Alprostadil intracavernous/urethra

Alprostadil intracavernous/urethral is a prescription medication used for the treatment of erectile dysfunction in men.

• Alprostadil intracavernous/urethral is available under the following different brand names: Caverject, Edex, Muse, PGE1, Prostaglandin E1, Viridal

Common side effects of Alprostadil intracavernous/urethral include:

• mild pain in the penis,
• mild pain in the urethra,
• mild testicular pain,
• redness of the penis, and
• warmth or burning in the urethra

Serious side effects of Alprostadil intracavernous/urethral include:

• lightheadedness,
• bleeding after an injection,
• painful erection that lasts 4 hours or longer,
• new or worsening pain in your penis, and
• redness, swelling, tenderness, lumps, unusual shape or curving of the erect penis

Rare side effects of Alprostadil intracavernous/urethral include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

 Adult dosage

Kit, intracavernosal

• 10 mcg
• 20 mcg
• 40 mcg
• Solution, injection
• 500 mcg/mL
• Solution reconstituted, intracavernosal
• 20 mcg
• 40 mcg
• Urethral suppository/pellet
• 125 mcg
• 250 mcg
• 500 mcg
• 1000 mcg

Erectile Dysfunction

Adult dosage

• Vascular, Psychogenic, or Mixed Etiology
  • Initial 2.5 mcg intracavernosal injection
  • Titrate by 2.5 mcg, THEN by 5-10 mcg intervals until the erection of less than 1 hr maintained; not to exceed 40 mcg (Edex) or 60 mcg (Caverject)
  • If no absolute response to the 2.5 mcg dose, may increase the second dose to 7.5 mcg followed by increments of 5-10 mcg
  • Once the appropriate dose is defined, the patient may self-administer injections at a frequency of fewer than 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 the erection of less than 1 hr maintained
• Intraurethral suppository
  • Dosage range: 125-1000 mcg intraurethral
  • Start: 125-250 mcg until the duration of action is about 30-60 min
  • Not to exceed 2 systems per 24 hr

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Alprostadil intracavernous/urethral has severe interactions with no other drugs.
• Alprostadil intracavernous/urethral has serious interactions with no other drugs.
• Alprostadil intracavernous/urethral has moderate interactions with the following drug:
  • eluxadoline
• Alprostadil intracavernous/urethral has minor interactions with the following drugs:
  • antithrombin alfa
  • antithrombin III
  • argatroban
  • bemiparin
  • bivalirudin
  • dalteparin
  • enoxaparin
  • fondaparinux
  • heparin
  • phenindione
  • protamine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

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 a pregnant woman unless a condom barrier is used (intracavernosal implant)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Alprostadil intracavernous/urethral?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Alprostadil intracavernous/urethral?”

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 the potential for breakage
• Patients with bleeding disorders or on anticoagulants, such as warfarin or heparin may have an increased propensity for bleeding after intracavernosal injection; use caution; compress site of injection with an 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 intracavernosal 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 diseases including human immunodeficiency virus (HIV)

Cardiovascular risk

• Physical examination of the 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 is defined as an 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 is not treated immediately, penile tissue damage and permanent loss of potency may result To minimize chances of prolonged erection or priapism, the 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 and Lactation

• Alprostadil is not indicated for use in females

Lactation

• Alprostadil is not indicated for use in females