Edex 10mcg Inj Cartridgekit (2 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 for indicated use in males
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Edex is a medicine injected directly into the side of the penis to help men with erectile dysfunction (ED) get and maintain an erection. It works by increasing blood flow to the penis, which helps it become firm.
How to Use This Medicine
Proper Use 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.
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 if attempted to be straightened.
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 needles in a designated needle/sharp disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the box when it is full.
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. If you have any questions or concerns, consult your doctor or pharmacist.
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.
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 if attempted to be straightened.
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 needles in a designated needle/sharp disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the box when it is full.
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. If you have any questions or concerns, consult your doctor or pharmacist.
Lifestyle & Tips
- Learn and practice proper injection technique with your healthcare provider.
- Rotate injection sites (e.g., left side, then right side) to prevent scarring.
- Do not inject more than the prescribed dose or more often than prescribed (maximum 3 times per week, with at least 24 hours between doses).
- Do not use Edex if you have a penile implant or conditions that increase your risk of prolonged erections (priapism).
- Avoid using other ED medications (like Viagra or Cialis) at the same time as Edex, as this can cause dangerously low blood pressure or a prolonged erection.
- Store the medication as directed (refrigerated or at room temperature, depending on formulation).
- Properly dispose of used needles and syringes in a sharps container.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 2.5 mcg (for vasculogenic, psychogenic, or mixed etiology ED) or 1.25 mcg (for neurogenic ED). Titrate in increments of 2.5 mcg, then 5 mcg, until an erection suitable for intercourse is achieved, lasting no longer than 60 minutes. Maintenance dose is typically 10-20 mcg. Maximum single dose is 60 mcg. Maximum frequency is 3 injections per week, with at least 24 hours between doses.
Dose Range:
1.25 - 60 mg
Condition-Specific Dosing:
Erectile Dysfunction (ED):
Initial dose 2.5 mcg (vasculogenic, psychogenic, mixed etiology) or 1.25 mcg (neurogenic etiology). Titrate to effective dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed (minimal systemic absorption)
Moderate:
No specific adjustment needed (minimal systemic absorption)
Severe:
No specific adjustment needed (minimal systemic absorption)
Dialysis:
No specific adjustment needed (minimal systemic absorption)
Hepatic Impairment:
Mild:
No specific adjustment needed (minimal systemic absorption)
Moderate:
No specific adjustment needed (minimal systemic absorption)
Severe:
No specific adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Alprostadil is a synthetic prostaglandin E1 (PGE1). It acts by relaxing the smooth muscle of the corpus cavernosum and dilating the cavernosal arteries, leading to increased arterial inflow and veno-occlusion. This effect is mediated by activation of adenyl cyclase, which increases intracellular cyclic AMP (cAMP) levels, resulting in penile erection.
Pharmacokinetics
Absorption:
Bioavailability:
High (local)
Tmax:
Local effect within minutes
FoodEffect:
Not applicable
Distribution:
Vd:
Not systemically relevant
ProteinBinding:
Not systemically relevant
CnssPenetration:
No
Elimination:
HalfLife:
30 seconds to 10 minutes (local)
Clearance:
Rapid local enzymatic clearance
ExcretionRoute:
Metabolites primarily via urine (80%) and feces (20%)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
5-20 minutes
PeakEffect:
5-20 minutes
DurationOfAction:
Duration of erection (typically 30-60 minutes, but dependent on dose and individual response)
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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 attention 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. 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 help:
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 help 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 attention 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. 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 help:
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 penile pain or discomfort.
- Unusual bruising, swelling, or bleeding at the injection site.
- Dizziness, lightheadedness, or fainting.
- Development of new penile curvature or lumps (fibrosis).
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 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 drugs, natural products, and vitamins, as well as any health problems you are experiencing. This information will help your doctor determine whether it is safe to take this medication in conjunction with your other treatments. Never start, 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 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 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 drugs, natural products, and vitamins, as well as any health problems you are experiencing. This information will help your doctor determine whether it is safe to take this medication in conjunction with your other treatments. Never start, 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, get up slowly from a sitting or lying position, 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 immediately. If you are unable to retrieve the broken end, seek medical attention right away.
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 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 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 immediately. If you are unable to retrieve the broken end, seek medical attention right away.
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 discuss any concerns with your doctor.
Overdose Information
Overdose Symptoms:
- Priapism (prolonged erection lasting >4 hours)
- Severe hypotension (low blood pressure)
- Dizziness
- Syncope (fainting)
What to Do:
Seek immediate medical attention. Management of priapism may involve aspiration of blood from the corpus cavernosum and/or intracavernosal injection of alpha-adrenergic agonists (e.g., phenylephrine). For hypotension, supportive care may be needed.
Drug Interactions
Contraindicated Interactions
- Patients with conditions predisposing to priapism (e.g., sickle cell anemia or trait, multiple myeloma, leukemia)
- Patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease)
- Patients with penile implants
Major Interactions
- Other treatments for erectile dysfunction (e.g., PDE5 inhibitors like sildenafil, tadalafil) - increased risk of severe hypotension and/or priapism
- Alpha-adrenergic blockers (e.g., prazosin, tamsulosin) - additive hypotensive effects
Moderate Interactions
- Anticoagulants (e.g., warfarin, heparin) - increased risk of injection site bleeding, hematoma, or ecchymosis
Monitoring
Baseline Monitoring
Patient history (cardiovascular disease, priapism risk factors, bleeding disorders)
Rationale: To identify contraindications and assess risk of adverse events.
Timing: Prior to initiation of therapy
Physical examination (including penile examination)
Rationale: To identify anatomical abnormalities of the penis (e.g., Peyronie's disease, fibrosis) and assess suitability for injection.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy of erection (duration and rigidity)
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.
Signs of priapism (erection lasting >4 hours)
Frequency: With each injection and for several hours post-injection
Target: Erection resolves within 60 minutes
Action Threshold: Seek immediate medical attention if erection lasts >4 hours.
Injection site reactions (pain, bruising, hematoma, swelling)
Frequency: With each injection
Target: Minimal or no reaction
Action Threshold: If severe or persistent, review injection technique or consider alternative therapy.
Penile fibrosis or curvature
Frequency: Periodically (e.g., every 3-6 months)
Target: No significant fibrosis or curvature
Action Threshold: If significant changes occur, discontinue therapy and evaluate.
Symptom Monitoring
- Erection lasting >4 hours (priapism)
- Severe penile pain
- Unusual penile bruising or swelling
- Development of penile curvature or nodules
- Dizziness or lightheadedness
Special Patient Groups
Pregnancy
Not applicable for indicated use in males.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable for indicated use in males.
Infant Risk:
Not applicable
Pediatric Use
Contraindicated. Not indicated for use in pediatric patients.
Geriatric Use
No specific dose adjustment required based on age alone. However, geriatric patients may have an increased prevalence of cardiovascular disease or other comorbidities that require careful consideration. Monitor for systemic hypotensive effects, although minimal systemic absorption limits this risk.
Clinical Information
Clinical Pearls
- Patients must be thoroughly trained on proper self-injection technique by a healthcare professional before first use.
- Emphasize the critical importance of seeking immediate medical attention for any erection lasting longer than 4 hours to prevent permanent penile damage.
- Advise patients to rotate injection sites (e.g., alternating sides of the penis) to minimize the risk of penile fibrosis and scarring.
- Alprostadil injection is not a contraceptive and does not protect against sexually transmitted infections.
- Patients should be advised to avoid using more than one dose within a 24-hour period and not to exceed 3 injections per week.
- The onset and duration of erection can vary significantly between individuals and with dose.
Alternative Therapies
- Oral phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Vacuum erection devices (VEDs)
- Penile prostheses (implants)
- Urethral suppositories (e.g., MUSE - Medicated Urethral System for Erection, also alprostadil)
- Lifestyle modifications (e.g., diet, exercise, smoking cessation, alcohol moderation)
- Psychological counseling
Cost & Coverage
Average Cost:
Varies widely, typically high per cartridge/kit
Generic Available:
Yes
Insurance Coverage:
Tier 3 or higher (Specialty drug)
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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.