Download Vol 11, Nbr 12 - International Journal of Pharmaceutical Compounding

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VO L U M E 1 1
NUMBER 12
Compounded Treatment
Options for Common
Men’s Health Issues
Male patients have unique healthcare needs as they age, and while men’s
health issues must be addressed, male patients at times can be particularly
challenging. Traditionally, men are less likely to seek medical advice and information than women are, yet the health issues that are of greatest concern to
men are often those that are uniquely male. In recent years, public awareness
has increased regarding many men’s health issues, which has helped to eliminate some of those barriers. Andropause, urinary symptoms, prostate health,
and sexual function are often among the top concerns for male patients. A
thoughtful dialogue between patients, clinicians, and pharmacists can address many of these priorities.
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Andropause and
Compounding Pharmacy
Often referred to as male menopause, andropause
has been the focus of many researchers and studies
in recent years. Andropause is a process involving
gradual alteration in sex hormone levels over a period of years, resulting in unbalanced testosterone and
estrogen levels. These changes can result in physiologic and psychological changes that may lead to
depression, impotence, and decreased libido.1 Historically, standard treatment has involved testosterone supplementation, often by injection. While this
choice may be therapeutically appropriate in some
cases, other men will benefit from a combination of
agents. In addition to low testosterone, many men
experience a decrease in dehydroepiandrosterone
(DHEA), androstenedione, and growth hormone.
Adrenal and thyroid deficiency is also common.2
Other prescription medications such as statins can
lead to an imbalance in hormone levels. The most
successful therapy begins with a thorough evaluation of the patient’s symptoms, possible drug interactions, and lab results. A well-versed pharmacist
can be of benefit in cases such as these, and many
compounding pharmacists have undergone additional training in hormone balancing and functional
endocrinology.
One of the major keys in treating andropause is to
use hormones that are bioidentical in nature. Physi-
ologic dosing and careful monitoring can restore many men to former levels, thus
alleviating symptoms. Compounding pharmacists can prepare physiologically equivalent forms of deficient hormones in a number of dosage forms, including transdermal
creams, oral capsules, and sublingual suspensions and troches.
Formulations for the Treatment
of Men’s health issues
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Prostate Health Aided by Compounded
Preparations
Sildenafil 100-mg Mini Troches
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A man’s risk for developing prostate problems increases sharply with age. Benign
Prostatic Hyperplasia (BPH) refers to a noncancerous growth of the prostate gland,
which often causes urinary symptoms. An enlarged prostate, though common in men
at midlife and beyond, may compress the urethra or cause the muscles around the
urethra to contract. Either of these problems can impede urine flow, leading to weak
stream, nocturia, incontinence, and recurrent urinary tract infections.3 Prostate cancer occurs when abnormal cells form in the tissues of the prostate gland. According
to the National Cancer Institute, every year more than 185,000 men in the U.S. are
diagnosed with prostate cancer, and nearly 30,000 men die of the disease. The development of prostate cancer is strongly linked with the conversion of testosterone to
dehydrotestosterone (DHT).2 A complete hormone profile is a logical initial step in
assessing the patient’s risk of developing prostate cancer and in the management of
BPH.
Studies have indicated that supplementation with saw palmetto extract can be of benefit in both the management of BPH and in prostate cancer prevention. Saw palmetto
is a naturally occurring plant product derived from the berries of the Serenoa repens.1
It appears to work primarily by blocking the conversion of testosterone to DHT.4 Saw
palmetto is widely used in Europe and is the preferred means of managing BPH in
countries such as Germany and Italy. Introduction of saw palmetto has been shown to
reduce symptoms of BPH with few or no side effects.4
Testosterone 10% Cream
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Rectal Suppository with Pygeum, Saw Palmetto,
and Vitamin E
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Prostaglandin E1/Papaverine Hydrochloride/
Phentolamine Mesylate Injection
injection, most find that with the use of a 28- to 30-gauge needle, this type of therapy
causes minimal discomfort. Further, patients have the ability to titrate the dose to
exactly what is needed to achieve erection.
Conclusion
Many men deal with health issues such as andropause, BPH, and ED as they age.
Many options are available for the treatment and prevention of these conditions, both
in the commercial market and with the help of a skilled compounding pharmacist.
Pharmacists are well-equipped to screen for possible drug interactions and adverse
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Saw palmetto may be compounded in a standardized dosage form, alone or in combination with other supplements shown to promote prostate health, such as Zinc and
Pygeum. Zinc has been shown to reduce the activity of 5-α- reductase, thus inhibiting
conversion of testosterone to DHT.5 Pygeum contains 14% triterpenes, which exhibit
anti-inflammatory properties.6 Pygeum stimulates secretory cells of the prostate gland
and enhances the integrity of capillaries and veins in the penile environment. It can be
compounded with saw palmetto for the management of BPH.6
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Erectile Dysfunction Easily
Treated with Compounded
Preparations
In the last decade, a dramatic paradigm shift has taken place
with regard to the public’s view of erectile dysfunction (ED)
and its treatment. With the advent of direct-to-patient marketing campaigns on the part of pharmaceutical companies,
the once rarely discussed condition has lost much of its former
stigma, allowing clinicians to effectively treat their patients.
ED is a relatively common problem, particularly among men
over the age of 60. ED may occur as a result of a physical disease such as diabetes, or it may be the result of an endocrine
imbalance. In many cases, ED is a side effect of commonly used
medications such as beta-blockers and antidepressants.7 Fortunately, a host of treatment options exist for men experiencing
ED, both in the commercial market and the specialized field of
pharmaceutical compounding.
As is the case with andropause and prostate health concerns, a
hormone evaluation is an important early step in the diagnosis
and treatment of ED. Often, simply achieving a proper balance of testosterone and regulating the adrenals can improve
erectile function.8 Compounding allows for specialized dosage
forms of bioidentical hormones, which can be prepared according to the specific needs of the individual patient and can help
patients achieve this necessary balance.
effects that may be contributing factors in these conditions, and play a valuable role
in patient education and treatment.
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Commonly used commercial treatments include phosphodiesterase V (PDE5) inhibitors such as sildenafil. The oral tablet form of sildenafil has
a limited bioavailability due to first-pass metabolism. Studies have shown that sublingual sildenafil is faster-acting and requires a smaller dose than the oral tablet form,
thus reducing the likelihood of adverse effects such as priapism and vision loss.9 Many
compounding pharmacists can prepare sildenafil either as a lozenge that dissolves under the tongue or a rapid-dissolving tablet that melts almost immediately.
Patients with diabetes are less likely to respond well to oral PDE5 inhibitors and often
need to explore other treatment options such as intracavernosal penile injections.10
Alprostadil, phentolamine, and papaverine are the most commonly used agents in
injectible ED therapies and can be prepared in various strengths and combinations
Often, simply achieving a
proper balance of testosterone
and regulating the adrenals
can improve erectile function.
according to the needs of the patient. These drugs work by increasing penile blood
flow. Alprostadil and papaverine cause relaxation of the cavernosal smooth muscle and
the penile blood vessels, while phentolamine antagonizes α-adrenoreceptors. One of
the most effective injectible therapies is a preparation including all three of these
drugs in a single injection. While many men are initially hesitant about trying a penile
References
1. Biundo B. Treating andropause: Prohormones and hormone metabolic modifiers.
IJPC 2001; 5(5): 351–353.
2. Milner M. Practical solutions to a profoundly underrated health-care crisis. IJPC
1999; 3(2): 77–79.
3. Edwards J. Diagnosis and management of Benign Prostatic Hyperplasia. AmerFam Phys 2008; 77(10): 1403–1410.
4. Gordon A, Schaughnessy A. Saw palmetto for prostate disorders. Amer Fam Phys
2003; 67(6): 1281–1283.
5. Meletis CD. Complementary medical approaches to Benign Prostatic Hyperplasia. IJPC 1999; 3(2): 85–87.
6. Weise G. Use of saw palmetto and pygeum in men. IJPC 1999; 3(2): 99–100.
7. Hedelin H, Ströberg P. Treatment of erectile dysfunction based on patient-reported outcomes: To every man the PDE5 inhibitor that he finds superior. Drugs
2005; 65(16): 2245–2251.
8. Beckman TJ, Abu-Lebdeh HS, Mynderse LA. Evaluation and medical management of erectile dysfunction. Mayo Clinic Proc 2006; 81(3): 385–390.
9. Deveci S, Peskircioglu L, Aygün C et al. Sublingual sildenafil in the treatment of
erectile dysfunction: Faster onset of action with less dose. Int J Urol 2004; 11(11):
989–992.
10. DiSanto ME. Contractile mechanisms in diabetes-related erectile dysfunction.
Curr Pharm Des 2005; 11(31): 3995–4010.
Written by: Shannon W. Fields, BA, CPhT
RxTriad-A publication of the International Journal of Pharmaceutical Compounding. © 2008 IJPC. All rights reserved.