alprostadil intracavernous/urethral (Rx)

Brand and Other Names:Caverject, Edex, more...Muse, PGE1, Prostaglandin E1, Viridal
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Dosing & Uses

AdultPediatric

Dosage 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)

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Interactions

Interaction Checker

and alprostadil intracavernous/urethral

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • eluxadoline

                  eluxadoline 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 alfa

                  alprostadil intracavernous/urethral increases effects of antithrombin alfa by pharmacodynamic synergism. Minor/Significance Unknown.

                • antithrombin III

                  alprostadil intracavernous/urethral increases effects of antithrombin III by pharmacodynamic synergism. Minor/Significance Unknown.

                • argatroban

                  alprostadil intracavernous/urethral increases effects of argatroban by pharmacodynamic synergism. Minor/Significance Unknown.

                • bemiparin

                  alprostadil intracavernous/urethral increases effects of bemiparin by pharmacodynamic synergism. Minor/Significance Unknown.

                • bivalirudin

                  alprostadil intracavernous/urethral increases effects of bivalirudin by pharmacodynamic synergism. Minor/Significance Unknown.

                • dalteparin

                  alprostadil intracavernous/urethral increases effects of dalteparin by pharmacodynamic synergism. Minor/Significance Unknown.

                • enoxaparin

                  alprostadil intracavernous/urethral increases effects of enoxaparin by pharmacodynamic synergism. Minor/Significance Unknown.

                • fondaparinux

                  alprostadil intracavernous/urethral increases effects of fondaparinux by pharmacodynamic synergism. Minor/Significance Unknown.

                • heparin

                  alprostadil intracavernous/urethral increases effects of heparin by pharmacodynamic synergism. Minor/Significance Unknown.

                • phenindione

                  alprostadil intracavernous/urethral increases effects of phenindione by pharmacodynamic synergism. Minor/Significance Unknown.

                • protamine

                  alprostadil intracavernous/urethral increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.

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                Adverse Effects

                >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

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                Warnings

                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
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                Pregnancy & Lactation

                Pregnancy: Alprostadil not indicated for use in females

                Lactation: Alprostadil not indicated for use in females

                Pregnancy 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.

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                Pharmacology

                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

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Prostin VR Pediatric injection
                -
                500 mcg/mL solution
                Muse intra-urethral
                -
                125 mcg suppos
                Muse intra-urethral
                -
                1,000 mcg suppos
                Muse intra-urethral
                -
                500 mcg suppos
                Muse intra-urethral
                -
                250 mcg suppos
                Muse intra-urethral
                -
                1,000 mcg suppos
                Muse intra-urethral
                -
                500 mcg suppos
                Muse intra-urethral
                -
                250 mcg suppos
                Muse intra-urethral
                -
                125 mcg suppos
                Caverject Impulse intracavernosal
                -
                20 mcg kit
                Caverject Impulse intracavernosal
                -
                10 mcg kit
                Caverject intracavernosal
                -
                40 mcg vial
                Caverject intracavernosal
                -
                40 mcg vial
                Caverject intracavernosal
                -
                20 mcg vial
                Caverject intracavernosal
                -
                20 mcg vial
                Edex intracavernosal
                -
                40 mcg kit
                Edex intracavernosal
                -
                20 mcg kit
                Edex intracavernosal
                -
                40 mcg kit
                Edex intracavernosal
                -
                10 mcg kit
                Edex intracavernosal
                -
                10 mcg kit
                Edex intracavernosal
                -
                20 mcg kit

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Select a drug:
                Patient Education
                alprostadil 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) 2022 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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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. 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.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.