Caverject Impulse

DRUG DESCRIPTION

CAVERJECT contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1) and is designated chemically as (11? ,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.

Alprostadil is a white to off-white crystalline powder with a melting point between 115 and 116C. Its solubility at 35C is 8000 micrograms (mcg) per 100 milliliter double distilled water.

The structural formula of alprostadil is represented below:

Caverject (alprostadil) structural formula illustration

CAVERJECT IMPULSE (alprostadil dual chamber system for injection) is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE (alprostadil dual chamber system for injection) is available in two strengths for intracavernosal administration:

10 microgram - The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol.

20 microgram - The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol.

When necessary, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.

What are the possible side effects of alprostadil (Caverject, Caverject Impulse, Edex, Muse, Prostin VR Pediatric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • bleeding from your urethra;
  • bleeding, bruising, or swelling where you injected the medication;
  • a painful erection that lasts 4 hours or longer;
  • ...

Read All Potential Side Effects and See Pictures of Caverject Impulse

What are the precautions when taking alprostadil dual chamber system for injection (Caverject Impulse)?

Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), blood system cancers (e.g., leukemia, multiple myeloma), sickle cell anemia.

Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method such as a latex or polyurethane condom during all sexual activity. Consult...

Read All Potential Precautions of Caverject Impulse


Caverject Impulse Consumer (continued)

SIDE EFFECTS: Mild/moderate pain, irritation, or slight bleeding at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: redness/tenderness/swelling of the penis, lumps/unusual curving of the penis.

In the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using alprostadil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), blood system cancers (e.g., leukemia, multiple myeloma), sickle cell anemia.

Use of this drug does not protect against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method such as a latex or polyurethane condom during all sexual activity. Consult your doctor or pharmacist for more details.


Caverject Impulse Patient Information Including Side Effects

Brand Names: Caverject, Caverject Impulse, Edex, Muse, Prostin VR Pediatric

Generic Name: alprostadil (injectable and transurethral) (Pronunciation: al PROS ta dil)

  • What is alprostadil (Caverject Impulse)?
  • What are the possible side effects of alprostadil (Caverject Impulse)?
  • What is the most important information I should know about alprostadil (Caverject Impulse)?
  • What should I discuss with my healthcare provider before using alprostadil (Caverject Impulse)?
  • How should I use alprostadil (Caverject Impulse)?
  • What happens if I miss a dose (Caverject Impulse)?
  • What happens if I overdose (Caverject Impulse)?
  • What should I avoid while using alprostadil (Caverject Impulse)?
  • What other drugs will affect alprostadil (Caverject Impulse)?
  • Where can I get more information?

What is alprostadil (Caverject Impulse)?

Alprostadil is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This alprostadil medication guide addresses only the adult male use of this medication in erectile disorders.

Alprostadil relaxes blood vessels and muscles in the penis. This increases blood flow into the penis, causing an erection.

Alprostadil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of alprostadil (Caverject Impulse)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • bleeding from your urethra;
  • bleeding, bruising, or swelling where you injected the medication;
  • a painful erection that lasts 4 hours or longer;
  • severe pain or irritation of your penis or urethra; or
  • redness, lumps, tenderness, unusual shape or curving of the erect penis.

Less serious side effects may include:

  • pain in your penis, urethra, or testicles;
  • headache, dizziness;
  • back pain;
  • a rash on the skin of your penis;
  • warmth or numbness of your penis; or
  • cough, stuffy nose, cold symptoms.

Your sexual partner may also experience side effects such as burning, itching, or irritation of the body areas that come into contact with your penis.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about alprostadil (Caverject Impulse)?

Alprostadil is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This alprostadil medication guide addresses only the adult male use of this medication in erectile disorders.

The injectable form of alprostadil is injected into the side of the penis. The transurethral form is a very small suppository (pellet) that is inserted into the opening of the penis (the urethra).

Use this medication exactly as it was prescribed for you. Using too much alprostadil can be very dangerous. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your first dose of this medicine will be given in your doctor's office so you can be observed for how well the medication works and if it causes any side effects. You will then be shown how to properly give the medication to yourself.

Do not give yourself an alprostadil injection or pellet if you do not understand the instructions for proper use. Call your doctor, nurse, or pharmacist for help with injection instructions. Using an alprostadil transurethral pellet improperly could cause damage to your urethra.

Alprostadil is used only when needed to get an erection. An erection should occur within 5 to 20 minutes after you use the medication, and should last for 30 to 60 minutes. The length of time your erection lasts may be slightly different from these averages.

Seek emergency medical attention if you think you have used too much of this medication. Symptoms of an alprostadil overdose may include feeling light-headed, fainting, or having a painful or prolonged erection lasting 4 hours or longer.

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