Edex 20mcg Inj Cartridgekit (2 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
Aug 1997
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 increasing blood flow to the penis, which is necessary for an erection. It is used for erectile dysfunction (ED) when other treatments are not suitable or effective.
How to Use This Medicine
Proper Administration 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. 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 never use a bent needle. If a needle becomes bent, do not attempt to straighten it, as this may cause it to break. After administering the dose, apply light 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 any signs of cloudiness, leakage, or particles. Do not use the medication if you notice any of these issues or if the solution has changed color.
Single-Use Only and Disposal
Each prefilled syringe or vial is intended for a single use only. Discard any remaining medication after administering the dose. Dispose of needles in a designated needle/sharp disposal box. Never reuse needles or other items. When the disposal box is full, follow local regulations for its 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 specific injection site with each dose of this medication.
Storage and Disposal
The storage requirements for this medication may vary depending on the brand. Some brands require refrigeration, while others should be stored at room temperature. If you are unsure about the storage instructions for your specific brand, 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 provided 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 never use a bent needle. If a needle becomes bent, do not attempt to straighten it, as this may cause it to break. After administering the dose, apply light 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 any signs of cloudiness, leakage, or particles. Do not use the medication if you notice any of these issues or if the solution has changed color.
Single-Use Only and Disposal
Each prefilled syringe or vial is intended for a single use only. Discard any remaining medication after administering the dose. Dispose of needles in a designated needle/sharp disposal box. Never reuse needles or other items. When the disposal box is full, follow local regulations for its 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 specific injection site with each dose of this medication.
Storage and Disposal
The storage requirements for this medication may vary depending on the brand. Some brands require refrigeration, while others should be stored at room temperature. If you are unsure about the storage instructions for your specific brand, 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 on the penis to prevent scarring or damage.
- Avoid alcohol consumption, as it can worsen dizziness or lightheadedness.
- Do not share needles or cartridges.
- Store the medication as directed (refrigerated or at room temperature, depending on specific product instructions).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 2.5 mcg, titrated to effective dose. Maintenance dose typically 2.5 mcg to 60 mcg per injection. Max 1 injection per 24 hours, and no more than 3 injections per week.
Dose Range:
2.5 - 60 mg
Condition-Specific Dosing:
erectileDysfunction:
Initial dose 2.5 mcg. 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 until an effective dose is reached, not exceeding 60 mcg. The erection should not last longer than 1 hour. If priapism occurs, the dose should be reduced or discontinued.
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, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Dialysis:
No specific recommendations; systemic exposure is minimal, but caution advised.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
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. This increases arterial inflow and traps blood within the lacunar spaces of the penis, leading to penile erection. It also inhibits platelet aggregation.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (local administration); rapid local absorption into corpus cavernosum.
Tmax:
Not applicable (local administration); onset of erection typically within 5-20 minutes.
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not available (primarily local action)
ProteinBinding:
Approximately 81% (to albumin)
CnssPenetration:
Limited (minimal systemic exposure)
Elimination:
HalfLife:
Approximately 5-10 minutes (in corpus cavernosum); systemic half-life of metabolites is longer (e.g., 30 minutes for 15-keto-PGE1)
Clearance:
Rapid local and systemic clearance
ExcretionRoute:
Metabolites primarily excreted in urine (approx. 90% within 24 hours) and feces (approx. 10%).
Unchanged:
Less than 1% (systemically)
Pharmacodynamics
OnsetOfAction:
5-20 minutes (after injection)
PeakEffect:
10-30 minutes (after injection)
DurationOfAction:
Dose-dependent, typically 30-60 minutes, or until ejaculation. Should not exceed 1 hour.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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 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.
- New lumps, curvature, or changes in the penis (signs of fibrosis or Peyronie's disease).
- Dizziness, lightheadedness, or fainting.
- Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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.
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 existing health problems. This information will help your doctor and pharmacist determine whether 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 first.
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.
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 existing health problems. This information will help your doctor and pharmacist determine whether 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 first.
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. 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. If you have questions or concerns, consult your doctor.
When using the injection form of this medication, there is a risk of the needle breaking. In some cases, the broken needle may remain 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 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. 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. If you have questions or concerns, consult your doctor.
When using the injection form of this medication, there is a risk of the needle breaking. In some cases, the broken needle may remain 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 discuss any concerns with your doctor.
Overdose Information
Overdose Symptoms:
- Prolonged erection (priapism)
- Severe penile pain
- Significant hypotension (dizziness, lightheadedness, fainting)
What to Do:
For priapism, seek immediate medical attention. Treatment may involve aspiration of blood from the corpus cavernosum and/or injection of alpha-adrenergic agonists (e.g., phenylephrine). For hypotension, supportive care. Call 1-800-222-1222 (Poison Control) or emergency services.
Drug Interactions
Major Interactions
- Other treatments for erectile dysfunction (e.g., oral PDE5 inhibitors like sildenafil, tadalafil, vardenafil, avanafil; other intracavernosal agents like papaverine, phentolamine): Concomitant use is contraindicated 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.
- Antihypertensives (e.g., alpha-blockers, ACE inhibitors, calcium channel blockers): Potential for additive hypotensive effects, though systemic absorption is minimal.
Monitoring
Baseline Monitoring
Comprehensive medical history and physical examination
Rationale: To identify underlying causes of ED, contraindications, and assess cardiovascular status.
Timing: Prior to initiation of therapy
Cardiovascular assessment
Rationale: To ensure patient is healthy enough for sexual activity and to identify risks for hypotension.
Timing: Prior to initiation of therapy
Patient training on injection technique
Rationale: To ensure proper and safe self-administration.
Timing: Before first self-injection
Routine Monitoring
Efficacy of erection
Frequency: With each injection
Target: Sufficient for sexual intercourse, lasting no longer than 1 hour
Action Threshold: If erection is insufficient, consider dose titration; if erection is too prolonged, consider dose reduction or medical intervention.
Duration of erection
Frequency: With each injection
Target: < 4 hours
Action Threshold: If erection lasts > 4 hours, seek immediate medical attention (priapism).
Injection site reactions (pain, bruising, hematoma)
Frequency: With each injection and follow-up visits
Target: Minimal to none
Action Threshold: Persistent or severe reactions may require re-evaluation of technique or discontinuation.
Penile fibrosis or Peyronie's disease
Frequency: Regularly during follow-up visits (e.g., every 3-6 months)
Target: Absence of new plaques or curvature
Action Threshold: Development of new penile angulation, cavernosal fibrosis, or Peyronie's disease requires discontinuation of therapy.
Symptom Monitoring
- Priapism (erection lasting > 4 hours)
- Severe penile pain
- Penile bruising or hematoma
- Penile curvature or angulation
- Nodules or lumps in the penis
- Dizziness or lightheadedness (signs of hypotension)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Not applicable. Edex is indicated for male erectile dysfunction.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable. Edex is indicated for male erectile dysfunction.
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 underlying cardiovascular conditions or be on medications (e.g., antihypertensives, anticoagulants) that require careful consideration. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Proper injection technique is paramount to minimize adverse effects like pain, bruising, and fibrosis. Patients must be thoroughly trained.
- Emphasize the importance of rotating injection sites (e.g., alternating sides of the penis and varying the exact spot) to prevent localized tissue damage and fibrosis.
- Educate patients on the critical importance of seeking immediate medical attention for priapism (erection lasting 4 hours or longer) to prevent permanent penile damage.
- Alprostadil is a second-line therapy for ED, often used when oral PDE5 inhibitors are contraindicated, ineffective, or not tolerated.
- Patients with anatomical deformities of the penis (e.g., severe angulation, cavernosal fibrosis, Peyronie's disease) are generally contraindicated due to increased risk of further damage or inadequate response.
Alternative Therapies
- Oral Phosphodiesterase-5 (PDE5) Inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Vacuum Erection Devices (VEDs)
- Penile Implants (prostheses)
- Urethral Alprostadil (Muse)
- Vascular surgery (rarely for specific cases of ED)
- Psychosexual counseling
Cost & Coverage
Average Cost:
Varies significantly, typically $100-$300+ per 2-pack cartridge kit
Generic Available:
Yes
Insurance Coverage:
Often Tier 3 or Specialty Tier; may require prior authorization or step therapy. Coverage varies widely by insurance plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.