Caverject Impulse 20mcg Kit (2 Syr)
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
Drug Class
Agents for erectile dysfunction
Pharmacologic Class
Prostaglandin E1 analog; Vasodilator
Pregnancy Category
Not applicable (for male use)
FDA Approved
Jun 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alprostadil 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 for erectile dysfunction when other treatments 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 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 medication.
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 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 bruising and other complications.
Storage and Disposal
The storage requirements for this medication vary by 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 medication.
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 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 bruising and other complications.
Storage and Disposal
The storage requirements for this medication vary by 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
- Follow proper injection technique as instructed by your healthcare provider.
- Do not inject more than once in 24 hours and no more than 3 times per week.
- Alternate injection sites (sides of the penis) to minimize local side effects.
- Do not use if you have conditions that predispose you to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
- This medication does not protect against sexually transmitted diseases (STDs). Use barrier methods if needed.
- Avoid alcohol consumption, as it may worsen erectile dysfunction or increase risk of dizziness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 2.5 mcg intracavernosally. If partial response, increase to 5 mcg, then 7.5 mcg, 10 mcg, 20 mcg, 40 mcg until optimal response. Maintenance dose: Individualized, typically 5-20 mcg. Max frequency: Not more than once daily and not more than 3 times per week.
Dose Range:
2.5 - 40 mg
Condition-Specific Dosing:
neurogenic_etiology:
Initial dose: 1.25 mcg. Titrate carefully.
vascular_etiology:
Initial dose: 2.5 mcg. Titrate carefully.
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 directly relaxing cavernosal smooth muscle and dilating the arteries of the corpus cavernosum. This leads to increased arterial inflow and veno-occlusion, trapping blood within the lacunar spaces, thereby inducing penile erection. It also inhibits platelet aggregation.
Pharmacokinetics
Absorption:
Bioavailability:
Rapidly absorbed from the corpus cavernosum.
Tmax:
Not applicable (local action, systemic levels are very low and transient).
FoodEffect:
Not applicable (intracavernosal administration).
Distribution:
Vd:
Not available (primarily local action).
ProteinBinding:
Approximately 81% bound to plasma proteins.
CnssPenetration:
Limited (minimal systemic exposure).
Elimination:
HalfLife:
Approximately 0.5-10 minutes (local half-life in corpus cavernosum); Systemic half-life is very short (seconds to minutes) due to rapid pulmonary metabolism.
Clearance:
Rapid.
ExcretionRoute:
Metabolites are primarily excreted renally (90%) and fecally (10%).
Unchanged:
Less than 1% (systemically).
Pharmacodynamics
OnsetOfAction:
5-20 minutes after injection.
PeakEffect:
5-20 minutes after injection.
DurationOfAction:
Duration of erection is dose-dependent and typically lasts for the duration of sexual intercourse, not exceeding 1 hour. Prolonged erections (>4 hours) are a potential adverse effect.
Safety & Warnings
Side Effects
Urgent 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
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which can occur even when not having sex. If left untreated, this may lead to permanent sexual dysfunction.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people experience no side effects or only mild 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which can occur even when not having sex. If left untreated, this may lead to permanent sexual dysfunction.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people experience no side effects or only mild 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 during or after injection.
- New or worsening penile curvature or lumps (Peyronie's disease).
- 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 treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 the risks associated with your condition, 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 adjust the dosage of any medication without consulting your doctor first.
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 the risks associated with your condition, 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 adjust the dosage 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, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.
Before consuming alcohol, consult your doctor to discuss any potential interactions. 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 are able to grasp the broken end, carefully remove it and contact your doctor immediately. However, 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, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.
Before consuming alcohol, consult your doctor to discuss any potential interactions. 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 are able to grasp the broken end, carefully remove it and contact your doctor immediately. However, 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:
- Prolonged erection (priapism)
- Severe penile pain
- Hypotension (rare, due to systemic absorption)
What to Do:
For priapism, seek immediate medical attention. Management may involve aspiration of blood from the corpus cavernosum and/or intracavernosal injection of alpha-adrenergic agents (e.g., phenylephrine). For other symptoms, supportive care. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Major Interactions
Moderate Interactions
- Alpha-blockers (e.g., Prazosin, Tamsulosin): May potentiate hypotensive effects, though systemic absorption is minimal. Monitor blood pressure.
- Vasodilators (e.g., Nitrates): May potentiate hypotensive effects, though systemic absorption is minimal. Monitor blood pressure.
Monitoring
Baseline Monitoring
Cardiovascular status
Rationale: To assess suitability for sexual activity and identify contraindications.
Timing: Prior to initiation of therapy.
Penile anatomy
Rationale: To rule out conditions like angulation, cavernosal fibrosis, or Peyronie's disease that may contraindicate use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Erection duration and quality
Frequency: During dose titration and ongoing therapy.
Target: Erection suitable for intercourse, lasting no more than 1 hour.
Action Threshold: Erection lasting >4 hours (priapism) requires immediate medical attention. Erection lasting 1-4 hours should be monitored. Inadequate response requires dose adjustment.
Injection site reactions (pain, bruising, hematoma)
Frequency: With each injection and during follow-up.
Target: Minimal to no reaction.
Action Threshold: Severe pain, persistent bruising, or significant hematoma may require re-evaluation of injection technique or discontinuation.
Signs of penile fibrosis/Peyronie's disease
Frequency: Periodically, especially with long-term use.
Target: Absence of palpable nodules or penile curvature.
Action Threshold: Development of nodules, curvature, or pain during erection may necessitate discontinuation and further evaluation.
Symptom Monitoring
- Penile pain during or after injection
- Prolonged erection (priapism)
- Penile bruising or hematoma
- Penile curvature or nodules
- Dizziness or lightheadedness (rare, due to systemic hypotension)
Special Patient Groups
Pregnancy
Not applicable for use in women. Alprostadil is indicated for male erectile dysfunction.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable for use in women. Alprostadil is indicated for male erectile dysfunction.
Infant Risk:
Not applicable
Pediatric Use
Not indicated for pediatric use. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, older patients may have underlying cardiovascular conditions that need to be considered before initiating therapy. Titrate dose carefully.
Clinical Information
Clinical Pearls
- Proper injection technique is paramount to minimize adverse effects and maximize efficacy. Patients must be thoroughly trained.
- Priapism (erection lasting >4 hours) is a medical emergency. Patients must be educated to seek immediate medical attention if this occurs.
- Patients should be advised to alternate injection sites (e.g., left side, right side) to prevent local complications like fibrosis.
- Alprostadil is often considered for patients who do not respond to or cannot tolerate oral PDE5 inhibitors.
- The Caverject Impulse device is designed for ease of use and self-administration, but initial training is crucial.
Alternative Therapies
- Oral Phosphodiesterase-5 (PDE5) inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil, Avanafil)
- Vacuum erection devices (VEDs)
- Penile implants (prosthesis)
- Urethral suppositories (e.g., MUSE - Medicated Urethral System for Erection, also alprostadil)
- Penile revascularization surgery (rarely indicated)
- Testosterone replacement therapy (if hypogonadism is present)
Cost & Coverage
Average Cost:
Varies, typically $100-$300 per 20mcg single-use kit
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty drug, may require prior authorization)
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 taken, the amount, and the time it occurred.