Caverject Kit

Alprostadil is given by injection into the blood-filled spaces of the penis. Your doctor will determine the appropriate dose of alprostadil by assessing the nature of the impotence. Your doctor will give an initial injection and then slowly increase the dose over the course of the next injections until the lowest dose for an effective erection is found. Erection should occur within 5 to 20 minutes after injection.

The initial dose of alprostadil is usually around 1.25 µg to 2.5 µg (depending on the cause of the erectile dysfunction). The amount of medication will be increased until the lowest effective dose is reached. The maximum daily dose should not exceed 60 µg. Alprostadil should be used no more than once a day and no more than 3 times a week, with at least 24 hours between each dose.

If the erection lasts for 2 hours, try to reduce the erection by methods suggested by the doctor. A prolonged erection (3 hours or more) should be reported to the doctor immediately.

Do not inject alprostadil into an erect penis. Never increase or decrease the dose without consulting your doctor. Once the correct dose has been found, the first few injections will take place at your doctor's office so you can learn how to inject the medication properly. Once your doctor is assured that you are comfortable with the procedure, you will be given a prescription for a kit to use at home.

Refer to the package insert for details on how to mix the medication and inject it properly. Everything you need to use the medication comes with the kit. It is important to visit your doctor regularly, at least once every 3 months during treatment, to ensure that the medication is working safely and effectively.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Caverject Kit (Alprostadil-urogenital) exactly as prescribed by your doctor.

Store unused vials of Caverject Kit (Alprostadil-urogenital) between 2°C and 30°C and do not let it freeze. Keep it out of the reach of children. Once mixed, the solution must be used immediately. Each vial is intended for a single use only. Safely discard any remaining solution after using the injection. Do not reuse or share needles.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause pain in the penis; it may cause a prolonged erection; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; when used, it may cause a temporary burning sensation. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

20 µg/vial kit
Each case contains a single-dose vial of alprostadil 20 µg sterile powder, 1 mL prefilled syringe of BWFI (bacteriostatic water for injection) diluent, a 27-gauge 0.5 inch needle, 2 alcohol swabs, and a patient administration leaflet. These cases are fitted with a lock designed for safe and convenient disposal of the contents after use. Once reconstituted, each mL contains alprostadil 20 µg, lactose monohydrate 172 mg, sodium citrate dihydrate 47 µg, benzyl alcohol 8.4 mg, and sterile water for injection qs.

Do not use alprostadil (Caverject®) if you:

• are allergic to alprostadil (Caverject®) or any ingredients of the medication
• are a man for whom sexual activity is inadvisable
• have conditions that increase the risk of priapism, such as sickle cell Anemia, Multiple Myeloma, or Leukemia
• have deformations of the penis, such as angulation, fibrosis, or Peyronie's disease
• have penile implants

Do not use Caverject Kit (Alprostadil-urogenital) if you are female or less than 18 years of age.

There may be an interaction between alprostadil (Caverject®) and any of the following:

• anticoagulants (e.g., Warfarin, Heparin)
• phosphodiesterase-5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood-borne diseases: The injection of alprostadil may cause a small amount of bleeding at the injection site. For those with a blood-borne disease, this may increase the risk of transferring the disease between sexual partners.

Prolonged erection: If the erection lasts for 2 hours, try to reduce the erection by methods suggested by your doctor. A prolonged erection (3 hours or more) or priapism (a painful erection lasting longer than 6 hours) should be reported to your doctor immediately.

Sexually transmitted infections (STIs): This medication does not reduce the risk of passing HIV or other sexually transmitted infections to others through sexual contact or blood contamination. It is recommended that latex condoms be used in combination with Caverject Kit (Alprostadil-urogenital) to protect against these infections.

This product must be used according to the instructions provided by your pharmacist. For more information, read the instructions in the package carefully. Generally, this medication is used only as needed. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.