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
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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

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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

            Women

            Newborns

            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)

            When sexual activity is inadvisable

            Cautions

            Discontinue therapy if signs of penile fibrosis develop

            Contact physician or seek immediate medical assistance if erection persists >4 hr (treat immediately to avoid permanent lose of potency

            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 combination with other vasoactive agents have not been studied; not recommended

            Priapism reported; to minimize chances of this occurring, titrate dose slowly to the lowest effective dose; advise patients to seek immediate medical assistance for an erection that persists longer than 4 hours

            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)

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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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            Formulary

            FormularyPatient Discounts

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            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.
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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.