Edex 10mcg Inj Cartridgekit (6 Pk)
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
Drug Class
Drugs for erectile dysfunction
Pharmacologic Class
Prostaglandin E1 analog; Vasodilator
Pregnancy Category
Not applicable
FDA Approved
Jun 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Edex is a medicine injected directly into the penis to help men get and keep an erection. It works by relaxing the blood vessels in the penis, allowing more blood to flow in and cause an erection. It's used when other treatments for erectile dysfunction haven't worked or aren't suitable.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. Administer the injection into the side of the penis as directed by your doctor or as described in the package insert.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Do not shake the vial or prefilled syringe.
3. Attach a new needle before each dose. Discard any bent needles, as they may break and cause injury. Never attempt to straighten a bent needle.
4. After administering the dose, apply light pressure to the injection site for 5 minutes to prevent bruising and until any bleeding stops.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles.
Do not use the medication if the solution has changed color.
Each prefilled syringe or vial is for single use only. Discard any remaining medication after administration.
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have questions, consult your doctor or pharmacist.
Administration Technique
Alternate the side of the penis and injection site with each dose to minimize the risk of complications.
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 Dose
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 provided information carefully. Administer the injection into the side of the penis as directed by your doctor or as described in the package insert.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Do not shake the vial or prefilled syringe.
3. Attach a new needle before each dose. Discard any bent needles, as they may break and cause injury. Never attempt to straighten a bent needle.
4. After administering the dose, apply light pressure to the injection site for 5 minutes to prevent bruising and until any bleeding stops.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles.
Do not use the medication if the solution has changed color.
Each prefilled syringe or vial is for single use only. Discard any remaining medication after administration.
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have questions, consult your doctor or pharmacist.
Administration Technique
Alternate the side of the penis and injection site with each dose to minimize the risk of complications.
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 Dose
This medication is used as needed. Do not use it more frequently than prescribed by your doctor.
Lifestyle & Tips
- Always use proper injection technique as instructed by your doctor or nurse.
- Rotate injection sites on the penis to avoid scarring or damage.
- Do not use more than one injection in a 24-hour period, and no more than three injections per week.
- Avoid alcohol or other substances that might impair your judgment or ability to inject safely.
- This medication does not protect against sexually transmitted diseases (STDs). Use condoms for STD prevention.
- This medication does not prevent pregnancy.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 2.5 mcg, titrated in increments of 2.5-5 mcg until an effective, but not prolonged, erection is achieved. Max single dose 40 mcg. Max frequency 3 times per week, with at least 24 hours between doses.
Dose Range:
2.5 - 40 mg
Condition-Specific Dosing:
neurogenic_etiology:
Initial dose 1.25 mcg, titrated cautiously.
renal_impairment:
No specific dose adjustment required.
hepatic_impairment:
No specific dose adjustment required.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required.
Dialysis:
No specific adjustment required; systemic absorption is minimal.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required.
Pharmacology
Mechanism of Action
Alprostadil is a synthetic prostaglandin E1 (PGE1) analog. It acts by directly relaxing the smooth muscle of the corpus cavernosum and dilating the cavernosal arteries, leading to increased arterial inflow and veno-occlusion, which results in penile erection. This effect is mediated by activation of adenylate cyclase, increasing intracellular cyclic adenosine monophosphate (cAMP) levels.
Pharmacokinetics
Absorption:
Bioavailability:
Local (intracavernosal); systemic bioavailability is very low due to rapid local metabolism.
Tmax:
Onset of action within 5-20 minutes.
FoodEffect:
Not applicable (intracavernosal injection).
Distribution:
Vd:
Not extensively studied due to local action; minimal systemic distribution.
ProteinBinding:
Approximately 81% bound to plasma proteins (albumin and alpha-1-acid glycoprotein).
CnssPenetration:
Limited
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 enzymatic degradation.
ExcretionRoute:
Metabolites primarily excreted renally (90%) and fecally (10%).
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
5-20 minutes
PeakEffect:
5-20 minutes
DurationOfAction:
Duration of erection is dose-dependent, typically 30-60 minutes, but should not exceed 1 hour.
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
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which may occur even when not having sex. If left untreated, this can lead to lasting sexual problems 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 contact your doctor or seek medical help if you're bothered by any of the following:
Penile pain
Other side effects not listed here
If you have questions or concerns about side effects, don't hesitate to reach out to 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
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which may occur even when not having sex. If left untreated, this can lead to lasting sexual problems 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 contact your doctor or seek medical help if you're bothered by any of the following:
Penile pain
Other side effects not listed here
If you have questions or concerns about side effects, don't hesitate to reach out to 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 during or after injection.
- New or worsening curvature or bending of the penis.
- Lumps or hard spots in the penis.
- Significant bruising or swelling at the injection site.
- Dizziness or lightheadedness.
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, including any symptoms.
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, as they may increase the risk of painful or prolonged erections (lasting more than 4 hours): leukemia, multiple myeloma, sickle cell anemia, or other conditions that may affect blood cells. If you are unsure about your condition, consult your doctor.
If you are female, as this medication is not approved for use in women.
Additionally, it is crucial to disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
as well as any existing health problems to your doctor and pharmacist. This information will help determine whether it is safe to take this medication with your other drugs and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first 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, including any symptoms.
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, as they may increase the risk of painful or prolonged erections (lasting more than 4 hours): leukemia, multiple myeloma, sickle cell anemia, or other conditions that may affect blood cells. If you are unsure about your condition, consult your doctor.
If you are female, as this medication is not approved for use in women.
Additionally, it is crucial to disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
as well as any existing health problems to your doctor and pharmacist. This information will help determine whether it is safe to take this medication with your other drugs and health conditions. Do not initiate, stop, or adjust 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, stand up slowly after sitting or lying down, and exercise caution 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 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, stand up slowly after sitting or lying down, and exercise caution 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 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), though rare due to minimal systemic absorption
What to Do:
For priapism, seek immediate medical attention (e.g., emergency room). Treatment may involve aspiration of blood from the corpus cavernosum or intracavernosal injection of an alpha-adrenergic agonist (e.g., phenylephrine). For systemic symptoms like hypotension, supportive care. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Major Interactions
- Other vasodilators (e.g., papaverine, phentolamine): Concomitant use with other intracavernosal agents is not recommended due to increased risk of priapism.
Moderate Interactions
- Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding or hematoma at the injection site.
- Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding or hematoma at the injection site.
- Alpha-blockers (e.g., prazosin, tamsulosin): Potential for additive hypotensive effects, though systemic absorption is minimal.
Monitoring
Baseline Monitoring
Patient education on proper injection technique
Rationale: To ensure safe and effective use and minimize adverse events.
Timing: Prior to first self-administration
Assessment of underlying cardiovascular health
Rationale: To identify patients for whom sexual activity is inadvisable or who may be at higher risk for systemic effects (though minimal).
Timing: Before initiation
Routine Monitoring
Duration of erection
Frequency: With each use
Target: Sufficient for intercourse, not exceeding 1 hour
Action Threshold: Erection lasting >4 hours (priapism) requires immediate medical attention.
Injection site for pain, bruising, fibrosis, nodule formation
Frequency: Regularly, with each use and during follow-up visits
Target: Absence of significant pain, bruising, or palpable abnormalities
Action Threshold: Persistent pain, significant bruising, or development of nodules/fibrosis warrants evaluation and potential discontinuation.
Blood pressure (if patient has cardiovascular risk factors or is on hypotensive medications)
Frequency: Periodically, especially during dose titration
Target: Stable, within patient's normal range
Action Threshold: Significant drop in blood pressure or symptoms of hypotension.
Symptom Monitoring
- Erection lasting longer than 4 hours (priapism)
- Severe penile pain
- Penile curvature or angulation
- Nodules or lumps in the penis
- Significant bruising or hematoma at injection site
- Dizziness or lightheadedness (rare, due to systemic absorption)
Special Patient Groups
Pregnancy
Not applicable for indicated use in male patients. Alprostadil is not indicated for use in women.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable for indicated use in male patients. Alprostadil is not indicated for use in women.
Infant Risk:
Not applicable
Pediatric Use
Not indicated for pediatric use in erectile dysfunction. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
No specific dose adjustment is required based on age. However, older patients may have underlying cardiovascular conditions or be on medications that could interact, requiring careful assessment and monitoring.
Clinical Information
Clinical Pearls
- Proper patient training on injection technique is crucial to minimize adverse events and ensure efficacy.
- Emphasize the importance of rotating injection sites (e.g., alternating sides and locations on the shaft) to prevent localized fibrosis or scarring.
- Priapism (erection lasting >4 hours) is a medical emergency and requires immediate intervention to prevent permanent penile damage.
- Patients should be advised to start with the lowest effective dose and titrate slowly to find the optimal dose that produces an erection suitable for intercourse without causing prolonged erection.
- Alprostadil is contraindicated 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), or penile implants.
- This medication does not offer protection against sexually transmitted infections.
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 - Medicated Urethral System for Erection, also alprostadil)
- Lifestyle modifications (e.g., diet, exercise, smoking cessation, alcohol reduction)
- Psychological counseling
Cost & Coverage
Average Cost:
Varies widely, typically $500-$1000+ per 6-pack of cartridges
Generic Available:
Yes
Insurance Coverage:
Varies by insurance plan; often Tier 3 or higher, may require prior authorization or be excluded.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.