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Heating Up: What Happens If Trimix Gets Warm?

Jun 6, 2023
Heating Up: What Happens If Trimix Gets Warm?

Trimix injections are a safe and effective treatment option for erectile dysfunction (ED). It is a compounded medication comprising phentolamine, papaverine, and alprostadil. Each of these medications has unique pharmacological properties that provide users with the greatest benefits while causing the fewest possible side effects. But, what happens if Trimix gets warm?

Compounded medications have many advantages, but they often require more care in terms of storage than non-compounded medications. Trimix degrades at room temperature and must be kept refrigerated or frozen. Each vial of Trimix is labeled with a beyond-use date. After this date, the medication is not expected to be effective. Expired Trimix is no longer considered effective.

What is Trimix?

Trimix is an injectable medication that is injected into the side of the penis using a small, fine needle. Many men start with oral ED medications and move to injectable medications for a variety of reasons, including a lack of effectiveness or increased side effects from oral medications. According to the American Urological Association, men should be offered a full range of treatment options for ED.

Research suggests that Trimix is over 95% effective for treating ED, and over 70% of men surveyed rate their satisfaction with penile injections as high.1

What Happens If Trimix Gets Warm

Trimix Stability Testing

Trimix loses its effectiveness over time, especially if it is not refrigerated. Alprostadil is the limiting factor in Trimix stability.

Stability testing has been completed on various strengths of Trimix ingredients, including alprostadil 5 µg/mL to 45 µg/mL, papaverine 15 mg/mL to 30 mg/mL, and phentolamine 0.4 mg/mL to 5 mg/mL, and a single-strength preparation containing alprostadil 30 µg/mL, papaverine 30 mg/mL, and phentolamine 2 mg/mL.

For testing, these medications were compounded and stored in two different settings. Beyond-use dates of 60 and 64 days were obtained when Trimix was frozen at -20 degrees Celsius and 30 days when it was refrigerated at 4 degrees Celsius.2

In another study, researchers tested Trimix’s stability at 3 degrees Celsius, 4 degrees Celsius, -20 degrees Celsius, and -70 degrees Celsius. When chemical testing was done, they found alprostadil was the least stable at room temperature and while refrigerated. About 8% of alprostadil’s potency loss occurred in five days at room temperature; under refrigeration, it lost 6% of its potency after one month and 11% after two months.

Frozen at -20°C and -70°C, less than 5% potency loss of the drug components occurred in 6 months. A beyond-use date of 6 months was established for -20 deg C (frozen) and one month when refrigerated at 4 degrees Celsius.3

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What temperature should Trimix be stored at?

According to Olympia compounding pharmacy, Trimix is shipped with ice packs, but it is normal for the ice packs to melt and for Trimix to feel warm. This will not affect Trimix’s potency. The Trimix vial you are currently using should be kept in the refrigerator at 32-39°F. It is safe to leave it at room temperature for brief periods of time.

If you order more than one vial, put the ones you aren’t using in the freezer and freeze them. This will extend their use-by date by up to a year.

What happens if Trimix gets warm?

Trimix’s effectiveness will wane over time. If you leave Trimix out of the refrigerator for any length of time, or if you keep it refrigerated rather than frozen for more than a month, this process will be sped up. When traveling, keep your Trimix in an ice-filled cooler.

Image of an empty vial

How long can Trimix last at room temperature?

In another study, researchers found that Trimix solution was clear, colorless, and stable for at least 55 days when refrigerated at 4 degrees Celsius (39 degrees Fahrenheit) at a degradation rate of 10%. The limiting factor was alprostadil.

The concentration values of papaverine and phentolamine did not decrease at two months, but alprostadil decreased to 70–76% depending on whether it was added to papaverine and phentolamine or tested alone. Adding papaverine and phentolamine seemed to increase the natural degradation of alprostadil.

When ready-to-use Trimix syringes are refrigerated at 4 degrees Celsius, variations in drug concentration are less than 10% of the initial concentrations.4

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) sets the acceptable degradation rate limit at 5%, so the Trimix expiration date is set at one month when refrigerated.

For Trimix preparations from Invigor Medical, patient and pharmacy history has shown that Trimix is effective frozen for up to six months and usable in the refrigerator for longer than the 28 days stated on the label. This agrees with the research that reports that alprostadil becomes less effective over time, losing about 6% of its effectiveness at one month refrigerated and 11% at two months and pharmacist recommendations.

Recommendations

Refrigerate one vial of Trimix and freeze the other vials. This reduces the possibility of bacterial contamination and helps maintain Trimix potency. According to Olympia Pharmacy, Trimix can be refrigerated for one month and frozen for up to a year. Trimix should only be kept out of the fridge for short periods of time. Use only Trimix solutions that are odorless, colorless, and clear.

Conclusion

If you’re looking to buy Trimix for ED treatment, it’s important to be aware of how temperature can affect its potency. Trimix, which is an effective compound medication, should be stored with care to maintain its effectiveness. With Invigor Medical, you can purchase Trimix that comes with clear instructions on proper storage—refrigerated for current use or frozen for future use, ensuring maximum efficacy. The specialists at Invigor Medical can also guide you on how to handle your medication with temperature sensitivity in mind. Visit Invigor Medical to get detailed information and to make your purchase.

Heating Up: What Happens If Trimix Gets Warm?

Frequently Asked Questions

What happens if you don’t refrigerate Trimix?

Not refrigerating Trimix can lead to a decrease in potency and effectiveness over time. Factors such as exposure to heat, light, or air can degrade the medication and reduce its ability to induce erections. It’s essential to follow proper storage guidelines and refrigerate Trimix to maintain its potency and efficacy.

What temperature should Trimix injections be stored at?

Trimix injections should be stored at a controlled room temperature, typically between 68°F to 77°F (20°C to 25°C). It’s important to avoid exposing Trimix to extreme temperatures or fluctuations, as this can affect its stability and effectiveness. Refrigerating Trimix may be necessary to prolong its shelf life, but it’s crucial to consult with a healthcare provider or pharmacist for specific storage instructions.

What can cause Trimix not to work?

Several factors can contribute to Trimix not working effectively. These include improper dosage, injection technique, or timing. Additionally, underlying health conditions such as cardiovascular disease, diabetes, or neurological disorders can affect the body’s response to Trimix. Psychological factors like stress, anxiety, or relationship issues can also impact erectile function. It’s essential to work closely with a healthcare provider to identify and address any potential causes of Trimix ineffectiveness.

How fast does Trimix degrade?

The degradation rate of Trimix can vary depending on factors such as storage conditions, temperature, and exposure to light or air. Generally, Trimix may degrade over time, particularly if not stored properly or if it exceeds its expiration date. It’s important to use Trimix within its recommended shelf life and follow proper storage guidelines to maintain its potency and effectiveness. Unused Trimix should be discarded according to healthcare provider or pharmacy instructions to avoid the risk of contamination or degradation.

Disclaimer
While we strive to always provide accurate, current, and safe advice in all of our articles and guides, it’s important to stress that they are no substitute for medical advice from a doctor or healthcare provider. You should always consult a practicing professional who can diagnose your specific case. The content we’ve included in this guide is merely meant to be informational and does not constitute medical advice.

Heating Up: What Happens If Trimix Gets Warm?

Leann Poston, M.D.

Dr. Leann Poston is a licensed physician in the state of Ohio who holds an M.B.A. and an M. Ed. She is a full-time medical communications writer and educator who writes and researches for Invigor Medical. Dr. Poston lives in the Midwest with her family. She enjoys traveling and hiking. She is an avid technology aficionado and loves trying new things.

References

  • Burnett AL, Nehra A, Breau RH, et al.: Erectile dysfunction: AUA guideline. J Urol 2018; 200: 633.
  • Patel G, Davis C, Liu Y, Ip K, Debideen KE, Anderson S, Byrne R, Herr D, Rhoads MM, Caputo R, Banov D, Bassani AS. Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design. Int J Pharm Compd. 2021 Jan-Feb;25(1):73-81. PMID: 33503012.
  • Trissel LA, Zhang Y. Long-term stability of Trimix: a three-drug injection used to treat erectile dysfunction. International journal of pharmaceutical compounding. 2004 May-Jun 2004;8(3):231-235.
  • Vieillard V, Eychenne N, Astier A, Yiou R, Deffaux C, Paul M. Physicochemical stability study of a new Trimix formulation for treatment of erectile dysfunction. Annales Pharmaceutiques Françaises. 2013/09/01/ 2013;71(5):358-363. https://doi.org/10.1016/j.pharma.2013.06.005

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