AdultPediatricDosage Forms & Strengths alprostadil intracavernous/urethral kit, intracavernosal 10mcg 20mcg 40mcg solution, injection 500 mcg/mL solution reconstituted, intracavernosal 20mcg 40mcg urethral suppository/pellet 125mcg 250mcg 500mcg 1000mcg Erectile Dysfunction Vascular, Psychogenic, or Mixed Etiology Initial 2.5 mcg intracavernosal injection Titrate by 2.5 mcg, THEN by 5-10 mcg intervals until erection of <1 hr maintained; not to exceed 40 mcg (Edex) or 60 mcg (Caverject) If no absolute response to 2.5 mcg dose, may increase second dose to 7.5 mcg followed by increments of 5-10 mcg Once appropriate dose defined, patient may self-administer injections at a frequency <3 times/week with at least 24hr between doses Neurogenic ED Initial 1.25 mcg intracavernosal injection Titrate by 1.25 mcg-2.5 mcg, THEN by 2.5-5 mcg until erection of <1 hr maintained Intraurethral suppository Dosage range: 125-1000 mcg intraurethral Start: 125-250 mcg until duration of action is about 30-60 min Not to exceed 2 systems per 24 hr Administration Intracavernous injection Use only the supplied diluent for reconstitution Use a 0.5-inch, 27- to 30-gauge needle Inject into the dorsolateral aspect of proximal third of penis, avoiding visible veins Alternate side of penis for injections Refrigerate at 2-8°C until dispensed After dispensing, stable for up to 3 months ≤25°C Contains benzoyl alcohol; this product is not indicated for children (see separate drug monograph for alprostadil IV for neonatal use to maintain patency of ductus arteriosus)Interaction CheckerEnter a drug name and alprostadil intracavernous/urethralNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (0)Serious - Use Alternative (0)Monitor Closely (1)eluxadolineeluxadoline increases levels of alprostadil intracavernous/urethral by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered OATP1B1 substrates.Minor (11)antithrombin alfaalprostadil intracavernous/urethral increases effects of antithrombin alfa by pharmacodynamic synergism. Minor/Significance Unknown.antithrombin IIIalprostadil intracavernous/urethral increases effects of antithrombin III by pharmacodynamic synergism. Minor/Significance Unknown.argatrobanalprostadil intracavernous/urethral increases effects of argatroban by pharmacodynamic synergism. Minor/Significance Unknown.bemiparinalprostadil intracavernous/urethral increases effects of bemiparin by pharmacodynamic synergism. Minor/Significance Unknown.bivalirudinalprostadil intracavernous/urethral increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.dalteparinalprostadil intracavernous/urethral increases effects of dalteparin by pharmacodynamic synergism. Minor/Significance Unknown.enoxaparinalprostadil intracavernous/urethral increases effects of enoxaparin by pharmacodynamic synergism. Minor/Significance Unknown.fondaparinuxalprostadil intracavernous/urethral increases effects of fondaparinux by pharmacodynamic synergism. Minor/Significance Unknown.heparinalprostadil intracavernous/urethral increases effects of heparin by pharmacodynamic synergism. Minor/Significance Unknown.phenindionealprostadil intracavernous/urethral increases effects of phenindione by pharmacodynamic synergism. Minor/Significance Unknown.protaminealprostadil intracavernous/urethral increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.antithrombin alfaMinor (1)alprostadil intracavernous/urethral increases effects of antithrombin alfa by pharmacodynamic synergism. Minor/Significance Unknown.antithrombin IIIMinor (1)alprostadil intracavernous/urethral increases effects of antithrombin III by pharmacodynamic synergism. Minor/Significance Unknown.argatrobanMinor (1)alprostadil intracavernous/urethral increases effects of argatroban by pharmacodynamic synergism. Minor/Significance Unknown.bemiparinMinor (1)alprostadil intracavernous/urethral increases effects of bemiparin by pharmacodynamic synergism. Minor/Significance Unknown.bivalirudinMinor (1)alprostadil intracavernous/urethral increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.dalteparinMinor (1)alprostadil intracavernous/urethral increases effects of dalteparin by pharmacodynamic synergism. Minor/Significance Unknown.eluxadolineMonitor Closely (1)eluxadoline increases levels of alprostadil intracavernous/urethral by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered OATP1B1 substrates.enoxaparinMinor (1)alprostadil intracavernous/urethral increases effects of enoxaparin by pharmacodynamic synergism. Minor/Significance Unknown.fondaparinuxMinor (1)alprostadil intracavernous/urethral increases effects of fondaparinux by pharmacodynamic synergism. Minor/Significance Unknown.heparinMinor (1)alprostadil intracavernous/urethral increases effects of heparin by pharmacodynamic synergism. Minor/Significance Unknown.phenindioneMinor (1)alprostadil intracavernous/urethral increases effects of phenindione by pharmacodynamic synergism. Minor/Significance Unknown.protamineMinor (1)alprostadil intracavernous/urethral increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown. >10% Urethral suppository Penile pain (32%) Urethral burning (12%) Intracavernous injection Penile pain (37%) 1-10% Urethral suppository Urethral bleeding/spotting (5%) Testicular pain (5%) Headache (3%) Intracavernous injection Prolonged erection, 4-6 hr (4%) Penile fibrosis (3%) Injection site hematoma (3%) Injection site echymosis (2%) Penile rash (1%) Penile edema (1%) <1% Urethral suppository Syncope (0.4%) Tachycardia, leg pain, perineal pain Intracavernous injection Priapism, >6 hr (0.4%) Injection site hemorrhage Postmarketing Reports Intracavernous injection device failure Needle breakage during administration Contraindications Hypersensitivity Predisposition to priapism (eg, sickle cell anemia, sickle cell trait, multiple myeloma, leukemia) Anatomical deformation of the penis, such as cavernosal fibrosis or Peyronie’s disease Penile implants Sexual intercourse with pregnant woman unless condom barrier used (intracavernosal implant) Cautions Discontinue therapy if signs of penile fibrosis develop The preservative benzyl alcohol contained in the intracavernosal dosage form has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients; this dosage form is not indicated for pediatric patients Syncope reported within 1 hr of using urethral suppository (pellet) The risk of breakage with superfine needles is high; needle breakage, with a portion of the needle remaining in the penis, requiring hospitalization and surgical removal reported; careful instruction in proper patient handling and injection techniques may minimize potential for breakage Patients with bleeding disorders or on anticoagulants, such as warfarin or heparin may have increased propensity for bleeding after intracavernosal injection; use caution; compress site of injection with alcohol swab or sterile gauze for 5 min Diagnose and treat underlying treatable medical causes of erectile dysfunction before initiating therapy Safety and efficacy of combinations of drug and other vasoactive agents injected intracavernosally not established in clinical studies; risks of prolonged erection, priapism, and hypotension may be increased Injections can lead to increased peripheral blood levels of alprostadil, especially in patients with significant corpora cavernosa venous leakage; avoid use in patients with known cavernosal venous leakage; may cause hypotension Counsel patients about protective measures necessary to guard against sexually transmitted disease including human immunodeficiency virus (HIV) Cardiovascular risk Physical examination of penis should be performed periodically, to detect signs of penile fibrosis; treatment should be discontinued in patients who develop penile angulation or cavernosal fibrosis There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease; treatments for erectile dysfunction should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment Priapism Prolonged erection defined as erection lasting between 4 to 6 hours in duration reported; in the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance; if priapism not treated immediately, penile tissue damage and permanent loss of potency may result To minimize chances of prolonged erection or priapism, drug should be titrated slowly to lowest effective dose Not for use in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia Pregnancy: Alprostadil not indicated for use in females Lactation: Alprostadil not indicated for use in femalesPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Relaxes arterial smooth muscle, producing vasodilation; allows blood flow and entrapment in the lacunar spaces of the penis Pharmacokinetics Half-Life: 5-10 min Onset: ED (intraurethral; muse): 30-60 min Protein bound: 81% Metabolism: chiefly in lungs via enzymatic oxidation (plasma levels may be higher in patients with pulmonary disease) Metabolites: Prostanoid metabolites (inactive) Excretion: Mainly in urine 90%, small amount in lung BRAND FORM. UNIT PRICE PILL IMAGE Edex intracavernosal- 40 mcg kitEdex intracavernosal- 40 mcg kitEdex intracavernosal- 10 mcg kitEdex intracavernosal- 20 mcg kitEdex intracavernosal- 20 mcg kitEdex intracavernosal- 10 mcg kitCaverject intracavernosal- 40 mcg vialCaverject intracavernosal- 40 mcg vialCaverject intracavernosal- 20 mcg vialCaverject intracavernosal- 20 mcg vialProstin VR Pediatric injection- 500 mcg/mL solutionMuse intra-urethral- 125 mcg supposMuse intra-urethral- 1,000 mcg supposMuse intra-urethral- 500 mcg supposMuse intra-urethral- 250 mcg supposMuse intra-urethral- 125 mcg supposMuse intra-urethral- 1,000 mcg supposMuse intra-urethral- 500 mcg supposMuse intra-urethral- 250 mcg supposCaverject Impulse intracavernosal- 20 mcg kitCaverject Impulse intracavernosal- 10 mcg kitCopyright © 2010 First DataBank, Inc.Select a drug:alprostadil injectionalprostadil intracavernosalalprostadil intra-urethralPrint Patient Educationalprostadil injection NO MONOGRAPH AVAILABLE AT THIS TIME USES: Consult your pharmacist. HOW TO USE: Consult your pharmacist. SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Consult your pharmacist. DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. NOTES: No monograph available at this time. MISSED DOSE: Consult your pharmacist. STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. Information last revised July 2016. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. 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Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. Plans Select State: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Done Non-Medicare