Edex

Name: Edex

Edex Overview

Edex is a prescription medication used to certain types of erectile dysfunction. Edex belongs to a group of drugs called vasodilators. These work by relaxing the muscles and blood vessels in the penis so that an erection can occur.

This medication comes in a solution form to be injected into the penis before sexual activity. You should be shown by a healthcare professional proper technique before self-use.

A common side effect of Edex is mild to moderate pain during injection. 

Uses of Edex

Edex is a prescription medication used to treat certain types of erectile dysfunction.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Actient Pharmaceuticals, LLC.

Edex Drug Class

Edex is part of the drug class:

  • Drugs used in erectile dysfunction

Uses For Edex

Alprostadil injection is used to treat men who have erectile dysfunction (also called sexual impotence). It belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. This medicine causes an erection because it increases the blood flow to the penis.

Alprostadil 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.

This medicine 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.

Pediatric

Alprostadil injection is not indicated for use in newborns and should not be used in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of alprostadil injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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 or
  • Heart or blood vessel disease or
  • Leukemia (blood related cancer) or
  • Multiple myeloma (blood related cancer) or
  • Priapism (prolonged erection) or
  • Sickle cell anemia (blood disorder) or
  • Sickle cell trait—Chance of problems occurring may be increased and this medicine should be used with caution in these patients.
  • Bleeding problems—Chance of bleeding at the injection site may be increased.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Priapism, history of—Patients with these conditions have an increased risk of priapism (erection lasting longer than 6 hours) while using alprostadil.

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

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 and pain at the injection site (short-term)
  • painful erection
Rare
  • Bruising or clotted blood in the penis at the injection site, 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.

What do I need to tell my doctor BEFORE I take Edex?

  • If you have an allergy to alprostadil or any other part of Edex (alprostadil injection).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have been told that you are not healthy enough to have sex.
  • If you have a deformed penis, penile implant, or other penile problems.
  • If you have any of these health problems: Polycythemia or thrombocythemia.
  • If you have any of these health problems: Leukemia, multiple myeloma, sickle cell anemia, or other health problems that may raise the chance of painful erection (hard penis) or an erection that lasts for longer than 4 hours. Ask your doctor if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Edex with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Edex, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Edex.

Review Date: October 4, 2017

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