TriMix-gel is a Good Example of the Value Found in Compounding Pharmacy.

For the patients who don’t find Viagra type pills helpful or can’t tolerate their side effects and for patients who cannot bring themselves to self-inject their own penis with a hypodermic needle, TriMix-gel is a good example of the value found in compounding pharmacy.

At Risk for ED

Risk for ED increases as men age.  The prevalence of ED for men at age 40 is 39%, men at age 50 is 50%, men at age 60 is 60% and the prevalence for men at age 70 is 67%, according to data from the Massachusetts Male Aging Study.[i]  Today, approximately 30 million men in the U.S. have erectile dysfunction.[ii]  Men with co-morbidities such as high blood pressure, heart disease, high cholesterol, and diabetes are disproportionably affected by ED.[iii]

Some of these conditions require medications that are incompatible with the use of PDE5s.[iv]  The “Men’s Attitudes to Life Events and Sexuality Phase I” study indicated that 38% of men with hypertension also had ED.[v]  Men with diabetes or high blood pressure are disproportionably represented in the ED population increased probability of ED.

Viagra – Reports of Viagra, Cialis, Levitra Type Tablets Side Effects

A large number of men cannot use Viagra-type tablets because they are reportedly ineffective. Countless others can’t take Viagra-type tablets because of existing medical conditions. Still more men complain they cannot tolerate the side effects, such as flushing, headaches, nausea, and sinusitis, etc.[vi], which can be significant and even dangerous.

Over-the-Counter – Caution for Over the Counter Viagra type Counterfeits

Many men have taken to over-the-counter remedies not regulated by the FDA. These pills and so called remedies often emanate from illegal bootlegging and counterfeit operations on the Internet. Additionally, many such products contain undeclared ingredients which can be harmful and undoubtedly dangerous.[vii]

Viagra – Physicians Most Popular First-Line Treatment

Physicians most popular first line treatment is Viagra. Viagra is one of three major drugs in the family of medicine known as phosphodiesterase type5 inhibitors (PDE5’s) which also includes Levitra and Cialis. Many men have preexisting conditions which preclude their use. For these men, Viagra-type tablets are dangerous and can cause loss of hearing, loss of sight, or even death.[viii]  Other men cannot tolerate the tablet’s side effects which can be significant and in some cases overwhelming. Patients report other treatments are cumbersome and/or ineffective.

Internet Viagra, Levitra, and Cialis

Any offer to buy Viagra, Levitra, or Cialis on the Internet should be met with extreme caution. If these drugs are priced from 10% to 70% of the regular retail cost, they are probably counterfeit drugs. These offers often come from clandestine labs, often in India or Asia, where profit trumps safety of the patient.

Some of these counterfeits rarely contain a therapeutic dose of anything and may contain ten to twenty percent of an active ingredient which may not even be sildenafil, vardinafil or tadalafil.  They may also contain undeclared ingredients, which can be unfit for human consumption.

Danger in Alleged Remedies Without Government Oversight

As a result, many men have felt compelled to resort to over-the-counter remedies that are not regulated by the FDA.[ix]  This is potentially dangerous because without governmental oversight of the safety of these products, patients are put at certain risk. Safety considerations are abandoned by patients who are desperate to find help. Additionally, these over-the-counter agents lack efficacy. Their medicinal properties are untested and, as such, have no scientific or medical corroboration.

Nutraceuticals

The word nutraceutical is a portmanteau of the words nutrition and pharmaceutical. Food supplements that are sold over-the-counter but are not approved by the FDA are called nutraceuticals. There are a plethora of over-the-counter imposters for treatment of ED. The patients who gravitate to these products are men who are uninformed as to their general ineffectiveness and potential consequences. Over-the-counter products are chosen by men who abandon caution because they are desperate for ED treatment. These men expose themselves to potentially dangerous substances as these over-the-counter products often contain undeclared ingredients which put the patient in harm’s way.

 Most Effective ED Treatment is Injection Therapy

The most effective non-surgical treatment for ED is penile injection, where a compound of three vasoactive dilators is injected directly into the penis.[x]

These three vasodilators in liquid form are more commonly known as trimix. Injection of a vasodilator directly into the corpora cavernosa (penis erection chambers), was introduced in 1983 by Dr. Brindley at the American Urological Association’s World Conference. He used a single vasodilator called papaverine. Since then, the evolution of the concept has emerged into what is now called trimix for injection.

For the patients who don’t find Viagra type pills helpful or can’t tolerate their side effects and for patients who cannot bring themselves to self-inject their own penis with a hypodermic needle, TriMix-gel is a good example of the value found in compounding pharmacy.


[i] Medical News Today. “Erectile Dysfunction Affects 18 Million Men in the U.S.” 2008. http://www.medicalnewstoday.com/articles/62145.php

[ii] New York Times: http://www.nytimes.com/1995/08/02/us/personal-health-with-more-help-available-for-impotence-few-men-seek-it.html?pagewanted=all.

[iii] Eardley I et al, Int J Clin Pract. 2007 Sep;61(9):1446-53. Epub 2007 Jul 26 http://www.ncbi.nlm.nih.gov/pubmed/17655685?ordinalpos=13&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

[iv] Pfizer Product Description, Chapter 7 http://labeling.pfizer.com/ShowLabeling.aspx?id=652 page 27

[v] Sun P et al, J Urol. 2005 Jul;174(1):244-8 at http://www.ncbi.nlm.nih.gov/pubmed/15947647?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

[vi] Official Pfizer Viagra website  https://www.viagra.com/questions

[vii] FDA Statement https://www.psychologytoday.com/blog/all-about-sex/201412/warning-men-erection-drugs-just-might-kill-you

[viii] FDA Summary of Reports of Death in Viagra Users Received at http://www.fda.gov/cder/consumerinfo/viagra/safety3.htm

[ix] FDA https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf

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