(al PROS ta dill)
- Prostaglandin E1
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caverject Impulse: 10 mcg [contains benzyl alcohol]
Caverject Impulse: 20 mcg
Edex: 10 mcg, 20 mcg, 40 mcg
Muse: 125 mcg (1 ea, 6 ea); 250 mcg (1 ea, 6 ea); 500 mcg (1 ea, 6 ea); 1000 mcg (1 ea, 6 ea)
Prostin VR: 500 mcg/mL (1 mL) [contains benzyl alcohol]
Generic: 500 mcg/mL (1 mL)
Solution Reconstituted, Intracavernosal:
Caverject: 20 mcg (1 ea)
Caverject: 20 mcg (1 ea); 40 mcg (1 ea) [contains benzyl alcohol]
Brand Names: U.S.
- Caverject Impulse
- Prostin VR
Causes vasodilation by means of direct effect on vascular and ductus arteriosus smooth muscle; relaxes trabecular smooth muscle by dilation of cavernosal arteries when injected along the penile shaft, allowing blood flow to and entrapment in the lacunar spaces of the penis (ie, corporeal veno-occlusive mechanism)
Insignificant following penile injection
IV: ~70% to 80% by oxidation during a single pass through the lungs; metabolite (13,14 dihydro-PGE1) is active and has been identified in neonates
Primarily urine (90% as metabolites) within 24 hours; feces
Onset of Action
Erectile dysfunction: 5 to 20 minutes
Time to Peak
Acyanotic congenital heart disease: Usual: 1.5 to 3 hours; Range: 15 minutes to 11 hours
Cyanotic congenital heart disease: Usual: ~30 minutes
Erectile dysfunction: Intracavernosal: 30 to 60 minutes; Transurethral: ~16 minutes
Duration of Action
Ductus arteriosus will begin to close within 1 to 2 hours after drug is stopped; Erectile dysfunction: Intended duration <1 hour
30 seconds to 10 minutes
Plasma: 81% to albumin
Special Populations Note
Pulmonary disease: May have reduced capacity to clear the drug.
Use: Labeled Indications
Patent ductus arteriosus (Prostin VR Pediatric): Temporary maintenance of patency of ductus arteriosus in neonates with ductal-dependent congenital heart disease until surgery can be performed. These defects include cyanotic (eg, pulmonary atresia, pulmonary stenosis, tricuspid atresia, Fallot's tetralogy, transposition of the great vessels) and acyanotic (eg, interruption of aortic arch, coarctation of aorta, hypoplastic left ventricle) heart disease.
Caverject, Edex, Caverject Impulse: Treatment of erectile dysfunction due to vasculogenic, psychogenic, neurogenic, or mixed etiology; Caverject may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction
Muse: Treatment of erectile dysfunction
Off Label Uses
Pulmonary hypertension in patients with congenital heart defects and left-to-right shunts (infants/children/adolescents)
Data from a limited number of pediatric patients (0.5 months to 19 years of age) studied suggest that alprostadil may be beneficial for the treatment of pulmonary hypertension in infants, children, and adolescents with congenital heart defects and left-to-right shunts [Weesner 1991]. Additional data may be necessary to further define the role of alprostadil in this condition.
Initial data suggest alprostadil is effective for the treatment of Raynaud phenomenon, decreasing both subjective and objective measures of the disease. Alprostadil appears to be well tolerated with only minor adverse effects. According to international consensus-derived recommendations for systemic sclerosis, IV iloprost or other IV prostanoids should be considered for use in the management of severe systemic sclerosis-related Raynaud phenomenon.
Intracavernous: Hypersensitivity to alprostadil or any component of the formulation; conditions predisposing men to priapism (eg, sickle cell anemia or trait, multiple myeloma, leukemia); men with anatomical deformation or fibrotic conditions of the penis (eg, angulation, cavernosal fibrosis, or Peyronie disease); penile implants
IV: There are no contraindications listed in the manufacturer's labeling.
Transurethral: Hypersensitivity to alprostadil or any component of the formulation; urethral stricture, balanitis, severe hypospadias and curvature, and in men with acute or chronic urethritis; men who are prone to venous thrombosis or who have a hyperviscosity syndrome (eg, sickle cell anemia or trait, thrombocythemia, polycythemia, multiple myeloma) predisposing them to priapism; use in men for whom sexual activity is inadvisable; sexual intercourse with a pregnant woman unless a condom barrier is being used
Documentation of allergenic cross-reactivity for prostaglandins is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Intracavernous (Caverject, Caverject Impulse, Edex): Individualize dose by careful titration; doses >40 mcg (Edex) or >60 mcg (Caverject) are not recommended: Initial dose must be titrated in health care provider setting. Patient must stay in the health care setting until complete detumescence occurs; if there is no response, then the next higher dose may be given within 1 hour; if there is still no response, a 1-day interval before giving the next dose is recommended; increasing the dose or concentration in the treatment of impotence results in increasing pain and discomfort.
Initial dose titration: According to the prescribing information for Caverject and Caverject Impulse, no more than 2 doses during the initial titration should be given within a 24 hour period.
Vasculogenic, psychogenic, or mixed etiology: Initiate dosage titration at 2.5 mcg.
If there is a partial response, increase dose by 2.5 mcg to a dose of 5 mcg and then, in increments of 5 to 10 mcg (depending on erectile response) until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached.
If there is no response to the initial 2.5 mcg dose, the second dose may be increased to 7.5 mcg and administered within 1 hour, followed by increments of 5 to 10 mcg (Edex).
If there is a response, then there should be at least a 24 hour interval before the next dose is given.
Neurogenic etiology (eg, spinal cord injury): Note: Caverject powder must be used to prepare a 1.25 mcg dose: Initiate dosage titration at 1.25 mcg; if there's a partial response, may increase to a dose of 2.5 mcg within 1 hour and if necessary, to a dose of 5 mcg; may increase further in increments of 5 mcg until the dose is reached that produces an erection suitable for intercourse, not lasting >1 hour.
Maintenance: Once an appropriate dose has been determined, patient may self-administer injections at a frequency of no more than 3 times/week with at least 24 hours between doses
Intraurethral (Muse Pellet):
Initial: 125 to 250 mcg
Maintenance: Administer as needed to achieve an erection; duration of action is about 30 to 60 minutes; use only two systems per 24-hour period
Raynaud phenomenon (off-labeled use): IV: 60 mcg over 3 hours once daily for 5 consecutive days (loading dose) followed by maintenance dosing of 60 mcg over 3 hours once every 30 days for 2 doses (Marasini 2004) or 60 mcg over 3 hours once daily for 6 consecutive days (Bartolone 1999) or 40 mcg (at a rate of 3 to 5 ng/kg/minute) twice daily for a minimum duration of 7 days and repeated every 3 to 4 weeks (Lamprecht 1998)
Use lowest effective dose. In clinical studies with Edex, higher minimally effective doses and a higher rate of lack of effect were noted. Refer to adult dosing.
Patent ductus arteriosus IV:
Prostin VR Pediatric: IV continuous infusion into a large vein, or alternatively through an umbilical artery catheter placed at the ductal opening: 0.05-0.1 mcg/kg/minute with therapeutic response, rate is reduced to lowest effective dosage. With unsatisfactory response, rate is increased gradually; maintenance: 0.01-0.4 mcg/kg/minute.
Note: Alprostadil is usually given at an infusion rate of 0.1 mcg/kg/minute, but it is often possible to reduce the dosage to 1/2 or even 1/10 without losing the therapeutic effect.
Note: Therapeutic response is indicated by increased pH in those with acidosis or by an increase in oxygenation (PO2) usually evident within 30 minutes.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Caverject Impulse: Provided as a dual-chamber syringe with diluent in one chamber. To mix, hold syringe with needle pointing upward and rotate plunger clockwise until it goes all the way in and stops (do not push on the plunger while trying to rotate it); turn upside down several times to evenly mix solution. Device can be set to deliver specified dose, each device can be set at various increments.
Caverject powder: Use only the supplied diluent for reconstitution (ie, bacteriostatic/sterile water with benzyl alcohol 0.945%).
Edex: Reconstitute with NS; use immediately following reconstitution. Discard any remaining solution in cartridge.
Prostin VR Pediatric: Prior to infusion, dilute with D5W, D10W, or NS to a maximum concentration of 20 mcg/mL per the manufacturer; use within 24 hours. Refer to manufacturer's labeling for detailed dilution recommendations. Avoid direct contact of undiluted alprostadil with the plastic walls of volumetric infusion chambers because the drug will interact with the plastic and create a hazy solution; discard solution and volumetric chamber if this occurs.
IV: Patent ductus arteriosus (Prostin VR Pediatric): IV continuous infusion into a large vein or alternatively through an umbilical artery catheter placed at the ductal opening; manufacturer recommended maximum concentration for IV infusion: 20 mcg/mL
Intracavernous: Erectile dysfunction
Caverject: Use a 1/2 inch, 29- or 30-gauge needle. Inject into the dorsolateral aspect of the proximal third of the penis, avoiding visible veins; alternate side of the penis for injections. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes after administration.
Caverject Impulse: Supplied as a disposable, single-dose, dual chamber syringe system. After attaching the provided needle assembly, select dose and inject into the dorsolateral aspect of the proximal third of the penis, avoiding visible veins; alternate side of the penis for injections. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes after administration.
Edex: Use a 1/2 inch, 27- to 30-gauge needle. Inject into the dorsolateral aspect of the proximal third of the penis, avoiding visible veins; alternate side of the penis for injections. Administer over a 5- to 10-second interval. Compress the site of injection with an alcohol swab for 5 minutes after administration.
Caverject Impulse: Store unreconstituted product at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Following reconstitution, store at 2°C to 25°C (36°F to 77°F) and use within 24 hours (do not freeze). Discard any unused solution.
Caverject powder: Store 20 mcg vials at 20°C to 25°C (68°F to 77°F). Store 40 mcg vials at 2°C to 8°C (36°F to 46°F) until dispensed. After dispensing, stable for up to 3 months at or below 25°C (77°F). Following reconstitution, all strengths should be stored at or below 25°C (77°F); do not refrigerate or freeze; use within 24 hours.
Edex: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
Muse: Store at 2°C to 8°C (36°F to 46°F); may be stored at room temperature (below 30°C [86°F]) for up to 14 days. Do not expose to temperatures >30°C (86°F). Each system is for single use only; discarded after use.
Prostin VR Pediatric: Refrigerate at 2°C to 8°C (36°F to 46°F). The following stability information has also been reported: May be stored at 20°C for up to 34 days or 30°C for up to 26 days (Cohen 2007).
Phosphodiesterase 5 Inhibitors: May enhance the adverse/toxic effect of Alprostadil. Avoid combination
>10%: Genitourinary: Penile pain, urethral burning
2% to 10%:
Central nervous system: Dizziness, headache, pain
Genitourinary: Testicular pain, urethral bleeding (minor), vulvovaginal pruritus (female partner)
<2%: Leg pain, perineal pain, tachycardia
>10%: Genitourinary: Penile pain
1% to 10%:
Central nervous system: Dizziness, headache
Genitourinary: Prolonged erection (>4 hours, 4%), penile disease, penile rash, penile swelling, Peyronie's disease
Local: Bruising at injection site, hematoma at injection site
<1%: Balanitis, injection site hemorrhage, priapism (0.4%)
1% to 10%:
Cardiovascular: Bradycardia, cardiac arrest, edema, hypertension, hypotension, tachycardia
Central nervous system: Dizziness, headache, seizure
Endocrine & metabolic: Hypokalemia
Hematologic & oncologic: Disseminated intravascular coagulation
Local: Local pain (in structures other than the injection site)
Neuromuscular & skeletal: Back pain
Respiratory: Cough, flu-like symptoms, nasal congestion, sinusitis, upper respiratory tract infection
<1%: Anemia, anuria, bradypnea, cardiac failure, cerebral hemorrhage, gastroesophageal reflux disease, hematuria, hemorrhage, hyperbilirubinemia, hyperemia, hyperirritability, hyperkalemia, hypoglycemia, hypothermia, jitteriness, lethargy, neck hyperextension, peritonitis, second degree atrioventricular block, shock, stiffness, supraventricular tachycardia, thrombocytopenia, ventricular fibrillation, wheezing (bronchial)
Concerns related to adverse effects:
• Apnea: [US Boxed Warning]: Prostin VR Pediatric: Apnea may occur in 10% to 12% of neonates with congenital heart defects, especially in those weighing <2 kg at birth. Apnea usually appears during the first hour of drug infusion.
• Hypotension/syncope: Intracavernous injections can increase peripheral blood levels of alprostadil, resulting in hypotension. Syncope has also been reported. Avoid use in men with known cavernosal venous leakage. Patients must be cautioned to avoid tasks such as operating machinery or driving following administration where injury could result if hypotension or syncope were to occur.
• Penile fibrosis: May occur when used for erectile dysfunction; discontinue use in men who develop penile angulation or cavernosal fibrosis.
• Priapism/prolonged erection: May occur when used for erectile dysfunction; instruct patient to seek immediate medical assistance if an erection persists ≥4 hours; discontinue therapy if priapism or prolonged erection occurs or if signs of penile fibrosis develop (penile angulation, cavernosal fibrosis, or Peyronie disease). To minimize the chances of prolonged erection or priapism, titrate slowly to the lowest effective dose. Use is contraindicated in men who have conditions that predispose them to priapism (eg, sickle cell anemia or trait, multiple myeloma, leukemia). Underlying causes of erectile dysfunction should be evaluated and treated prior to therapy.
Disease related concerns:
• Cardiovascular disease: Treatment for erectile dysfunction should not be used in men whom sexual activity is inadvisable because of underlying cardiovascular status.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Neonates: Prostin VR Pediatric: Use with caution in neonates with bleeding tendencies.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
• Administration: Muse: Urethral abrasion resulting in minor bleeding or spotting may occur from improper administration.
• Needle breakage: Caverject and Caverject Impulse: A superfine needle is used for administration. Needle breakage (a portion of the needle remaining in the penis) has been reported; hospitalization and surgical removal may be necessary.
• Patency of ductus arteriosus: Appropriate use: Prostin VR Pediatric: Infuse for the shortest time at the lowest dose consistent with good patient care. Use for >120 hours has been associated with antral hyperplasia and gastric outlet obstruction.
Blood pressure, respiratory rate, heart rate, temperature, degree of penile pain, duration of erection, adequate detumescence after dosing, signs of infection
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies. Alprostadil is not indicated for use in women. The manufacturer of Muse recommends a condom barrier when being used during sexual intercourse with a pregnant woman.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber severe penile pain, erectile redness, lumps, swelling, or curving; injection site irritation; angina; tachycardia; dizziness; passing out; severe headache; shortness of breath; bruising; bleeding; or priapism (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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- Drug class: impotence agents