Edex 40mcg Inj Cartridge Kit (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
FDA Approved
Oct 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 create 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 Administration
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
Each prefilled syringe or vial is intended for a single use only. After administering the dose, discard any remaining medication. 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, 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 Administration
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
Each prefilled syringe or vial is intended for a single use only. After administering the dose, discard any remaining medication. 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, 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
- Learn proper injection technique from your healthcare provider. Incorrect injection can cause serious side effects.
- Do not inject more than 3 times per week, and allow at least 24 hours between injections.
- Do not use if you have conditions that make you prone to prolonged erections (e.g., sickle cell anemia, multiple myeloma, leukemia).
- Avoid sharing needles or cartridges.
- Store medication as directed (refrigeration often required for powder, room temperature for reconstituted solution for limited time).
- This medication does not protect against sexually transmitted diseases (STDs).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized titration, typically 5-20 mcg per dose. Max 40 mcg per dose. Not more than 3 times per week, with at least 24 hours between doses.
Dose Range:
2.5 - 40 mg
Condition-Specific Dosing:
initial_dose:
2.5 mcg (for neurogenic ED) or 5 mcg (for vasculogenic/mixed ED), or 1.25 mcg if history of priapism or severe hypotension with other ED treatments.
titration:
Increase by 2.5-5 mcg increments until optimal response (erection suitable for intercourse, lasting no longer than 1 hour).
maintenance:
Once optimal dose is determined, patient self-administers.
Pediatric Dosing
Neonatal:
Not established (Not indicated for ED)
Infant:
Not established (Not indicated for ED)
Child:
Not established (Not indicated for ED)
Adolescent:
Not established (Not indicated for ED)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific dose adjustment recommended, but use with caution due to potential for systemic effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but use with caution due to potential for systemic effects.
Pharmacology
Mechanism of Action
Alprostadil is a synthetic prostaglandin E1 (PGE1). It induces erection by relaxing cavernosal smooth muscle and dilating the penile arteries, thereby increasing arterial inflow and trapping of blood in the lacunar spaces. This process involves activation of adenyl cyclase, leading to increased intracellular cyclic adenosine monophosphate (cAMP) levels, which in turn causes smooth muscle relaxation.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (local administration)
Tmax:
5-20 minutes (onset of erection)
FoodEffect:
Not applicable (intracavernosal injection)
Distribution:
Vd:
Not available (primarily local action)
ProteinBinding:
Approximately 81% (to albumin and alpha-globulin)
CnssPenetration:
Limited
Elimination:
HalfLife:
5-10 minutes (intracavernosal)
Clearance:
Rapid
ExcretionRoute:
Primarily renal (90% of metabolites within 24 hours), with a small amount via feces.
Unchanged:
Less than 1% (systemically)
Pharmacodynamics
OnsetOfAction:
5-20 minutes
PeakEffect:
5-20 minutes
DurationOfAction:
Up to 60 minutes (duration of erection suitable for intercourse), depending on dose and individual response.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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 long-term sexual dysfunction and impotence.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Penile pain
This is not an exhaustive list of all 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 medical attention right away:
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 long-term sexual dysfunction and impotence.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Penile pain
This is not an exhaustive list of all 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) - seek immediate medical attention.
- Severe pain in the penis.
- New or worsening curvature, lumps, or changes in the penis.
- Dizziness, lightheadedness, or fainting.
- Signs of infection at the injection site (redness, swelling, pus).
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 treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms 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.
If you have been diagnosed with polycythemia or thrombocythemia.
If you have any of the following health conditions: leukemia, multiple myeloma, sickle cell anemia, or other conditions that may increase the risk of painful erections (priapism) or prolonged erections lasting more than 4 hours. 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 you determine if it is safe to take this medication with your other treatments. Do not initiate, stop, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the symptoms 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.
If you have been diagnosed with polycythemia or thrombocythemia.
If you have any of the following health conditions: leukemia, multiple myeloma, sickle cell anemia, or other conditions that may increase the risk of painful erections (priapism) or prolonged erections lasting more than 4 hours. 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 you determine if it is safe to take this medication with your other treatments. Do not initiate, stop, or modify the dosage of any medication without first 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 exercise caution when navigating 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 essential to consult with your doctor to discuss any concerns or questions you may have.
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 exercise caution when navigating 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 essential to consult with your doctor to discuss any concerns or questions you may have.
Overdose Information
Overdose Symptoms:
- Priapism (prolonged erection lasting more than 4 hours)
- Severe penile pain
- Hypotension (low blood pressure)
- Dizziness or fainting
What to Do:
Seek immediate medical attention. For priapism, medical intervention (e.g., aspiration of blood, intracavernosal injection of alpha-adrenergic agents) may be necessary. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Major Interactions
- Other erectile dysfunction treatments (e.g., PDE5 inhibitors like sildenafil, tadalafil): Concomitant use is not recommended due to potential for severe hypotension and/or prolonged erection/priapism.
- Anticoagulants (e.g., warfarin, heparin): Increased risk of hematoma or bleeding at the injection site.
Moderate Interactions
- Antihypertensives (e.g., alpha-blockers, diuretics): May have additive hypotensive effects, especially in patients prone to orthostatic hypotension.
- Vasodilators (e.g., nitrates): Potential for additive hypotensive effects.
Monitoring
Baseline Monitoring
Erectile Dysfunction Etiology
Rationale: To determine appropriate initial dosing and assess suitability for alprostadil.
Timing: Prior to initiation of therapy
Cardiovascular Status
Rationale: To assess patient's ability to tolerate sexual activity and potential systemic effects of alprostadil.
Timing: Prior to initiation of therapy
Penile Anatomy
Rationale: To check for conditions like Peyronie's disease or penile fibrosis that may contraindicate use.
Timing: Prior to initiation of therapy
Injection Technique Training
Rationale: Ensure patient can safely and effectively self-administer the injection.
Timing: Prior to first self-injection
Routine Monitoring
Efficacy of Erection
Frequency: During dose titration and periodically thereafter
Target: Erection suitable for intercourse, lasting no longer than 60 minutes.
Action Threshold: If erection is insufficient or lasts too long, adjust dose or consider alternative therapy.
Injection Site Reactions
Frequency: With each injection and during follow-up visits
Target: Minimal pain, bruising, or swelling.
Action Threshold: Persistent pain, significant hematoma, or signs of infection require evaluation.
Penile Fibrosis/Peyronie's Disease
Frequency: Periodically (e.g., every 3-6 months)
Target: Absence of palpable nodules, curvature, or plaques.
Action Threshold: Development of new curvature, nodules, or signs of fibrosis may require discontinuation.
Duration of Erection
Frequency: With each injection
Target: Erection should not exceed 60 minutes.
Action Threshold: Erection lasting > 4 hours (priapism) requires immediate medical attention.
Symptom Monitoring
- Priapism (erection lasting > 4 hours)
- Severe penile pain
- Penile curvature or angulation
- Penile fibrosis or nodules
- Injection site hematoma or bruising
- Dizziness or lightheadedness (especially upon standing)
Special Patient Groups
Pregnancy
Not applicable. Alprostadil (Edex) is indicated for use in males for erectile dysfunction and is not intended for use in women.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable. Alprostadil (Edex) is indicated for use in males for erectile dysfunction and is not intended for use in women.
Infant Risk:
Not applicable
Pediatric Use
Not indicated for pediatric use for erectile dysfunction. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
No specific dose adjustment is required based on age alone. However, geriatric patients may have a higher incidence of underlying cardiovascular disease or other comorbidities that could affect the safety profile. Use with caution and consider overall health status.
Clinical Information
Clinical Pearls
- Proper patient training on injection technique is paramount to minimize adverse events and ensure efficacy.
- Patients should be advised to alternate injection sites (e.g., left and right side of the penis) to reduce the risk of localized adverse effects like fibrosis.
- The most common adverse effects are penile pain, prolonged erection, and priapism. Patients must be educated on how to manage a prolonged erection and when to seek emergency care.
- Alprostadil does not protect against sexually transmitted infections.
- Patients should be screened for cardiovascular risk factors before starting therapy, as sexual activity itself poses a cardiac risk.
- Avoid use in patients with conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia) or with anatomical deformities of the penis (e.g., severe angulation, cavernosal fibrosis, Peyronie's disease).
Alternative Therapies
- Oral phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Vacuum erection devices (VEDs)
- Penile implants (prostheses)
- Urethral suppositories (e.g., MUSE - Alprostadil urethral suppository)
- Penile revascularization surgery (rarely indicated)
- Testosterone replacement therapy (if hypogonadism is present)
Cost & Coverage
Average Cost:
$500 - $1000+ per 6-pack of 40mcg cartridges
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Non-preferred brand/Specialty drug)
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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.