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The following safety information outlines the important risks and precautions associated with the use of alprostadil injection. Please review this information carefully and consult your healthcare provider if you have any questions or concerns.

• Prolonged Erection (Priapism): Seek immediate medical attention if an erection persists beyond 4 hours, as this can cause permanent damage. Alprostadil injection is not recommended for individuals with conditions like sickle cell anemia, multiple myeloma, or leukemia that increase the risk of prolonged erections. Your healthcare provider will prescribe the lowest effective dose and monitor your dosage every 3 months. Never adjust your dose without consulting your provider.

• Penile Scarring: Rarely, prolonged use of alprostadil injection may cause scarring and penile curvature. Regular examinations will be conducted by your provider to monitor for scarring. If detected, you will be advised to discontinue use.

• Low Blood Pressure: Alprostadil injection may lead to low blood pressure, causing dizziness, lightheadedness, or fainting. If these occur, sit immediately to prevent falls. Take the lowest necessary dose to minimize this risk, especially if you are on other medications that lower blood pressure.

• Bleeding at Injection Site: Minor bleeding may occur. If you use blood thinners or have a bleeding disorder, your risk increases. Apply sterile gauze or an alcohol swab to the site for 5 minutes post-injection. Discuss the risks with your provider if you are on blood thinners.

• Heart Problems from Sexual Activity: Sexual activity can strain the heart, particularly if you have a history of heart problems. Avoid using alprostadil injection if advised against sexual activity by your provider. Report symptoms like chest pain, dizziness, or nausea immediately.

• Needle Breakage: There is a risk of needle breakage during injection, which may require surgical removal. Ensure you fully understand the injection process and seek guidance from your provider or pharmacist if needed.

• Not for Children: Caverject and Caverject Impulse contain benzyl alcohol, which is unsafe for children and can cause severe side effects such as "gasping syndrome." Only Prostin VR, an intravenous form of alprostadil, is appropriate for specific neonatal heart conditions.

• Sexually Transmitted Infections: Alprostadil injection does not protect against STIs, including HIV. Use condoms, undergo regular STI testing, and limit sexual partners. Female partners of childbearing age should consider contraception.

Contraindications: Avoid using alprostadil injection if you have conditions that predispose you to prolonged erections (e.g., sickle cell anemia, leukemia, multiple myeloma), an abnormally-formed penis or Peyronie's disease, or if you have penile implants. Always consult your healthcare provider if any of these conditions apply to you.

Common side effects:

• Penile pain

Less common but important to monitor:

• Bleeding or bruising at the injection site
• Penile curvature
• Development of scar tissue in the penis
• Hematoma (blood pooling) at or near the injection site

Serious side effects:

• Prolonged erection (lasting more than four hours)
• Heart-related symptoms (chest pain, dizziness, or nausea)

When using alprostadil, it's important to be aware of potential interactions with other medications, as these can affect its safety and effectiveness. Alprostadil is a vasodilator, meaning it relaxes blood vessels to increase blood flow. Combining it with other medications that have similar effects can amplify these actions, leading to unintended side effects.

Medications That May Interact with Alprostadil:

• Antihypertensive Agents: Drugs used to lower blood pressure, such as calcium channel blockers, beta-blockers, and angiotensin II receptor antagonists, may enhance the blood pressure-lowering effects of alprostadil. This combination can increase the risk of hypotension (low blood pressure), leading to dizziness or fainting.

• Vasodilators: Other medications that dilate blood vessels, like iloprost or Isosorbide Mononitrate, can intensify alprostadil's vasodilatory effects, potentially causing significant drops in blood pressure.

• Anticoagulants and Antiplatelet Drugs: Medications that prevent blood clotting, such as Dipyridamole, may increase the risk of bleeding when used with alprostadil, which can inhibit platelet aggregation.

• Phosphodiesterase Type 5 (PDE5) Inhibitors: Drugs like Avanafil, Sildenafil, Tadalafil, and Vardenafil, commonly used to treat erectile dysfunction, may have additive effects when combined with alprostadil, increasing the risk of hypotension and priapism (prolonged erections).

Considerations Based on Administration Method:

The likelihood of systemic interactions varies depending on how alprostadil is administered:

• Intracavernosal Injection or Urethral Suppository: These methods result in minimal amounts of alprostadil entering the bloodstream, reducing the potential for systemic drug interactions. However, in individuals with significant venous leakage in the penis, there's a higher chance of alprostadil entering the circulation, which could lead to systemic effects like hypotension.

• Intravenous Administration: This method leads to higher systemic levels of alprostadil, increasing the potential for interactions with other medications that affect blood pressure or bleeding risk.

Recommendations:

Before starting alprostadil, inform your healthcare provider about all medications you're currently taking, including prescription drugs, over-the-counter medications, and supplements. This will help assess potential interactions and ensure the safe use of alprostadil. Always follow your healthcare provider's instructions regarding dosage and administration to minimize risks.