Edex 20mcg Inj Cartridgekit (6 Pk)
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
Drug Class
Erectile Dysfunction Agent
Pharmacologic Class
Prostaglandin E1 Analog; Vasodilator
Pregnancy Category
Not applicable (for male use)
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alprostadil is a medicine injected directly into the penis to help men with erectile dysfunction (ED) get and maintain an erection. It works by relaxing the blood vessels in the penis, allowing more blood to flow in and cause an erection.
How to Use This Medicine
Proper Administration of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Administer the injection into the side of the penis as directed by your doctor or as described in the package insert. Before and after handling the medication, wash your hands thoroughly.
Preparation and Injection Technique
Do not shake the medication. Attach a new needle before each dose, and discard any bent needles. Never attempt to straighten a bent needle, as it may break. After administering the dose, apply gentle pressure to the injection site for 5 minutes to prevent bruising and continue until any bleeding stops.
Inspecting the Medication
Before use, inspect the solution for cloudiness, leakage, or particles. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Single-Use Only and Disposal
Each prefilled syringe or vial is intended for single use only. Discard any remaining medication after administration. Dispose of needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Alternating Injection Sites
To minimize the risk of bruising or other complications, alternate the side of the penis and the injection site with each dose.
Storage and Disposal
The storage requirements for this medication may vary depending on the brand. Some brands require refrigeration, while others can be stored at room temperature. If you are unsure about the storage instructions, consult your pharmacist.
Missed Doses
This medication is used as needed. Do not use it more frequently than prescribed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Administer the injection into the side of the penis as directed by your doctor or as described in the package insert. Before and after handling the medication, wash your hands thoroughly.
Preparation and Injection Technique
Do not shake the medication. Attach a new needle before each dose, and discard any bent needles. Never attempt to straighten a bent needle, as it may break. After administering the dose, apply gentle pressure to the injection site for 5 minutes to prevent bruising and continue until any bleeding stops.
Inspecting the Medication
Before use, inspect the solution for cloudiness, leakage, or particles. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Single-Use Only and Disposal
Each prefilled syringe or vial is intended for single use only. Discard any remaining medication after administration. Dispose of needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Alternating Injection Sites
To minimize the risk of bruising or other complications, alternate the side of the penis and the injection site with each dose.
Storage and Disposal
The storage requirements for this medication may vary depending on the brand. Some brands require refrigeration, while others can be stored at room temperature. If you are unsure about the storage instructions, consult your pharmacist.
Missed Doses
This medication is used as needed. Do not use it more frequently than prescribed by your doctor.
Lifestyle & Tips
- Follow your doctor's instructions carefully for injection technique and dosage.
- Do not use more than one injection in a 24-hour period, and no more than three injections per week.
- Rotate injection sites to prevent scarring or damage to the penis.
- Avoid alcohol consumption, as it can worsen dizziness or lightheadedness.
- This medication does not protect against sexually transmitted diseases (STDs) or pregnancy. Use barrier methods if needed.
- Report any prolonged erection (lasting more than 4 hours) immediately to your doctor or seek emergency medical attention.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 2.5 mcg intracavernosally. Titrate in 2.5-5 mcg increments until an erection suitable for intercourse is achieved, not lasting longer than 1 hour. Maintenance dose: Typically 5-20 mcg. Max dose: 60 mcg per injection. Frequency: Not more than 3 times per week, with at least 24 hours between doses.
Dose Range:
2.5 - 60 mg
Condition-Specific Dosing:
initial_dose_erectile_dysfunction:
2.5 mcg intracavernosally. If partial response, increase to 5 mcg. If no response, increase to 7.5 mcg. Subsequent doses can be increased in 5-10 mcg increments.
maintenance_dose_erectile_dysfunction:
The dose that produces an erection suitable for intercourse, not lasting more than 60 minutes. Typically 5-20 mcg.
maximum_frequency:
Not more than 3 times per week, with at least 24 hours between doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific dose adjustment recommended due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Alprostadil is a synthetic prostaglandin E1 (PGE1) analog. It acts by binding to specific PGE1 receptors on the smooth muscle cells of the corpus cavernosum. This binding activates adenyl cyclase, leading to an increase in intracellular cyclic adenosine monophosphate (cAMP) levels. Elevated cAMP causes relaxation of the trabecular smooth muscle and dilation of the cavernosal arteries, resulting in increased arterial inflow and veno-occlusion, which traps blood within the lacunar spaces, leading to penile erection.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (local action); minimal systemic absorption after intracavernosal injection.
Tmax:
Onset of erection typically within 5-20 minutes.
FoodEffect:
Not applicable (intracavernosal injection).
Distribution:
Vd:
Not well characterized due to local action.
ProteinBinding:
Approximately 81% bound to plasma proteins (albumin and alpha-1-acid glycoprotein).
CnssPenetration:
Limited/Negligible systemic penetration.
Elimination:
HalfLife:
Approximately 0.5-10 minutes (local half-life in corpus cavernosum); systemic half-life is very short (seconds to minutes).
Clearance:
Rapid local and systemic clearance.
ExcretionRoute:
Metabolites are primarily excreted renally (approximately 90% within 24 hours) and fecally (approximately 10%).
Unchanged:
Less than 1% of the injected dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
5-20 minutes after injection.
PeakEffect:
Variable, typically within 10-30 minutes.
DurationOfAction:
Erection typically lasts 30-60 minutes, or until ejaculation. Should not exceed 1 hour.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Redness, lumps, swelling, tenderness, or curving of the erection (hard penis)
Irritation at the injection site
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Severe headache
Shortness of breath
Unexplained bruising or bleeding
Swelling of the leg veins
If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical help immediately. This can occur even when you are not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction and impotence.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Penile pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Redness, lumps, swelling, tenderness, or curving of the erection (hard penis)
Irritation at the injection site
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Severe headache
Shortness of breath
Unexplained bruising or bleeding
Swelling of the leg veins
If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical help immediately. This can occur even when you are not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction and impotence.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Penile pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Erection lasting longer than 4 hours (priapism)
- Severe penile pain
- New or worsening penile curvature or lumps (fibrosis)
- Significant bruising or swelling at the injection site
- Dizziness or fainting
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have been advised against engaging in sexual activity due to health concerns.
If you have a deformed penis, penile implant, or other penile problems.
Certain health conditions, such as polycythemia or thrombocythemia.
Conditions that may increase the risk of painful erections or prolonged erections (lasting more than 4 hours), including leukemia, multiple myeloma, sickle cell anemia, or other relevant health issues. If you are unsure, consult your doctor.
If you are female, as this medication is not approved for use in women.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have been advised against engaging in sexual activity due to health concerns.
If you have a deformed penis, penile implant, or other penile problems.
Certain health conditions, such as polycythemia or thrombocythemia.
Conditions that may increase the risk of painful erections or prolonged erections (lasting more than 4 hours), including leukemia, multiple myeloma, sickle cell anemia, or other relevant health issues. If you are unsure, consult your doctor.
If you are female, as this medication is not approved for use in women.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Before consuming alcohol, discuss the potential risks with your doctor. It is crucial to note that this medication does not protect against the transmission of diseases like HIV or hepatitis through sexual contact. Always use a latex or polyurethane condom during sexual activity, and consult your doctor if you have any questions or concerns.
When using the injection form of this medication, there is a risk of the needle breaking, which can result in part of the needle remaining in the penis. If the needle breaks and you can grasp the broken end, carefully remove it and contact your doctor. However, if you are unable to retrieve the broken end, seek medical attention immediately.
This medication contains benzyl alcohol, which can cause severe side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. As this medication is not approved for use in children, it is vital to discuss any concerns with your doctor.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Before consuming alcohol, discuss the potential risks with your doctor. It is crucial to note that this medication does not protect against the transmission of diseases like HIV or hepatitis through sexual contact. Always use a latex or polyurethane condom during sexual activity, and consult your doctor if you have any questions or concerns.
When using the injection form of this medication, there is a risk of the needle breaking, which can result in part of the needle remaining in the penis. If the needle breaks and you can grasp the broken end, carefully remove it and contact your doctor. However, if you are unable to retrieve the broken end, seek medical attention immediately.
This medication contains benzyl alcohol, which can cause severe side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. As this medication is not approved for use in children, it is vital to discuss any concerns with your doctor.
Overdose Information
Overdose Symptoms:
- Priapism (prolonged erection)
- Severe penile pain
- Hypotension (low blood pressure)
- Dizziness or fainting
What to Do:
For priapism, seek immediate medical attention. Management may involve aspiration of blood from the corpus cavernosum and/or intracavernosal injection of an alpha-adrenergic agonist (e.g., phenylephrine). For hypotension, supportive care may be needed. Call 1-800-222-1222 (Poison Control) for further guidance if needed.
Drug Interactions
Contraindicated Interactions
- Other treatments for erectile dysfunction (e.g., oral PDE5 inhibitors, other intracavernosal agents) due to risk of priapism.
Major Interactions
- Anticoagulants (e.g., warfarin, heparin): Increased risk of hematoma or bleeding at the injection site.
- Antihypertensives: Although systemic absorption is minimal, theoretical risk of additive hypotensive effects, especially in patients prone to orthostatic hypotension.
Monitoring
Baseline Monitoring
Cardiovascular status assessment
Rationale: To ensure patient is healthy enough for sexual activity and to identify contraindications (e.g., unstable cardiovascular disease).
Timing: Prior to initiation of therapy.
Penile and perineal examination
Rationale: To identify anatomical abnormalities or conditions that may contraindicate use (e.g., severe penile curvature, fibrotic plaques).
Timing: Prior to initiation of therapy.
Patient education on injection technique
Rationale: Crucial for safe and effective self-administration and to minimize adverse effects.
Timing: Prior to first self-injection.
Routine Monitoring
Duration of erection
Frequency: With each use
Target: 30-60 minutes
Action Threshold: If erection lasts >4 hours, seek immediate medical attention (priapism).
Injection site reactions (pain, bruising, swelling)
Frequency: With each use
Target: Minimal to none
Action Threshold: Persistent or severe pain, significant bruising/hematoma, or swelling should be reported.
Penile fibrosis or Peyronie's disease progression
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Absence of new plaques or worsening curvature
Action Threshold: Development of new penile curvature, nodules, or fibrotic plaques may require discontinuation.
Blood pressure (if patient is on antihypertensives)
Frequency: As clinically indicated, especially if symptoms of hypotension occur.
Target: Within patient's normal range
Action Threshold: Significant drop in blood pressure or symptomatic hypotension.
Symptom Monitoring
- Priapism (erection lasting >4 hours)
- Severe penile pain
- Penile swelling or bruising
- Penile curvature or nodules (signs of fibrosis)
- Dizziness or lightheadedness (signs of hypotension)
Special Patient Groups
Pregnancy
Not indicated for use in women. No data available on use in pregnant women.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not indicated for use in women. Not known if alprostadil is excreted in human milk.
Infant Risk:
Not applicable
Pediatric Use
Contraindicated in pediatric patients. Safety and efficacy have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, geriatric patients may have underlying cardiovascular conditions or be on medications that could interact, requiring careful assessment and monitoring.
Clinical Information
Clinical Pearls
- Proper patient selection and education on injection technique are paramount to minimize adverse effects and ensure efficacy.
- Patients must be instructed on the management of priapism and the importance of seeking immediate medical attention for erections lasting longer than 4 hours.
- Rotation of injection sites (e.g., alternating sides and locations on the shaft) is crucial to prevent localized adverse effects like fibrosis or scarring.
- Alprostadil is often considered for patients who fail or have contraindications to oral PDE5 inhibitors.
- The initial dose should be administered in a healthcare setting to monitor for response and adverse effects, and to ensure proper technique.
Alternative Therapies
- Oral phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Vacuum erection devices (VEDs)
- Penile implants (prostheses)
- Urethral alprostadil suppository (Muse)
- Penile revascularization surgery (rarely indicated)
- Psychosexual counseling
Cost & Coverage
Average Cost:
Varies widely, typically $500-$1000+ per 6-pack of 20mcg cartridges
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Specialty drug), may require prior authorization or step therapy.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.