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Bi-Mix injectable, 5mL (lyophilized)

SKU
994-emp

Formula: Papaverine HCl 30mg/Phentolamine Mesylate 1mg/mL

Bi-Mix is a self-administered penile injection, typically considered as part of a powerful class of agents to assist with treatment of erectile dysfunction in males. Bi-Mix contains two drugs designed to work synergistically; Papaverine and Phentolamine Mesylate. Papaverine is a vasodilator, which causes blood vessels to expand and helps produce an erection by allowing the increase of blood flow to the penis. Phentolamine induces an erection when injected into the penis by relaxing and dilating blood vessels, along with elevating cardiac output. Bacteriostatic water and mixing syringe are provided for reconstitution. Syringes and needles for injection ordered separately.

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Instructions

Bi-Mix injectable, 5mL

Topics

Use:

This medication is used to treat certain causes of Erectile Dysfunction. It should begin to
work within 5-20 minutes, and its effects should last about 1 hour.

Precautions:


• Follow the dosage regimen your doctor prescribed. Do not use higher doses than recommended.
• Wait a minimum of 24 hours between injections.
• Do not use more than 3 times per week.
• Keep your medication in the light-protective bag provided.
• If the medication becomes cloudy or changes in appearance, throw it away.

Do not use the medication if it:
• Has particles or is cloudy.
• Has expired according to the date on the label.

Do Not Use This Medication If You Have: 
• Hypersensitivity or allergy to any component of this formulation.
• Conditions predisposing you to priapism (a painful erection lasting 4 hours or more): sickle cell anemia, multiple myeloma, or leukemia.
• Anatomical deformation of the penis or with penile implants.
• Been told by your physician that sexual activity is inadvisable or contraindicated.

Possible Side Effects:


• Penile pain
• Headache
• Dizziness
• Injection site bruising
• Prolonged erection

What is priapism: 

Priapism is an involuntary erection which lasts more than 4 hours and is unrelieved by ejaculation.  This condition is a true urological emergency and early treatment allows the best chance for functional recovery.  

How to prevent priapism when taking Tri-Mix or other penile injection therapies (ICP):

  • NEVER take Tri-Mix or any ICP injection within same 24hr period as Viagra/Cialis/Levitra or other ED meds.
  • Start LOW and go SLOW with your dose.  Never start higher than 0.05-0.12ml (5-12 units on syringe) for the FIRST injection. Then gradually increase from there for optimal results.

 

If you experience priapism, or an erection lasting longer than 2 hours:

  • Nonpharmacologic measures - should be attempted first and may be implemented in conjunction with one of the pharmacologic treatments listed below.
    • Apply ice to perineum/scrotal area- If an icepack is not available, you can use a frozen bag of fruit or vegetables.
    • Walk/jog upstairs- This can help redirect blood flow from the penis.
    • Pharmacologic measures:
      • Over-the counter (OTC) medication options (select one)
        • Sudafed with pseudoephedrine – take 30mg orally. Note: federal regulations require medications containing pseudoephedrine be sold behind the pharmacy or service counter. Patients will need to provide a valid photo ID to purchase this medication.
        • Benadryl - take 25mg-50mg orally

If you experience priapism, or an erection lasting longer than 3 hours:

  • Pharmacologic measures:
    • Prescription (Rx) medication option
      • Phenylephrine HCl 0.1% - Inject 0.25ml into the penis every 3-5 minutes (alternating sides) or up to a dose escalation of 1,000 mcg (1mL) for up to one hour until detumescence occurs. After injection, the puncture site should be compressed and the corpora cavernosa massaged to facilitate drug distribution. If you have been prescribed Tri-Mix or any other ICP injection and are concerned about priapism you may request a prescription for Phenylephrine to have on hand.   

If you experience priapism, or an erection lasting longer than 4 hours:

  • If these steps do not work and erection has been present for 4hrs and/or is exquisitely painful then immediately visit the ER for treatment. 
  • If you experience lumps, swelling, tenderness, or curving of the erect penis, contact your physician.

If these do not work and erection has been present for 4hrs and/or is exquisitely painful then immediately visit the ER for treatment. 



Patient Instructions

Bi-Mix- Papaverine HCl 150 mg, Phentolamine Mesylate 5 mg. 5 mL Vial. Lyophilized.

(prescription may also be written as Bi-Mix- Papaverine HCl 30 mg/mL, Phentolamine Mesylate 1 mg/mL. 5 mL Vial).

Each bottle of Bi-Mix will arrive lyophilized (in powder form) and will need to be reconstituted (mixed) with a separate solution (diluent).The diluent is Bacteriostatic Water for Injection, USP. This is sterile water containing 0.9% Benzyl Alcohol added as an antimicrobial preservative. Refrigerate or freeze  after reconstitution according to the storage instructions below.

Reconstitution Directions

Before you begin: Gather the materials you will need on a clean flat surface. Wash hands with soap and water and then dry.

Step 1: Remove the caps from the Bi-Mix injectable vial of powder and bacteriostatic water vial. Wipe the tops with the alcohol swabs and let dry.

Note: if using a 3ml/cc mixing syringe steps 2 - 6 will need to be completed 2 times (in 2mL and 3mL increments) to transfer all the fluid into the powder.

Step 2: Using the mixing syringe tighten the needle to the hub then pull hack the plunger to bring in 5 mL/cc of air.

Step 3: Push the plunger in to add 5 mL of air to the vial and then draw out 5 mL of bacteriostatic water by slowly pulling the plunger back out.

Step 4: Remove the needle from the bacteriostatic water vial and insert it into the Bi-Mix injectable vial of powder.

Step 5: Push the plunger to release the 5 mL of bacteriostatic water into the Bi-Mix injectable vial of powder.

Step 6: Draw out the same volume of air that you've injected (5 mL) from the Bi-Mix injectable medication vial before pulling the needle out. This will keep the pressure equal within the vial. Gently swirl (do not shake) the Bi-Mix injectable vial around until the solution is clear.

Step 7: Discard the remaining bacteriostatic water and store the Bi-Mix injectable vial acording to the storage directions below.

What items do I need to give a shot? 

  • One alcohol wipe.
  • Vial containing the injectable medication.
  • The correct size needle and syringe (included in your package)
  • You may want to use gloves for your protection or the protection of the person getting the shot.

Syringe Education

  • 1cc Insulin syringe (displays units):  Each line on the barrel of an insulin syringe is equal to 10 units of medication once the medication is mixed. So, if your Doctor orders 100 units of medication, you will draw enough medication to fill the syringe to the ‘10’ line. 
  • Larger syringes are not recommended for administration of this medication.
Syringes

 

How to draw up the medication

  1. Gather the materials you will need and place them on a table near the chair or bed where you will be sitting down.
  2. Wash hands with soap and water and then dry.
  3. Use an alcohol wipe to cleanse the rubber stopper.
  4. With a fresh, unused syringe, pull back on the plunger to the amount you are injecting, bringing air into the syringe. Your Doctor will decide the dose and frequency that you will be using Bi-Mix, which will be provided in these instructions.
  5. Now, remove the plastic cap from the needle. Insert the needle into the vial and slowly push (inject) the air from the syringe into the vial. This will displace the liquid in the vial when you withdraw the medication.
  6. Turn the vial and syringe upside down and carefully draw the fl­uid back into the syringe to the line designating the desired amount of medication. If you see any air bubbles, lightly tap or ­flick the syringe to draw the bubbles to the top (the end with the needle) and expel the air. Note that a small amount of medication may release as well. This is normal. You are now ready to inject.
  7. Turn the bottle and syringe upside down. Draw up the recommended dosage into the syringe. Tap the syringe gently and push the plunger to remove air bubbles.
  8. Place the bottle and syringe right side up on the table. Gently remove the syringe from the vial and recap the needle.
  9. Replace the needle with a fresh one. 

How to administer (inject) the medication  

  1. You should be sitting upright or slightly reclined when performing the injection. You will be injecting this medication into the corpora cavernosa, the spongy tissue on the sides of the penis. 
  2. Choose an injection site on the side of the shaft of the penis (shaded area shown in the picture), in the first onehalf area closest to the base of the penis. AVOID VISIBLE BLOOD VESSELS. penile injection001
  3. Holding the head of your penis, stretch it lengthwise along your thigh so that you can clearly see the injection site. penile injection5
  4. Clean the injection site with a new alcohol swab. 
  5. Remove the cover from the needle. Position the penis firmly against your thigh to keep it from moving during the injection. Hold the syringe between your thumb and index finger. Using a steady motion, push the needle straight into the selected site until the metal part is almost entirely in the penis. With a steady motion, push down on the plunger so that the entire volume of solution is slowly injected. Grasp the syringe barrel and pull the needle out of your penis. penile injectionpenile injection4
  6. Apply pressure to the injection site with the alcohol swab for about 5 minutes. 
  7. Place the used syringe in a sharps container for disposal. Do not reuse the syringe. 

***Remember: Alternate the side of the penis and vary the injection site with each use.


How do I dispose of used syringes and needles? 

You can purchase a Sharps Container, a hard-plastic container made for used syringes and needles, at your local pharmacy. If you did not purchase this container with your medication, you can use a hard-plastic container with a screw-on top such as a clothing softener or hard plastic detergent bottle. Be sure you can put both the syringe and the needle into the container easily. Whatever container you choose, be sure needles cannot break through the sides, bottom or top. Call your primary care physician or your local pharmacy to find out what your state or local requirements are for disposing of used syringes and needles.

Sharps Container

Storage

Once mixed, keep Bi-Mix in the refrigerator and it will last 3 months. Storing in the freezer will extend the life of the medication to 6 months. If you store this medication in the freezer, you will need to take the vial out of the freezer and let it thaw completely out on the counter. You should not see any ice in the vial before using. Prior to being mixed, Bi-Mix powder can be kept at room temperature although it is good habit to store unmixed Bi-Mix in the refrigerator. If Bi-Mix  is left out of the fridge for more than 3 days after being mixed, discard the vial. 

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