A multiclinic, placebo-controlled, double-blind study of prostaglandin E1 in Raynaud's syndrome. Annals of the rheumatic diseases. 1985 Nov;     [PubMed]
Kumar A,Shariff M,Doshi R, Alprostadil and Contrast-Induced Nephropathy. Angiology. 2019 Jul 22;     [PubMed]
Yoshihara H, Prostaglandin E1 Treatment for Lumbar Spinal Canal Stenosis: Review of the Literature. Pain practice : the official journal of World Institute of Pain. 2016 Feb;     [PubMed]
Linet OI,Ogrinc FG, Efficacy and safety of intracavernosal alprostadil in men with erectile dysfunction. The Alprostadil Study Group. The New England journal of medicine. 1996 Apr 4;     [PubMed]
Costa P,Potempa AJ, Intraurethral alprostadil for erectile dysfunction: a review of the literature. Drugs. 2012 Dec 3;     [PubMed]
Padma-Nathan H,Hellstrom WJ,Kaiser FE,Labasky RF,Lue TF,Nolten WE,Norwood PC,Peterson CA,Shabsigh R,Tam PY,Place VA,Gesundheit N, Treatment of men with erectile dysfunction with transurethral alprostadil. Medicated Urethral System for Erection (MUSE) Study Group. The New England journal of medicine. 1997 Jan 2;     [PubMed]
Roehl SL,Townsend RJ, Alprostadil (Prostin VR Pediatric Sterile Solution, The Upjohn Company). Drug intelligence     [PubMed]
Costabile RA,Mammen T,Hwang K, An overview and expert opinion on the use of alprostadil in the treatment of sexual dysfunction. Expert opinion on pharmacotherapy. 2008 Jun;     [PubMed]
Hopkins SJ, Pharmacology: Prostin VR. Nursing mirror. 1982 Aug 4;     [PubMed]

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