Classes
DEA Class; Rx
Common Brand Names; Caverject, Edex, Muse, PGE1, Prostaglandin E1, Viridal
- Prostaglandins, Genitourinary
Description
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
Indications
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)
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%)
Warnings
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)
Pregnancy and Lactation
Pregnancy: Alprostadil not indicated for use in females
Lactation: Alprostadil not indicated for use in females
Maximum Dosage
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.
How supplied
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