Muse

Agents used for Maintaining a Patent Ductus Arteriosus
Other Agents for ED

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
 
Dilution for Intravenous or Intra-arterial Infusion
Dilute 1 mL (500 mcg) of the concentrate in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to an approximate concentration of 2 to 20 mcg/mL.
When using a device with a volumetric infusion chamber, add the proper amount of diluent to the chamber first and then add the concentrate. Avoid direct contact of the concentrate with the wall of the plastic volumetric infusion chamber, which may change the appearance of the chamber and create a hazy solution. If this occurs, replace the solution and volumetric infusion chamber.[30848]
ASHP Recommended Standard Concentrations for Pediatric Continuous Infusions: 5 mcg/mL or 10 mcg/mL.
Maximum concentration should not exceed 20 mcg/mL.
Storage: Store diluted solution at room temperature for up to 24 hours.[30848]

Continuous Intravenous Infusion
Infusion into a large vein is the preferred route of administration.
The infusion rate depends on the concentration of the final solution and the desired dosage.
Periodically monitor IV site; ensure reliable IV access because the duration of effect is short and a significant interruption in therapy could have serious adverse consequences.
Closely monitor respiratory status, cardiovascular status, and temperature during alprostadil administration. Facilities and equipment for assisted ventilation should be readily available.

Intra-arterial Infusion [i.e., umbilical artery catheter (UAC) positioned at the ductal opening]
The infusion rate depends on the concentration of the final solution and the desired dosage.
Ensure reliable UAC access because the duration of alprostadil's effect is short and a significant interruption in therapy could have serious adverse consequences.
Flushing may be the result of an incorrectly positioned intra-arterial catheter; assess catheter placement if flushing occurs.
Closely monitor respiratory status, cardiovascular status, and temperature during alprostadil administration. Facilities and equipment for assisted ventilation should be readily available.[30848] [51814]
 
Intracavernous Administration
Discussion with the patient about expectations of alprostadil therapy is important. Therapy should be initiated under the supervision of a health care provider to test a patient's responsiveness and to demonstrate proper administration technique. Patient education can minimize the likelihood of local adverse effects associated with faulty administration technique.
Patient self-injection should only begin after the patient has received and reviewed a copy of the patient instructions provided by the manufacturer and has been instructed carefully and trained well about proper administration techniques. Follow-up visits with the prescribing health care provider should occur every 3 months or as clinically appropriate to assist the patient in adjusting to alprostadil therapy and assess safety and efficacy of the treatment.
Remind patient not to exceed dose limits. The maximum frequency of use is no more than 1 injection per 24-hour period and no more than 3 injections per week.
 
Reconstitution of CAVERJECT
Refer to the patient information and 'Instructions for Use' in the manufacturer label for complete detailed instructions on reconstitution and needle preparation steps.
Ensure proper vial strength is selected for the dose to be administered (20 or 40 mcg vial).
Reconstitute Caverject vials by adding 1 mL of bacteriostatic water for injection to vial. (NOTE: The syringe/needle should be in a straight line with the Caverject vial when injecting the diluent into the sterile powder vial and when removing the correct dose for injection from the Caverject vial).
After adding the diluent but before removing the syringe from the vial, the contents of the vial should be swirled gently until a clear solution is obtained. Do not use the solution if it is cloudy, colored, or contains particles.
The desired dose can then be withdrawn into the same syringe.
Replace the needle used for reconstitution with a 29 or 30-gauge 1/2 inch needle prior to injection.
Storage: Unused reconstituted solution may be stored for up to 24 hours if stored below 25 degrees C (77 degrees F) and not refrigerated or frozen.[30849]
 
Reconstitution of CAVERJECT IMPULSE
Refer to the patient information and "Instructions for Use' in the manufacturer label for complete detailed instructions on preparing the syringe and injection preparation steps.
Ensure proper Caverject Impulse syringe is selected for the dose to be administered (10 or 20 mcg syringe).
Prepare the injection immediately before use.
Open the sealed plastic tray and remove the syringe, needle assembly, and alcohol swabs. Swab the rubber membrane at the tip of the syringe.
Pick up the needle assembly, grasp the paper tab, and peel off the paper cover. Hold the needle assembly by the cap and press the needle assembly onto the tip of the syringe. Turn it clockwise until the needle assembly is firmly locked into place.
Remove the outer protective cap from the needle by twisting it clockwise. Do not remove the inner protective cap (thin plastic tube covering the needle).
Hold the syringe system with the needle pointing upward. The plunger rod should still be fully extended with all threads visible. Slowly rotate the plunger rod clockwise until it goes all the way in and stops. Do not push on the plunger while trying to rotate it.
Turn the syringe upside down several times to make sure the solution is evenly mixed. The solution should be clear. Do not use if discoloration or particles are present.
Holding the syringe with needle upward, carefully remove the inner protective cap from the needle. Lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. With the syringe pointed upward, push in the plunger rod until it stops to push any air out.
Set the dose by locating the dose window on the syringe and slowly turning the plunger rod clockwise until the correct dose number appears in the center of the window. If the correct number is passed, keep turning the plunger in the same direction until the correct number comes around again. Do not try to turn the syringe backwards. The syringe is now ready for use.
Storage: Unused reconstituted solution may be stored for up to 24 hours if stored between 2 degrees C and 25 degrees C (36 F to 77 F). Do not freeze.
Caverject Impulse is for single-use only. Properly discard the entire injection delivery system and any remaining solution after use.
 
Reconstitution of EDEX
Prepare the injection immediately before use.
The Edex injection device is used to reconstitute the single-dose dual-chamber cartridge. Use the plunger and force the sterile 0.9% Sodium Chloride injection (1.075 mL) in one chamber into the other chamber containing alprostadil.
After reconstitution, the Edex injection device is used to administer the dose of alprostadil; use only with the cartridges and needles supplied in the Edex cartridge packs.
Do not administer unless solution is clear. Do not add any drugs or solutions to the injection solution. Discard unused drug solution. The reconstituted injection solution should not be stored.[55990]
 
Intracavernous Injection Administration
Alprostadil intracavernosal injection cartridge devices are designed for one-time use. After the single-use, the injection device and remaining solution should be discarded. Of note, the needle used for administration of alprostadil solution is a superfine (27 to 30-gauge) needle; with such a fine needle, breakage is possible. Patients should be carefully instructed on proper injection technique to minimize the risk of needle breakage. Needles or syringes should not be shared.
The head of the penis should be held between the thumb and forefinger and stretched lengthwise along the thigh while sitting upright or slightly reclined. The needle of the syringe is then positioned so that the drug will be injected into a corpus cavernosum underneath the tunica albuginea along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Blood vessels, corpus spongiosum, subcutaneous tissue, urethra, and dorsal neural vascular structures should be avoided as injection sites.
Once positioned, the needle of the syringe provided by the manufacturer should be pushed straight into the site using a steady motion until the metal portion of the needle is almost entirely in the penis; the dose should then be injected slowly over 5 to 10 seconds into the chosen corpus cavernosum.
The syringe should be withdrawn and pressure applied to the injection site with an alcohol swab for 5 minutes (or until bleeding stops) to avoid hematologic complications, especially in patients receiving concomitant anticoagulant therapy. Injection site and side of the penis should be rotated to minimize adverse effects related to repeated local injection.
Patient should be cautioned against use of severely bent needles and should not attempt to straighten a bent needle as this can increase the risk of breakage. Patient should also avoid reuse of syringes and needles. Give patient instructions on proper disposal of syringes and needles in the puncture-resistant container provided by the manufacturer.[30849] [55990]

Intraurethral Administration
Alprostadil (MUSE) is administered as an urethral suppository.
The initial dose titration should occur under the supervision of a physician in order to test a patient's responsiveness, to demonstrate proper administration technique, and to monitor for evidence of hypotension.
After the patient has been instructed on proper administration technique, the alprostadil urethral suppository (MUSE) may be self-administered. Each patient MUST receive the Patient Package Insert (i.e., step-by-step patient instructions) at the initiation of therapy.
Remind patients not to exceed recommended dose limits. The maximum frequency of use is no more than 2 urethral suppository systems per 24-hour period.
 
Urethral Suppository (MUSE) Administration
The alprostadil urethral suppository (MUSE) is designed to be self-administered after proper education and dose titration. Each patient MUST receive the Patient Package Insert which specifies proper Instructions for Use when initiating therapy.
For urethral insertion only. Do not administer by any other route.
Key administration points:
Immediately prior to administration, patient should urinate and gently shake the penis several times to remove excess urine. The medicated pellet has been specially developed to dissolve in the small quantity of urine that remains in the urethra after urination.
Carefully open the foil pouch and allow the applicator to slide out.
Then remove the protective cover from the applicator stem without pushing the applicator button or touching the applicator stem or tip. Save the foil pouch and cover to later discard the MUSE applicator.
Visually inspect the MUSE system to make sure the pellet is present.
To straighten the urethra, patient should, while sitting or standing, take several seconds to gently and slowly stretch the penis upward to its full length, with gentle compression from top to bottom of the glans.
Slowly insert the MUSE stem into the urethra up to the collar. If any discomfort or a pulling sensation occurs, withdraw the applicator slightly and then gently reinsert.
To administer suppository, gently and completely push down the button at the top of the applicator until it stops to ensure that the medicated pellet is completely released. The patient should then hold the applicator in this position for 5 seconds, then, gently rock the applicator from side to side in order to separate the medicated pellet from the applicator tip. Instruct the patient not to apply too much pressure in order to avoid scratching the lining of the urethra and causing it to bleed.
Remove applicator while keeping the penis upright.
Without touching the stem of the applicator, visually inspect the applicator tip to make sure the pellet is no longer in the applicator. If residual medication is present, gently reinsert into the urethra and repeat.
After administration, instruct patient to hold the penis upright and stretched to its full length and roll the penis firmly between the hands for at least 10 seconds to ensure that the medication is adequately distributed along the walls of the urethra. If a burning sensation is felt, the patient may continue to roll the penis for an additional 30 to 60 seconds or until the burning subsides. Then, to increase blood flow to the penis and enhance erection, the patient should sit, stand, or walk about for 10 minutes while the erection is developing.
Instruct patient on proper disposal of unit.

apnea / Delayed / 10.0-12.0
bradycardia / Rapid / 7.0-7.0
seizures / Delayed / 4.0-4.0
phimosis / Delayed / 3.0-3.0
heart failure / Delayed / 0-1.0
ventricular fibrillation / Early / 0-1.0
myocardial infarction / Delayed / 1.0-1.0
cardiac arrest / Early / 1.0-1.0
penile edema / Early / 1.0-1.0
visual impairment / Early / 1.0-1.0
disseminated intravascular coagulation (DIC) / Delayed / 0-1.0
anuria / Delayed / 0-1.0
hyperkalemia / Delayed / 0-1.0

penile pain / Rapid / 29.0-37.0
urethral pain / Early / 0-13.0
hematoma / Early / 3.0-5.0
sinus tachycardia / Rapid / 0-3.0
hypotension / Rapid / 1.0-3.0
erythema / Early / 2.0-3.0
penile fibrosis / Delayed / 3.0-3.0
hypertension / Early / 2.0-2.0
peripheral edema / Delayed / 0-2.0
hypertriglyceridemia / Delayed / 2.0-2.0
wheezing / Rapid / 0-1.0
bleeding / Early / 0-1.0
respiratory depression / Rapid / 0-1.0
tachypnea / Early / 0-1.0
edema / Delayed / 1.0-1.0
supraventricular tachycardia (SVT) / Early / 0-1.0
peripheral vasodilation / Rapid / 0-1.0
hyperemia / Delayed / 0-1.0
priapism / Early / 0-1.0
anemia / Delayed / 0-1.0
thrombocytopenia / Delayed / 0-1.0
hyperbilirubinemia / Delayed / 0-1.0
hematuria / Delayed / 0-1.0
urinary retention / Early / 0-1.0
hypercholesterolemia / Delayed / 1.0-1.0
hyperglycemia / Delayed / 1.0-1.0
hypoglycemia / Early / 0-1.0

injection site reaction / Rapid / 2.0-15.0
fever / Early / 14.0-14.0
flushing / Rapid / 10.0-10.0
vaginal irritation / Early / 5.8-5.8
testicular pain / Early / 1.0-5.0
dizziness / Early / 1.0-4.0
ecchymosis / Delayed / 2.0-4.0
headache / Early / 2.0-3.0
pruritus / Rapid / 3.0-3.0
rhinitis / Early / 2.0-2.0
back pain / Delayed / 1.0-2.0
perineal pain / Early / 0-2.0
diarrhea / Early / 2.0-2.0
lethargy / Early / 0-1.0
hypothermia / Delayed / 0-1.0
irritability / Delayed / 0-1.0
syncope / Early / 0-1.0
muscle cramps / Delayed / 0-1.0
mydriasis / Early / 0-1.0
nausea / Early / 0-1.0
xerostomia / Early / 0-1.0
gastroesophageal reflux / Delayed / 0-1.0
weakness / Early / 0-1.0
rash / Early / 0-1.0
diaphoresis / Early / 0-1.0
hypoesthesia / Delayed / 0-1.0
urinary urgency / Early / 0-1.0
increased urinary frequency / Early / 0-1.0

Apnea is experienced by approximately 10% to 12% of neonates and infants with congenital heart disease defects treated with intravenous alprostadil. Apnea is most often seen in premature neonates weighing less than 2 kg at birth and usually occurs during the first hour of drug infusion. Respiratory status should be monitored throughout treatment and neonatal use of alprostadil requires a specialized care setting and should only be undertaken where ventilatory assistance is immediately available. Alprostadil should be used cautiously in neonates and infants with respiratory depression.

Caverject, Caverject Impulse, Edex, Muse, Prostin VR

Rx

Prostaglandin E-1 
Used for erectile dysfunction (ED) and to maintain patency of ductus arteriosus in neonates until surgery
Erectile dysfunction products include an intraurethral insert (Muse) and intracavernosal injection (Caverject or Edex); other dosage forms under investigation
Prostin VR Pediatric is an IV form used in neonates; use requires respiratory monitoring due to risk of apnea

0.05 to 0.1 mcg/kg/minute continuous IV or intra-arterial (umbilical) infusion, initially. After a therapeutic response is achieved (i.e., increased pO2 in infants with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in infants with restricted blood flow), reduce the dose to the lowest possible dose that maintains the response. Dose may be decreased from 0.1 to 0.05 to 0.025 to 0.01 mcg/kg/minute; if response to 0.05 mcg/kg/minute is inadequate, dosage may be increased. Usual dose: 0.01 to 0.1 mcg/kg/minute.[30848] 0.01 to 0.02 mcg/kg/minute may effectively maintain patency while minimizing the risk of apnea.[63412] Max: 0.4 mcg/kg/minute; however, high infusion rates do not usually produce greater effects and have a higher incidence of adverse effects.[30848]

0.05 to 0.1 mcg/kg/minute continuous IV or intra-arterial (umbilical) infusion, initially. After a therapeutic response is achieved (i.e., increased pO2 in infants with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in infants with restricted blood flow), reduce the dose to the lowest possible dose that maintains the response. Dose may be decreased from 0.1 to 0.05 to 0.025 to 0.01 mcg/kg/minute; if response to 0.05 mcg/kg/minute is inadequate, dosage may be increased. Usual dose: 0.01 to 0.1 mcg/kg/minute.[30848] 0.01 to 0.02 mcg/kg/minute may effectively maintain patency while minimizing the risk of apnea.[63412] Max: 0.4 mcg/kg/minute; however, high infusion rates do not usually produce greater effects and have a higher incidence of adverse effects.[30848]

2.5 mcg initially, injected into the corpus cavernosa, adjusting the dosage by 2.5 mcg increments, to 5 mcg, then by 5 mcg increments according to patient response. Maximum 60 mcg/dose. Do not administer more than 3 times per week, with a minimum of 24 hours between doses.

2.5 mcg initially, injected into the corpus cavernosa. If there is a partial response, may be increase by 2.5 mcg to 5 mcg and then in 5 to 10 mcg increments according to patient response until the dose producing an erection suitable for intercourse and not more than 1 hour in duration achieved. If there is no response to the initial 2.5 mcg dose, the second dose may be increased to 7.5 mcg, followed by increments of 5 to 10 mcg. Patient must remain in physician's office until complete detumescence occurs. If there is no response, the next higher dose may be given within 1 hour. If there is a response, wait at least a 1-day interval before giving the next dose. Do not administer more than 3 times per week, with a minimum of 24 hours between doses.

125 or 250 mcg by intraurethral insertion, initially, as a single dose as needed. Adjust the dose on separate occasions in a stepwise manner until an erection that is sufficient for sexual intercourse is achieved. Dose range: 125 to 1,000 mcg/dose. Max: 2 doses/24 hours.

1.25 mcg initially, injected into the corpus cavernosa, adjusting the dosage by 2.5 mcg increments, to 5 mcg, then by 5 mcg increments according to patient response. Maximum 60 mcg/dose. Do not administer more than 3 times per week, with a minimum of 24 hours between doses.

1.25 mcg initially, injected into the corpus cavernosa. May increase by 1.25 mcg to a dose of 2.5 mcg, followed by an increment of 2.5 mcg to a dose of 5 mcg, and then in 5-mcg increments until a dose producing an erection suitable for intercourse and not more than 1 hour in duration achieved. Patient must remain in physician's office until complete detumescence occurs. If there is no response, the next higher dose may be given within 1 hour. If there is a response, wait at least a 1-day interval before the next dose is given. Do not administer more than 3 times per week, with a minimum of 24 hours between doses.

Triple drug regimen dose ranges reported in literature: 0.2 to 0.4 mg phentolamine plus 8 to 16 mg papaverine plus 10 to 20 mcg alprostadil per injection. Although alprostadil monotherapy has a high efficacy rate, reaching up to 70%, triple drug therapy with alprostadil, papaverine, and phentolamine has a response rate of up to 92%. Individual dosages are determined by series of trial injections under physician supervision. Limit use to 1 injection in a 24-hour period, given no more than 3 times per week.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Acebutolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Angiotensin II receptor antagonists: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as angiotensin II receptor antagonists (angiotensin receptor blockers, or ARBs), may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Angiotensin-converting enzyme inhibitors: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as angiotensin-converting enzyme inhibitors (ACE inhibitors), may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Atenolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Atenolol; Chlorthalidone: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Beta-blockers: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Betaxolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Bisoprolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Brimonidine; Timolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Calcium-channel blockers: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, like calcium channel blockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Carteolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Carvedilol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Central-acting adrenergic agents: (Minor) The concomitant use of systemic alprostadil injection and central-acting antihypertensive agents may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Dorzolamide; Timolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Doxazosin: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as doxazosin, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Eplerenone: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as eplerenone, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Epoprostenol: (Minor) Systemic alprostadil and epoprostenol are both prostaglandins that reduce blood pressure, and would not be commonly prescribed together at the same time. The concomitant use of systemic alprostadil injection and epoprostenol would be expected to cause additive hypotension. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Esmolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Heparin: (Moderate) Caution is advised with the concomitant administration of alprostadil injection for dilation of the ductus arteriosis and heparin infusions. Coadministration resulted in a 140% increase in partial thromboplastin time and a 120% increase in thrombin time in a study of 12 healthy volunteers receiving alprostadil 90 mcg infusion over 3 hours and heparin 5000 units. Monitor patients for increased bleeding if these agents are used together.
Ibuprofen lysine: (Contraindicated) As ibuprofen lysine is used for the pharmacologic closure of patent ductus arteriosus (PDA), do not administer to patients who require alprostadil injection for dilation of the ductus arteriosus for oxygenation and perfusion. Alprostadil injection for pediatric use (Prostin VR) has been used with the standard therapy for neonates with restricted pulmonary or systemic blood flow which includes antibiotics (e.g., penicillin and gentamicin), vasopressors (e.g., dopamine, isoproterenol), cardiac glycosides, and diuretics (e.g., furosemide).
Iloprost: (Minor) Systemic alprostadil and epoprostenol are both prostaglandins that reduce blood pressure, and would not be commonly prescribed together at the same time. The concomitant use of systemic alprostadil injection and epoprostenol would be expected to cause additive hypotension. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Labetalol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Levobunolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Loop diuretics: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as loop diuretics, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Mecamylamine: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as mecamylamine, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Metoprolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Metoprolol; Hydrochlorothiazide, HCTZ: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Nadolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Nebivolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Nebivolol; Valsartan: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Phenoxybenzamine: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as phenoxybenzamine, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Pindolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Potassium-sparing diuretics: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as spironolactone or other potassium-sparing diuretics, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Prazosin: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as prazosin, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Propranolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Propranolol; Hydrochlorothiazide, HCTZ: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Sotalol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Terazosin: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as terazosin, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Thiazide diuretics: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as thiazide diuretics, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Timolol: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as beta-clockers, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Treprostinil: (Minor) Systemic alprostadil and treprostinil are both prostaglandins that reduce blood pressure, and would not be commonly prescribed together at the same time. The concomitant use of systemic alprostadil injection and treprostinil would be expected to cause additive hypotension. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.
Vasodilators: (Minor) The concomitant use of systemic alprostadil injection and antihypertensive agents, such as the vasodilators, may cause additive hypotension. Caution is advised with this combination. Systemic drug interactions with the urethral suppository (MUSE) or alprostadil intracavernous injection are unlikely in most patients because low or undetectable amounts of the drug are found in the peripheral venous circulation following administration. In those men with significant corpora cavernosa venous leakage, hypotension might be more likely. Use caution with in-clinic dosing for erectile dysfunction (ED) and monitor for the effects on blood pressure. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to alprostadil. However, in clinical trials with alprostadil intracavernous injection, anti-hypertensive agents had no apparent effect on the safety and efficacy of alprostadil.

Alprostadil/Prostin VR Intravenous Inj Sol: 1mL, 500mcg
Caverject/Caverject Impulse/Edex Intracavernous Inj Pwd F/Sol: 10mcg, 20mcg, 40mcg
Muse Urethral Supp: 250mcg, 500mcg, 1000mcg

Dependent on indication for therapy and product prescribed.

Dependent on indication for therapy and product prescribed.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Doses greater than 0.4 mcg/kg/minute IV of Prostin VR Pediatric are not recommended.

Alprostadil is a smooth muscle relaxant. For the treatment of erectile dysfunction (ED), alprostadil binds to specific receptors in human penile tissue, which causes an increase in intracellular cAMP. Human cavernosus smooth muscle cells respond to alprostadil by releasing intracellular calcium into the surrounding medium. Smooth muscle relaxation accompanies the reduction in cytoplasmic free calcium concentration. Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum which is essential for the maintenance of a flaccid and non-erect penis. An erection is induced by relaxing trabecular smooth muscle and dilating cavernosal arteries. Dilation of the cavernosal arteries is accompanied by increased arterial inflow velocity and increased venous outflow resistance. As a result, the lacunar spaces expand and blood becomes entrapped secondary to compression of venules against the tunica albuginea. This process is also referred to as the corporal veno-occlusive mechanism.
 
Alprostadil (prostaglandin E1) is one of a family of naturally occurring acidic lipids with various pharmacologic effects. Vasodilation, inhibition of platelet aggregation, and stimulation of intestinal and uterine smooth muscle are among the most notable of these effects. In the treatment of ductus arteriosus-dependent congenital heart defects, alprostadil maintains ductal patency by relaxing the smooth muscles of the ductus arteriosus. Alprostadil is only effective if given prior to complete anatomic closure of the ductus arteriosus. Administration of alprostadil to neonates with cyanotic congenital heart defects (restricted pulmonary blood flow) results in an increase in pulmonary blood flow and/or increase in mixing between the systemic and pulmonary circulation which leads to a temporary increase in arterial oxygen partial pressure (PO2) and oxygen saturation. The response of the cyanotic neonate to alprostadil therapy is also inversely related to pretreatment PO2. The greatest response appears to be in those neonates with low pretreatment PO2 (less than 20 torr), narrowing ductus arteriosus, and who are 4 days old or younger. Neonates with PO2 values of 40 torr or more usually have little response to alprostadil. In neonates with restricted systemic blood flow, administration of alprostadil can result in prevention or correction of acidemia, increased cardiac output with increased systemic blood pressure, increased femoral pulse volume, increased renal blood flow and function, decreased gradient of descending to ascending aortic blood pressures (in neonates with coarctation of the aorta), and/or decreased ratio of pulmonary artery pressure to descending aortic pressure (in neonates with interruption of the aortic arch). Unlike in cyanotic neonates, the efficacy of alprostadil in acyanotic neonates does not depend on age or pretreatment PO2.

Alprostadil is administered by intravenous infusion, intracavernosal injection, or via an urethral suppository. Once in the systemic circulation, alprostadil is bound primarily to albumin (81%). No significant binding to erythrocytes or white blood cells occurs. Alprostadil is completely metabolized in the lung to several metabolites with a first-pass pulmonary elimination of 60% to 90% of PGE1. The main metabolites (15-keto-PGE1, 15-keto-PGE0, and PGE0) are primarily excreted in the urine (88%) and feces (12%) over 72 hours; total excretion is essentially complete within 24 hours after administration. The terminal half-life of PGE1 is approximately 9 to 11 minutes.

Intravenous administration of alprostadil requires a continuous infusion of the drug because approximately 80% of the dose is metabolized in one pass through the lungs, mostly by beta- and omega-oxidation. There is no evidence of tissue retention of alprostadil or its metabolites following IV administration.

Intracavernosal Route
After intracavernosal administration, minimal systemic absorption occurs. After intracavernous injection of 20 mcg of alprostadil, peak concentrations of 16.8 +/- 18.9 pg/mL were reached within 2 to 5 minutes and decreased to endogenous plasma levels within 2 hours. The absolute bioavailability estimated from systemic exposure was 98% as compared to the same dose given by short-term IV infusion. Any alprostadil absorbed by the intracavernous route is rapidly metabolized in the lungs. After intracavernous injection of 20 mcg of alprostadil, terminal half-lives of 15-keto-PGE0 and PGE0 were 40.9 +/- 16.5 minutes and 63.2 +/- 31.1 minutes, respectively. Following intracavernosal administration, erection usually occurs within 5 to 20 minutes and may last for about 1 to several hours. Tolerance to the beneficial vascular effects does not appear to occur.
 
Intraurethral Route
After intraurethral administration, minimal systemic absorption occurs. Any alprostadil absorbed by this route is rapidly metabolized. Alprostadil given via the urethra is delivered directly to the urethral lining for transfer via the corpus spongiosum to the corpora cavernosa. The onset of effect is within 5 to 10 minutes after urethral administration and the duration of effect is approximately 30 to 60 minutes and will vary from patient to patient.

Given the indications for use, alprostadil would not be expected to be used during lactation. Use in the lactating female during breast-feeding is not indicated.