Hormone Therapy Guide

A basic outline of products/services available through Nationwide MD’s

network of physicians.

Nationwide MD Inc.

(888)959-9304 Office

(888)959-9304 Fax

www.nationwideMD.net

info@nationwidemd.net

Introduction 3

About NATIONWIDE MD 4

Our Mission 5

Administrative Service 6

What is Hormone Replacement Therapy 7

Bto-Identical Hormone replacement Therapy (BHRT 8

Erectile Dysfunction 8

Hypogonadism 8

Hypogonadism Causes Primary -Secondary 8

Testosterone Replacement Therapy 9

Symptoms of Low Testosterone 9

Human Growth Hormone 9

Medications, Indications and Usage for HRT 10

Testosterone Cypionate injections 10

Testosterone Enanthanate Injections 11

Nandrolone Deaconate 11

Armidex 11

HCG 12

Consultant Protocol 13·34

Important Memorandum 35

Injection Reference Sites 36·39

Compounding Definitions 40

Compounding 41·43

Compounding vs. Traditional pharmacy 44·45

Definition of a generic drug and the FDA requirements 46

HRT Q&A 54-57

Medi·Spa and Service 58

Notes 59·64

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Introduction

This quick reference guide is a back to the basic reminder of the protocols set in place to guide

the consultants. The reference guide has basic reminders of common usage a nd client c a r e as new and

existing client o f Hormone replacement therapy.

This reference guide has pharmacy compounding meaning and definitions. Use this guide as quick

reference to medication and its usage. This guide a l s o tells you the company and its mission.

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About Nationwide MD

NATIONWIDE MD Inc. addresses the needs of both males and females who wish not only to prevent

disease, but to enhance their health and optimize their genetic aging potential.

We provide skillful management for a wide range o f hormones. Using a customized high quality bio-

identical hormone replacement treatment approach, sophisticated use of nutritional supplements and lifestyle

changes, including stress reduction and exercise, our medical experts enhance your body's potential to slow

down aging.

As a leader in Advanced Preventive and Rejuvenation Medicine, NATIONWIDE MD is dedicated to

offering successful anti-aging treatment protocols using bio-identical hormones formulated by our network

of compounding pharmacies who uphold our commitment to provide our clients with tailored treatment

plans by maintaining their focus on customizing dosages that are consistent with our physician's

expectations and complementary to our client's needs.

Our staff is headed by a medical director who is a long-standing member of the American Academy of

Anti-Aging M e d i c i n e (A4M). He has extensive background and experience in the key areas of medicine

relevant to this specialty. He is board certified in: Anti-Aging M e d i c i n e , F a m i l y

Practice and Clinical Nutrition Additionally, he specializes in Environmental, Bariatric and

Integrative Medicine.

NATIONWIDE MD clients receive constant support and guidance from our knowledgeable and experienced

staff of service consultants who coordinate the gathering and attainment of all relevant medical information,

laboratory testing, and case assignment to one of our network physicians. Individualized programs are

designed by our leading-edge physicians. Using an instructional approach, they take af f i rmat ive

steps b y working with e a c h client o n a case-by-case basis to determine the most bene f icial method

for achieving the desired result.

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Our Mission

NATIONWIDE MD's goal is to enhance the physical and mental wellbeing of our clients through

the optimization of their health.

We accomplish this by recognizing the uniqueness of each individual, and then customizing a treatment

regimen to reflect their personal health goals utilizing the latest anti-aging and integrative principles.

Our medical specialty is founded on the application of advanced medical technologies for the early

detection, prevention, treatment, and reversal of age-related dysfunction, disorders, and diseases.

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Administrative Services

• Secure Messaging System

• Wellness Tool tracking and communication

• Focus on total body custom software and tracks results

• Keep track of weight-loss and exercise

• Provide advanced efficient, and user friendly ordering and patient management application.

• Automated Order process

• Role based content and security

• Online facility admin and patient advisor user guides.

• Generated PDF invoices and prescriptions

• Configurable email notifications for special events

• Lead assignment and tracking capability

• Digitally signed prescriptions

• Facility specific product formulary

• Web based application

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What is Bio-Identical Hormone Replacement?

NATIONWIDE MD’s patient Network bio identical hormone replacement therapy doctors take an

integrated approach to anti-aging medicine for both men and women. The customized programs

prescribed by our physicians include proper fitness, nutrition and supplements in combination

with possible anti-aging bio identical hormones.

This preventive medical approach helps put an end to suffering and the negative effects caused by

stress induced adrenal fatigue, peri-menopause, menopause, post-menopause, andropause (the

male menopause), hyperthyroidism and hypothyroidism.

Men and women often mistakenly believe that fatigue, low sex drive, insomnia, weight gain and

other symptoms of menopause, andropause, adrenal fatigue and thyroid disorders are just an

inevitable part of getting older. However, these symptoms are in fact caused by imbalanced

hormones of the body.

Many people have found relief with bio identical hormone replacement therapy. This natural

therapy is considered anti-aging because it works to combat the symptoms attributed to aging and

it can improve longevity and quality of life.

Hormones decline as we age. Bio identical hormone therapy serves to replace the hormones that

your body needs to function; mainly estrogen, testosterone, progesterone, a n d cortisol.

NATIONWIDE MD network physician use bio identical hormones versus bio-similar or synthetic

hormones.

Bio identical hormones a re molecule-by-molecule, e x a c t l y the same as the hormones p r e s e n t

in the human body. Synthetic hormones a r e intentionally d i f f e r e n t . Because drug companies

cannot patent a bio identical structure, t h e y make synthetic hormones that are patentable. There

are several branded versions now available for use in the kind of hormone replacement therapy

(HRT) typical of synthetic hormones (Premarin, Prempro and Provera are common examples),

however, these are generally a one-size-fits-all dosage regime unlike bio identical hormones.

Although the field of anti-aging medicine has been around for many years many practitioners are

not familiar with it and have not had specific training. Conversely, NATIONWIDE MD has

dedicated network of bio-identical hormone anti-aging physicians have been certified in the field and

are experts in hormone replacement therapy.

NATIONWIDE MD doctors will assess your individual needs and work to restore balance to your

hormones by customizing a bio identical hormone replacement therapy plan integrated with proper

nutrition and fitness that is specifically for you and your particular needs.

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Bio-Identical Hormone Replacement Therapy (BHRT)

Bio-identical hormones are those that are molecularly identical to the hormones produced in the

body. These hormones are chemicals that are derived from sources of yam or soybean. Steroids

and hormones are taken from animals and plants then altered to be identical in molecular structure.

Sometimes referred to as natural hormones, are used to treat menopause symptoms, peri-menopause,

and post-menopause. The major benefit of BHRT is that treatment doses are individualized. Bio-

identical hormones are metabolized, stored, and converted into other hormones naturally.

Erectile Dysfunction

Erectile dysfunction, also known as ED, is the inability to achieve and sustain an erection for

sexual intercourse. Erectile dysfunction can happen at any age however it is more common in the

elderly. By age 45, most men have experienced erectile dysfunction at some of the time. ED varies

in severity; some men have a total inability to achieve an erection, others have an inconsistent

ability to achieve an erection, and still others can sustain only brief erections.

Hypogonadism

Male Hypogonadism is a condition in which the body doesn't produce enough of the male sex

hormone testosterone also known as primary testicular failure originates from a problem in the r'

testicles.

Primary - This type of Hypogonadism - also known as primary testicular failure

originates from a problem in the testicles.

Secondary - This type of Hypogonadism - indicates a problem in the hypothalamus or the

pituitary gland

Either type of Hypogonadism may be caused by an inherited (congenital) trait or something that

happens later in life (acquired), such as an injury or an infection.

Causes of Hypogonadism - Primary and Secondary

Klinefelter syndrome

Undescended testicles

Mumps orchitis

Hemochromatosis

Injury to the testicles

Cancer treatment

Kallmann syndrome

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Pituitary disorders

Inflammatory disease

HIVJAIDS

Medications

Obesity

Normal aging

Testosterone Replacement Therapy

Testosterone is a hormone produced by the testicles and is responsible for the proper

development of male sexual characteristics. Testosterone is also important for maintaining

muscle bulk, adequate levels of red blood cells, bone density, sense of well-being, and sexual and

reproductive function. The options available for testosterone replacement are

• Intramuscular injections - can be injected directly into the muscles, or implanted as pellets

in the soft tissues.

• Testosterone patches - Androderm is a skin patch worn on the arm or upper body.

• Testosterone gels that are applied daily to the shoulders, upper arms, or abdomen.

The symptoms of low testosterone

• Low sex drive (libido)

• Depression

• Irritability

• Low sense of well-being

• Erectile dysfunction

• Fatigue and poor energy level

• Difficulty concentrating

Human Growth Hormone

Human growth hormone is a naturally occurring substance produced by the pituitary glands in

the body; works by increasing the amount of IGF-l that your liver produces. IGF-l prevents

Insulin from transporting glucose to cells. Growth hormone is a peptide hormone secreted by the pituitary

gland that stimulates growth and cell reproduction. Testosterone, HGH (Human Growth Hormone), DHEA

and others, can give men a better opportunity for a healthy and vigorous life. Male hormone

replacement therapy can have a significant and positive impact on men's health including fitness, strength

and sex drive.

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For adults who have a growth hormone deficiency, injections of human growth hormone can:

• Increase bone density

• Increase muscle mass

• Decrease body fat

~ • Increase exercise capacity

Human growth hormone is also approved to treat AIDS-or HIV-related muscle wasting.

MEDICATIONS, INDICATIONS AND

USAGE FOR HRT

Testosterone Cypionate injection, USP is indicated for replacement therapy in the male in

conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary Hypogonadism (congenital or acquired) testicular failure due to cryptorchidism,

bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic Hypogonadism (congenital or acquired) idiopathic gonadotropin or

LHRHdeficiency or pituitary-hypothalamic injuryfrom tumors, trauma, or radiation.

TESTOSTERONE CYPIONATE INJECTION, USP

100 mg/ml and 200 mg/rnl

Testosterone Cypionate injection, USP, for intramuscular injection, contains Testosterone

Cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic

hormone testosterone.

Testosterone Cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and

soluble in vegetable oils.

INDICATIONS AND USAGE

Males: Androgens are indicated for replacement therapy in conditions associated with a

deficiency or absence of endogenous testosterone

Primary Hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism,

bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.

Hypogonadotropic Hypogonadism (congenital or acquired) -idiopathic gonadotropin or

LHRHdeficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation.

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TESTOSTERONE ENANTHATE INJECTION USP

Testosterone Enanthate Injection is a clear, colorless to pale yellow sterile oleaginous solution of

Testosterone Enanthate for intramuscular use. Testosterone Enanthate is a white or creamy white,

crystalline powder. It is odorless or has a faint odor characteristic of heptanoic acid. It is insoluble

in water, very soluble in ether and soluble in vegetable oils.

INDICATIONS AND USAGE

Males: Androgens are indicated for replacement therapy in conditions associated with a

deficiency or absence of endogenous testosterone

Primary Hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism,

bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.

Hypogonadotropic Hypogonadism (congenital or acquired) -idiopathic gonadotropin or

LHRHdeficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation.

NANDROLONE DECANOATE INJECTION, USP

Nandrolone deaconate injection is intended for deep intramuscular injection only, into the gluteal

muscle preferably. A sterile oleaginous solution containing per ml: Nandrolone Deaconate 200

mg with Benzyl Alcohol 5% as solubilizer /preservative, in Sesame Oil. Nandrolone deaconate

occurs as a fine, white to creamy white, crystalline powder. It is odorless, or may have a slight odor.

Nandrolone deaconate is soluble in chloroform, in alcohol, in acetone, and in vegetable oils. It is

practically insoluble in water.

Arimidex

Arimidex - also known as Anastrozole also works well as an adjunct to Hormone Replacement

Therapy, It has also been tested to reduce estrogen including estradiol, in men; preventing

possible prostate enlargement. Armidex helps to maintain some natural testosterone production, while

taking an exogenous source of testosterone as well.

HCG

HCG as it is commonly called is really an acronym for Human Chorionic Gonadotropin Hormone. It

has many functions and is used medically to treat a variety of conditions. HCG is a hormone

naturally produced in the body. HCG is a hormone which plays different roles in male and female

sexual development. In men, physicians may prescribe HCG to increase or restore testosterone

production. Both men and women use HCG for weight loss this method is not FDA-approved.

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Function

HCG acts like luteinizing hormone (LH). In males, LH tells the testes to produce testosterone. In

men undergoing hormone replacement therapy, their testes may stop producing testosterone, so

HCG can remind their testes to keep producing testosterone. HCG also raises sperm counts, so it

can improve male fertility

Men suffering from androgen disorders take HCG to jump start their testosterone production. A

prescription medication, HCG is injected subcutaneously

Benefits of HCG Therapy for men with low testosterone include the following:

• Improve male sexual performance

• Enhance mood in men

• Reduce depression in men

• Increased energy and vitality

• Increase male bone density

• Improve male fertility

• Increased strength and endurance

• Regulate distribution of body fat

• Increase body hair growth

• Reduce risk of heart disease

• Develops lean muscle mass with exercise

• Increased male sex drive

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Consultant Protocol

When NATIONWIDE MD receives a new potential candidate for BHRT, ED, TRT or GHRT we do

a proper pre- screening .

1. Patient Bio

a. Full Name

b. DOB (avg. age 30-70yrs old) (under 30 will need previous medical records with

conditions) rare.

c. Phone

d. Address

e. Email

f. Height

g. Weight

h. History of use (if any)

2. Patient is instructed to either complete the HHQ online or we can email or hard copy mail a

copy for completion.

3. Patient is then instructed in order to become a potential candidate for these therapies they

will need to submit a physical by their medical professional, PCP, RN, ARNP, etc.

4. Patient is then instructed to arrange for diagnostic testing.

I.e. Serum, Saliva, urine (not common).

a. Serum is the preferred method for the initial evaluation of potential patient for males.

They are instructed that they need an Endocrine evaluation for the Physician to

evaluate for possible treatment. Females can either do Serum or Saliva.

b. Patient can be arranged through Labcorp, Access med labs or their PCP.

5. Once all medical records are received, documentation of Physical and Lab analysis are in

then we submit through Our Med soft system for pre-approval from physician. A notation by

the patient care coordinator can be added at this time with any specifics regarding the

possible patient. I.e.; history of use, possible interest for programs, etc.

6. Physician then does an initial review to rule out any possible cross indications of medical

conditions that could hinder or negatively affect the patients program.

7. Physician then sends pre-approval back to PCCfor the follow up regarding pre- approved

therapies. There will be a drop down section of all pre-approved therapies by category

that a patient is pre- qualified for.

8. PCCthen reviews any notations and goes over possible protocols with patient. This can

sometimes be affected by patients financial abilities so all matters are discussed

accordingly.

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Medication Protocols:

1. Testosterones: General census is the Test Cypionate is most commonly used for the Majority

of patients. The therapeutically doses vary based on patient body weight and previous usage.

Recommended therapeutically dosage is between .25cc to 3cc's based on patient specific needs.

(i.e.: Hypogonadism patients. HIV positive patient/Muscle wasting patient).

Typical dosage is 1-2 cc pr wk or between 200-500mg. These are the dosages that will

typically

Increase a patients low T levels to a normal range. Alternative testosterones are based on

history and conversion rates.

2. Patient is instructed that a Normal Range is between 700-1000 and should not be higher

For long term therapy. Patient is also made aware of alternative test therapies such as Test

Troches, Topical and Capsules.

3. New patients are instructed to do a follow up lab to check on the CBC/dif and T levels

every 6 months.

Existing patients (Over a year) are then required to do an annual Complete BW to make

sure

No other issues are occurring, including an updated physical.

4. Patients are also instructed that a proper protocol also includes the usage of HCG and anti

estrogens to prevent possible side effects such as Hypogonadism and gynocamastia. This is

also determined by the patient Health History, Labs and previous usage of therapies.

5. Patients are also instructed if they opt out of these therapies (not recommended) that if

they are

Experiencing any of these side effects to contact the office immediately to adjust the

program

According to Dr. Protocols. (i.e.: HCG, Anastrazole/Tamoxifen),

6. All patient s are then told that the possible program has to be finalized by the Prescribing

physician. They have also agreed that these medications if prescribed will be for medicinal

use

Only and will not be prescribed for performance enhancement or aesthetics. (Our

disclosure forms also have this to be signed off by the patient.)

7. Patients will also be notified that the Physician will contact them to discuss therapies via

phone.

They have also been made aware that based on certain states that they will be required to

come into a Face to Face visit with Prescribing Physician on an annual basis. (i.e.: NY,

Oklahoma, etc). ..

8. Added therapies can also include Stanozolol (wasting, edema, shbg levels) Nandrolone

(muscle wasting, joint pain and post injury), Oxandrolone (muscle wasting, weight gain,

post - surgery).

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Stanozolol is then explained that should not be on for more than a certain period of time

consecutively (i.e. 3mo) then off for the same period of time. (Dosage range l00mg 3x

prwk).

Nandrolones is also explained on the benefits (increase joint mobility, faster recovery

time, and post injury) and side effects (loss oflibido, potential estrogen builds up). This

medication is not to be used more than 20 weeks consecutively before removing from

program for 10 weeks. Nandrolone will also stay in a patients system for an avg. of 3-4

after discontinued use so they will still experience benefits.

Oxandrolone is an alternative medication for (muscle wasting, weight gain, post- surgery or

illness). This medication is very mild in Oral format so a patient can be on for longer

periods.

Formula: (2 mg per pound - Max allowed within 6 months)

ERECTILE DYSFUNCTION:

1. This is a typical initial complaint that most patients come in with. Loss of erection,

libido, etc.

2. Patient is advised to document any previous injuries to the head or testes to make sure

their

Are no possible pituitary issues. Medications that are available are basic ED meds,

Viagra, Cialis, levitra and now the compounded versions in more specific dosing and

administration (i.e. Troches).

3. The next and last alternative treatment is Injectable Tri-Mix therapy. Very common in

the older population because the other medications will not work based on health

history. The majority of patients requesting these therapies have been diagnosed and

treated for this ailment by other medical professionals. (i.e.: Boston Medical Group) The

patients just seem

To not want to pay the High costs of going to these specialty centers.

ALL ED medications is explained to be used accordingly to instructions and if

experiencing erections longer than 4 hours to go to the emergency room.

GROWTH HORMONE DEFICINECY:

1. Any growth hormone program has to have an IGF-l test to show low levels. The preferred

protocol for a potential new patient seeking these therapies or shown deficiencies is to first

start on the Sermorelin protocol to stimulate the natural secretion from the pituitary. This

program is not advised for candidates over the age of 48 because studies have shown that

at this age group

The pituitary is not secreting enough to justify the stimulation, hence the alternative HGH

programs.

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Formula: (Mcg Dosage = LBS/ 2.2 * 3.5)

All HGH possible patients are also told to disclose and hereditary cancer history in their

family.

If no possible cancer factors are involved then the dosage is based on height and weight.

Formula: (IU Dosage = LBS/ 2.2 * 0.03)

ADJUNCT THERAPIES:

Thyroid Dysfunction: Liothyronine.

Vitamin B Deficiency Low Energy: Cyancabolomin Methylcabolomin

Hair Loss DHT Conversion: Finasteride, Propecia, Proscar HCG:

Weight loss program, Dr. Simeon's protocol.

RECEIPT OF MEDICATIONS

Once a patient receives their medication they are sent an email with the protocols

And procedure of administering their therapy.

They are instructed if they have any questions or concerns regarding the therapy

To contact the corporate office.

If one of our Medical Assistants cannot handle the call then it is either forwarded to the

Pharmacy for explanation of the physician.

ALL Clinical Advisors are instructed that they cannot give medical advice nor interpret

and medical Deficiencies. They are instructed to discuss the Benefits of the programs and

possible Side effects of these programs.

Patient is then instructed that we will follow up with them every 4 weeks to note their

Progress and or concerns. They are also explained that at any given time if they have

Any questions to contact the corporate office.

On the 8th week, based on a 10 week program the PCC will contact patient to follow up

And to see if they are ready for their refill.

No refill will be filled until 70-80% usage is completed by law. Exceptions can be made

For loss, breakage or damaged meds but will be noted and the patient is instructed that

this

Is a onetime occurrence and cannot be continued. (This is a case by case scenario)...

All calls and emails are monitored and or recorded for training and compliance concerns.

The med soft system will allow the workflow of the Patient Practice- NATIONWIDE MD

Pharmacy

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Workflow to be very dynamic; all actions on Medsoft are time stamped for authentication

Of user ...

NATIONWIDE MD and all of its affiliates and contractors are obligated to follow every

aspect of all state and federal regulations rega rd ing the medicinal therapies a n d

treatment p r o g r a m s .

Cia lis Tadalafil

General I n f or ma t i on : Used to treat male sexual funct ion p r o b l e m s (impotence or

erectile dysfunction). Tadalafil is Cialis active ingredient. Erection lasting longer than four hours

must go to emergency room; epinephrine c o u n t e r a c t s p r o l o n g e d erections.

Directions: As needed 30 minutes before intercourse w i t h or without food.

Common side effects: Headache. Stomach upset, back pain. Muscle pain, nasal stuffiness,

flushing, pain in arms or legs, dizziness. Or vision changes.

Clomiphene Citrate

General Information: Used typically for post program helps to clean out receptor s i t e s flush out

extra estrogen from body. 50 mg only compounded, Clomide name brand available in generic

Common side effects: Stomach upset, bloating, abdominal/pelvic fullness, flushing, breast

tenderness, headache, dizziness. Vision changes, eye pain.

Serious s i d e e f f e c t s : Severe pain/swelling in the lower abdomen (pelvic) area, sudden/rapid

weight g a i n . Nausea/vomiting, d i a r r h e a , shortness of breath, change in the a m o u n t of

urine, pain/redness/swelling of the legs, chest pain, fast/irregular heartbeat.

Cyanacobalamin Methylcobalamin (Vitamin B-12)

General Information: Cyanacobalamin (Fast-acting l a s t about 4 8 hours) is a man-made

form of vitamin B12 used to treat l o w levels of this vitamin. Vitamin B12 helps your body use fat

and carbohydrates for energy and makes new protein. It is also important f o r normal blood. Cells

and nerves. This medication is for intramuscular injection. Methylcobalamin:_Sustain release stays in your body for about a week (Inject once a week)

Directions: Cyanacobalamin: Inject 1 ml 3 times a week i n t r a m u s c u l a r l y . Methylcobalamin:

Inject 1 ml once a week intramuscularly.

Common side e f f e c t s : Pain/redness at the injection s i t e , mild diarrhea. Itching or a feeling of

swelling all over the body.

Serious s i d e e f f e c t s : This medication may cause hypokalemia. Symptoms are muscle

cramps, weakness, irregular heartbeat

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Cytomell Liothyronine

General Information: Liothyronine is used t o treat hypothyroidism. It replaces a hormone that is

normally produced by the thyroid gland. This medication is also used to lower t h y r o i d function in

certain diseases such a s enlarged thyroid gland ( goiter) and Hashimoto’s thyroiditis. It is also used

to t e s t thyroid activity. Liothyronine is a man-made hormone that replaces the body's natural

thyroid hormone (T3). Take this med icat ion by mouth w i t h o r without food, usually i n the

morning. Take this m e d i c a t i o n 4 hours before or after t a k i n g any products containing

aluminum or iron, such as antacids, sucralfate, and vitamins/minerals.

Common side effects: Nausea, in rare instances, some temporary hair loss may occur during the

first few months of starting this drug.

Serious s i de e f f e c t s : Headache, irritability, trouble sleeping, nervousness, increased

sweating, heat intolerance, diarrhea, menstrual changes, chest pain, trouble breathing with exercise,

fast/irregular/pounding heartbeat, swelling of the arms/legs, extreme weakness.

DHEA/Pre~nenolone

General Information: DHEA is a sex hormone and is recommended to be taken while on HCG to

help prevent the shutdown of pregnenolone production in your body; which HCG can cause when

on it for a long period of time.

DHEA also appears to be useful in combating auto-immune disorders, especially lupus (systemic

Lupus e r y t h e m a t o s u s ). DHEA has demonstrated the potent ia l for preventing or treating a

broad range of other disorders including cancer (especially breast cancer], obesity, senile

dementia, osteoporosis, chronic fatigue syndrome, depression, and weakened immune

systems. Supplemental DHEA often markedly improves physical flexibility and e n d u r a n c e .

DHEA often decreases appetite by increasing the l e v e l s o f cholecystokinin, the hormone that

t e l l s yo ur b r a i n that you've had e n o u g h to e a t . It also tends to inhibit the conversion of

glucose to fat, which keeps people from gaining as much weight from eating carbohydrates as

they otherwise would. In some c a s e s , D H E A can significantly improve one's cholesterol

profile, raising HDL levels a n d lowering LDL levels.

Pregnenolone is a p r e c u r s o r to the body's other naturally occurring hormones,

including dehydroepiandrosterone (DHEA), progesterone, estrogen, testosterone, and

cortisol. Pregnenolone is synthesized directly from c h o l e s t e r o l and i s responsible for countless

functions in our bod ies . Pregnenolone acts t o improve memory and c o m b a t depression and h a s

p o we r f u l anti-inflammatory arthritis pain r e l i e v i n g properties. Some p eop le find

pregnenolone improves energy, vision, memory, clarity of thinking, wellbeing, and o f t e n

sexual enjoyment or libido. It may be considered a good brain e n h a n c e r in those w h o are

deficient.

Directions: Apply 1 ml topically to your wrist or inner thighs every day (rotate sites, best to

apply medication after showering and wait at least 30 minutes after application before you have

any contact with others to prevent transfer of medication)

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Side effects: (DHEA) acne, hair loss, stomach upset and high blood pressure. Some women can

have changes in menstrual c y c l e , facial hair growth, and a deeper vo ice . Liver problems:

DHEA might make liver problems w o r s e . Diabetes: DHEA can affect how insulin works in the

body. If you have diabetes, monitor your blood sugar carefully.

Side effects: (Pregnenolone) overstimulation and insomnia, irritability, anger or anxiety, acne,

Headaches, possible scalp hair loss (if used daily for prolonged periods), irregularities of heart

rhythm, heart palpitations.

Danazole

General In f o r m a t i o n : Danazole is an anabolic used to treat hypogonadism ( when the sex glands

produce little or n o ho rmo ne s ). This me dica t i on is recommended to b e taken along

w i t h testosterone and does not affect testosterone levels. The available dosages for this medication

are between 5 0 -100 mg.

Directions: 1 tab by mouth every day.

Common side e f f ec t s : Weight gain. Acne, flushing, sweating, voice changes (hoarseness, change

in pitch), a b n o r m a l growth o f body hair (in women), vaginal d r y n e s s /irritation, or decreased

breast size.

Serious side e f f e c t s : Swelling hands/ankles/feet, menstrual changes (such as spotting, m i s s e d

periods), mental/mood changes.

Finasteride Propecia Proscar (brand name)

General Information: This medication is used to treat male pattern (androgenetic alopecia) at the

crown and in the middle of the scalp. It should be used by adult men only. This medication w o r k s

b y decreasing t h e amount o f a natural b o d y hormone (DHT). Decreasing t h e amount o f DHT

leads to increased hair re-growth and slower hair loss. Hair growth on other parts o f the body is

not affected by finasteride. You must continue t o take this medication t o maintain your hair

growth. When you stop taking finasteride, any gain in hair quantity is generally lost wi th in 12

months. This medication is normally t a k e n along wi th testosterone. Normal ranges for DHT

levels are (40-575)

Directions: Take 1 pill by mouth 3 times a week

Common side effects: Decreased sexual a b i l i t y /desire. In some m e n , this m e d i c a t i o n can decrease the amount of semen released during sex.

Serious side effects: Lump in the breast, nipple discharge, breast enlargement/tenderness/pain,

pain in the testicles, inability to urinate.

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General Information: Various brands o f this medication are used for the treatment of one of the

following medical c o n d i t i o n s : growth failure, growth h o r m o n e deficiency. Intestinal

disorder (short bowel syndrome) o r HIV-related weight loss or wasting.

Common side effects: Headache. Nausea, vomiting, fatigue. Muscle pain, or weakness.

Serious s i d e e f f e c t s : Development of a limp, persistent fatigue, unusual/unexplained

weight gain. Persistent cold intolerance , persistent slow heartbeat , fast he a r t bea t , e ar

pain/itching. Hearing problems, joint/hip/knee pain. Numbness/tingling, unusual increase in

t h i r s t or urination, swelling h a n d s /ankles/feet. Change i n the appearance or size of any

mole, severe headache, persistent nausea/vomiting, severe stomach/abdominal pain, vision

problems or changes, seizure.

Ghrelin

General I n f o r m a t i o n : Ghrelin i s a po tent stimulator of growth hormone from t h e

anterior pituitary g l a n d . This medication c a n be taken every day; inject medication a t bed time

because your body secrets growth hormone while sleeping. This medication may also cause

drowsiness.

Mixing instructions: Depressurize Ghrelin vial first. Slowly inject 3ml of bacteriostatic water

into Ghrelin vial do not shake vial gently swirl vial between h a n d s to dissolve medication. Once

the medication h a s been mixed store medication i n refrigerator. Inject 300- 600 mcg per day at

bed time. Every 10 on insulin syringe is 100 units.

Directions: Inject .25 ml sub-q every day at bed time.

Side effects: Increased appetite

General I n f o r m a t i o n : HCG works b y causing t he testes t o release m a l e sex hormones.

This medication i s also used in women to treat fertility problems. So both male and female

patients should take extra precautions w h e n on this medication to prevent an y unwanted

p r e g n a n c y . It is recommended that you take this medication while taking testosterone; 4-5

weeks after starting testosterone your body starts to recognize the free flowing testosterone

which in turn causes your body to stop production of its natural LH hormone. HCG helps to

prevents t h i s so your LH levels do not plateau and everything s t a ys in balance. It is also

recommended t h a t you inject HCG one day before testosterone injection.

Mixing instructions: Start by depressurizing your HCG vial, next you draw up the correct

amount of bacteriostatic water (depending the amount of units per vial normally 1:1 follow

doctors sig) slowly inject water into HCG vial, do not shake vial you gently swirl vial between

hands to dissolve medication once the medication has been mixed it is to be stored in

refrigerator. Medication should be clear if cloudiness is noticed then medication is no good.

Directions: Inject 250 IV (25 on insulin syringe) sub-q twice a week.

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Common side e f f e c t s : Headache. restlessness, tiredness, mild swelling or water weight

gain; depression; breast tenderness and swelling and or injection site inflammation and pain,

ovarian hyper-stimulation syndrome, multiple births in pregnancy.

Serious s i d e effects: swelling of the ankles/feet mental/mood changes.

HGH/Tev-Tropin

General Information: Various brands of this medication are used for the treatment of one of the

following medical conditions: growth failure, growth hormone deficiency. intestinal disorder

(short bowel syndrome) or HIV-related weight loss or wasting. HGH should be taken 5 days on 2

days off. HGH contains 191 amino acids. Tev-Tropin contains 192 amino acids.

Mixing Instructions: Depressurize Tev-Tropin vi a l first. Slowly inject 1 .5ml of bacteriostatic

water into vial do not shake vial gently swirl vial between hands to dissolve medication. Once the

medication has been mixed store medication in refrigerator. Inject at bed time on empty stomach.

Every 10 on insulin syringe is 1 unit.

Common side effects: Headache, Nausea, vomiting, fatigue, muscle, pain, or

weakness.

Serious side effects: Development of a limp, persistent fatigue, unusual/unexplained weight

gain, persistent cold intolerance, persistent slow heartbeat, fast h ea rtbeat , and ear

p a i n /itching. Hearing problems, joint/hip/knee pain, numbness/tingling, unusual increase in t h i r s t

or urination, swelling hands /ankles/feet. Change in the appearance or size of any mole, severe

headache, persistent nausea/vomiting, severe stomach/abdominal pain, vision problems or

changes, seizure.

Hydrocortisone

General I n f o r m a t i o n : Hydrocortisone is a natural substance (corticosteroid hormone)

m a d e by the adrenal gland.

It is used to treat conditions such as adrenal fatigue syndrome, arthritis,

blood/hormone/immune system disorders, skin and eye conditions, breathing problems, cancer

and severe allergies. It decreases yo u r immune system’s response t o various diseases to reduce

symptoms s u c h as pain, swelling and allergic-type reactions. Hydrocortisone i s also used to treat

low hydrocortisone levels caused b y diseases o f the adrenal g l a n d (such as Addison’s disease.

adrenocortical insufficiency). Corticosteroids are needed i n many ways for the body to function

well. They are important f o r salt and water balance and keeping blood pressure normal. Because

this drug works by weakening t h e immune system, it may lower your ability to fight infections.

This may make you more likely to get a serious infection or make any infection you have worse.

Use of this medication f o r prolonged or repeated periods m a y result in oral thrush or a yeast

infection. This medication may infrequently m a k e your blood sugar level rise, which can cause or

worsen d i a b e t e s (symptoms o f high blood sugar increased t h i r s t a n d urination). If you

already have diabetes, be sure to check your blood sugars regularly.

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Common side effects: Nausea, heartburn, h e a d a c h e , dizziness, menstrual pe r io d change,

trouble sleeping, increased s wea t i n g , acne.

Serious side effects: Unusual tiredness, swelling ankles/feet, unusual weight gain, Vision

problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes, muscle

weakness/pain, thinning skin, slow wound healing, bone pain, black/bloody stools, vomit that

looks like coffee grounds, stomach/abdominal pain.

Letrozole

General Information: Letrozole d e c r e a s e s the amount o f estrogen t h e body makes. It is

the strongest anti e s t r o g e n on the m a r k e t and m o s t e x pe n s i ve . Used when A n a s t r o z o l e

is not working.

Common side effects: Hot f l a s h e s , hair loss, j o i n t /bone/muscle pain, tiredness,

unusual sweating, nausea. Diarrhea. Dizziness and trouble sleeping.

Serious side effects: Bone fractures. Mental/mood changes, swelling of arms/legs,

blurred vision.

General Information: If patient has sulfa allergies this medication cannot be taken.

Methionine: it assists in the breakdown of fats and thereby prevents the build-up of fat in the

arteries, as well as assisting with the digestive system and removing heavy metals from the body

since it can be converted to cytosine, which is a precursor to gluthione, which is of prime

importance in detoxifying the liver.

Inositol: helps to m a i n t a i n proper electrical energy and nutrient transfer across the

cell membrane. It also acts as a lipotropic w h i c h converts f a t s into other u s e f u l products.

Inositol helps establish healthy cell membranes, w h i c h facilitate nerve impulses.

Choline: Assists in controlling your weight as well as cholesterol l e ve l s , keeping cell membranes

healthy a n d in preventing gallstones. It is also most useful in the maintenance of the nervous

system, assisting memory and learning, and may help to fight infections, including hepatitis and

AIDS. Choline is critical for normal membrane s t r u c t u r e a n d function.

Choline: is the major precursor of betaine, and it is used by the kidneys to maintain water

balance and by the liver as a source of methyl-groups for methionine formation. It is also used to

produce the important n e u r o t r a n s m i t t e r acetylcholine.

Side effects: Possible could burn while injecting, Redding of injection site

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Minocycline

General Information: Minocycline is used to treat a wide variety o f infections, including acne.

This medication belongs to the class of antibiotics known as tetracycline. It works by stopping the

growth o f bacteria. Swallow this medication whole . Take each dose with a full glass of water (8

ounces) u n l e s s your doctor directs you otherwise. Do not lie down for 10 minutes a f t e r taking

this medication. For this reason, do not take it right before bedtime. You may take minocycline

with food or milk if stomach upset occurs, unless your doctor directs you otherwise.

Common side effects: Nausea, vomiting, diarrhea, lightheadedness, dizziness, unsteadiness,

drowsiness, mouth sores, or cough.

Serious side effects: Sunburn (sun sensitivity), muscle pain, difficult or painful swallowing,

change in the amount of urine, pink urine, brown/gray tooth discoloration, blue/gray/brown

discoloration of the skin/lips/tongue/gums, numbness/tingling of the hands/feet.

Unusual fatigue, new signs of infection, hearing changes, easy bruising/bleeding, headache, vision

changes.

Nandrolone Deco nate

General Information: Known c o m m o n l y as “ Deca” flushes estrogen through your

s y s t e m lubricating j o i n t and aiding in muscle repair. This is a short acting medication if

used for long periods of time it can cause muscle wasting. This medication should b e

taken in 3 month increments.

Side effects: Estrogen build up, Fluid buildup (edema), low libido.

Oxandrolone

General Information: This medication is used to help people regain weight they have lost due to

certain medical conditions (such as s u r g e r y , chronic infection, trauma, long t e r m use

o f corticosteroid medication such as hydrocortisone/prednisone). It is also used to relieve bone

pain due to bone loss (osteoporosis) and muscle wasting. Oxandrolone belongs to a class of drugs

known as anabolic steroids. These drugs are similar to male hormones made by the body. This

medication can cause your body to hold on to extra body water (edema). This can increase your

risk of heart failure. Tell your doctor immediately if any of these unlikely but serious signs of

water retention or heart failure occur, decreased exercise ability, hands/ankles/feet swelling,

unusual tiredness, shortness of breath while lying down. This medication can also decrease

sperm production in males.

Common side effects: Nausea, vomiting, skin color changes, oily skin, acne, hair loss,

increased/decreased sexual interest

Serious side effects: Mental/mood changes, trouble sleeping/snoring, signs of serious liver

disease (persistent abdominal pain/nausea, unusual tiredness, yellowing of the eyes/skin, dark

23

urine), trouble urinating (male only), breast swelling/tenderness (male only), to

frequent/prolonged erections (male only)

In females: Deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged

Clitoris, and irregular menstrual .

Oxytocin Nasal Spray

General Information: Oxytocin is best known for its roles in sexual reproduction, in particular

during and after childbirth. It is released in large amounts after distension of the

cervix and uterus during labor, facilitating birth. And after stimulation of the nipples.

Facilitating breastfeeding. Recent s t u d i e s h a v e begun t o investigate oxytocin’s role in

various behaviors, including orgasm. Social recognition, pair bonding. Anxiety. And

maternal behaviors. For this reason, it is sometimes r e f e r r e d t o as the “love hormone". Oxytocin

causes a euphoria effect increasing y o u r l ibido . Oxytocin is destroyed in the gastrointestinal

t r a c t , and therefore m u s t be administered by injection or as nasal spray. Oxytocin has a half-

life of typically about three minutes in the blood.

Side effects: Nausea, vomiting, more intense or abrupt contractions o f the

Phosphatidylserine

General Information: Phosphatidylserine is a chemical. The body can make phosphatidylserine,

but gets most of what it needs from foods. Phosphatidylserine supplements were once made from

cow brains, but now are commonly manufactured from cabbage or soy. Phosphatidylserine is

used for Alzheimer's disease, age-related decline in mental function, improving thinking skills in

young people, attention deficit-hyperactivity disorder, depression, preventing exercise-induced

stress, and improving athletic performance.

Side effects: Insomnia and stomach upset, particularly at doses over 300 mg.

Progesterone

General Information: Progesterone is a type of female hormone ( progestin). This medication is

similar to the progesterone that your body naturally makes and is given to replace the hormone

when your body is not making enough of it. In women who are not pregnant and not going

through menopause, this medication is used to restore normal menstrual periods that have

stopped for several months (amenorrhea). Progesterone is also used as part of combination

hormone replacement therapy with estrogens to reduce menopause symptoms. Progesterone is

added to estrogen replacement t h e r a p y to reduce the risk of cancer of the uterus.

Common side effects: Nausea, bloating, breast tenderness, headache, change in

v a g i n a l discharge, mood swings, blurred vision , dizziness, or drowsiness.

Serious side effects: Unusual vaginal bleeding, mental/mood changes, swelling of the

hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face,

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Yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark urine,

unusual tiredness.

Sermorelin GHRP

General Information: Stimulates your pituitary to produce your own natural HGH. Sermorelin,

which was first developed in the 1970's is a peptide which contains a total of 29 amino acids and

encourages the pituitary gland to produce more Human Growth hormone. Today, Sermorelin is

combined with GHRP-6 which is a growth hormone releasing peptide (also known as growth-

releasing factor). This combination, when administered via daily injections, will encourage your

pituitary gland to secrete HGH at a much higher rate.

Mixing instructions: Depressurize Ghrelin vial first. Slowly inject 3ml of bacteriostatic water

into Ghrelin vial do not shake vial gently swirl vial between hands to dissolve medication. Once

the medication has been mixed store medication in refrigerator. Inject 300- 600 mg per day at

bed time. Every 10 on an insulin syringe is 100 units

Side effects: Headache. Flushing, increase in activity (hyperactivity). GHRP: Increased appetite

Serious side effects: Trouble swallowing, vomiting, tightness i n the chest.

Triamterene HCTZ

General i n f o r m a t i o n : This d rug i s used to treat high blood p r e s s u r e . Lowering h i g h

blood pressure helps prevent strokes , heart attacks and kidney problems. This combination i s used

by people who have developed or are at risk for having low potassium levels

on hydrochlorothiazide. It causes you to make more urine, which helps your body get rid of extra

salt and water. This medication a l s o reduces e x t ra fluid in the body caused by conditions s u c h

as heart f a i l u r e , liver disease or kidney disease. This can lessen symptoms s u c h as shortness

o f breath o r swelling in your ankles or feet. It is best to avoid taking this medication wi th in 4

hours of your bedtime to prevent having to get up to urinate.

Common side effects: Dizziness, lightheadedness, headache or upset stomach.

Serious side effects: Fainting muscle cramps/weakness, slow/fast/irregular heartbeat,

u n u s u a l decreased u r i n a t i o n , unusual dry mouth/thirst, decrease in vision, eye pain.

Tamoxifen

General information: Used to remove estrogen from your body. Also helps to lower LDL levels.

Common s i d e effects: Hot flashes, Nausea, leg cramps, hair thinning, or headache. A loss of

sexual ability/interest may occur in men.

Serious s i d e e f f e c t s : Vision changes, eye pain, easy bruising/bleeding, mental/mood

changes, swelling of ankles/feet. Unusual tiredness, s t o m a c h /abdominal pain, persistent

nausea/vomiting, dark urine, yellowing eyes/skin, s i g n s of infection.

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Testosterone

General Information: This medication is used in men who do not make enough of a natural

substance called testosterone. In males, t e s t o s t e r o n e is responsible for many normal

functions, including growth and development of the genitals, m u s c l e s , and bones. It also helps

c a u s e no rmal sexual development (puberty) in b o y s . Testosterone belongs to a c l a s s of

d r u g s known as androgens. It works by affecting many body s y s t e m s so that t h e body c a n

develop and funct ion normally. This medication can cause y o u r body to hold on to extra b o d y

water (edema). This can increase your risk o f heart failure (signs of water retention/heart

failure; decreased exercise ability, hands/ankles/feet swelling, unusual tiredness, shortness of breath

while lying d o w n ). This medication can also decrease sperm production in males.

Recommendations: Inject 4-5 d a y s apart from e a c h other intramuscularly (gluteus maxim

us, vastus lateralis, lateral deltoid muscle) store a w a y f r o m s u n l i g h t and heat. Patient should

n o t go over 6 0 0 mg a week.

Common side effects: Nausea, vomiting, skin color changes (red can mean Bop is up), oily

skin, acne, hair loss, increased/decreased sexual interest, testicular atrophy (increase HCG),

puffiness of face, chest, and abdomen (estrogen builds up).

Serious side e f f e c t s : Mental/mood changes, trouble sleeping/snoring, signs of ser ious

liver disease (persistent abdominal pain/nausea, unusual tiredness, yellowing of the ‘eyes/skin,

dark urine), trouble urinating (male only), breast swelling/tenderness (male only),

to frequent/prolonged erections (male only)

In female: Deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris,

irregular menstrual periods.

Reaction times

Aqueous suspension: 1- days fast acting

Cypionate: 3-5 days slow acting

Proprionate: 1-2 days fast acting (increase swelling and soreness)

Enanthate: 5-7 days slow acting

Proplonate /Cypicnate: (Bi-mix) Fast/slow acting

Enanthate/Propionate: 200/50mg Fast/slow acting

Enanthate /Cyplonate/Propionate: 100/100/50 (higher risk of side effects, patient must be on all

3 types oftestosterone before they can go on this mix)

Testosterone cream: Available from 1 - 25% Female 2% average Male 5 - 20% average

26

Viagra Sildenafil

General Information: Sildenafil (active ingredient) i s used to treat male sexual function

problems ( impotence or erectile dysfunction) by blocking a certain enzyme (phosphodiesterase-

PDE5) in the body. In combination with sexual stimulation, s i l de na f i l works by helping

the blood flow into the penis to achieve and maintain an erection. If you have erections lasting

longer than four hours go directly to the emergency room. Epinephrine counteracts the effects of

prolonged erections.

Common side effects: Dizziness, lightheadedness, headache, flushing, heartburn, nosebleeds. Trouble

sleeping, or swollen hands/ankles/feet. Vision changes such as increased sensitivity to light,

blurred vision, or trouble telling blue and green colors apart.

Vitamin D3

General Information: Vitamin D is a vitamin. It can be found in small amounts i n a few foods, including fa t ty fish such as herring, m a c k e r e l , sardines a n d tuna. But most vitamin D - 80%

to

90% of what the body gets - is obtained through exposure to sunlight. Vitamin D is used for

preventing and treating rickets, a disease that is caused by not having enough vitamin D. Vitamin

D is also used for treating weak bones (osteoporosis), bone pain (osteomalacia), bone loss in

people with a condition called hyperparathyroidism, and an inherited disease (osteogenesis

imperfecta) in which the bones are especially brittle and easily broken. It is also used for

preventing falls and fractures in people at risk for osteoporosis, and preventing low calcium and

bone loss (renal osteodystrophy) in people with kidney failure. Vitamin D is used for conditions

of the heart and blood vessels, including high blood pressure and high cholesterol. It is also used

for diabetes, obesity, muscle weakness, lubricating joints, multiple sclerosis, rheumatoid arthritis,

chronic obstructive pulmonary disease, asthma, bronchitis, premenstrual syndrome and tooth

and gum disease.

Recommended: 50000 units weekly

Common side effects: (when taking too much) weakness, fatigue, sleepiness, headache, loss of appetite, dry mouth, metallic taste, nausea, vomiting.

Kidney disease: Vitamin D may increase calcium levels and increase the risk of "hardening of the

arteries” in people with serious kidney disease. This must be balanced with the need to prevent

renal osteodystrophy, a bone disease that occurs when the kidneys fail to maintain the proper

levels of calcium and phosphorus in the blood. Calcium levels should be monitored c a r e f u l l y in

people with kidney disease.

High levels of calcium i n the blood: Taking vitamin D could make this condition worse.

Atherosclerosis: Taking vitamin D could make this condition worse.

Sarcoidosis: Vitamin D may increase calcium levels in people with sarcoidosis. This could lead to

kidney stones and other problems. Use vitamin D cautiously.

27

Histoplasmosis: Vitamin D may increase calcium levels in people with histoplasmosis. This could

lead to kidney stones and other problems. Use vitamin D cautiously.

Over-active parathyroid gland ( hyperparathyroidism): Vitamin D may increase calcium

levels in people with hyperparathyroidism. Use vitamin D cautiously.

Lymphoma: Vitamin D may increase calcium levels in people with lymphoma. This could lead to

kidney stones and other problems. Use vitamin D cautiously

L-Arginine

General Information: L-arginine is a chemical b u i l d i n g b l o c k called “ an amino a c i d .” It

is obtained f r o m the diet and is necessary f o r the body to make proteins. L-arginine is found in

red meat, poultry, fish, and dairy products. It can also be made in a laboratory a n d used as

medicine L-arginine i s used for heart and blood vessel conditions i n c l u d i n g congestive h ea r t

f a i l u r e . Chest pain. High blood pressure a n d coronary artery disease. L-arginine is also used

for recurrent p a i n in the legs due to blocked arteries, d e c r e a s e d m e n t a l capacity in the

elderly, erectile dysfunction and m a l e infertility. Some people u s e L-arginine f o r preventing the

cold, high blood pressure , improving a t h l e t i c performance , boosting the immune system. You

can also apply L-arginine to the skin to speed wound healing and for increasing blood flow to cold

hands and feet. Especially in people with diabetes. It is also used as a cream for sexual problems in

both men and women and to stimulate IGF-levels. Patients who have HSV should not take L-

arginine; it can sometimes cause an outbreak.

Side effects: Abdominal pain, bloating, diarrhea, gout, blood abnormalities, allergies, airway

inflammation, worsen in g of asthma, and low blood pressure.

L-Carnitine

General Information: L-carnitine is an amino acid (a building block for proteins) that is

naturally produced in the body. Carnitine is a substance t h a t helps the body turn fat into energy.

Your body makes it in the liver and kidneys and stores it in the skeletal muscles, heart, brain, and

sperm. Some studies do show that oral carnitine r e d u c e s f a t mass; increases m u s c l e mass, and

reduce fatigue, which may contribute t o weight loss in some people. Some people use L-carnitine

for muscle disorders a s s o c i a t e d w i t h certain AIDS medications, m a l e infertility, and anorexia.

Chronic fatigue syndrome, diabetes, overactive thyroid. Attention deficit-hyperactivity

disorder, leg ulcers, Lyme disease. And to improve a t h l e t i c performance and endurance.

Preliminary s t u d i e s suggest propionyl-L-carnitine may help improve m a l e s e x ua l

function . One study found that carnitine improved the effectiveness of sildenafil (Viagra) in

men with diabetes who had not previously responded to Viagra. In another study, a

combination of propionyl-L carnitine and acetyl-I-carnitine improved the effectiveness of Viagra

in men who had erectile dysfunction after prostate surgery. Some research suggests that L-

carnitine may help prevent or reduce symptoms of an overactive thyroid, such as insomnia,

nervousness, heart palpitations, and tremors.

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Side e f f e c t s : Nausea, vomiting, s t o m a c h u p s e t , h e a r t b u r n , diarrhea, and se i zure s . It

can also cause the urine, breath, and sweat to have a "fishy" odor.

L- Glutamine Powder

General Information: Glutamine i s an amino acid, found naturally i n the body. It is the most

abundant f r e e amino acid in the body. Glutamine is produced in the muscles and is distributed b y

the blood to the organs that need it. Glutamine might help gut function, the immune system, and

other essential processes in the b o d y , especially i n times o f stress. It is also important

for providing “ fuel" (nitrogen and carbon) to many different cells in the body. Glutamine is needed

to make other chemicals in the body such as other ami no acids and glucose (sugar). Glutamine

is used to counter s o m e of the side effects of medical treatments. For example, it is used for

side effects of cancer chemotherapy including diarrhea, pain and swelling inside the

mouth (mucositis), nerve pain (neuropathy), and muscle and joint pains caused by the cancer

drug Taxo!. Glutamine is also used to protect the immune system and digestive system in

people undergoing radio chemotherapy for cancer of the esophagus. Additionally, glutamine is

used for improving recovery after bone marrow transplant or bowel surgery, increasing well-

being in people who have suffered traumatic injuries, and preventing infections in critically

ill people. Some people use glutamine for digestive system conditions such as stomach ulcers,

ulcerative colitis, and Crohn's disease. It is a lso u s e d f o r d e p r e s s i o n , moodiness,

irritability, anxiety, insomnia, and enhancing exercise p e r f o r m a n c e . People who have

HIV (AIDS) sometimes use glutamine to p r e ve n t weight loss. Glutamine is also used for

attention deficit-hyperactivity disorder, a urinary condition called cystinuria, sickle cell

anemia, and for alcohol withdrawal support.

Side effects: Potential side effects of glutamine are not known.

Milk- Thistle

General Information: Milk thistle is a plant. The above ground parts and seeds are used to make

medicine the seeds are more commonly used. Milk thistle is used most often for liver disorders,

including liver damage caused by chemicals, Amanita phalloides mushroom poisoning, jaundice,

chronic inflammatory liver disease, cirrhosis of the liver, and chronic hepatitis. Nevertheless,

researchers have not yet concluded with certainty that milk thistle is effective for any of these

uses. Milk thistle is also used for loss o f appetite, heartburn (dyspepsia), and g a l l b l a d d e r

complaints. Some people use milk thistle for diabetes, hangover , diseases of the spleen, prostate

cancer, malaria, depression, uterine complaints, increasing breast milk f l o w , and starting

menstrual flow. Milk thistle s e e d might protect l i ve r cells from toxic chemicals and drugs. It

also seems to have antioxidant a n d anti-inflammatory effects. Milk thistle plant extract might

enhance the effects of estrogen.

Side e f f e c t s : Sometimes causes a laxative e f f e c t , nausea, d i a r r h e a , indigestion, intestinal

g a s , bloating, fullness or pain and loss of appetite.

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Saw Palmetto

General Information: Saw palmetto i s a plant. Its ripe fruit is used to make medicine. Saw

palmetto is best k n o w n for i ts use i n decreasing symptoms of an en larged prostate. Saw

palmetto i s used for treating c e r t a i n types of prostate infections. It is also sometimes u s e d ,

in combination w i t h other herbs, to treat prostate c a n c e r . Some people use saw palmetto for

colds and coughs, sore throat, asthma, chronic bronchitis, chronic pelvic pain syndrome, and

migraine headache. It is also used to increase u r i n e flow, to promote r e l a x a t i o n a n d to

enhance sexua l drive (as and aphrodisiac) a n d can help with baldness. Some men report that

using saw palmetto with beta-sitosterol makes them grow more and better h a i r . Saw palmetto

s e e m s to decrease estrogen levels in the body. Taking saw palmetto along with estrogen pills

might decrease the effectiveness of estrogen pills. Surgery: Saw palmetto might slow blood

clotting.

Common side effects: Dizziness, headache, nausea, vomiting, constipation, a n d diarrhea. Some

people have reported that saw palmetto causes impotence

Anastrozole

General Information: Anastrozole h e l p s to lower estrogen l e v e l s in your body to help

prevent estrogen b u i l d up for patients w h o are taking testosterone signs of estrogen b u i l d up

are a puffy face/abdomen redness o f face or gynocamastia. It is recommended t h a t you take this

medication one day after testosterone injection.

Directions: Capsules by mouth two times a week.

Common side effects: Constipation. diarrhea, nausea, vomiting, upset stomach, loss of appetite,

body aches and pains, breast swelling/tenderness/pain, headache, dry mouth, scratchy throat,

increased cough, dizziness, trouble sleeping, tiredness/weakness, flushing and sweating (hot

flashes/hot flushes), vaginal bleeding, hair thinning, and weight change.

Serious Side effects: Mental/mood changes, numbness/tingling/swelling of the hands or feet,

persistent cough, unusual vaginal discharge/burning/itching/odor, unusually stiff muscles,

pain/redness/swelling of the arms or legs, vision changes, bone pain, bone fracture, signs of

infection.

Androgel

General Information: This m e d i c a t e d gel c o n t a i n s testosterone. It is used for

hormone replacement in men who are not able to produce enough testosterone

(hypogonadism). In patients with d i abe t e s , e s p e c i a l l y t h o s e t a k i n g insu l in ,

te stosterone may decrease y o u r blood sugar. Symptoms of low blood sugar include

shakiness, n e r v o u s n e s s , rapid pulse and sweating. Androgel is a topical medication and it is

recommended that you apply medication to your wrist or inner thigh (rotate locations) after

showering; avoid direct contact with other persons for at least 30 minutes after application to

avoid transfer of medication to others.

Common side effects: Redness/irritation at the application si te or acne may occur.

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Serious side e f fec t s : Persistent nausea/vomiting, severe stomach/abdominal pain, dark urine,

yellowing eyes/skin, swelling hands/ankles/feet. Breast pain/enlargement, very

slow / shallow/difficult breathing (possibly while sleeping), difficulty urinating, increased

urination ( especially at night), change in the amount o f urine, pain/swelling/redness in the legs,

mental/mood change, testicle pain/tenderness.

Armor Thyroid

General Information: Thyroid hormone i s used to treat hypothyroidism. It is a natural

product made from animal thyroid glands (usually a pig's). It replaces or provides more thyroid

hormone, which is normally produced by the thyroid gland. Having enough thyroid h o r m o n e i s

important for maintaining normal m e n t a l a n d activity. This medication is also used to treat

other types of thyroid disorders (such as certain types of goiters, thyroid cancer). Armour

thyroid is sometimes g i v e n to patients who are on HCG because H C G has a tendency o f

lowering thyroid production l e v e l s . Take medication on an empty stomach, if patient has allergies

to pork products then medication should not be taken.

Common side effects: Hair loss may occur during the first few months of treatment. This effect is

usually temporary a s your body adjusts to this medication.

Serious side effects: High thyroid hormone levels occur: increased sweating, sensitivity to heat,

mental/mood changes, tiredness, diarrhea, shaking, headache, shortness of breath.

B-Complex

General Information: The vitamin B-complex refers to all of the known essential water-soluble

vitamins except for vitamin C. These include thiamine (vitamin Bl, riboflavin (vitamin

B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin,

folic acid and the coalmines (vitamin B1 2 ). It is recommended that you take B-complex when

on testosterone; testosterone can lower B-complex production.

Health benefits: Support and increase the rate of metabolism, Maintain healthy skin, hair

and muscle tone, Enhance immune and nervous system function, Promote cell

growth and division, including that of the red blood cells that help prevent anemia. B vitamins

have also been hypothesized t o improve the symptoms o f attention defic i t hyperactivity disorder .

Caverject Impulse/Tri-Mix

General I n f o r m a t i o n : This medication is used to treat male sexual function. It works by

helping the blood flow into the penis to achieve and maintain an erection. This medication is not

recommended for use in men with penile implants. This medication is given by injection into the

penis as directed by your doctor. This medication shou ld usually work within 5 to 20 minutes to

produce an erection that lasts for about 1 hour. The manufacturer recommends t h a t this

medication be used no more than 3 times a week with at least 1 day between e a c h dose. Make

sure your medicine is stored at room temperature. Do not use any leftover Caverject solution. Do

not use other medical treatments for ED while you are using Caverject. For erections lasting for

more than four hours go to emergency room.

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Compounding

Compounding is the method of preparing c u s t o m i z e d medications to help meet unique

physician and patient needs.

Compounding pharmacists w o r k closely with physicians to assure that the medicines are created

and administered while providing great benefit to the patient with least amount of side-effects.

Just about any kind of medication can be formulated and compounded t o meet specific

medication need. Whether it’s a suppository, t r a n s d e r m a l cream, lozenge or solution,

physicians and their patients c a n obtain results by choosing a compounded a p p r o a c h .

Human preparations that are currently compounded:

Sterile injections

Oral suspensions and pastes

Capsules

Topical creams, ointments and lotions

Ophthalmic preparations

Optic solutions and non-aqueous suspensions

Transdermal

Flavor specialization

Sugar-free formulations

Combination medications

Customized dosage forms

Lollipops

Troches

Preservative-Free Medications

Suppositories

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Press in Bottle Adapters

Make measuring s i m p l e , accurate and prevents t he mess and spillage associated with conventional

dosing tools. Adapters are available in assorted sizes and tightly screw onto the medication bottle

with a convenient flip top cap which are custom fit to oral dosing syringes (also available in

numerous sizes).

Creams / Ointments

Transdermal o r vaginal application to deliver a variety of medications s u c h as hormones, steroids

and antibiotics. Once a cream or ointment is prepared, it is then run through an ointment mill

which essentially pulverizes the powdered drug to eliminate the potential for a gritty texture

making the preparation smooth and silky.

Powders

Medication powders may be mixed with flavored or effervescent bases which are later measured

and dissolved in water, juice or applesauce f o r oral administration. Powders can also be placed in

an insufflators for "puffing" a drug directly onto a wound which requires hea l ing (such as a

diabetic ulcer) without adding unnecessary moisture to the treatment area.

Solutions

Typically are for topical use (aqueous based) although oral solutions in place of suspensions a r e

quite common depending on the nature of the d r u g being compounded. Bottles for dispensing are

available in various sizes with specialized closures such as an enema tip, nasal spray tips, throat

Or topical spray tips and pumps dispensers. Flip top caps, roll-on applicators a nd many

more available to solve a patients medicat ion d e l i ve r y needs.

Powder and Oil Capsules

Made custom to order, and are available in clear gelatin, vegetarian, o r color coded capsules in a

multitude o f sizes depending on the amount of drug required. Capsules are quality control tested for

accurate weight and even drug distribution. Various fillers are available for special needs such as

dye free, lactose free, and sustained release bases can be added to prolong the metabolization

Of the medication.

Transdermals

Transdermal creams, ointments, lotions, solutions and gels are available for the effective delivery

of many medications and can be dispensed in jars, tubes, syringes, roll on applicators and Boston

round bottles for example.

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Troches

Gelatin based sublingual squares that can be easily cut into halves or fourths to adjust dosing.

They are artificially sweetened a n d flavored to patient preference a n d will dissolve under the

tongue in less than a couple of minutes, Ideal for children or patients u na b le to swallow capsules

or tablets.

COMPOUNDING DEFINTIONS

Compounding

Compounding is the branch of medicine in which a pharmacist formulates and makes a

Medication for his/her p a t i e n t .

Compounding Pharmacist

A compounding p h a r m a c i s t i s a specialized healthcare professional w h o has received

special education and training in the art of pharmaceutics a n d medication p roduc t ion .

Pharmaceutics Pharmaceutics i s the science of medication de l ive r y forms. Capsules or injections are examples of

A medication delivery form.

Delivery Form

A delivery form is a method or device by which a patient receives a medication.

Compounding Overview

Compounding is a branch of medicine in which a pharmacist formulates and makes a medication

For his/her patient. A compounding ph a rmac i s t i s a specialized healthcare p ro f e s s i o n a l who

has received special education and training in the art of pharmaceutics. Pharmaceutics i s the

science of medication de l ive ry forms. Capsules or injections are examples of a medication

delivery form.

Compounding and Healthcare

Compounding allows a patient to receive the correct drug amount in a delivery system tailored

To an individual to aid in the treatment, a m e l i o r a t i o n o r prevention o f a medical condition.

Under the current healthcare system medication are manufactured to accommodate the majority

of potential patients without regard for individual variability. Most medications come in only a

small variety of strengths a n d dosage forms so a patient that requires a strength or dosage form that

in unavailable i s forced to accept the second-best opt ion that is commercially available.

Compounding provides the individual a way to receive a tailored drug regimen that is outside of

the scope of the commercia l pharmaceutical company’s domain.

Compounding also allows a patient to receive a medication that is not available such as an

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Investigation drug or a discontinued drug. A compounding pharmacist can purchase lab tested

bulk chemicals and formulate a medication in such a case.

Compounding Pharmacy

A compounding pharmacy is a specialized pharmacy that h a s professional staff proficient in the

art of compounding.

Compounding Pharmacist A compounding pharmacist is a healthcare provider, who is specialized in the branch of

medicine, involved in the production of individualized medications. A compounding pharmacist

has typically taken s e v e r a l hours o f specialized training in the art of compounding.

Additionally, a compounding pharmacist usually devotes a great d e a l of his/her practice of

pharmacy to the art of compounding.

Compounding Innovation

Compounding innovation is the central feature of a compounding practice. Often a request is

made tha t c a u s e s a compounding pharmacist to research and formulate a specific

c o m p o u n d . The innovations made in the field of compounding are usually shared with

colleagues thus expanding the potential impact compounding has upon the lives of pharmacy

patients.

Compound Formulation A compound formulation is the recipe t h a t i s created to direct t h e compounding pharmacist

in the production of the specific m e d i c a t i o n .

Under system t h r o u g h reduction of costs g e n e r a t e d by improving patient outcomes.

Compounding Education

Compounding education involves the s tudy of pharmaceutics, pharmacy calculations,

pharmacokinetics, continuing education and compounding seminars to improve the eff icacy

of the compounding pharmacist.

Compounding resources Compounding resources include many p h a r m a c y publications such as Martindale’s,

Remington's, the USP, the International Journal of Compounding Pharmacy and collaborative

exchanges between pharmacists specialized in the practice of compounding. Additional

compounding resources include t h e International Academy of Compounding Pharmacists,

PubMed, P C C A and various Internet sites d evo ted to the transferable of compounding

information.

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Compounding equipment i n c l u d e s something as simple as an electronic balance to

something as complicated as an automated c a p s u l e -filling machine.

Compounding Supplies

Compounding supplies are items that are indirectly necessary for the production o f a

compounded m e d i c a t i o n . Examples of such item include weight boats, spatulas and mortar

and pestles.

Compounding Calculations

Compounding calculations are mathematical c o m p u t a t i o n s t h a t are performed e a c h time

a medication i s compounded to ensure accuracy of the prescribed c o m p o u n d . Compounding

calculations include weight to weight, volume to volume and weight to volume ratios.

Additionally, compounding ca l cu la t ions often involve calculating proper dosing, expected

yields and expected losses.

Aseptic Compounding USP 797 United States Pharmacopoeia 795 and 797

Aseptic compounding is the practice and art of preparing p r e s c r i p t i o n s t h a t need to be

sterile. Current United States Pharmacopoeia guidelines in USP 797 chapter on sterile or aseptic

compounding gi ve standards t h a t need to be followed to be able to fill sterile compounded

prescriptions. Along with sterile irrigation prescriptions, the Minnesota State Board of Pharmacy

requires that pharmacies compound sterile inhalation solutions, sterile baths and soaks for

organs and tissues, sterile injections, sterile powders for injection, sterile metered sprays, and

sterile ophthalmic and sterile otic, ear, preparations. A pharmacy that engages in sterile aseptic

compounding n e e d s to comply with both USP 795 and USP 797 guidelines.

Soderlund Village Drug

• Committed to your health and safety

• Committed to complying with the USP 797 rules and guidelines to ensure sterility of your

Prescription

• Committed to complying with the USP 795 rules and guidelines to ensure potency and quality

of your compounded p r e s c r i p t i o n

• Committed to complying with the Minnesota Board of Pharmacy sterile compounding

requirements

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• Committed to continued professional aseptic training

• Committed to facility and equipment that meets or exceeds the sterility requirements

• Committed to quantitative analysis both with our own professional chemistry lab and outside

confirmatory labs

• Committed to sterility testing of both sterile compounds and procedures

• Committed to accepting referrals for sterile compounding from our colleagues in Mankato and

surrounding areas

• We are committed to you!

Compounding Dosage Forms

Compounding dosage forms are the types of delivery methods used to dose a patient. Examples

of a compounding dosage form include capsules, tablets, transdermal vehicles, gels, creams,

ointments, injections, drops, inhalants, suppositories, troches, powders, decoctions, concoctions,

suspensions, solutions, nasal sprays, shampoos, sublingual and other delivery methods.

Additionally a compounding d o s a g e form includes a devise such as a dropper b o t t l e , an

applicator, a syringe, etc.

Compounding Technique

Compounding technique is the procedure and methodology that is employed by the

Compounding p h a r m a c i s t t o produce a compounded m e d i c a t i o n . Compounding

technique includes experiential judgment as to the amount of liquid needed to produce

cohesion while avoiding encrustation of a tablet triturate and various other learned methods

necessary to produce a suitable compound.

Compounding Triad

The compounding triad is the three-part relationship b e t w e e n the patient, physician and

pharmacist. The physician prescribes t h e medication; the pharmacist c om p o un d s a n d

dispenses the medication to the patient af t e r a consultation. The patient receives the type of

personalized care they deserve and allows compounding pharmacists to provide exceptional,

patient-oriented service.

Compounding Referrals

Compounding referrals are guidance from a medical professional directing a patient toward an

Individualized t h e r a p y via compounding. Compounding referrals are also made

through education and publications.

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Compounding Law

Compounding law involves the regulations that govern the practice of pharmacy. Many

government a g e n c i e s such as the FDAoften get involved or intervene in the practice of

compounding when they believe the compounding pha rmac y or pharmacist i s acting outside

their realm of practice.

Compounding and the Patient

Compounding owes its entire existence to the satisfaction of the patient. Patients have become

educated through various ways as to the health benefits of compounding. Spokes people like

Suzanne Summers have explained publicly the benefits of natural hormone r e p l a c e m e n t

t h e r a p y. The increased awareness a m o n g patients and physicians regarding the positive

effects of compounding has created a desire for personalized m e d i c a t i o n s . The reality is that

patients are driving the compounding indus t r y by demanding ind ividua l i zed therapies.

Compounding and the Physician

Many physicians have become well aquatinted w i t h the advantages of compounding and regularly

prescribe compounded p r e s c r i p t i o n s for their patients. In today's consumer driven

healthcare system a patient desiring to be prescribed a compounded prescription can often call a

compounding pharmacy for a referral to a physician versed in compounding benefits.

Compounding Pharmaceutics

Compounding pharmaceutics is the science of medication delivery forms; recipients and devices

used in the practice of compounding to produce an efficacious compounded m e d i c a t i o n .

Definition of a generic drug and the FDA requirements

A generic drug is the chemical equivalent of a drug that has an e x p i r e d patent. When a brand

name drug’s patent expires, other pharmaceutical companies can produce the same active chemical

compound and sell the drug under its generic name. In the United States, the Food and Drug

Administration ( FDA) requires that all drugs, whether b rand s name drug or a generic drug, meet

standards o f safety, strength, purity and effectiveness. A drug may be chemically exact but not

bioequivalent. In other words, two different products of the same drug may not get into the body

in exactly the same way. Bioequivalence depends on how the drug is formulated and how it is

absorbed a n d eliminated by the body. Other ingredients c a n affect the absorption o f the drug.

These include starch fillers, gum-like substances a n d other products which allow a drug to be

formulated i n t o a pill or capsule. Factors such as a person’s age, body mass, kidney, liver and

intestinal funct ion can also affect the absorption o f the drug by the body.

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For a drug to be marketed u n d e r a generic label, the manufacturer must comply with FDA

standards. The FDA states that generic drugs must be therapeutically equivalent to the brand

name drug. Numerous studies have attempted t o show differences in brand and generic drugs.

With a few exceptions, most studies have not shown true statistical differences between brand

name drugs and generic drugs. The few cases where differences exist occur mostly in drugs that

have a narrow “therapeutic index." The "therapeutic index" is the difference between the drug's

Effective amount in the body and the level at which the drug causes an undesirable o r toxic effect.

In order to ensure its safety and effectiveness, a generic drug undergoes i n t e n s i v e testing. The

FDA sets up guidelines and requires st r ic t testing in order to determine w h i c h drugs act the same

way in the body. Generic drugs that have been tested and approved by the FDA to be

therapeutically equivalent t o brand name drugs are published in a guide that is updated monthly

and is found in most pharmacies. The guide lists drugs classified as therapeutically equivalent to

each other, and gives them an "A"rating. If the FDA does not consider a drug therapeutically

equivalent, it is given a "B" rating. Most pharmacies purchase drugs with an "A"rating to dispense as

generic. Ask your pharmacist about the rating of your particular generic medication.

Drug costs continue to rise

Price appears to be the real difference between most brand and generic drugs. Rising health care

costs -- and the cost of drugs in particular - have received a lot of media attention. The fastest

growing segment of health care costs is prescription benefits, which is increasing at an average rate

of 11.2% annually. Senior citizens are especially at risk for rising drug costs. Drug costs for seniors

are rising faster than for any other age group. Among patients 70 years and older, drug costs rose

14% in 1999, while the average drug costs for all other age groups rose 9.6%. In late July 2000,

several health maintenance o r g a n i z a t i o n s ( HMOs) announced t he y would pull out of the

Medicare program by the end of the year, affecting nearly a million senior citizens. The HMOs state

that they can no longer

Afford to insure seniors. A number of factors account for these rising costs. Advances in technology (gene therapy and biotechnology, for

Example) have contributed t o the increases. People are living longer and using more drugs to do

so. It is fair to add that some of the new expensive drugs are actually less costly overall than

conventional t he rapie s , s u c h as surgery.

Generic drugs are less expensive than brand name drugs

Generally, generic drugs are less expensive than brand name drugs. On average, most generic

Drugs are approximately h a l f the price of their brand name counterparts. Based on 1999 values of

the Average Wholesale Price, the brand name blood pressure drug called Hydrodiuril® was eight

times more expensive than its generic counterpart, hydrochlorothiazide. The anti-depressant

Elavil® was twice the cost of its generic amitriptyline. However, tamoxifen is an exception to the

rule. Here, the brand name manufacturer b o u g h t exclusive rights to the generic. Since the same

company owns the rights to both brand and generic tamoxifen, the price for the generic is only 1

cent less! Currently, the Federal Trade Commission is investigating the manufacturer's actions,

since they appear to have discouraged o t h e r companies from marketing gener ic tamoxifen.

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Presently, many drug companies are merging, with larger companies acquiring smaller generic

companies. These changes have affected the price difference between b r an d and generic

products. Since a company may own both the brand and generic names, it prices the generic at a

higher price to discourage sales of the generic. Because of this, people may not get the savings

benefits of generic drugs.

What contributes t o the cost of drugs?

Why are drugs so expensive? There are various answers to this question. Technology has played

a role in the development o f more effective medications. Creation of larger manufacturers

through mergers and buy-outs of smaller pharmaceutical companies has provided the

Opportunity t o increase the cost of generic medications. Annual inflation plays a role, as does the

increased utilization of drugs by the American public. Pharmaceutical companies explain the

need for making a profit as being tied to the research and development costs for newer, more

Effective medications. The estimated cos t of research and development i n the year 2000 is

estimated a t $38 billion. To put this in perspective, the budget for federal research is approximately

a third of this figure. It takes an average of seven years for a drug to go through the FDA approval

process, thus delaying any potential p ro f i t s . The marketing of drugs by

Pharmaceutical companies are expensive. Marketing strategies include advertisements in all of

the media, weekend and dinner meetings for physicians and pharmacists t o promote specific drug

"give-a ways" with the pharmaceutical company’s logo (pens, magnets, pads of paper, etc.) and

drug samples to physicians. These promotions a r e intended to increase physician and consumer

exposure to information a b o u t a particular d r u g . This exposure to information m a y increase

consumer requests f o r certain drugs that have not been previously prescribed b y the physician.

Pharmaceutical c o m p a n i e s a lso provide grants to medical groups, universities a n d hospitals to

develop educational p r o gr am s fo r patients wi th specific disease conditions. These grants assist

in the

Development c o s t s and ongoing costs of programs a n d services that help patients

maintain optimal healthy living. These funds are provided a s a part of the community

benefit monies pharmaceutical companies de s i gna te as efforts to partner wi th physicians.

Should consumers p a y more for brand name drugs?

The human body is always changing, and factors such as diet, metabolic rate and hormones can

affect how a drug acts in the body. For the most part, these changes are not cause for alarm, but it

is important t o realize that a person may try the same brand or generic medication and have a

different experience a t different times. However, in most instances, the generic and brand name

drugs are both working in the body.

Without much success, a number of studies have attempted t o prove particular b rand drugs are

more efficacious than their generic counterparts. Of particular con trove rsy i s one well-

publicized story in which a brand name manufacturer paid a university researcher to prove the

brand drug was superior to the generic. The researcher actually found the generic to be equivalent

and even

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Somewhat better . What resulted was a long battle between the researcher and the manufacturer,

because the manufacturer refused to publish the data to support that the generic was superior to

their brand name drug. Seven years later, the brand manufacturer published another study

opposing the researcher's results. However, the FDAis now requiring all manufacturers of that

drug to demonstrate that their products are equivalent.

To summarize, generic drugs, if they have been approved by the FDA, are as safe and effective as

the brand name product. Pharmacists, using scientific information, ensure patient safety. This

often means recommending alternative therapies to providers and patients. A final note to think

about is that receiving a generic drug is not like shopping at a discount retailer for a pair of jeans.

If the clothing industry had guidelines similar to drug manufacturers, copy-cat jeans would be

required to use the same material, thread, stitching and so on that higher end manufacturers use

to make a pair of famous-name pants. Of course, one cannot compare a drug's effect on the body

to the appearance and durability of a pair of jeans, but if the government required both pairs of

jeans to be exactly alike, would you still want to pay the higher price?

Compounding vs. Traditional Pharmacy

Traditional pharmaceutical needs mean that your physician prescribes you a dose and form of a

specific medication. For example ...you are prescribed 2 capsules of your medication three times

per day with food. Now, you may not be able to tolerate the casing of the capsule, or your

Schedule may be such that you can't eat those three meals a day at the appropriate times. So, you

aren't as compliant with these instructions and therefore, the effect of the prescription is not as

effective.

So, your physician contacts one of the compounding pharmacists at Precision Compounding

Pharmacy and working together as a team, you, your physician, and our pharmacist determine a

better solution. You are given an effervescent powder to mix with water and drink once daily.

Now, with this customized solution, you are able to take the entire regime of your prescription

and made well.

Life's Problems

Some patients do not respond to traditional methods of treatment manufactured by drug

companies. Many patients are allergic to preservatives or dyes, or are sensitive to standard drug

strengths, or cannot tolerate a specific dosage form. These unique medical problems can be

solved with the triad relationship of patient, physician, and pharmacist working closely together.

With a physician's consent, a compounding pharmacist can compound preservative or dye free

medications, customized strengths of medications, or different dosage forms. Children and the

elderly population often benefit the most from customized compounded medications.

Common areas of compounding include:

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Is Compounding Pharmacy new?

No, compounding has been used in the creation of medicines since the beginning of time;

however, since the latter 20th century we have seen a rise in the rebirth of compounding

pharmaceutical alternatives to traditionally manufactured prescriptions and medications.

What kinds of prescriptions can be compounded?

Almost any kind. Compounded prescriptions are ideal for any patient requiring unique dosages

and/or delivery devices, which can take the form of solutions, suppositories, sprays, oral rinses,

lollipops, and even as trans dermal sticks. Compounding applications can include: Bio-identical

Hormone Replacement Therapy (BHRT) for menopause and andropause, Veterinary, Hospice,

Pediatric, Ophthalmic, Dental, Otic, Dermatology, Medication Flavoring, Chronic Pain

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• Acne • Exercise/Sports

Injuries

• Oral Lesions

• Alzheimer's • Head Lice • Otic Infections

• Andropause

(Male Menopause)

Hemorrhoids

Parkinson's

• Arthritis Disorders • Hospice Needs • Pets Needs

• Autistic Spectrum • Hyperhidrosis • Postpartum Needs

• Bio- Identical

Hormone

Replacement

Therapy (BHRT)

• Infertility

• Scars & Keloids

• Chronic Diaper Rash • Migraine Headaches • Snoring

• Chronic Pain

Management

Disorder

• Multiple Sclerosis

• Warts

• Chronic U'I'Is

Vaginitis

• Nausea & Vomiting

• Wound Therapy

• Dental Needs • Neonatal Needs • Wrinkles & Age Spots

• Erectile Dysfunction • Neuropathies

Management, Neuropathies, Sports medicine, Infertility, Wound Therapy, Podiatry, and

Gastroenterology.

Will my insurance cover compounded medications?

Because compounded medications are exempt by law from having the National Drug Code ID

numbers that manufactured products carry, some insurance companies will not directly

reimburse the compounding pharmacy. However, almost every insurance plan allows for the

patient to be reimbursed by sending in claim forms. While you may be paying a pharmacy

directly for a compounded prescription, most insurance plans should cover the final cost.

Precision Compounding Pharmacy will provide you the proper form and documentation to

provide to your insurance company.

Is it legal and is it safe?

Compounding has been part of healthcare since the origins of pharmacy, and is used widely today in

all areas of the industry, from hospitals to nuclear medicine. Over the last decade,

Compounding resurgence has largely benefited from advances in technology, quality control, and

research methodology. The Food and Drug Administration has stated that compounded

prescriptions are both ethical and legal as long as they are prescribed by a licensed practitioner for

a specific patient and compounded by a licensed pharmacy. In addition, compounding is regulated

by state boards of pharmacy.

Who can take compounded medications?

Compounding medications can be taken by anyone who has difficulty with traditional forms and

dosages. Often, parents have a tough time getting their children to take medicine because of the

taste. A compounding pharmacist can work directly with the physician and the patient to select a

medication's properties and the patient's taste preference.

Compounding pharmacists also help patients who are experiencing chronic pain. For example,

some arthritic patients cannot take certain medications due to gastrointestinal side effects.

Working with their physician, a compounding pharmacist can provide them with a topical

preparation with the anti-inflammatory or analgesic their doctor has prescribed for them.

Compounded prescriptions often are used for pain management with hospice care.

In addition to human patients, many veterinaries will work with a compounding pharmacist to

create a medicine for your pet that can be more easily administered.

How does compounding benefit me?

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There are several reasons why pharmacists compound prescription medications. The most

important one is what the medical community calls "patient non-compliance." Many patients are

allergic to preservatives or dyes, or are sensitive to standard drug strengths. With a physician's

consent, a compounding pharmacist can change the strength of a medication, alter its form to make

it easier for the patient to ingest, or add flavor to it to make it more palatable. The pharmacist also

can prepare the medication using several unique delivery systems, such as a sublingual troche or

lozenge, a lollipop, or a transdermal gel. Or, for those patients who are having a difficult time

swallowing a capsule, a compounding pharmacist can make a suspension instead.

Does my doctor know about compounding?

Prescription compounding is a rapidly growing component of many physicians' practices. But in

today's world of aggressive marketing by drug manufacturers, some may not realize the extent of

compounding resurgence in recent years.

What are the types of compounding solutions/forms or dosages?

Below is a list of some common examples of compounding dosage forms:

Oral/Topical Syringes--improves dosing accuracy

Capsules--extended-release formulations

Troches--"lozenges" that dissolve in the mouth

Popsicles--great alternative, especially during the summer

Gummy Gels--chewable forms are great with kids

Lollipops--convenient dosage form for extended delivery and local effect

Transdermal Gel, Cream, and Stick--great alternative to oral form

Emollient Cream--helpful for dermatological conditions

Dauber Bottle--ideal for liquid preparations

Lip Balm Application’s--super for "spot" applications

Ophthalmic Preparations--for treatment of eye problems

Otic Medications--for treatment of ear problems

Injectables

Suppositories

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Rapid Dissolve Tablets

Tablet Triturates--easily dissolved tablets under the tongue.

Who regulates compounding pharmacies?

Compounding is regulated by individual state boards of pharmacy. The Food and Drug

Administration (FDA) has stated that compounded prescriptions are both ethical and legal as long

as they are prescribed by a licensed practitioner for a specific patient and compounded by a licensed

pharmacy.

Compounding vs. Traditional Pharmacy

Traditional pharmaceutical needs mean that your physician prescribes you a dose and form of a

specific medication. For example... you are prescribed 2 capsules of your medication three times per

day with food. Now, you may not be able to tolerate the casing of the capsule, or your

Schedule may be such that you can't eat those three meals a day at the appropriate times. So, you

aren't as compliant with these instructions and therefore, the effect of the prescription is not as

effective.

So, your physician contacts one of the compounding pharmacists at Precision Compounding

Pharmacy and working together as a team, you, your physician, and our pharmacist determine a

better solution. You are given an effervescent powder to mix with water and drink once daily.

Now, with this customized solution, you are able to take the entire regime of your prescription

And made well.

History of Compounding

Compounding has been a part of pharmacy since the profession began. There is only one group of

health care professionals--pharmacists--possessing the knowledge and skills required to

compound and prepare medications to meet patients' unique needs. Extemporaneously

compounding safe, effective prescription products for patients who require special care in a

pharmacy is fundamental.

Pharmacy's heritage spans some 5,000 years, and centers on the provision of pharmaceutical

products for patients. In the early years of American pharmacy, compounded formulas were the

primary source for medications.

As a medication therapy manager, pharmacists were called upon to provide alternatives to assist

patients in becoming compliant with the prescribed therapy. Because most commercially

available and prescribers in overcoming non-compliance problems is to rely on customized

options ...a compounding pharmacist to work in conjunction with the patient and physician to

form a strong triad team approach to the patient's success. Using fundamental pharmacy

53

History of Compounding

Compounding has been a part of pharmacy since the profession began. There is only one group

of health care professionals--pharmacists--possessing the knowledge and skills required to

compound and prepare medications to meet patients' unique needs. Extemporaneously

compounding safe, effective prescription products for patients who require special care in a

pharmacy is fundamental.

Pharmacy's heritage spans some 5,000 years, and centers on the provision of pharmaceutical

products for patients. In the early years of American pharmacy, compounded formulas were the

primary source for medications.

As a medication therapy manager, pharmacists were called upon to provide alternatives to assist

patients in becoming compliant with the prescribed therapy. Because most commercially

available and prescribers in overcoming non-compliance problems is to rely on customized

options ...a compounding pharmacist to work in conjunction with the patient and physician to

form a strong triad team approach to the patient's success. Using fundamental pharmacy

knowledge, compounding pharmacists invested time and effort to create dosage form

Alternatives to enhance therapy compliance for difficult patients and unique cases.

54

HRT Questions and Answers

1. Q. What are bio-identical hormones and where do they come from?

A. Bio-identical hormones are made from botanical plants such as soy and yams. The human body cannot

convert soy or yams directly into natural hormones, so the natural plants must be pharmaceutically

processed to produce natural bio-identical progesterone and bio-identical Bi-Est and Tri-Est, the estrogens,

in a transdermal cream or oral supplement. These final products, when either rubbed on the skin or

swallowed by the patient, are identified by the human body as being biologically identical to the natural

hormones of their body. In other words, from a chemical standpoint, the body responds to the hormones as

if it was the naturally produced identical biological structure of the hormones of the body, rather than a

foreign substance being introduced occurs with synthetic hormones.

2. Q.I have read that hormone replacement therapy mimics the body's natural hormones but does not really

replace them as bio-identical hormones do? Can you explain this?

A. Hormone replacement therapy classically has been with the use of synthetic hormones, and when used, these

synthetic hormones flood the receptor sites not only of the hormone receptor sites they are intended to attach to and

alter, but also the receptor sites of many other steroid hormones which should not be effected .. As is often the case in

nature, more is not always better and in fact, as in this case, when these other receptor sites are over-flooded, it has

been found that they often shut down their function and are no longer able to act in the required manner for the

normally healthy functions required elsewhere by the body, thus causing the unwanted and sometimes seriously

risky chemical alterations that lead to unwanted symptoms and sometimes pathology.

3. Q. Are using bio-identical hormones safe even if I have a family history of cancer?

A. If a patient has had a positive estrogen receptor cancer in the past, It is not recommended to prescribe either

estrone or estradiol forms of estrogen. Not to Estrone form of estrogen patients, even if they have never had breast

cancer, since estrone is the most cancer permissive and therefore highest risk, of the forms of estrogens.

Estriol vaginal cream, however, is not contra-indicated for patients with a history of breast cancer. In fact, there have

been studies to show that Estriol is a protective form of estrogen. It has been found to act against the stronger forms

of estrogen, those that occur naturally from the patient's own body and the even more toxic xeno-estrogens, which

originate in increasing intensity in our modern environment. Estriol significantly decreases and sometimes

Eliminates the often-reported troublesome symptom of painful sexual intercourse for patients. It is possible to

prescribe a weak estrogen such as Estriol to reach estrogen receptor sites in a patient, as it will then block the

absorption of the strong xeno-estrogens, thereby protecting the patient from any future reoccurrence of breast

cancer.

Progesterone can be used for patients with a previous history of breast cancer. Progesterone used alone has been

found protective against breast cancer. In contrast, any form of estrogen cream used on the breast directly increases

metabolism and the mitotic activity of the cells two hundred fold. Breast cancer can also have positive receptor cells

for progesterone, although the relevance of this is more controversial.

If, a patient does have positive progesterone receptors, possibly prescribe progesterone after thorough discussion

and counseling, and only if the patient fully understands the implications and possible risks but still chooses to

proceed with natural progesterone treatment based on the probability of its positive benefits.

4. Q. Have there been any medical studies done on the safety and efficacy of bio-identical hormones?

A. This has really been answered in question 3. There are literally hundreds of reputable published studies over

a period of many decades confirming the safety of using bio-identical

55

5. Q. How can bio-identical hormones help fight the symptoms of aging?

A. Bio-identical natural hormones are anti-inflammatory and therefore anti-aging by their nature of action. Bio-

identical hormones fit into receptor sites like a lock and key mechanism. The effect of the hormones is specific to the

dose required by the bio-identical hormones. In nature, more is not necessarily better. In fact, even natural hormones

if prescribed in too high a dosage can cause adverse side effects, such as sedation.

6. Q. Will bio-identical hormones help with hot flashes, sleepless nights and memory problems?

A. Natural progesterone is very effective in the treatment of hot flashes. Half the patients with hot flashes respond

positively to progesterone treatment alone, and do not require any estrogen, even bio-identical estrogen. The other

half does receive relief with further supplementation of natural transdermal estrogen. Changes in the CRP reading.

Oral estrogen also reduces efficiency of the thyroid as it produces an increased level of thyroid bonding globulin,

which in turn often results in patients having subclinical hypothyroid and resulting weight gains and retention.

Bio-identical hormones especially help insomnia. The progesterone trans dermal cream used in the evening has a

mild sedative effect, but the oral form of progesterone passes through the liver and has an even greater degree of

sedation. Oral progesterone is therefore used specifically as a treatment for insomnia and is prescribed to be used at

night before sleep for this reason. Natural transdermal progesterone, absorbed through the skin only, can be used

both morning and evening without any prohibitive sedative effects.

We have found that patients report improved memory with the use of bin-identical hormones as lubrication of brain

synapses seems to allow quicker cognition, alleviating this common symptom of hormone balance occurring with

menopause and simple aging.

7. Q. I have real that if I get my hormones back in balance, I will continue to menstruate. Is this true?

A. Used in high doses, therapy using higher doses of oral estrogen can result in a menstruation when the patient

takes a few days break from the medication at monthly intervals. Continuing monthly menstruations is considered by

some to be a youth-sustaining cycle for the female body. Recurring menstruation is either desirable or necessary for

adequate overall protection in bin-identical hormone therapy. Estrogen should be prescribed only transdermally, in

lower doses. With these lower doses of transdermal estrogen, even a break of a week each month will not create

menstruation in patients. Most report they find it desirable to preclude menstruation while at the same time gaining

all the positive effects of natural hormone treatment at lower less drastic levels.

8. Q. I understand that hormonal fluctuations can occur throughout the month, depending on my lifestyle and

the amount of stress that I am under. I have heard about tracking hormone levels and coming up with a

program that is individual to suit my specific needs. Can you comment on this?

A. You can change the hormone levels each day tailoring treatment to a personal physiological treatment, based on

the amount of cream used and prescribed dosage. In fact, the safest program of bio-identical hormone treatment

would include abstaining from use of the transdermal cream for one week of each month. This mimics the natural

cycle in which the hormones in a woman's body would naturally ebb to a lower level once a month in the normal

cycle of a premenopausal woman.

Some do not find it desirable to take a full week break from the transdermal cream since their flushing symptoms in

particular return on day 4 or day S. In these cases, a patient can take 5 days as a break rather than a full week, and

depending on their own unique response to cessation of the hormones, sometimes even a shorter period. There is

always a short lag period of several days once the patient restarts the transdermal bin-identical cream use before the

bio-identical hormones fully rebalances the body again. For some patients, the break time needs to be shortened to

preclude adverse symptoms, particularly flushing.

In most cases, on day 7 a patient in her natural cycle would begin an estrogen increase. If monitored along the cycle,

the estrogen levels would show they continue a gradual increase towards mid-cycle, and so a slightly increased

56

amount of the cream could be used at the peak of the mid-cycle to balance out and normalize the cycle. On or

approximately day 14, ovulation occurs in the normal reproductive cycle, and at this point progesterone is added by

the body to the estrogen levels. Naturally, occurring levels of progesterone elevate from day 14, peaking at day 20

and then decreasing by day 25 before preparing the body for a break at approximately day 28.

By adjusting quantity and dosage of the transdermal cream, a patient can adjust her own cycle to optimally and

smoothly follow the normal ebb and flow pattern, precluding any negative symptoms.

9. Q. I worry about getting the exact dosage that I need through bio-identical hormone creams. Is it not possible to

get the hormones that 1 need in a capsule?

A., the use of oral capsules creates possible problems, in that in order for the body to receive and use the hormones by

this method, they must first pass through and be metabolized by the liver. It is not desirable for estrogen to pass

through the liver because of the side effects discussed in the previous answer, specifically lowering the thyroid levels.

Additionally, intake of oral estrogen lowers sex drive or libido because oral intake increases production of a sex-

binding globulin, which attaches to free testosterone hormones. Blocking the free testosterone in turn lowers sex

drive. The oral path of taking even bio-identical hormones can therefore result in not only a subclinical hypothyroid

function, with attendant fatigue and weight management problems, but also a reduced, even eliminated, libido.

Bio-identical hormones should be prescribed transdermally. Even if you choose an allopathic or typical type of hormone

replacement, the patient should always consider using the trans dermal route through the skin, rather than the oral

route through the liver because of the negative side effects. Using natural progesterone treatment only in the

evenings, which means the patient's body does not have as high levels of progesterone during the day as they would

if taken orally.

However, especially in some patients with insomnia, oral capsule intake of progesterone in the evenings only does

help considerably alleviate this symptom, and can be prescribed in quite accurate required dosage via oral capsules.

Transdermal cream use can also be very accurate in dosage delivery, especially if dispensed via syringes marked off

with dosage lines, as the cream is already blended by a compounding pharmacy and prepared to be delivered via the

syringe in equal balanced dosages

10. Q. My doctor knows nothing about these natural hormones. Where can I get help?

If you want to read books that have been written by other physicians on bio-identical hormones, Other books that I

would suggest are those of the late Dr. John Lee, What Your Doctor Might Not Tell You About Menopause and What

Your Doctor Might Not Tell You About Perimenopause. Dr. Lee's excellent book, What Your Doctor May Not Tell You

about Breast Cancer, has considerable pertinent information regarding the use of progesterone in bio-identical

hormone therapy.

The other book, which I would suggest, is The Hormone of Desire by Dr. Susan Reiko, a psychiatrist who writes about

the extremely important role of natural testosterone in the replacement of hormone therapy.

SUMMARY:

In summary, natural bio-identical hormone therapy is the present and growing future of hormone replacement

therapy. Neither patients nor doctors have to wait 50 years for medicine to change and catch up. Physicians

throughout the world are now beginning to realize that you cannot fool Mother Nature, and if you try to do so, there

are frequently negative consequences. Use of synthetic hormones has now been shown by many studies and by much

experience to have adverse side effects, leading to dangerous complications such as breast cancer, heart stress and

other clinical problems.

The Women's Health Study of 2002 has shown that use of synthetic hormones is not the healthy way to replace

women's hormones. Human female bodies do need natural bio-identical hormones, which can be used for optimal

57

health. The lock and key effect of natural treatment works perfectly with the body and within a 12-hour period, the

body has dissipated 50% of the hormone naturally.

Natural bio-identical hormone treatment therefore appears to me to be the desirable future of hormone replacement

therapy.

More and more physicians are now beginning to research, assimilate and practice natural bio-identical hormone

therapy. Within the next 25 years, this will be the ideal medical standard for hormone replacement therapy and will

be taught to new doctors in our medical schools. Current graduates of medical schools are not being given the

current information and updates on this emerging hormone replacement therapy alternative to synthetic treatment

Some doctors are still confusing natural progesterone with synthetic progestin.

If your hormone replacement therapy does not feel right to your body, it probably is not right for you .

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