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Edex

Edex(alprostadil) – Actient

THERAPEUTIC CLASS

Prostaglandin E1

INDICATIONS

Treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

ADULT DOSAGE

Adults: Intracavernosal inj; give over 5-10 sec interval and use lowest possible effective dose. If there is no initial response, may give next higher dose within 1 hr. If there is a response, allow 1-day interval before the next dose. Reduce dose if erection is >1 hr. Give no more than 3X/week; allow at least 24 hrs between doses. Dose range: 1-40mcg. Vasculogenic/Psychogenic/Mixed Etiology: Initial: 2.5mcg. Titrate: If there is a partial response, increase to 5mcg and then in increments of 5-10mcg, depending upon erectile response, until the dose that produces an erection suitable for intercourse and not >1 hr is reached. If there is no response, increase 2nd dose to 7.5mcg followed by increments of 5-10mcg. Pure Neurogenic Etiology (Spinal Cord Injury): Initial: 1.25mcg. Titrate: May increase to 2.5mcg, then to 5mcg, and then by 5mcg increments until the dose that produces an erection suitable for intercourse and not >1 hr is reached. First inj must be carried out in physician's office.

HOW SUPPLIED

Inj: 10mcg/mL, 20mcg/mL, 40mcg/mL

CONTRAINDICATIONS

Predisposition to priapism (eg, sickle cell anemia or trait, multiple myeloma, leukemia), anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, Peyronie's disease), penile implants, men for whom sexual activity is inadvisable or contraindicated, women, children, or newborns.

WARNINGS/PRECAUTIONS

Prolonged erection (>4 hrs) and priapism reported; titrate slowly to lowest effective dose to minimize risk. Increased peripheral blood levels of PGE1 and its metabolites may lead to hypotension and/or dizziness. Carefully examine penis at start of therapy and at regular intervals (eg, every 3 months) to identify any penile changes; d/c if penile angulation, cavernosal fibrosis, or Peyronie's disease develops; may resume treatment if penile abnormality subsides. Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy.

ADVERSE REACTIONS

Penile pain, prolonged erection, penile angulation and fibrosis, local bleeding, ecchymosis, hematoma, penis disorder, upper respiratory infection, influenza-like symptoms.

DRUG INTERACTIONS

Not recommended with other vasoactive agents. Increased propensity for bleeding after inj with anticoagulants (eg, warfarin, heparin). Significant changes in PTT and thrombin time with heparin; use with caution.

PREGNANCY

Contraindicated for use in women.

MECHANISM OF ACTION

Prostaglandin E1; relaxes trabecular smooth muscle and dilates cavernous arteries that leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea.

PHARMACOKINETICS

Absorption: Absolute bioavailability (98%); Cmax=16.8pg/mL; Tmax=2-5 min. Distribution: Plasma protein binding (93%). Metabolism: Corpus cavernosum and lungs via oxidation and reduction; 15-keto-PGE1, 15-keto-PGE0, PGE0 (active metabolites). Elimination: Urine (88%), feces (12%); (PGE1) T1/2=9-11 min, (PGE0) T1/2=63.2 min, (15-keto-PGE0) T1/2=40.9 min.

ASSESSMENT

Assess for previous hypersensitivity to the drug, predisposition to priapism (eg, sickle cell anemia or trait, multiple myeloma, leukemia), anatomical deformation of the penis, penile implant, contraindications for sexual activity, and possible drug interactions.

MONITORING

Monitor for prolonged erection, priapism, penile abnormalities, penile fibrosis, hematoma, upper respiratory tract infection, hypotension, dizziness, increase or decrease in BP and pulse rate, and other adverse effects.

PATIENT COUNSELING

Instruct to contact physician if an erection persists for >6 hrs, if any penile pain develops, if nodules or hard tissue in the penis develops, or if any penile redness, swelling, tenderness, or curvature of erect penis occurs. Instruct not to reuse or share needles or cartridges. Provide instruction for the proper disposal of needles and cartridges. Counsel that drug offers no protection from transmission of sexually transmitted or blood-borne diseases.

ADMINISTRATION/STORAGE

Administration: Intracavernous route. Use immediately after reconstitution. Discard any unused sol remaining in the cartridge. Refer to PI for further preparation and administration instructions. Storage: 25°C (77°F); excursions permitted between 15-30°C (59-86°F). Do not store reconstituted sol.


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    Edex

    Edex

    Generic Name: alprostadil (Intraurethral route, Intravenous route, Intracavernosal route)

    al-PROS-ta-dil

    OverviewSide EffectsInteractionsMore… Intravenous route(Solution) Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used only where ventilatory assistance is immediately available .

    Commonly used brand name(s)

    In the U.S.

    • Caverject
    • Edex
    • Muse
    • Prostin VR Pediatric

    In Canada

    • Muse Micro

    Available Dosage Forms:

    • Powder for Solution
    • Kit
    • Suppository
    • Solution

    Therapeutic Class: Erectile Dysfunction Agent

    Pharmacologic Class: Prostaglandin

    Uses For Edex

    Alprostadil belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. Alprostadil is used to produce erections in some men who need treatment for erectile dysfunction (sexual impotence). This medicine causes an erection because it increases the blood flow to the penis.

    Alprostadil injection should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

    Alprostadil is used alone or with medical tests to help diagnose erectile dysfunction that may be caused by nerve or blood vessel problems in the penis.

    Alprostadil is available only with your doctor’s prescription.

    Before Using Edex

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Geriatric

    This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Heparin

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased
    • Bleeding problems—Chance of bleeding at the place of injection may be increased
    • Infection of penis or
    • Red or itchy (inflamed) penis—Conditions may worsen with the use of alprostadil suppositories. Also, local skin problems and minor bleeding from inserting the suppository may occur
    • Conditions causing thickened blood or slower blood flow, including leukemia; multiple myeloma (tumors of the bone marrow); polycythemia, sickle cell disease, or thrombocythemia (blood problems) or
    • Priapism (history of)—Patients with these conditions have an increased risk of priapism (erection lasting longer than 6 hours) while using alprostadil

    Proper Use of alprostadil

    This section provides information on the proper use of a number of products that contain alprostadil. It may not be specific to Edex. Please read with care.

    Special patient directions come with the suppositories and some of the injection medicines. Read the directions carefully before using the medicine.

    For the injections—There are several alprostadil products that can be injected. Although the injection method is the same, the mixing procedures are different. Be sure you know which of these products you will be using and the proper way to mix the injection.

    • One product called Alprostadil for Injection (brand names Caverject and Edex) is available as a powder in an injection bottle (vial). Caverject must be mixed with a solution called Bacteriostatic Water for Injection USP. Edex must be mixed with a solution called Sodium Chloride Injection USP. The solution for mixing comes with your product and may be already loaded into a syringe or contained in another injection bottle (vial).
    • Another product is called Alprostadil Injection (brand names Prostin VR Pediatric and Prostin VR). Although the medicine is already in solution, it is much too strong to be injected into the penis. The solution must be mixed (diluted) with another liquid that is sold as a separate prescription, called 0.9% Sodium Chloride Injection USP. In most cases, a pharmacist will make this solution for you, giving you the proper strength that you need. Check with your doctor or pharmacist to make sure the solution has been diluted before using it.

    It is important to follow several steps to prepare your alprostadil injection correctly. Before drawing up the medicine into the syringe:

    • Wash your hands with soap and water.
    • Set the bottles on a clean surface. Wipe the top of the injection bottles with an alcohol swab. Do not wipe the needle. Throw away the alcohol swab.
    • You may need to attach the needle to the syringe. Do not take the cap off yet.

    How to mix Caverject:

    • If the syringe already contains the Bacteriostatic Water for Injection USP, then you need only add the plunger to the syringe. To do this:
      • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
      • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
      • You are now ready to mix the water and the powder. Skip to the directions under the title, “To mix the water and powder.”
    • If the syringe does not already contain the Bacteriostatic Water for Injection USP, you must withdraw 1 milliliter (mL) of it from the bottle provided. To do this:
      • Pick up the syringe and take the cap off the needle. Pull the plunger back to the 1-mL mark on the syringe. This pulls air into the syringe. Insert the needle into rubber top of the bottle while it is upright and inject the 1 mL of air into the bottle.
      • Turn the bottle upside down using one hand. Be sure the tip of the needle is covered by solution.
      • With your other hand, pull the plunger back slowly to withdraw 1 mL of solution into the syringe. Remove the needle and skip to the directions under the title, “To mix the water and powder.”
    • To mix the water and powder:
      • Insert the needle into the bottle of alprostadil and inject 1 milliliter of Bacteriostatic Water for Injection USP from your syringe into the bottle of alprostadil.
      • Remove the needle from the bottle, holding the barrel of the syringe.
      • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
      • Follow the directions below, “How to draw your dose into the syringe.”

    How to mix Edex:

    • The syringe already contains the Sodium Chloride Injection USP. You need only attach the needle to the syringe and add the plunger. To do this:
      • Remove the needle from its package. Do not remove the needle cap. Gently screw the needle into place on the syringe tip.
      • Pick up the rod-like plunger and place it within the barrel of the syringe until it touches the rubber piece. Gently screw the plunger into the rubber piece until it seems secure. Do not use a lot of force.
      • Hold the syringe by the barrel (not the plunger) and take the cap off the needle.
      • You are now ready to mix the Sodium Chloride Injection USP and the powder.
      • Insert the needle into the bottle of alprostadil and inject 1.2 milliliters of the Sodium Chloride Injection USP from your syringe into the bottle of alprostadil.
      • Remove the needle from the bottle, holding the barrel of the syringe.
      • Gently swirl the bottle to mix the powder into the solution, turning it upside down to wet all the powder in the bottle.
      • Follow the directions below, “How to draw your dose into the syringe.”

    How to mix Prostin VR or Prostin VR Pediatric:

    • You will need to get exact mixing instructions from your doctor or pharmacist if you are given two solutions to be mixed. Follow them carefully, asking the pharmacist or doctor any questions that you might have before injecting the medicine.
    • After you or the pharmacist has mixed these solutions, follow the directions below, “How to draw your dose into the syringe.”

    How to draw your dose into the syringe (for all injection products):

    • Check the solution to make sure it is clear. Do not use the mixture if you can see anything solid in the solution or if the solution is cloudy or colored.
    • After the alprostadil solution is mixed and the needle is inserted into the alprostadil bottle, turn the bottle with the syringe as a unit upside down in one hand. Be sure the tip of the needle is covered by the solution. With your other hand, pull the plunger back slowly to draw the correct dose of the medicine into the syringe.
    • Hold the syringe with the measuring scale at eye level to see that the proper dose is withdrawn and to check for air bubbles. To remove air bubbles, tap gently on the measuring scale of the syringe to move any bubbles to the top of the syringe near the needle.
    • If your dose measures too low in the syringe, withdraw more solution from the bottle. If there is too much medicine in the syringe, put some back into the bottle. Then check your dose again.
    • Remove the needle from the bottle, holding the barrel of the syringe, not the plunger.
    • Place the cover back on the needle. You are now ready to inject your dose. Follow the directions below, “How to give the alprostadil injection.”

    How to give the alprostadil injection:

    • Choose a spot on your penis as directed by your doctor where you will give the injection.
    • Clean the injection site with alcohol. Sitting upright or slightly reclined, hold your penis against the side of your thigh so that it cannot move.
    • Remove the cover from the needle and hold the needle at a 90-degree angle to the place of injection.
    • Insert the needle until almost all of the metal part of the needle is inserted into the penis.
    • Do not inject the medicine just under the surface of the skin, at the top or head of the penis, or at the base of the penis near the scrotum or testes. Avoid injecting the medicine into blood vessels that you can see.
    • Press the plunger down slowly, taking 5 to 10 seconds to release the dose into the penis.
    • The injection is usually not painful. If the injection is very painful or if you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection.
    • Remove the needle and recap it.
    • After you have completed the injection, put pressure on the place of injection for about 5 minutes or until any bleeding stops. This will prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that the medicine will work better.

    Choose a different place of injection each time you use the medicine to prevent skin problems. This includes switching the place of injection from the right side of the penis for one injection to the left side for the next injection.

    After a single-use injection is mixed, the medicine must be used immediately. Throw away any unused mixture in the syringe. It cannot be stored for a later injection.

    Do not reuse your needles.

    How to throw away the syringes and bottles safely:

    Dispose of your materials properly. Caverject comes in a plastic case that can be permanently locked with the red locking device that is included with the packaging. When the case label is removed, you can see a hole in the center of the case. The red locking device can be inserted and, by firmly pressing it down with your thumb, you will permanently lock the case. The locked case is safe to be thrown away.

    If you do not have the plastic case or are using Prostin VR or Prostin VR Pediatric injection, unscrew the needle from the barrel of the syringe. Then bend, break, or cut the needle into two pieces with wire cutters. The pieces can be placed in a heavy plastic container, such as a bleach container, and thrown away. Or you may give them to a health care professional to throw away. If you have any questions about disposing of the syringe and needles, ask your health care professional.

    For suppositories—Before inserting the suppository, you should urinate. The small amount of urine normally left in your urethra will help dissolve the suppository after it is inserted.

    How to insert suppositories:

    • Remove the delivery device containing the suppository from the foil. Remove the cap from the applicator stem.
    • Stretch your penis upward to extend its length, pressing your penis top and bottom. Gently insert the delivery stem up to its collar into your urethra (located at the top of the penis). If you have pain or a pulling feeling in the penis, withdraw the device and start again.
    • Press the button down slowly as far as it will go. This releases the suppository into the urethra. After holding the delivery device within your penis still for 5 seconds, carefully rock the penis and delivery device as a unit from side to side. This helps remove the suppository from the device.
    • Remove the delivery device while your penis is upright. Look at the device to make sure that the suppository was completely released.
    • Repeat the process if a part of the suppository remains in the device.
    • After the suppository is completely released, roll your penis between your hands for 10 seconds. This helps to dissolve the suppository. If you feel any stinging, continue this motion to help stop it.
    • Sitting, standing, or walking for 10 minutes while an erection is developing helps increase the blood flow to your penis to gain a proper erection.

    How to throw away the suppository delivery device safely:

    • Replace the cap on the delivery device. After storing it in the foil, fold and throw away.

    For injections or suppositories—This medicine usually begins to work in about 5 to 10 minutes. You should attempt intercourse within 10 to 30 minutes after using the medicine. An erection may continue after ejaculation.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For the treatment of erectile dysfunction:
      • For injection dosage form:
        • Adults—1.25 to 60 micrograms (mcg) as a single dose once a day. Your exact dose will be determined by your doctor. Inject this medicine very slowly into your penis as shown to you by your doctor ten to thirty minutes before intercourse. Allow five to ten seconds to completely inject the dose. Do not inject more than one dose within twenty-four hours. Also, do not use this medicine for more than two days in a row or more than three times a week.
      • For suppository dosage form:
        • Adults—125, 250, 500, or 1000 mcg as a single dose once a day. Your exact dose will be determined by your doctor. Insert this medicine into the urethra of your penis as shown to you by your doctor ten to thirty minutes before intercourse. Do not insert more than two doses within twenty-four hours.

    Storage

    Store in the refrigerator. Do not freeze.

    You may store the suppositories in the refrigerator, but do not freeze them.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Alprostadil for Injection while in the powder form can be stored at room temperature (between 15 and 25 °C or 59 and 77 °F) for 3 months. After it is mixed, the solution must be used immediately. Suppositories may be stored at room temperature

    Precautions While Using Edex

    Do not use alprostadil if you have a penile implant unless advised by doctor.

    If using the alprostadil suppository, use a condom when having sexual intercourse with a pregnant female. Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medicine on early pregnancy are not known.

    Use alprostadil exactly as directed by your doctor . Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

    Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

    If you notice bleeding at the place where you injected the medicine, put pressure on the spot until the bleeding stops. If it doesn’t stop within 10 minutes, check with your doctor.

    Edex Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Rare

    • Curving of penis with pain during erection
    • erection continuing for 4 to 6 hours
    • erection continuing longer than 6 hours with severe and continuing pain of the penis
    • swelling in or pain of the testes

    Symptoms of too much medicine being absorbed into the body

    • Dizziness
    • faintness
    • pelvic pain
    • flu-like symptoms

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Bleeding at place of injection, short-term
    • mild bleeding or spotting from urethra (suppository only)
    • pain at place of injection
    • painful erection
    • stinging of urethra (suppository only)

    Rare Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.

    • Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

    See also: Edex side effects (in more detail)

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    Edex

    Edex

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

    Brand Name: Caverject, Caverject Impulse, Edex, Muse

    OverviewSide EffectsInteractionsMore…

    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 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.

    You should not use this medication if you are allergic to alprostadil, or if you have sickle cell anemia, leukemia, a bone marrow tumor, a curved or deformed penis, penile fibrosis or Peyronie’s disease, a penile implant, or if you have been told you should not have sexual intercourse for health reasons.

    Before using alprostadil, tell your doctor if you have heart disease, high blood pressure, a bleeding disorder, a history of blood clots, or a disease that could be passed in blood (such as hepatitis or HIV).

    The injectable form of alprostadil is injected into the side of the penis. The transurethral pellet is a very small suppository 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. The medicine comes with patient instructions for safe and effective use. Follow these directions carefully.

    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.

    Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. Call your doctor, nurse, or pharmacist if you have any questions. 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.

    Seek emergency medical attention if you have a painful or prolonged erection lasting 4 hours or longer.

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

    You should not use this medication if you are allergic to alprostadil, or if you have:

    • sickle cell anemia or the sickle cell anemia trait;

    • leukemia;
    • a tumor of the bone marrow (multiple myeloma);
    • a curved or deformed penis;
    • penile fibrosis or Peyronie’s disease;
    • if you have a penile implant; or
    • if you have been told you should not have sexual intercourse for health reasons.

    To make sure you can safely use alprostadil, tell your doctor if you have any of these other conditions:

    • a history of blood clots;

    • heart disease, high blood pressure (hypertension);
    • a bleeding or blood-clotting disorder; or
    • a disease that could be passed in blood (such as hepatitis or HIV).

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

    Caverject, Caverject Impulse, Edex, or Muse should not be used by women or by anyone under 18 years old.

    How should I use alprostadil?

    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. Wait at least 1 day after your first dose before using the medicine again.

    Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Using too much alprostadil can be very dangerous.

    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.

    The injectable form of alprostadil is injected into the side of the penis.

    The transurethral pellet is a very small suppository that is inserted into the opening of the penis (the urethra).

    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.

    Alprostadil comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

    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.

    Use a disposable needle only once. 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.

    Prepare your alprostadil dose only when you are ready to use the medicine. Do not shake the mixed medicine. After mixing, the medication should be clear. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

    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.

    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.

    To be sure this medication is not causing harmful effects, your penis may need to be examined every 3 months. Visit your doctor regularly.

    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 or call the Poison Help line at 1-800-222-1222.

    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?

    This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

    Taking this medication will not prevent you from passing a disease such as hepatitis or HIV to your sexual partner. Avoid having unprotected sex. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

    Alprostadil side effects

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

    Stop using alprostadil and call your doctor at once if you have a serious side effect such as:

    • feeling light-headed, fainting;

    • trouble urinating, blood in your urine;
    • 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:

    • unusual discharge from your penis; or

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

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

    See also: Edex side effects (in more detail)

    What other drugs will affect alprostadil?

    Tell your doctor about all other medicines you use, especially:

    • blood pressure medication; or

    • a blood thinner such as heparin or warfarin (Coumadin, Jantoven).

    This list is not complete and other drugs may interact with alprostadil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

    Next Page → Side Effects

    More Edex resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Interactions
    • Support Group
    • 12 Reviews - Add your own review/rating
    • Generic Availability

    Compare Edex with other medications

    • Erectile Dysfunction

    Where can I get more information?

    • Your pharmacist can provide more information about alprostadil.

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    Edex

    Edex

    Generic Name: alprostadil (al-PROS-ta-dil)

    Brand Name: Edex

    OverviewSide EffectsInteractionsMore…

    Edex is used for:

    Treating erectile problems in men.

    Edex is a prostaglandin (PGE-1). It works by relaxing certain muscles in the penis and widening blood vessels, which increases blood flow to the penis and helps to cause an erection. When the effect of the alprostadil wears off, blood flow returns to normal and the erection disappears.

    Do NOT use Edex if:

    • you are allergic to any ingredient in Edex
    • you have blood problems (eg, sickle cell anemia or sickle cell trait, leukemia), bone marrow problems (eg, multiple myeloma), or other conditions that may increase your rick for a prolonged, painful erection (priapism)
    • you have a penile implant, deformed penis, or certain other penile problems (eg, Peyronie disease, fibrosis of the penis)
    • you have any other physical reason that you should not have sexual intercourse

    Contact your doctor or health care provider right away if any of these apply to you.

    Before using Edex:

    Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have inflammation or infection of the penis, kidney problems, urinary problems (eg, inflammation or narrowing of the urethra), or a history of prolonged or painful erections
    • if you use other medicine for erectile problems
    • if you have a blood-borne disease (eg, HIV, hepatitis)

    Some MEDICINES MAY INTERACT with Edex. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Anticoagulants (eg, warfarin) or heparin because the risk of bleeding may be increased

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Edex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Edex:

    Use Edex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • An extra patient leaflet is available with Edex. Talk to your pharmacist if you have questions about this information.
    • Edex is injected into the penis to produce an erection. A health care provider will teach you how to prepare and use Edex. Be sure you understand how to use Edex. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
    • Check the medicine carefully before you prepare it. Do not use the medicine if it is discolored, if the cartridge is cracked or damaged, or if the amount of medicine in the cartridge seems less than usual.
    • Edex may appear cloudy right after you mix it. This may be due to air bubbles in the syringe. Do not use if Edex if it remains cloudy, contains particles, or is discolored after you mix it.
    • Use Edex right away after you mix it. Do not store mixed medicine for future use.
    • If the needle breaks during the injection, grasp and remove the broken end if possible and contact your doctor. Contact your doctor right away if the needle breaks and you cannot remove it.
    • Use each cartridge one time only. Throw the cartridge away once it is used. Do not reuse any medicine left in the container.
    • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
    • Edex usually starts to work within 5 to 20 minutes after you inject it and lasts about 30 to 60 minutes.
    • Do not use more than one dose of Edex in a 24-hour period or more than 3 doses per week without first checking with your doctor.
    • If you forget to use Edex and you still intend to engage in sexual activity, use it as soon as you remember or as directed by your doctor.

    Ask your health care provider any questions you may have about how to use Edex.

    Important safety information:

    • Edex may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Edex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Do NOT use more than the recommended dose or change your dose without checking with your doctor.
    • Seek medical attention if you experience a painful erection or have an erection that lasts for more than 4 hours (priapism). If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
    • Edex does not protect against the spread of sexually transmitted diseases (STDs) (eg, HIV) or blood-borne diseases (eg, hepatitis B). Use barrier methods of birth control (eg, condoms) if you have an STD or blood-borne disease.
    • If your partner experiences vaginal dryness or painful vaginal sensations, talk with your doctor. It might be necessary to use a water-based lubricant during sexual intercourse.
    • You will need to have regular check-ups with your doctor while you are using Edex. Be sure to keep all doctor and lab appointments.
    • Use Edex with caution in the ELDERLY; they may be more sensitive to its effects.
    • PREGNANCY AND BREAST-FEEDING: It is not known if Edex can cause harm to the fetus. It is not known if Edex if found in breast milk. Edex is not approved for use in women.

    Possible side effects of Edex:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Mild bleeding at the injection site; mild genital pain.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal ejaculation; bleeding from the tip of the penis; bloody urine or change in the amount of urine; chest pain; curving of the erect penis; dizziness; fainting; fast or irregular heartbeat; new or worsening genital pain; painful or prolonged erection; redness, lumps, swelling, tenderness, inflammation, numbness, strange sensation, or discoloration of the penis; severe or persistent bleeding or bruising at the injection site; severe or persistent pain, swelling, or redness at the injection site; swelling of the leg veins; white patches or discharge from the penis.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; lasting pain in the penis; lightheadedness; painful or prolonged erection (eg, erection lasting more than 4 hours).

    Proper storage of Edex: Store Edex at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Edex out of the reach of children and away from pets.

    General information:

    • If you have any questions about Edex, please talk with your doctor, pharmacist, or other health care provider.
    • Edex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Edex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Edex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Edex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Edex.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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