Dosing & Uses
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)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (12)
- 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.
- warfarin
alprostadil intracavernous/urethral increases effects of warfarin by pharmacodynamic synergism. Minor/Significance Unknown.
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
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
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.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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Prostin VR Pediatric injection - | 500 mcg/mL solution |  | |
| Muse intra-urethral - | 250 mcg suppos |  | |
| Muse intra-urethral - | 500 mcg suppos |  | |
| Muse intra-urethral - | 1,000 mcg suppos |  | |
| 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 - | 125 mcg suppos |  | |
| Edex intracavernosal - | 40 mcg kit |  | |
| Edex intracavernosal - | 40 mcg kit |  | |
| Edex intracavernosal - | 20 mcg kit |  | |
| Edex intracavernosal - | 10 mcg kit |  | |
| Edex intracavernosal - | 10 mcg kit |  | |
| Edex intracavernosal - | 20 mcg kit |  | |
| Caverject intracavernosal - | 20 mcg vial |  | |
| Caverject intracavernosal - | 40 mcg vial |  | |
| Caverject intracavernosal - | 40 mcg vial |  | |
| Caverject intracavernosal - | 20 mcg vial |  | |
| Caverject Impulse intracavernosal - | 10 mcg kit |  | |
| Caverject Impulse intracavernosal - | 20 mcg kit |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
alprostadil injection
ALPROSTADIL - INTRACAVERNOSAL
(al-PROS-ta-dil)
COMMON BRAND NAME(S): Caverject
USES: This medication is used to treat male sexual function problems (erectile dysfunction). It works by helping the blood flow into the penis to achieve and maintain an erection.This medication is not for use in women or children.This medication is not recommended for use in men with penile implants.
HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into the penis as directed by your doctor. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Choose an injection site on the other side of the penis from the site of the last dose, using a different area each time. After injection, apply pressure to the injection site with an alcohol swab for about 5 minutes to avoid bruising. Do not use a bent needle to inject this medication. If the needle is bent, replace it with a new needle. If the needle breaks during injection, contact your doctor right away.Dosage is based on your medical condition and response to therapy. This medication should usually work within 5 to 20 minutes to produce an erection that lasts for about 1 hour. The manufacturer recommends that this medication be used no more than 3 times a week with at least 1 day between each dose.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.Inform your doctor if your condition persists or worsens (for example, if the drug does not produce an erection or it becomes more difficult to get an erection).
SIDE EFFECTS: Mild/moderate pain, irritation, or slight bleeding at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: redness/tenderness/swelling of the penis, lumps/unusual curving of the penis.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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: Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), blood system cancers (such as leukemia, multiple myeloma), sickle cell anemia.Use of this drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method such as a latex or polyurethane condom during all sexual activity. Consult your doctor or pharmacist for more details.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin, heparin).
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: Do not share this medication with others.Keep all regular medical appointments, and have regular checkups to monitor the effectiveness and safety of this medication.
MISSED DOSE: Not applicable.
STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.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.
Information last revised December 2021. Copyright(c) 2021 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.
Formulary
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