About TriMix-gel® (prostaglandin, papaverine, phentolamine)

About Trimix for Injection

The Most Effective Treatment for ED

The most effective non surgical treatment for ED is penile injection.[i] This is where a combination of vasodilators is injected with a needle directly into the penis just before sexual activity. Its most common form is a liquid called trimix for injection.

Trimix is a compound of vasodilators when combined for use at the same time, as “trimix for injection”, has not been reviewed by the FDA for the specific indication of erectile dysfunction. But these vasodilators, have been reviewed individually, and have been in medical use for decades.

The compound needs to be kept refrigerated until use, at which time it is injected into the side of the penis before sexual activity.

This triple mix compound known as trimix for injection, contains the vasodilators prostaglandin, papaverine, and phentolamine. Trimix has been widely prescribed by physicians for the treatment of ED for many years.[ii]

Physicians and patients agree, trimix for injection is the “Gold Standard” for non-surgical treatment of ED. In fact, the American Urological Association (AUA) recommends trimix for injection in their official protocol for urologists who treat ED. https://www.auanet.org/guidelines/erectile-dysfunction#x2650

Self-Inject

A drawback to injection therapy is the patient must always be aware the medicine could cause priapism or prolonged erection. Any erection lasting more than four hours is a medical emergency and the erection must be detumesced (brought down) immediately.

Many Men Can’t Self-Inject

Most primary care physicians are not equipped or comfortable enough to encourage or train patients on injection therapy. In addition, even though a patient may have success with injections, there remains a high drop-out rate of 70 to 80 percent due to a lingering dissatisfaction with the thought of self-injection into one’s own penis. Even though trimix for injection delivers significant results, many men object to the idea of injecting their own penis with a hypodermic needle.[iii]

TriMix-gel is a good example of the value found in compounding pharmacy.

About TriMix-gel®

Failure on Viagra Type Tablets is not a Straight Road to Injections

Patients who have failed on Viagra type tables have been informed of the superior results of penile injection therapy, but most men object to the thought of self-injection with a hypodermic needle into their own penis.

TriMix-gel® (prostaglandin, papaverine, phentolamine) contains the exact same prescription medications or vasodilators as trimix for injection. These TriMix-gel ingredients, exactly like trimix for injection, have not been reviewed by the FDA for the specific indication of erectile dysfunction. But these vasodilators have been individually tested and accepted by physicians for use with patients for several decades now.

The TriMix-gel Difference

The difference between trimix for injection and TriMix-gel is “NO NEEDLE”. The active ingredients have been lyophilized (dry freeze) into powder form. The powder is mixed with a medicated gel at time of use and then applied at the tip of the penis. There is no needle.

This is accomplished with a novel patented methodology (US patent number 9,005,183). At the time of use, before sexual activity, the patient uses an “Easy Applicator System™” application device that stores, mixes, and applies the medicine. There is no needle.

  • TriMix-gel does not have to be refrigerated. Therefore, the patient can carry the medicine on his person at room temperature. This is well received by mobile, active patients.
  • TriMix-gel uses a gel carrier, not a hard pellet placed one and one quarter inches into the urethra.
  • TriMix-gel does not require the patient to semi-self-catheterize himself with plastic device placed one and one quarter inches into the urethra.
  • At the time of use, before sexual activity, the patient uses an innovative “All-In-One” application device that stores, mixes, and applies the medicine.
  • And most importantly, before sexual activity, an ED patient will not have to use a hypodermic needle to self-inject his own penis.

No Injections – No Needles

Doctors frequently treat patients with medicine that may be FDA approved specifically for one purpose, but they may also find the same medicine appropriate for another purpose. For instance, Hista Vent DA is an antihistamine, a drug indicated for use for people who suffer from seasonal allergies. For many people, Hista Vent DA makes them drowsy. Therefore, doctors have been known to prescribe Hista Vent DA for use at bedtime as an aid to fall asleep. This practice is known as prescribing “off label”.

The Food and Drug Administration (FDA) has not yet reviewed TriMix-gel, and therefore it has not been approved for the specific indication of ED.  However, individual components of TriMix-gel have been approved by the FDA[iv] and doctors can write prescriptions in the best interest of their patients with agreement and endorsement of peer review and without involvement of government. TriMix-gel ingredients have been used and prescribed by doctors for decades for various purposes, including the treatment of ED.[v]  Urologists view the use of these ingredients as safe and have been prescribing them to ED patients for years.

TriMix-gel is composed of formulated drugs, novel components and a patented overall system and methodology that require a prescription for patient use.

TriMix-gel is a good example of the value found in compounding pharmacy.


[i] Duff, E, McCullough A.  Current Sexual Health Reports, Volume 3, Number 3 / September, 2006 found at http://www.springerlink.com/content/d98120983v31v2gj/.

[ii] Nehra, A, Curr Urol Rep. 2001 Dec;2(6):468-72 at http://www.ncbi.nlm.nih.gov/pubmed/12084233?ordinalpos=11&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

[iii] Ibid

[iv] Food and Drug Administration.  Obtained at:  http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

[v] Nehra, A, Curr Urol Rep. 2001 Dec;2(6):468-72 at http://www.ncbi.nlm.nih.gov/pubmed/12084233?ordinalpos=11&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum