Caverject 40mcg Inj Vial

Manufacturer PFIZER US Active Ingredient Alprostadil Injection(al PROS ta dill) Pronunciation Al-PROS-tah-dil
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
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Drug Class
Agent for Erectile Dysfunction
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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 1995
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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 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, and do not use a bent or damaged needle. If a needle becomes bent, do not attempt to straighten it, as this may cause it to break.
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, and follow local regulations for disposing of the box when it is full. 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 vary by brand. Some brands require refrigeration, while others should be stored at room temperature. If you are unsure about the storage instructions, consult your pharmacist.

Missed Dose

This medication is used as needed, so you do not need to follow a regular dosing schedule. However, do not use the medication more frequently than directed by your doctor.
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Lifestyle & Tips

  • Always use a new, sterile needle and syringe for each injection.
  • Rotate injection sites on the penis (alternate sides and locations) to prevent scarring and fibrosis.
  • Do not inject into the same spot twice in a row.
  • Do not use more than one injection in a 24-hour period and no more than three injections per week.
  • Avoid using alcohol or other recreational drugs, as they can impair erectile function and potentially interact with the medication.
  • Do not use alprostadil with other erectile dysfunction medications (e.g., Viagra, Cialis) due to the risk of dangerously prolonged erections (priapism) and low blood pressure.
  • Properly dispose of used needles and syringes in a sharps container.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose 2.5 mcg (neurogenic ED) or 1.25 mcg (vasculogenic/mixed ED), titrated to effective dose. Max single dose 60 mcg. Not more than once daily and not more than 3 times per week.
Dose Range: 1.25 - 60 mg

Condition-Specific Dosing:

Erectile Dysfunction (ED) - Neurogenic etiology: Initial dose: 2.5 mcg intracavernosally. If partial response, increase by 2.5 mcg to 5 mcg, then by 5 mcg increments until optimal dose is reached. Max single dose: 60 mcg.
Erectile Dysfunction (ED) - Vasculogenic, psychogenic, or mixed etiology: Initial dose: 1.25 mcg intracavernosally. If partial response, increase by 1.25 mcg to 2.5 mcg, then by 5 mcg increments until optimal dose is reached. Max single dose: 60 mcg.
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Pediatric Dosing

Neonatal: Not established (Caverject is for ED)
Infant: Not established (Caverject is for ED)
Child: Not established (Caverject is for ED)
Adolescent: Not established (Caverject is for ED)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended due to rapid local metabolism and minimal systemic exposure.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.
Dialysis: No specific dose adjustment recommended.

Hepatic Impairment:

Mild: No specific dose adjustment recommended due to rapid local metabolism and minimal systemic exposure.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose 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 corpus cavernosum and dilating the cavernosal arteries, leading to increased arterial inflow and veno-occlusion, which traps blood within the lacunar spaces, resulting 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: Not applicable (local intracavernosal administration)
Tmax: Not applicable (local effect, onset within 5-20 minutes)
FoodEffect: Not applicable

Distribution:

Vd: Not available (primarily local effect)
ProteinBinding: Approximately 81% (to albumin)
CnssPenetration: Limited (minimal systemic exposure)

Elimination:

HalfLife: Approximately 0.5-10 minutes (local intracavernosal); Systemic half-life is very short (e.g., 30 seconds to 1 minute) due to rapid pulmonary metabolism.
Clearance: Rapid (primarily local and pulmonary metabolism)
ExcretionRoute: Metabolites primarily excreted renally (approximately 90% within 24 hours) and fecally (approximately 10%).
Unchanged: Less than 1% (systemically)
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Pharmacodynamics

OnsetOfAction: 5-20 minutes after intracavernosal injection
PeakEffect: 5-20 minutes after intracavernosal injection
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 Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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

Erectile Dysfunction Warning

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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Penile pain

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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 1 hour: Contact your doctor immediately.
  • Erection lasting longer than 4 hours (priapism): Seek immediate emergency medical attention. This is a medical emergency that can cause permanent damage to the penis.
  • Severe penile pain, swelling, or bruising that does not resolve.
  • Development of lumps, bumps, or curvature in the penis (signs of penile fibrosis or Peyronie's disease).
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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 determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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, 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 remember 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 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. This medication is not approved for use in children. It is essential to discuss the potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Priapism (erection lasting >4 hours)
  • Severe penile pain
  • Hypotension (low blood pressure), dizziness, lightheadedness

What to Do:

For priapism, seek immediate emergency medical attention. Management may involve aspiration of blood from the corpus cavernosum and/or intracavernosal injection of alpha-adrenergic agonists (e.g., phenylephrine). For hypotension, supportive care.

Drug Interactions

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Contraindicated Interactions

  • Other treatments for erectile dysfunction (e.g., oral PDE5 inhibitors like sildenafil, tadalafil, vardenafil, avanafil) due to increased risk of priapism and/or hypotension.
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Moderate Interactions

  • Anticoagulants (e.g., warfarin, heparin, direct oral anticoagulants): Increased risk of injection site hematoma or bleeding.
  • Antihypertensives: Although systemic absorption is minimal, theoretical risk of additive hypotensive effects, especially in patients prone to orthostatic hypotension.
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Confidence Interactions

Monitoring

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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

Patient education on proper injection technique

Rationale: To ensure safe and effective self-administration and minimize adverse effects.

Timing: Prior to first self-injection

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Routine Monitoring

Duration of erection

Frequency: With each dose

Target: Erection sufficient for intercourse, not exceeding 1 hour.

Action Threshold: If erection lasts >1 hour, patient should seek medical attention. If >4 hours, seek immediate medical attention for priapism.

Injection site for hematoma, bruising, pain

Frequency: With each dose and during follow-up visits

Target: Minimal to no bruising/pain

Action Threshold: Significant or persistent pain, large hematoma, or signs of infection require medical evaluation.

Penile examination for fibrosis or curvature

Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)

Target: Absence of palpable nodules, plaques, or significant curvature.

Action Threshold: Development of penile fibrosis, nodules, or angulation may necessitate discontinuation of therapy.

Blood pressure (especially in patients on antihypertensives)

Frequency: Periodically, especially during dose titration

Target: Within normal limits for the patient

Action Threshold: Significant hypotension or orthostatic changes may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Penile pain (during or after injection)
  • Prolonged erection (priapism, erection lasting >4 hours)
  • Penile fibrosis, nodules, or curvature
  • Injection site bruising, swelling, or hematoma
  • Dizziness or lightheadedness (rare, due to systemic hypotension)

Special Patient Groups

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Pregnancy

Not applicable. Caverject is indicated for use in adult males.

Trimester-Specific Risks:

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

Not applicable. Caverject is indicated for use in adult males.

Infant Risk: Not applicable
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Pediatric Use

Caverject is not indicated for use in pediatric patients for erectile dysfunction. Safety and efficacy have not been established 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 or be on multiple medications, which should be considered. Caution should be exercised in patients with pre-existing cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Proper patient selection and education on injection technique are crucial for successful and safe use.
  • Patients should be instructed on how to manage a prolonged erection (e.g., applying ice packs, seeking medical attention for erections >1 hour, and immediate emergency care for priapism >4 hours).
  • Rotation of injection sites is essential to minimize the risk of penile fibrosis, which can lead to permanent penile deformity.
  • The lowest effective dose should be used to achieve an erection sufficient for intercourse, not exceeding 1 hour.
  • Alprostadil is often considered for patients who do not respond to or have contraindications to oral PDE5 inhibitors.
  • Patients should be advised to avoid sharing needles or vials.
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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, which also contains alprostadil)
  • Lifestyle modifications (e.g., diet, exercise, smoking cessation, alcohol reduction)
  • Psychological counseling
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Cost & Coverage

Average Cost: Variable (typically $100-$300 per vial, depending on strength and pharmacy) per 1-2 vial(s)
Generic Available: Yes
Insurance Coverage: Specialty Tier (often requires prior authorization and may have quantity limits)
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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 details. If you have any questions or concerns about your 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 information about the medication taken, the amount, and the time it happened.