Caverject Impulse 10mcg Kit (2 Syr)

Manufacturer PFIZER US Active Ingredient Alprostadil Injection(al PROS ta dill) Pronunciation al-PROS-ta-dill
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
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Drug Class
Erectile Dysfunction Agent
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Pharmacologic Class
Prostaglandin E1 Analog; Vasodilator
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Pregnancy Category
Not applicable (for male use)
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FDA Approved
Sep 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Alprostadil 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.
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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 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 gentle pressure to the injection site for 5 minutes to prevent bruising and continue until any bleeding stops.

Important Safety Precautions

Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. Each prefilled syringe or vial is intended for single use only; discard any remaining medication after administration. Dispose of used needles in a designated needle/sharp disposal box, and do not reuse needles or other materials. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.

Administration Site Rotation

To minimize the risk of bruising or other complications, alternate the side of the penis and the 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 Dose Instructions

This medication is used as needed, and you should not use it more frequently than directed by your doctor. If you have any questions or concerns about using this medication, consult your doctor or pharmacist for guidance.
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Lifestyle & Tips

  • Learn proper injection technique from your healthcare provider.
  • Rotate injection sites to prevent scarring and fibrosis.
  • Do not use more than 3 times per week and allow at least 24 hours between doses.
  • Store the medication as directed (refrigerated or at room temperature depending on formulation, protect from light).
  • Discard needles and syringes safely in a sharps container.

Dosing & Administration

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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, and 40 mcg until an erectile response suitable for intercourse is achieved. Maintenance dose should be the lowest effective dose.
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

erectileDysfunction: Administer intracavernosally. Dosing should be individualized. Do not use more than 3 times per week, with at least 24 hours between doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended.
Dialysis: No specific adjustment recommended.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended.

Pharmacology

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Mechanism of Action

Alprostadil is a synthetic prostaglandin E1 (PGE1) analog. It acts by relaxing the smooth muscle of the corpora cavernosa and 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, leading to increased intracellular cyclic AMP (cAMP) levels.
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Pharmacokinetics

Absorption:

Bioavailability: High (local administration)
Tmax: 5-20 minutes (onset of erection)
FoodEffect: Not applicable (intracavernosal)

Distribution:

Vd: Not available (primarily local action)
ProteinBinding: Approximately 81% (to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 5-10 minutes (systemic elimination of active metabolites)
Clearance: Rapid
ExcretionRoute: Primarily renal (metabolites), small amount in feces.
Unchanged: Less than 1% (systemically)
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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

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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

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.

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 persist, 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.
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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 (fibrosis).
  • Significant bruising or bleeding at the injection site.
  • Dizziness or lightheadedness.
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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.

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 medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
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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, consult with your doctor to discuss any potential interactions. It is crucial to note that this medication does not prevent the transmission of sexually transmitted diseases like HIV or hepatitis. 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.
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Overdose Information

Overdose Symptoms:

  • Prolonged erection (priapism)
  • Severe penile pain
  • Hypotension (rare)

What to Do:

For priapism, seek immediate medical attention. Treatment may involve aspiration of blood from the corpus cavernosum and/or intracavernosal injection of an alpha-adrenergic agonist (e.g., phenylephrine). Call 1-800-222-1222 (Poison Control) for general overdose information.

Drug Interactions

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Major Interactions

  • Other erectile dysfunction treatments (e.g., oral PDE5 inhibitors like sildenafil, tadalafil, vardenafil, avanafil; other intracavernosal agents like papaverine, phentolamine): Concomitant use may increase the risk of priapism.
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Moderate Interactions

  • Anticoagulants (e.g., warfarin, heparin): May increase the risk of hematoma or bruising at the injection site.
  • Antihypertensives: May cause additive hypotensive effects, though systemic absorption is minimal.

Monitoring

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Baseline Monitoring

Cardiovascular status

Rationale: To assess suitability for sexual activity and potential risks of systemic effects.

Timing: Prior to initiation of therapy

Penile anatomy

Rationale: To identify conditions that may contraindicate use (e.g., severe curvature, fibrotic plaques).

Timing: Prior to initiation of therapy

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Routine Monitoring

Duration of erection

Frequency: With each dose

Target: Sufficient for intercourse, but not exceeding 1 hour

Action Threshold: If erection lasts > 4 hours, seek immediate medical attention (priapism).

Injection site reactions (pain, bruising, fibrosis)

Frequency: With each dose and during follow-up visits

Target: Minimal to none

Action Threshold: Persistent pain, significant bruising, or development of penile fibrosis warrants re-evaluation and potential discontinuation.

Blood pressure

Frequency: Periodically, especially in patients with cardiovascular disease

Target: Within normal limits for the patient

Action Threshold: Significant hypotension, though rare, requires evaluation.

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Symptom Monitoring

  • Penile pain
  • Prolonged erection (priapism)
  • Penile fibrosis or curvature
  • Bruising or hematoma at injection site
  • Dizziness or lightheadedness (rare, due to systemic hypotension)

Special Patient Groups

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Pregnancy

Not indicated for use in women. No known risk to a fetus if used by a male partner.

Trimester-Specific Risks:

First Trimester: Not applicable
Second Trimester: Not applicable
Third Trimester: Not applicable
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Lactation

Not indicated for use in women. No known risk to a nursing infant if used by a male partner.

Infant Risk: Not applicable
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Not indicated for use in this population.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, older patients may have underlying cardiovascular conditions that should be considered before initiating therapy. The lowest effective dose should be used.

Clinical Information

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Clinical Pearls

  • Proper injection technique is crucial to minimize side effects and maximize efficacy. Patients should be thoroughly trained by a healthcare professional.
  • Priapism (erection lasting > 4 hours) is a medical emergency and requires immediate intervention to prevent permanent penile damage.
  • Penile fibrosis, including Peyronie's disease, is a potential long-term complication, especially with prolonged use. Regular follow-up is important.
  • Patients with conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia) should use alprostadil with extreme caution or avoid it.
  • Alprostadil does not protect against sexually transmitted diseases.
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Alternative Therapies

  • Oral phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
  • Vacuum erection devices
  • Penile implants (prosthesis)
  • Urethral suppositories (Muse - alprostadil)
  • Penile revascularization surgery (rarely)
  • Lifestyle modifications (e.g., diet, exercise, smoking cessation, alcohol reduction)
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300 per 2-syringe kit
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization)
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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 check with your pharmacist for more information. 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 details about the medication taken, the amount, and the time it happened.