Your safety is our first priority. Learn more about key medication details, possible side effects, warnings, and other important information about Tri-Mix below.
Prescribing Information
Tri-Mix is a compounded injectable medication used for erectile dysfunction. It combines three active ingredients:
- Papaverine
- Phentolamine
- Prostaglandin E1, also known as alprostadil
Tri-Mix is administered by intracavernosal injection directly into the erectile tissue of the penis. The compounded combination is not an FDA-approved finished drug product, and FDA does not review compounded medications for safety, effectiveness, quality, or labeling before they are dispensed.
Depending on the prescription, Tri-Mix may be dispensed in one of the following 5 mL formulations:
- Papaverine 30 mg/mL / Phentolamine 1 mg/mL / Prostaglandin E1 10 mcg/mL
- Papaverine 30 mg/mL / Phentolamine 2 mg/mL / Prostaglandin E1 20 mcg/mL
The appropriate formulation and dose must be selected and individually adjusted by the prescribing provider. Treatment may begin at approximately 0.05 mL, equal to 5 units on a U-100 insulin syringe, when directed by the provider. The dose may then be gradually adjusted based on effectiveness, erection duration, tolerability, and the specific formulation prescribed.
Do not increase or decrease the dose without instructions from your provider. Do not use more than the prescribed maximum dose. Tri-Mix should not be used more than once in 24 hours or more than three times per week.
Important: Only include a specific maximum of 0.5 mL or 50 units here if that limit has been confirmed by the prescribing medical team for both available formulations.
Boxed Warning
Tri-Mix does not have an FDA-approved boxed warning because the compounded combination does not have an FDA-approved prescribing label.
The most important risks include prolonged erection or priapism, penile fibrosis or scar tissue, penile injury, bleeding, infection, dizziness, and low blood pressure.
Common and Possible Side Effects
Common or possible side effects may include:
- Penile pain or aching
- Bruising or bleeding at the injection site
- Injection-site redness, swelling, or irritation
- Prolonged erection
- Dizziness
- Headache
- Low blood pressure or lightheadedness
- Penile scar tissue, hard areas, nodules, or curvature
Important Safety Information
Tri-Mix may not be appropriate for people who:
- Have sickle cell disease or sickle cell trait, multiple myeloma, leukemia, or another condition that increases the risk of priapism
- Have severe penile curvature, penile fibrosis, Peyronie’s disease, or another significant penile deformity
- Have a penile implant
- Are allergic to papaverine, phentolamine, alprostadil, or another ingredient
- Have been advised that sexual activity is medically inadvisable
Tell your provider about all medical conditions and medications, particularly:
- Blood thinners or anticoagulants
- Bleeding disorders
- Heart or cardiovascular disease
- Low blood pressure or fainting
- Previous priapism or prolonged erections
- Peyronie’s disease or penile scar tissue
- Previous penile surgery or injury
- Other oral, injected, or topical erectile-dysfunction medications
Intracavernosal alprostadil labeling warns that patients taking anticoagulants may experience increased injection-site bleeding and that treatment can cause hypotension, prolonged erections, priapism, and penile fibrosis.
Safe Injection Requirements
Use Tri-Mix only after receiving hands-on injection training from a qualified healthcare professional.
- Use only the formulation and dose shown on your prescription label.
- Confirm that you understand the syringe-unit conversion before injecting.
- Never estimate or guess the dose.
- Clean the injection site as instructed.
- Alternate the side and location of each injection.
- Do not inject into visible veins, the top or underside of the penis, scar tissue, or an irritated or infected area.
- Use a new sterile syringe and needle for every injection.
- Never share syringes, needles, medication vials, or injection supplies.
- Apply pressure to the injection site after removing the needle, especially if you take a blood thinner.
- Place used needles and syringes in an approved sharps container.
- Do not combine Tri-Mix with another ED medication unless your prescribing provider specifically directs you to do so.
- Do not inject another dose if the first dose does not produce the desired response.
Patients should be trained before at-home intracavernosal treatment, alternate injection sites, use a new needle for each injection, and avoid changing their dose without provider guidance.
Prolonged Erection or Priapism
An erection lasting more than four hours is a medical emergency.
Seek immediate emergency medical treatment if your erection lasts four hours or longer, even if it is not painful. Delayed treatment can result in permanent penile tissue damage and long-term erectile dysfunction. FDA-approved intracavernosal alprostadil labeling instructs patients to seek immediate medical assistance when an erection persists longer than four hours.
Follow any earlier intervention or rescue instructions provided by your prescribing provider. Do not attempt to treat a prolonged erection using unapproved home remedies or additional medication unless your provider has given you a specific written protocol.
Reporting Side Effects
To report a suspected adverse reaction or medication-quality problem, contact your healthcare provider and submit a report through FDA MedWatch, or call 1-800-FDA-1088.
