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Alprostadil

 
  Generic Name: Alprostadil (injectable and transurethral) (al PROS ta dil)
 
  Brand Names: Caverject, Caverject Impulse, Edex, Muse, Prostin VR Pediatric, Edex Refill  
     
   
 

What is alprostadil?

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 is the most important information I should know about alprostadil?

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.

What should I discuss with my healthcare provider before using alprostadil?

Do not use alprostadil if you have:

  • sickle cell anemia or the sickle cell anemia trait;

  • leukemia;

  • a tumor of the bone marrow (multiple myeloma);

  • chronic urination problems;

  • a history of blood clots;

  • a curved or deformed penis;

  • penile fibrosis or Peyronie's disease; or

  • if you have been told you should not have sexual intercourse for health reasons.

Before using alprostadil, tell your doctor if you have:

  • a bleeding or blood-clotting disorder;

  • a disease that could be passed in blood (such as hepatitis or HIV);

  • heart disease;

  • high blood pressure (hypertension); or

  • if you have a penile implant.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

Use a condom to prevent transfer of this medication to your sexual partner if she is pregnant or could become pregnant.

Alprostadil should not be used by women or by anyone under 18 years old.

How should I use alprostadil?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. 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.

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).

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.

To be sure this medication is not causing harmful effects, your penis will need to be examined on a regular basis. It is important that you not miss any scheduled appointments.

Alprostadil injectable is a powder medicine that comes with a sterile liquid for mixing it. Caverject Impulse is a brand of alprostadil injectable supplied as a needle and syringe that contains both the powder medicine and the sterile liquid. The dose is automatically mixed when you turn a dial on the end of the syringe. The Caverject Impulse syringe is designed for only one use. Carefully follow the instructions provided with this product.

Do not mix alprostadil injectable or draw your dose into a syringe until you are ready to give yourself an injection. Do not shake the mixed medication. After mixing, the medication should be clear, without any particles in it.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

The Caverject Impulse device uses a very thin needle, which could break easily. If the needle breaks during injection and you can see and grasp the broken end, remove it and contact your doctor. If you cannot remove the broken end, call your doctor right away.

An alprostadil injection can cause bleeding where the needle is placed. This can make it easier for your sexual partner to be exposed to your blood. Before using this medication, tell your doctor if you have a virus such as hepatitis or HIV, which can be passed to another person who comes into contact with your blood.

Do not use more than 2 alprostadil pellets in one day (24 hours). Do not use more than 3 alprostadil injections per week. Allow at least 24 hours to pass between injections.

Storing this medicine:

  • Keep each urethral pellet in its original foil pouch until you are ready to use it. Store the foil pouches in the refrigerator. You may store the pouches at room temperature for up to 14 days.
  • Store alprostadil injectable at room temperature. The 40 microgram strength of unmixed alprostadil can be stored at room temperature for up to 3 months, or until the expiration date on the label, whichever happens first.
  • Do not expose alprostadil products to freezing or very hot temperatures. Do not store your medication in a closed automobile, or pack it into luggage that will be placed into a cargo area during travel.

What happens if I miss a dose?

Since alprostadil is used as needed, you will not be on a dosing schedule.

What happens if I overdose?

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

What should I avoid while using alprostadil?

Alprostadil can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Alprostadil side effects

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.

Alprostadil Dosing Information

Usual Adult Dose for Erectile Dysfunction:

Parenteral:

Erectile dysfunction of vasculogenic, psychogenic or mixed etiology:
Initial: 2.5 mcg injected intracavernously into the lateral penis. If there is a partial response, the dose may be increased, within one hour, by 2.5 mcg to a dose of 5 mcg, and then in increments of 5 to 10 mcg, depending on erectile response, until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. If there is no response to the initial dose of 2.5 mcg dose, the second dose may be increased to 7.5 mcg within one hour, followed by increments of 5 to 10 mcg. No more than 2 doses should be given within a 24-hour period during initial titration.

Erectile dysfunction of pure neurogenic etiology (spinal cord injury):
Initial: 1.25 mcg injected intracavernously into the lateral penis. If there is a partial response, the dose may be increased,within one hour, by 1.25 mcg to a dose of 2.5 mcg, followed by an increment of 2.5 mcg to a dose of 5 mcg, and then in 5 mcg increments until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. No more than 2 doses should be given within a 24-hour period during initial titration.

Maximum: doses of greater that 60 mcg are not recommended.

Transurethral suppository:
The dosage strengths of alprostadil suppositories include 125 mcg, 250 mcg, 500 mcg, and 1000 mcg per urethral suppository. The administration of these dose forms of alprostadil requires substantial assistance and patient education by qualified health care professionals. It is recommended that patients begin with either the 125 mcg or 250 mcg urethral suppositories and increase or decrease the dose based on clinical response. The lowest dose necessary to maintain an erection suitable for intercourse and achieve full detumescence within 1 hour is optimal.

Usual Pediatric Dose for Patent Ductus Arteriosus:

Initial: alprostadil for injection to treat patent ductus arteriosus must be administered via continuous IV infusion. Begin infusion with 0.05 to 0.1 mcg/kg/min. If the response to this initial dose is inadequate, the dosage can be increased up to 0.4 mcg/kg/min, although in general, higher infusion rates do not produce greater effects.

Maintenance: after a therapeutic response is achieved, reduce the infusion rate to the lowest possible dosage that maintains the response. This may be accomplished by slowly reducing the dosage in a stepwise fashion from 0.1 to 0.05 to 0.025 to 0.01 mcg/kg/min.

What other drugs will affect alprostadil?

Before using alprostadil, tell your doctor if you are using any of the following drugs:

  • nitroglycerin;

  • hydralazine (BiDil); or

  • a blood thinner such as warfarin (Coumadin), heparin, dalteparin (Fragmin), danaparoid (Orgaran), or enoxaparin (Lovenox).

This list is not complete and here may be other drugs that can interact with alprostadil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about alprostadil.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.02. Revision Date: 4/12/2009 4:39:51 PM.;
 
 
 
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