Papaverine (Injection)

Papaverine is a type of medicine known as a vasodilator. Vasodilators make blood vessels widen, which increases blood flow. Papaverine is used to help some men with erectile dysfunction achieve erections. When papaverine is injected into the penis (intracavernosal), it boosts blood flow to the penis, leading to an erection.

Men who do not have erectile dysfunction should not use papaverine injection as a sexual aid. Using this medicine incorrectly can lead to permanent damage to the penis and loss of the ability to have erections.

You can get papaverine only with a prescription from your doctor.

Use Papaverine (Injection) exactly as your doctor instructs. Do not use more than prescribed and do not use it more often than directed. Using too much can cause an erection that lasts too long and does not go away when it should. This condition is called priapism and can be very dangerous. If the effect does not go away, the blood supply to the penis may be cut off, leading to permanent damage.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may indicate priapism and requires immediate treatment to prevent permanent damage.

If you see bleeding at the injection site when using papaverine, apply pressure to the area until the bleeding stops. If the bleeding does not stop, consult your doctor.

It is important for you to check your penis regularly. Speak with your doctor if you notice a lump where the medicine was injected or if your penis is becoming curved. These could be signs of unwanted tissue growth (called fibrosis) that should be evaluated by your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against its benefits. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Many medicines have not been specifically studied in older people. Because of this, it may not be known if they work the same way in older adults as they do in younger adults, or if they cause different side effects in older people. Although there is no specific information comparing the use of papaverine for erectile dysfunction in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Piperaquine
• Riociguat
• Terfenadine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary 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.

• Adagrasib
• Amiodarone
• Amisulpride
• Apomorphine
• Aripiprazole Lauroxil
• Atazanavir
• Buprenorphine
• Ceritinib
• Chloroquine
• Citalopram
• Clofazimine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Deutetrabenazine
• Dexmedetomidine
• Efavirenz
• Encorafenib
• Entrectinib
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gepirone
• Glasdegib
• Hydroxychloroquine
• Hydroxyzine
• Inotuzumab Ozogamicin
• Ivosidenib
• Ketoconazole
• Lefamulin
• Lenvatinib
• Leuprolide
• Lofexidine
• Macimorelin
• Methadone
• Metronidazole
• Mirtazapine
• Mobocertinib
• Nilotinib
• Olanzapine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paroxetine
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Quetiapine
• Quizartinib
• Relugolix
• Ribociclib
• Selpercatinib
• Sertraline
• Siponimod
• Solifenacin
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Trazodone
• Triclabendazole
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ginkgo

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works for you. Be sure to tell your doctor if you have any other medical issues, especially:

• Bleeding problems—These conditions increase the risk of bleeding at the injection site.

• Liver disease—Papaverine can cause liver damage when given in ways that allow it into the bloodstream (by mouth or by injection into a muscle, a vein, or an artery); when papaverine is given by intracavernosal injection, liver damage is much less likely because the medicine enters the bloodstream very slowly.

• Priapism (history of) or
• Sickle cell disease—Patients with these conditions have an increased risk of priapism (an erection lasting longer than 4 hours) while using papaverine.

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

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

Rare

• Dizziness
• Erection lasting more than 4 hours, or painful erection
• Lumps in the penis

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:

Less common

• Bruising or bleeding at the injection site
• Mild burning along the penis
• Difficulty in ejaculating
• Swelling at the injection site

Papaverine injected into the penis may cause tingling at the tip of the penis. This is no cause for concern.

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.

Available Dosage Forms:

• Solution

Therapeutic Class: Peripheral Vasodilator

To give papaverine injection:

• Cleanse the injection site with alcohol. Using a sterile needle, inject the medicine slowly and directly into the base of the penis as instructed by your doctor. Papaverine should not be injected just under the skin. The injection is usually not painful, although you may feel some tingling in the tip of your penis. If the injection is very painful or you notice bruising or swelling at the place of injection, that means you have been injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection.
• After you have completed the injection, put pressure on the place of injection to prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that it will work better.

This medicine usually begins to work in about 10 minutes. You should attempt intercourse within 2 hours after injecting the medicine.

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 injection dosage form: For the treatment of erectile dysfunction: Adults—30 to 60 milligrams (mg) injected very slowly into the area of your penis as directed by your doctor. Allow one or two minutes to completely inject the dose. Do not inject more than one dose in a day. Also, do not use this medicine more than two days in a row or more than three times a week.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.