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Bio-Identical HGH Hormone Replacement Therapy


Written by Dr. Welsh, Published on 11 July 2013

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Bio-Identical Hormone Replacement Therapy and HGH Deficiency

It is becoming more and more commonly known that HGH levels begin to drop as a natural result of the aging process. In certain individuals, Growth Hormone Levels can drop to rates which have a significant impact on health and wellness. Although every person on the planet follows the same gradual and downward track in regard to their HGH Levels, some experience this decline faster than others. Do you feel that you may be a victim of Adult-Onset Human Growth Hormone Deficiency?

Human Growth Hormone and Testosterone Combination Therapy

In men, a number of the complications of HGH Deficiency are related to the symptoms of Testosterone Deficiency. At the Conscious Evolution Institute, we've realized that a significant number of men simultaneously suffer from the effects of both Low Human Growth Hormone Levels and Low-T. When a patient is experiencing a severe deficiency of both of these vital hormones, the negative effects appear to stack exponentially, creating even greater and more significant complications as a result of hormone imbalance.

Many patients will only need one form of therapy or the other. The numerous diagnostic tests that we perform will highlight exactly where your medical issues likely arise, and will help us prepare a treatment regimen that appeals directly to your needs and desires. Many patients will see the greatest level of benefit from a combination-approach that utilizes both HGH Hormone Replacement Therapy and Testosterone Replacement Therapy in order to restore a more harmonious balance of hormones, which has the capacity to benefit the patient in numerous and vital ways.

Hormone Treatments for those that don't Qualify for Bio-Identical HGH

In addition to Bio-Identical Hormone Replacement Therapy, we also utilize other therapies and techniques in the case of patients that may not qualify directly for HGH Injections. Among these treatments are L-Ornithine and L-Arginine Amino Acid Treatments, which can achieve modest boosts in evening HGH Secretion if administered just as you head to bed.

In order to monitor your treatment and assess the benefits of therapy, we occasionally draw blood samples in order to determine the success of your treatment, as well as monitor for any potential minor complications which may lead us to adjust your treatment.

Physical Symptoms of Growth Hormone Deficiency

Human Growth Hormone Deficiency affects systems throughout the body, but some of the most obvious physical changes that take place as a result of HGH Deficiency are increased fat around the midsection, the development of sharp lines and wrinkles, thinning hair, and significant changes in sleep quality.

Human Growth Hormone for Those That Need It

We should note that, although we specialize in Human Growth Hormone Replacement Therapy, only patients that display a clinical and diagnosable need for HGH Replacement, as outlined by the Endocrine Society's Criteria for Deficiency, qualify for Human Growth Hormone HRT. There are a number of other treatment options available with which we can assist you (such as Sermorelin Acetate Therapy or Amino Acid Treatment), but as a result of the legal status of HGH, we may be unable to provide Human Growth Hormone Injections for your particular case.

Hormone Balance Key to a Long and Healthy Life

At the Conscious Evolution Institute, we are keenly aware of the importance of Hormone Balance in preserving health and wellness throughout the lifespan. We have years of clinical experience in assisting patients to achieve a greater state of Hormone Optimization, and if you feel that the aging process is wearing you down prematurely, we are confident that we can help you take steps to achieving a renewed state of vitality.

Symptoms of Human Growth Hormone Deficiency

Changes in Body-Fat Metabolism which increase the rate at which you accumulate unhealthy adipose body fat, especially around the midsection. These changes occur in spite of the fact that you do not change your activity level or your diet.

A Decrease in Lean Muscle Mass that is not the result of changes in physical activity. Human Growth Hormone and Testosterone both play significant roles in muscle development, and as these hormones begin to decline, it becomes harder to build and maintain muscle mass.

Decline in Sex Drive is associated with both Human Growth Hormone Deficiency and Testosterone Deficiency. If you don't feel as interested in sex as you were in the past, and that change is not the result of emotional or relationship-related issues between you and your partner, you may experience significant benefit from Hormone Replacement Therapy.

Both sexes may also experience Changes in Sexual Arousal which make sexual activity difficult or embarrassing. In men, this means that you may have trouble getting it up or keeping it up. In women, this means that you might not be physically ready for sex, which can make the experience uncomfortable or even painful.

Both Human Growth Hormone Deficiency and Low-T can contribute to changes in bone structure which can Decrease Bone Mineral Density and increase the risk of medical disorders such as Osteoporosis.

Human Growth Hormone is one of the body's most important metabolites. If you suffer from Low Levels of HGH, you will likely experience Significant Reductions in Stamina, Endurance, and Vitality, which affect you in both your day to day life and your ability to engage and enjoy physical activity.

Changes in skin tone also occur when HGH Levels Decline. Human Growth Hormone plays a role in both the strength of the muscles underneath the skin and the fullness and beauty associated with proper water balance. When HGH Production gets too low, this can increase the incidence of Fine Lines and Wrinkles associated with age.

The metabolic changes that occur as a result of Human Growth Hormone Deficiency also change the way that your body balances cholesterol. This can lead to an imbalance which encourages Increased Levels of Unhealthy LDL Cholesterol while Decreasing Levels of Healthy HDL Cholesterol.

HGH Deficiency not only affects the skin, but the hair as well. Human Growth Hormone Deficiency can contribute to both Premature Graying and Severe Changes in the Health of the Hair, making the strands more brittle and less smooth and luxurious.

Human Growth Hormone is intricately related to proper physiological rehabilitation and healthy immune function. People that suffer from HGH Deficiency are much More Likely to Get Sick. Also, they Take Longer to Heal and Recover from Injury than their counterparts with a healthier hormone balance.

Reduced Renal Function can also occur as a direct result of changes in hormone balance. The kidneys depend upon Human Growth Hormone in order to maintain optimal function.

Cardiovascular Complications are a significant and potentially life threatening symptom of Human Growth Hormone Deficiency. Changes in fat metabolism encourage LDL Cholesterol Levels to soar in the blood stream, and Human Growth Hormone helps prevent dangerous plaques from forming in the arteries by breaking down Triglycerides and LDL Cholesterol in the blood stream.

Many patients with Growth Hormone Deficiency even suffer from Changes in Cognitive Function. There is evidence that HGH Deficiency is correlated with poorer cognitive function as a result of age, and may even contribute to Alzheimer's disease and other disorders of the brain.

Hormone Deficiency Significantly Damages Long-Term Health

A recent clinical survey of nearly 4,000 men showed that men with Healthy Levels of Testosterone and HGH are considerably less likely to die of any premature cause than men with lower levels of either of these hormones. There is a direct correlation between hormone balance and mortality risk.

A New Approach to Human Growth Hormone Replacement Therapy

As a result of current laws regarding the sale and distribution of HGH, there are many patients that do not qualify for Human Growth Hormone Injections that may still benefit significantly from increase HGH Levels. Although Growth Hormone Shots aren't as accessible as we believe that they should be, there are still a number of innovative ways to naturally or medically increase Human Growth Hormone Levels.

The Conscious Evolution Institute combines proven medical therapies with 21st Century Nutritional, Dietary, and Lifestyle Plans in order to encourage optimal hormone production which helps restore a more youthful physiological state.

Based upon the diagnostic data that we receive from your hormone profile and physical, as well as the symptoms that you display, we will have more than enough information to design a health care regimen that conforms to your own personal and unique needs as an individual.

Decades of scientific study regarding the importance of Human Growth Hormone has shown that HGH Deficiency leads to a number of major negative physiological changes, including reduced fat metabolism, reduced bone mineral density, and muscle atrophy. In addition to these three major symptoms, Human Growth Hormone Deficiency also has a detrimental effect upon exercise capacity, energy production, and cardiovascular health. HGH Deficiency is like a weight on your shoulders, dragging you down in almost every way imaginable.

There is hope, however. Every year, new studies come out which show how Human Growth Hormone Replacement has the potential to restore healthier, more optimal function.

In addition to Human Growth Hormone, our physicians will also test for any other hormonal issues or deficiencies that you may be dealing with. The most effective approach to Hormone Replacement is to optimize your entire endocrinological system. If you are eligible, combining therapies will produce more potent benefits than simply restoring HGH Levels alone.

The Conscious Evolution Institute: Premium Care from Accredited Professionals

At the Conscious Evolution Institute, we realize that every patient that contacts us has a unique set of needs and desires, and this is why we offer such a personalized approach to Hormone Replacement. We work with you to find the Hormone Treatment Option which best fits the needs of your body, your financial circumstances, as well as your future goals and desires, in order to provide you with the healthcare that you deserve as a patient. Although we specialize in Hormone Replacement, we understand that long term health and longevity are about more than simply hormone balance.

Benefits of HGH Hormone Replacement

  • Improved Rehabilitation Outcomes after Exercise and Physical Injury

  • Improved Cholesterol Balance

  • Lower Blood Pressure, Improved Blood Flow

  • Better Skin Health

  • Increased Fat Metabolism

  • Increased Muscle Tone and Mass

  • Improved Kidney Filtration

  • Stronger Bones

  • Stress Alleviation and Anxiety Reduction


Drugs Banned From Sports


Written by Dr. Welsh, Published on 18 January 2013

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Performance Enhancing Drugs in Athletics

Information provided by the Conscious Evolution Institute

Athletic competitors are always trying to get an edge over the competition. Usually, they do this by training hardputting their blood, sweat, and tears into their trade in order to become the best that they can be. Other athletes, however, take shortcuts. There are a number of ways that athletes can do this, and, although effective, performance enhancing drugs and medical techniques provide an unfair advantage to these players that has the potential to put honest athletes out of work.

Lance Armstrongs appearance on Oprah recently is the most relevant example today, but a decade ago it was the great baseball homerun shootouts of the early 2000s. In the 1980s and 1990s, the primary stories involving performance enhancing drugs involved Olympic Track and Field athletes. Although we at the Conscious Evolution Institute are major proponents for Human Growth Hormone and Testosterone Replacement Therapy, we understand that they should not be used for athletic performance enhancing purposes because of the unfair work environment that they provide to athletes who do not turn to the substances.

We strongly support the use of drugs such as HGH Shots and Testosterone Injections for their rejuvenative, Anti-Aging purposes, however. Below, are a list of commonly used performance enhancing drugs that are regularly banned in amateur, professional, and Olympic sport.

Categories of Banned Performance Enhancing Drugs

Stimulants and Performance Enhancement

Although not the most talked about form of performance enhancing drug, stimulants are commonly tested for by athletic organizations such as Major League Baseball and the International Olympic Committee. Stimulants are medicines and illicit drugs which boost mental and athletic performance by increasing physical and mental stimulation. They have a tendency to boost competitive desire and allow players to attain higher levels of alertness for longer periods of time.

Take baseball for exampleBaseball is a sport of split second reaction times and decision making. The pitcher throws the ball, and the batter has less than a second to judge the trajectory of the ball and take a swing. Stimulants such as yellowjackets, adderol, and amphetamines have the ability to provide precious extra milliseconds for the batter to react accurately and make clean contact with the ball. In addition to this, stimulants have a tendency to increase levels of aggression that allow players in high contact sports such as football the desire to drive their opponent straight into the ground.

Stimulants also reduce tiredness and help athletes enhance their energy level. Baseball is well-known for the use of stimulants through the seventies and eighties. Baseball players are on a gruelling schedule, playing through well over 100 games a year, all over the country. They are expected to maintain peak performance even under these conditions, and if they slip up, the risk of being demoted back to the minor leagues is high for unestablished players. Stimulants were often used in order to help players get amped up for every game, every night.

Dangers of Stimulant Abuse

Although the performance benefits of stimulants are well-documented, misuse of stimulants can lead to a number of health and behavioural problems as well. Abuse of stimulants can raise blood temperature to unhealthy levels as well as elevate blood pressure to a dangerous rate. Stimulant abuse increases the chances of heart attack and stroke in mid-adulthood because of the increased strain on the cardiovascular system. Stimulant abuse can also disrupt the normal function of the heart, leading to an irregular heartbeat.

Examples of Stimulants

Although cocaine and methamphetamine are well known illegal stimulants, there are a number of other stimulants that can be acquired either through prescription or over the counter. There are other nutritional and herbal supplements that can be purchased from diet and nutrition stores as well. Stimulants prohibited from athletic performance include:

  • Terbutaline

  • Strychnine

  • Salmenterol

  • Salbutamol

  • Phentermine

  • Phenylpropanolamine

  • Pipradol

  • Pentylentrazol

  • Mesocarb

  • Fencamfamine

  • Ephedrines

  • Cocaine

  • Carphedron

  • Bromantan

  • Amphetamines

  • Amiphenazole

  • amineptine



Steroids and Performance Enhancement

Steroids are another form of Performance Enhancing Drugperhaps the form which receives the most attention from the media. Anabolic Steroids enhance the bodys ability to withstand and develop muscle through weightlifting and other forms of intense exercise. These Steroids work by mimicking the function of the testosterone that our bodies endogenously produce. The effects that bodybuilders and professional athletes use Testosterone primarily for is to strengthen their muscles and bones in order to hit harder on the field, run faster on the track, and enhance their physique in a culture which desire and appreciate aesthetically large and impressive muscles.

Professionals who use anabolic steroids such as Testosterone shots have the ability to train more frequently than their peers, and for longer periods of time. They are also able to put more strain on their muscles and still see results, because Testosterone helps feed hungry muscles the protein that they need to take on an enhanced workload. In the medical arena, steroids have been used for decades as a means to decrease recovery time and increase rehabilitative outcomes for patients who are suffering from significant illness or are in the process of recovering from major surgery.

Steroids like Testosterone creams have also been shown to be especially effective in treating Age-related disorders such as Low-T and Adult-onset hypogonadism as well. As men age, their natural Testosterone levels start to dwindle, and the positive effects of healthy Testosterone levels begin to diminish. Testosterone helps these patients maintain healthy baseline levels of Testosterone in order to maintain enhanced physical and mental health. Testosterone Therapy has also been shown to be beneficial in women for restoring sexual desire and alleviating depression as well as maintaining muscle and bone health. The positive health benefits provided for women with the use of Testosterone are with low doses intended to replenish normal levels of female testosterone.

Symptoms of Steroid Abuse

Of course, since Testosterone is the primary male androgen, Abuse of testosterone and other steroids in women can lead to the development of unwanted male traits. These women develop muscles which are similar to those in men. In addition to this body hair begins to grow in traditionally male patterns as well. The breasts often shrink in size as Testosterone crowds out the female bodys own natural estrogen production. Personality traits normally dominant in males such as aggression also have a tendency to develop.

In patients of both sexes, the abuse of Testosterone can reduce fertility outcomesin males, because the influx of outside steroids reduces the bodys ability to produce its own sperm and testosterone after the patient has ceased Testosterone Injection, and in women because the flood of Testosterone inhibits the function of Estrogen in the female reproductive cycle. Testosterone abuse can lead to male infertility as well as acne.

Abuse of Steroids can also lead to kidney damage, because the body is not optimized to function with an excess of Testosterone or other androgens. Steroid abuse is also bad for the heart, and increases the risk of cardiovascular disease and hardened arteries. Excess Steroid levels also increase the chance of developing reproductive cancers such as prostate cancer. Oral steroid consumption is tightly correlated with liver damage, because the liver is only designed to handle a certain load of amino acids, and damage begins to build up when the organ processes too much.

A few common anabolic steroids are stanozolol, nandrolone, and androstenedione.

Diuretics and Performance Enhancement

Diuretics are another group of substances substance which are banned for use in many professional and amateur sports. The legitimate medical use of Diuertics is to decrease fluid levels in the body as a treatment of serious medical issues such as liver disease, kidney disease, heart failure, and hypertension. These drugs are also used to treat issues such as edema, commonly known as fluid retention, and any medical issue that leads to high levels of swelling. In the most direct of terms, diuretics cause patients to urinate more often in order to release excess fluid within the body.

The reason that many diuretics are banned substances in professional athletics is that they are commonly used in order to hide the use and abuse of performance enhancing drugs from drug testing. As time has passed and new techniques have been developed, professional and Olympic drug testing has become more sophisticated, and more and more drugs are testable. Diuretics reduce concentrations of performance enhancing drugs in the urine in order to increase the chances that a player will pass a drug test even when currently using drugs which are banned from the sport.

In sports such as boxing or wrestling, diuretics are often used in order to drop weight quickly in order to qualify for lower weight classes. Although Diuretics are not performance enhancing drugs in and of themselves, their unwarranted presence in the urine or bloodstream of an athlete is an implicit admission that the athlete has something to hide, therefore, in many sports, the use of these drugs is bannable.

Symptoms of Diuretic Abuse

Diuretics can also have an adverse effect on the body when used in excess. The over use of these drugs can lead to significant and even life-threatening dehydration. Our bodies need a significant amount of water in order to function properly, and diuretic abuse deprives the body of proper hydration, which prevents the kidneys from performing filtration properly, damaging them severely over the long term. Heart damage can also result from long term diuretic abuse, because the blood will be under-hydrated and thickened as well. Over time this can lead to total heart failure.

Diuretics often banned in Professional, Amateur, and Olympic Sports:

  • Triamterene

  • Spironalactone

  • Mersalyl

  • Hydrochlorothiazide

  • Mannitol

  • Furosemide

  • Ethacrynic acid

  • Chlorthalidone

  • Bumetanide

  • Acetazolamide


Human Growth Hormone InjectionsHGH Truths

Aside from Testosterone and other Anabolic Steroids, the Performance Enhancing Drug most discussed in the media today is Human Growth Hormone. Like Testosterone and other androgens, HGH is produced naturally by the human body. Human Growth Hormone spurs the growth and development of the bones and the muscles and promotes fat breakdown and the synthesis of proteins. For this reason, it is possible to gain an athletic edge with HGH. Recently, Lance Armstrong came out and admitted that he used Human Growth Hormone Shots in order to boost performance, which allowed him to become the most well-known cyclist in the world.

HGH Effects

Human Growth Hormone injections increase energy and allow the body to create muscle mass and strength at an enhanced rate. It also helps athletes stay in enhanced physical shape because it efficiently converts unhealthy fat into energy the muscles use to stay active. Since HGH bolsters the cell division and reproduction, it also greatly reduces downtimes and soreness associated with vigorous exercise, allowing individuals to train more effectively. HGH Anti-Aging effects continue to be uncovered yearly.

Injectable HGH has been proven to be a highly effective therapy in adult patients who suffer from HGH Deficiency, but it is illegal for use in the United States without a diagnosed deficiency. Although Human Growth Hormone is incredibly safe for the treatment of HGH Deficiency, there are a number of side effects associated with the abuse of the hormone. This is because HGH Hormone Replacement Therapy is only intended to restore normal, healthy levels of Human Growth Hormone, whereas Professional athletes who abuse HGH flood their body with levels of HGH higher than the body can actually produce.

Side Effects of HGH Abuse

Systematic abuse of Human Growth Hormone can lead to arthritis, carpal tunnel syndrome, and edema. In addition to this, HGH Abuse can lead to a disorder known as acromegaly as well. Acromegaly is a condition where the bones of the jaw, hands, and feet begin to grow in size outward. The plates of the bones prevent them from growing longer after puberty, so they grow outward instead, creating aesthetic distortions which can lead to joint discomfort, pain, and even eating and breathing difficulties when severe.

EPO for Performance Enhancement

Erythropoietin (also known as EPO) is a performance enhancing drug that is most associated with endurance sports such as cross-country skiing and long distance running. This hormone is naturally secreted by the kidneys in order to increase the number of red blood cells present in the blood stream. Red blood cells are responsible for the circulation of oxygen through the blood, and for professional and Olympic athletes that perform in sports that feature a long period of extended exertion; this increases the effectiveness of the blood supply, allowing these athletes to push themselves harder and faster than ever before. Although most popular among these endurance athletes, there are also lesser advantages to having an increased red blood cell count which also benefit athletes who perform anaerobically, such as weightlifters and short distance sprinters.

Symptoms of EPO Abuse

Abuse of EPO can lead to a number of circulatory issues, such as hypertension and clogged veins and arteries. EPO abuse can lead to a cardiovascular system which is simply overloaded with red blood cells. This overload can also lead to Brain edema which can cause seizures, migraines, vision problems, and a number of other disorders associated with increased intracranial pressure.

Beta-Blockers for Performance Enhancement

Whereas most performance enhancing drugs are associated with increases in alertness, muscle generation, and muscular and cardiovascular amplification, Beta-Blockers are used for a different purpose. The medical purpose of Beta-Blockers is to treat heart disease, high blood pressure, and angina by slowing down the heart rate and reducing the speed at which blood circulates through the body.

For precision athletes such as archers, dart throwers, and target shooters, Beta-Blockers have the ability to increase accuracy by reducing trembling and allowing participants the ability to make accurate throws between heartbeats. Abuse of Beta-Blockers has been proven to lead to depression, exhaustion, and heart failure. If blood pressure becomes too low, then the body does not have the energy to perform adequately, and the body can simply shut down.

Blood Doping for Performance Enhancement

Although not a drug, blood doping is also a common form of performance enhancement which provides unfair advantage to unscrupulous athletes. Doping the blood is the act of using red blood cells or products which proliferate red blood cells and increase an athletes red blood cell count by reintroducing them through injections. In the most common form of blood doping, athletes have a portion of their red blood cells drawn from their blood stream and preserved for a later date. Over time, the athletes body replenishes their depleted blood cell count. At a time around one month before they are expected to perform, they have the preserved red blood cells re-injected, which provides an athletic boost which can be compared to EPO.

Symptoms of Blood Doping Abuse

There are a number of complications and dangers that can arise from the procedure. After the red blood cells have been drawn, the body will often react negatively in the form of chills and fatigue. When the red blood cells are injected back into the body, fever and edema can result as well. Blood doping can also result in major infections of the blood which can be life threatening. Also, long term blood doping can result in eventual liver and kidney breakdown. Brain damage can also result. The body is designed for gradual changes in red blood cell count, and drastic changes that occur through frequent and drastic changes through blood doping can adversely affect the body in significant ways.

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We at the Conscious Evolution Institute do not condone the use of performance enhancing drugs for athletic performance enhancement, but we do recognize that there are many useful and legal purposes for treatments such as Human Growth Hormone and Testosterone Replacement Therapy. If you are interested in the use of Hormone Replacement as a means to correct hormonal deficiency, our clinic provides all of the tools you need to live a longer, happier, healthier life. Call or contact us today if you have any questions!


Nutropin HGH Detailed Description


Written by Dr. Welsh, Published on 15 January 2016

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Description

Nutropin is a Growth Hormone derived from recombinant DNA. Nutropin is of 191 residue amino acids and has a molecular weight 22,125 daltons. The sequence of Nutropin's amino acids is perfectly identical to the sequence of HGH derived naturally from the pituitary. Nutropin is from a specific lab strain of the E. coli bacteria as a precursor chemical. It consists of the recombinant Human Growth Hormone molecule that is by a signal for secretion that originates with a protein from the E. coli bacteria. This precursor chemical travels through the protective membranes of the cells. After the E. coli secretion signal is initiated, the native protein enters into the periplasm, and the protein begins to be folded correctly into Human Growth Hormone.

Nutropin is an intensely purified preparation. The biological potency of Nutropin is configured through a bioassay designed to proliferate Growth Hormone cells.

Nutropin is a white, sterile freeze-dried powder that is by subcutaneous injection after it has with Bacteriostatic Water for Injection, USP, and the preservative benzyl alcohol. After the product has been reconstituted, it is nearly isotonic at a 5 mg/mL concentration of Human Growth Hormone. It also has a pH of about 7.4.

Every 5 mg vial of Nutropin holds 5 mg (about 15 IU) somatropin which has 1.7 mg glycine 45 mg of mannitol, and 1.7 mg sodium phosphates (1.3 mg sodium phosphate dibasic, 0.4 mg sodium phosphate monobasic).

Every 10 mg vial of Nutropin holds 10 mg (about 30 IU) somatropin which has 3.4 mg glycine 90 mg of mannitol, and 3.4 mg sodium phosphates (2.6 mg sodium phosphate dibasic, 0.8 mg sodium phosphate monobasic).

Bacteriostatic Water for Injection, USP, is sterilized water that contains 0.9% benzyl alcohol per milliliter. This sterilized water is in a vial that can be used multiple times. The benzyl alcohol acts as a preservative which protects the fluid from microbial contamination. The pH of the dilutant is 4.5-7.

Clinical Pharmacology

General

In vivo and in vitro clinical and preclinical testing have provided ample evidence that Nutropin is equivalent therapeutically to Human Growth Hormone naturally derived from the pituitary. Children who do not secrete adequate levels of Growth Hormone endogenously, patients who suffer from chronic renal insufficiency (CRI), and patients who suffer from Turner syndrome all report benefits when taking Nutropin. Patients who took Nutropin were found to experience an increase in their rate of growth and also an increase in their Insulin-like Growth Factor-1 (IGF-I) levels in a manner than is compatible with Human Growth Hormone naturally produced by the pituitary.

Benefits that have been shown through studies regarding Nutropin, somatrem, somatropin, and/or Human Growth Hormone derived naturally from the pituitary include:

A. Tissue Growth --

1) Skeletal Growth: Growth Hormone stimulates skeletal growth in

young patients that experience growth failure as a result of inadequate secretion of natural Growth Hormone, or as a secondary effect of chronic kidney insufficiency or also with patients that suffer from Turner syndrome. Turner syndrome is a genetic disorder which seriously hinders hormone production and has devasting effects on the physiology of a woman from birth. It is caused when the second chromosome does not form properly, or does not develop at all, leaving only one functional X chromosome. Growth of the long bones of the skeleton is a result of the expansion of the epiphyseal plates that are on the ends of the growing bone. The metabolism and growth of the cells of the epiphyseal plates are stimulated directly by Growth Hormone and Insulin-like Growth Factor-1, an important stimulator of Growth Hormone. Levels of Insulin-like Growth Factor-1 in the blood serum are low in adolescents and children who are deficient in GH, but their levels increase when treated with Growth Hormone. In these young patients, new bone begins to develop in the growth plates after Growth Hormone and Insulin-like Growth Factor-1 have been introduced to the body. As one reaches the end of puberty, the growth plates fuse, and adult height is in.

2) Cell Growth: Human Growth Hormone leads to an increase in both the size and number of skeletal muscle cells. This leads to enhanced strength as there are more muscle fibers. Each individual muscle fiber can handle a larger load as well.

3) Organ Growth: Growth Hormone has a direct effect on the size of the internal organs, including the kidneys. It also increases the mass of red cells. Growth Hormone Treatment of genetic dwarf or hypophysectomized rats (rats that had their pituitary glands removed) leads to organ development that is in proportion to the growth of the rest of the body. In healthy rats that were induced with uremia (high levels of nitrogen) through nephrectomy, Growth Hormone promoted body and skeletal growth.

B. Protein Metabolism: Proper growth is in part by protein synthesis which is caused by Growth Hormone. This is through retention of nitrogen that reveals itself through a lower level of nitrogen excreted through the urine, as well as clinical testing for nitrogen in the blood urea which occurs during Growth Hormone Therapy.

C. Carbohydrate Metabolism: Growth Hormone is a significant controlling mechanism in charge of carbohydrate. In patients that do not adequately secrete Growth Hormone, hypoglycemia is during periods of fast. This issue is largely resolved with Human Growth Hormone Therapy. It is a possibility that Growth Hormone therapy can lead to a decrease in the body's sensitivity to insulin. Patients who are not for chronic kidney insufficiency and/or Turner syndrome have a higher risk to develop intolerance to glucose. Human Growth Hormone treatment provided to children or adults has resulted in an increase in post-meal insulin levels and serum fasting. These two results happen most commonly with those that are overweight or obese. Also, post-meal glucose, mean fasting, and A1c hemoglobin (a measure of blood glucose) stays at a healthy level.

D. Lipid Metabolism: In patients who are Growth Hormone Deficient, Growth Hormone Therapy led to the mobilization of lipids, a reduction in stores of body fat, increased fatty acids entering the plasma, and lower levels of cholesterol in the plasma.

E. Mineral Metabolism: Use of Growth Hormone leads to the retention of potassium in the body. This retention apparently is due to the enhanced cell growth that begins to occur. Inorganic phosphorus levels in the blood serum can sometimes increase modestly among patients who undergo Growth Hormone Therapy because they do not produce enough Growth Hormone on their own, have a chronic kidney deficiency, or suffer from Turner syndrome. This is because Growth Hormone enhances the metabolic processes associated with growth of bone, in addition to improving tubular reuptake of phosphate by the kidneys. Serum calcium levels do not change significantly among these patients. Retention of sodium also occurs. Adults that developed a Growth Hormone Deficiency as children display low levels of bone mineral density (Acronym: BMD). (See also Precautions: Laboratory Tests.)

F. Metabolism of the Connective Tissues:Growth Hormone chondroitin sulfate synthesis and collagen synthesis in addition to encouraging the urinary expulsion of hydroxyproline.

Pharmacokinetics

Absorption after Subcutaneous InjectionThe total bioavailability of recombinant HGH after being injected subcutaneously into a healthy adult male is to be 81 plus or minus 20%. The terminal mean t after subcutaneous injection is much longer than the terminal mean after intravenous injection (2.1 plus or minus 0.43 hr vs. 19.5 plus or minus 3.1 min). This indicates that subcutaneous injection of Growth Hormone causes the compound to be released slowly and at a more modest rate.

DistributionRecombinant Human Growth Hormone Animal Research has shown that Growth Hormone is vital to organ function, especially to the kidneys and liver. The distribution volume at steady state for Recombinant Human Growth Hormone in a healthy adult male is around 50 mL/kg of body weight, essentially the serum volume.

MetabolismBoth the kidney and liver have been proven to be essential organs for the proper metabolism of Growth Hormone. Animal research provides evidence that the kidneys are the primary organs of clearance. Growth Hormone filtration occurs at the glomerulus and Growth Hormone is by the proximal tubules. After that it is inside the kidney cells into its component amino acids, after which the acids return to normal circulation.

Elimination--The terminal mean t after intravenous injection of recombinant Human Growth Hormone adult males in good health is to be 19.5 plus or minus 3.1 minutes. Elimination of recombinant Human Growth Hormone after intravenous injection among healthy children and adults is to range from 116-174 mL/hr/kg.

Formulation bioequivalenceNutropin [somatropin injection derived from recombinant DNA] has to be the bioequivalent of Nutropin [somatropininjection derived from recombinant DNA]. This is upon statistical evaluation of Area Under the Curve (AUC) and mean C.

Special Populations

PediatricCurrent research data suggests that there is no difference in Human Growth Hormone clearance between children and adults.

GenderThere is no data available for exogenously injected recombinant Human Growth Hormone. The data that have been collected regarding methionyl Human Growth Hormone, naturally produced and extracted pituitary Growth Hormone, and endogenous Growth Hormone produce no evidence that suggests that men and women clear GH at different rates.

GeriatricsThe limited amount of published research shows that Growth Hormone plasma clearance and normal steady-state GH plasma concentration do not appear to be different among young and elderly populations.

RaceThe half-life values for endogenous Growth Hormone in healthy black males is not to be any different than the half-life values of Growth Hormone for healthy white males. There are no available data regarding other races.

Growth Hormone Deficiency (GHD)The reported values regarding the clearance of recombinant Human Growth Hormone in children and adults suffering from GHD range from 138-245 mL/hr/kg. These values are similar to those that occur in healthy children and adults. The terminal mean t values following subcutaneous and intravenous administration in pediatric and adult Growth Hormone Deficiency patients have also proven to be similar to the values observed in the population of healthy adult males.

Kidney InsufficiencyAdults and children who suffer from end-stage renal disease (ESRD) and chronic renal failure (CRF) to to clear Human Growth Hormone at a lower rate than healthy individuals. Endogenous Growth Hormone production can sometimes increase in individuals suffering from ESRD. Even so, no accumulation of Human Growth Hormone has in children with ESRD of CRF that are normal Growth Hormone Replacement Therapy.

Turner SyndromeNo pharmacokinetic data is currently available regarding Turner syndrome and Growth Hormone Therapy. It has, however, that absorption, half life, and clearance rates for internally produced Growth Hormone for this population show little difference when compared to the rates of healthy patients and patients only suffering from Growth Hormone Deficiency.

Hepatic InsufficiencyA reduction in recombinant Growth Hormone clearance has in patients that are suffering from extreme liver dysfunction. The clinical significance of this data is still unknown.

Summary of Pharmacokinetic Nurotropin Parameters in Adult Men of Good Health

0.1 mg (about 0.3 IU a)/kg SubC max C

(g/L) max T

(hour) t 1/2

(hour) (Area Under the Curve)

ghr/L) Ev/F SubC

(mL/[hrkg])

Average b

67.2 / 6.2 / 2.1 / 643 / 158

CV

29 / 37 / 20 / 12 / 12

Key

maximum

t1/2life

Ev=systemic

F SubC =biological subcutaneously (indeterminant);

CV=variation coefficient

SubC=subcutaneous

a

b

Effectiveness Studies

Nutropin's upon as a of CRI

Two randomized, controlled, multi-center clinical trials were conducted in an effort to learn whether Nutropin treatment before patients who are suffering from chronic renal insufficiency receive renal transplants could possibly lead to an improvement in growth rate and a decrease in height deficit. One of the studies was a placebo-controlled, double-blind trial, and the second trial was randomized and open-label. In both of these controlled studies, that participants took a Nutropin dose of 0.05 mg/kg/day (0.35 mg/kg/wk). These doses were given daily by means of subcutaneous injection. Taking data from both studies of patients who underwent treatment for two full years resulted in 62 participants who received Nutropin treatment and 28 participants who were either untreated or treated by placebo. The year one mean rate of growth was 10.8 cm/yr for patients treated with Nutropin, as compared to an average rate of growth of 6.5 cm/yr for the untreated/placebo controls.


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