Nationwide MD Hormone therapy guide

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A sweet manual to hormone replacement treatment products and services. Call now to speak with one of our clinical specialists now to get you started on the path to youthfullness.

A sweet manual to hormone replacement treatment products and services. Call now to speak with one of our clinical specialists now to get you started on the path to youthfullness.

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  • 1. Nationwide MD Inc. (888)959-9304 Office Hormone Therapy Guide A basic outline of products/services available through Nationwide MD’s (888)959-9304 Fax network of physicians.www.nationwideMD.netinfo@nationwidemd.net
  • 2. Introduction 3About NATIONWIDE MD 4Our Mission 5Administrative Service 6What is Hormone Replacement Therapy 7Bto-Identical Hormone replacement Therapy (BHRT 8Erectile Dysfunction 8Hypogonadism 8Hypogonadism Causes Primary -Secondary 8Testosterone Replacement Therapy 9Symptoms of Low Testosterone 9Human Growth Hormone 9Medications, Indications and Usage for HRT 10Testosterone Cypionate injections 10Testosterone Enanthanate Injections 11Nandrolone Deaconate 11Armidex 11HCG 12Consultant Protocol 13·34Important Memorandum 35Injection Reference Sites 36·39Compounding Definitions 40Compounding 41·43Compounding vs. Traditional pharmacy 44·45Definition of a generic drug and the FDA requirements 46HRT Q&A 54-57Medi·Spa and Service 58Notes 59·64 2
  • 3. IntroductionThis quick reference guide is a back to the basic reminder of the protocols set in place to guidethe consultants. The reference guide ha s basic reminders of common usage a n d client c a r e as new andexisting client o f Hormone replacement therapy.This reference guide has pharmacy compounding meaning and definitions. Use this guide as quickref erence to medication and its usage. This guide a l s o tells you the company and its mission. 3
  • 4. About Nationwide MDNATIONWIDE MD Inc. addresses the needs of both males and females who wish not only to preventdisease, but to enhance their health and optimize their genetic aging potential.We provide skillful management for a wide r a n ge o f hormones. Using a customized high quality bio-identical hormone replacement treatment approach, sophisticated use of nutritional supplements and lifestylechanges, including stress reduction and exercise, our medical experts enhance your bodys potential to slowdown aging.As a leader in Advanced Preventive and Rejuvenation Medicine, NATIONWIDE MD is dedicated tooffering successful anti-aging treatment protocols using bio-identical hormones formulated by our networkof compounding pharmacies who uphold our commitment to provide our clients with tailored treatmentplans by maintaining their focus on customizing dosages that are consistent with our physiciansexpectations and complementary to our clients needs.Our staff is headed by a medical director who is a long-standing member of the American Academy ofAnti-Aging M e d i c i n e (A4M). He has extensive background and experience in the key areas of medicinerelevant to this specialty. He is board certified in: Anti-Aging M e d i c i n e , F a m i l yPractice and Clinical Nutrition Additionally, he specializes in Environmental, Bariatric andIntegrative Medicine.NATIONWIDE MD clients receive constant support and guidance from our knowledgeable and experiencedstaff 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 aredesigned by our leading-edge physicians. Using an instructional approach, they take a f f i r m a t i vesteps b y working with e a c h client o n a case-by-case basis to determine the most b e ne f i c i a l methodfor achieving the desired result. 4
  • 5. Our MissionNATIONWIDE MDs goal is to enhance the physical and mental wellbeing of our clients throughthe optimization of their health.We accomplish this by recognizing the uniqueness of each individual, and then customizing a treatmentregimen 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 earlydetection, prevention, treatment, and reversal of age-related dysfunction, disorders, and diseases. 5
  • 6. 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 6
  • 7. What is Bio-Identical Hormone Replacement?NATIONWIDE MD’s patient Network bio identical hormone replacement therapy doctors take anintegrated approach to anti-aging medicine for both men and women. The customized programsprescribed by our physicians include proper fitness, nutrition and supplements in combinationwith possible anti-aging bio identical hormones.This preventive medical approach helps put an end to suffering and the negative effects caused bystress induced adrenal fatigue, peri-menopause, menopause, post-menopause, andropause (themale menopause), hyperthyroidism and hypothyroidism.Men and women often mistakenly believe that fatigue, low sex drive, insomnia, weight gain andother symptoms of menopause, andropause, adrenal fatigue and thyroid disorders are just aninevitable part of getting older. However, these symptoms are in fact caused by imbalancedhormones of the body. Many people have found relief with bio identical hormone replacement therapy. This naturaltherapy is considered anti-aging because it works to combat the symptoms attributed to aging andit can improve longevity and quality of life.Hormones decline as we age. Bio identical hormone therapy serves to replace the hormones thatyour body needs to function; mainly estrogen, testosterone, progesterone, a n d cortisol.NATIONWIDE MD network physician use bio identical hormones versus bio-similar or synthetichormone s .Bio identical hormones a r e molecule-by-molecule, e x a c t l y the same as the hormones p r e s e n tin the human body. Synthetic hormones a r e intentionally d i f f e r e n t . Because drug companiescannot patent a bio identical structure, t h e y make synthetic hormones t ha t are patentable. Thereare 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 arenot familiar with it and have not had specific training. Conversely, NATIONWIDE MD hasdedicated network of bio-identical hormone anti-aging physicians have been certified in the field andare experts in hormone replacement therapy.NATIONWIDE MD doctors will assess your individual needs and work to restore balance to yourhormones by customizing a bio identical hormone replacement therapy plan integrated with propernutrition and fitness that is specifically for you and your particular needs. 7
  • 8. 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 doesnt produce enough of the male sex hormone testosterone also known as primary testicular failure originates from a problem in ther 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 8
  • 9. Pituitary disordersInflammatory diseaseHIVJAIDSMedicationsObesityNormal agingTestosterone Replacement TherapyTestosterone is a hormone produced by the testicles and is responsible for the properdevelopment of male sexual characteristics. Testosterone is also important for maintainingmuscle bulk, adequate levels of red blood cells, bone density, sense of well-being, and sexual andreproductive 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 concentratingHuman Growth HormoneHuman growth hormone is a naturally occurring substance produced by the pituitary glands inthe body; works by increasing the amount of IGF-l that your liver produces. IGF-l preventsInsulin from transporting glucose to cells. Growth hormone is a peptide hormone secreted by the pituitarygland that stimulates growth and cell reproduction. Testosterone, HGH (Human Growth Hormone), DHEAand others, can give men a better opportunity for a healthy and vigorous life. Male hormonereplacement therapy can have a significant and positive impact on mens health including fitness, strengthand sex drive. 9
  • 10. 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. 10
  • 11. TESTOSTERONE ENANTHATE INJECTION USPTestosterone Enanthate Injection is a clear, colorless to pale yellow sterile oleaginous solution ofTestosterone 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 insolublein water, very soluble in ether and soluble in vegetable oils.INDICATIONS AND USAGEMales: Androgens are indicated for replacement therapy in conditions associated with adeficiency 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, USPNandrolone deaconate injection is intended for deep intramuscular injection only, into the glutealmuscle preferably. A sterile oleaginous solution containing per ml: Nandrolone Deaconate 200mg with Benzyl Alcohol 5% as solubilizer /preservative, in Sesame Oil. Nandrolone deaconateoccurs 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 ispractically insoluble in water.ArimidexArimidex - also known as Anastrozole also works well as an adjunct to Hormone ReplacementTherapy, It has also been tested to reduce estrogen including estradiol, in men; preventingpossible prostate enlargement. Armidex helps to maintain some natural testosterone production, whiletaking an exogenous source of testosterone as well.HCGHCG as it is commonly called is really an acronym for Human Chorionic Gonadotropin Hormone. Ithas many functions and is used medically to treat a variety of conditions. HCG is a hormonenaturally produced in the body. HCG is a hormone which plays different roles in male and femalesexual development. In men, physicians may prescribe HCG to increase or restore testosteroneproduction. Both men and women use HCG for weight loss this method is not FDA-approved. 11
  • 12. FunctionHCG acts like luteinizing hormone (LH). In males, LH tells the testes to produce testosterone. Inmen undergoing hormone replacement therapy, their testes may stop producing testosterone, soHCG can remind their testes to keep producing testosterone. HCG also raises sperm counts, so itcan improve male fertilityMen suffering from androgen disorders take HCG to jump start their testosterone production. Aprescription 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 12
  • 13. Consultant ProtocolWhen NATIONWIDE MD receives a new potential candidate for BHRT, ED, TRT or GHRT we doa 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. 13
  • 14. 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 3ccs 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). 14
  • 15. 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 ifexperiencing 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. 15
  • 16. 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. Simeons 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 16
  • 17. 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 r e g a r d i n g the medicinal therapies a n d treatment p r o g r a m s .Cialis TadalafilGeneral I n f o r ma t i o n : Used to treat male s e xua l func t i on p r o b l e m s (impotence orerectile dysfunction). Tadalafil is Cialis active ingredient. Erection lasting longer than four hoursmust 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 f ood .Common side effects: Headache. Stomach upset, back pain. Muscle pain, nasal stuffiness,flushing, pain in arms or legs, dizziness. Or vision changes.Clomiphene CitrateGeneral Information: Used typically for post program helps to clean out receptor s i t e s flush outextra estrogen from body. 50 mg only compounded, Clomide name brand available in genericCommon side effects: Stomach upset, bloating, abdominal/pelvic fullness, flushing, breasttenderness, headache, dizziness. Vision changes, eye pain.Serious s i d e e f f e c t s : Severe pai n /swelling in the lower abdomen ( pelvic) area, sudden/rapidweight 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 ofurine, pain/redness/swelling of the legs, chest pain, fast/irregular heartbeat.Cyanacobalamin Methylcobalamin (Vitamin B-12)General Infor mati on : Cyanacobalamin (Fast-acting l a s t about 4 8 hours) is a man-madeform of vitamin B12 used to treat l o w levels of this vitamin. Vitamin B12 helps your body use fatand carbohydrates for energy and makes new protein. It is also important f o r normal blood. Cellsand nerves. This medication i s 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 ofswelling all over the body.Serious s i d e e f f e c t s : This medication may cause hypokalemia. Symptoms are musclecramps, weakness, irregular heartbeat 17
  • 18. Cytomell LiothyronineGeneral Information: Liothyronine is used t o treat hypothyroidism. It replaces a hormone that isnormally produced by the thyroid gland. This medication is also used to lower t h y r o i d function incertain diseases such a s enlarged thyroid gland ( goiter) and H a s hi m o t o ’ s thyroiditis. It is also usedto t e s t thyroid activity. Liothyronine is a man-made hormone that replaces the bodys naturalthyroid hormone (T3). Take this m ed i cat i o n by mouth w i t h o r without food, usually i n themorning. Take t hi s m e d i c a t i o n 4 hours before or after t a k i n g any products containingaluminum or iron, such as antacids, sucralfate, and vitamins/minerals.Common side effects: Nausea, in rare instances, some temporary hair loss may occur during thefirst few months of starting this drug.Serious s i de e f f e c t s :Headache, irritability, trouble sleeping, nervousness, increasedsweating, heat intolerance, diarrhea, menstrual changes, chest pain, trouble breathing with exercise,fast/irregular/pounding heartbeat, swelling of the arms/legs, extreme weakness.DHEA/Pre~nenoloneGeneral Information: DHEA is a sex hormone and is recommended to be taken while on HCG tohelp prevent the shutdown of pregnenolone production in your body; which HCG can cause whenon it for a long period of time.DHEA also appears to be useful in combating auto-immune disorders, especially lupus (systemicLupus e r y t h e m a t o s u s ). DHEA has demonstrated the pote nt ia l for preventing or treating abroad range of other disorders including cancer (especially breast cancer], obesity, seniledementia, osteoporosis, chronic fatigue syndrome, depression, and weakened immunesystems. 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 ho r m o ne thatt e l l s y o u r b r a i n that youve had e n o u g h to e a t . It also tends to inhibit the conversion ofglucose to fat, which keeps people from gaining as much weight from eating carbohydrates asthey otherwise would. In some c a s e s , D H E A can significantly improve ones cholesterolprofile, raising HDL levels a n d lowering LDL levels.Pregnenolone is a p r e c u r s o r to the bodys other naturally occurring hormones,including dehydroepiandrosterone (DHEA), progesterone, estrogen, testosterone, andcortisol. Pregnenolone is synthesized directly from c h o l e s t e r o l and i s responsible for countlessfunctions in our b o d i es . Pregnenolone acts t o improve memory and c o m b a t depression and h a sp o w e r f u l anti-inflammatory arthritis pain r e l i e v i n g properties. Some p e o p l e findpregnenolone improves energy, vision, memory, clarity of thinking, wellbeing, and o f t e nsexual enjoyment or libido . It may be considered a good brain e n h a n c e r in those w h o aredeficient.Directions: Apply 1 ml topically to your wrist or inner thighs every day (rotate sites, best toapply medication after showering and wait at least 30 minutes after application before you haveany contact with others to prevent transfer of medication) 18
  • 19. Side effects: (DHEA) acne, hair loss, stomach upset and high blood pressure. Some women c a nhave changes in menstrual c y c l e , facial hair growth, and a deeper vo i c e . Liver problems:DHEA might make liver problems w o r s e . Diabetes: DHEA can affect how insulin works in thebody. If you have diabetes, monit or 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 heartrhythm, heart palpitations.DanazoleGeneral I n f o r m a t i o n : Danazole is an anabolic used to treat hypogonadism ( when the sex glandsproduce little or n o h o r m o n e s ). This m e d i c a t i o n is recommended to b e taken alongw i t h testosterone and does not affect testosterone levels. The available dosages for this medicationare between 5 0 -100 mg.Directions: 1 tab by mouth every day.Common side e f f e c t s : Weight gain. Acne, flushing, sweating, voice changes (hoarseness, changein 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 decreasedbreast size.Serious side e f f e c t s : Swelling hands/ankles/feet, menstrual changes ( such as spotting, m i s s e dperiods), mental/mood changes.Finasteride Propecia Proscar (brand name)General Information: This medication is used to treat male pattern (androgenetic alopecia) at thecrown and in the middle of the scalp. It should be used by adult men only. This medication w o r k sb y decreasing t h e amount o f a natural b o d y hormone (DHT). Decreasing t h e amount o f DHTleads to increased hair re-growth and slower hair loss. Hair growth o n other parts o f the body isnot affected by finasteride. You must continue t o take this medication t o maintain your hairgrowth. When you stop taking finasteride, a n y gain in hair quantity is generally lost w i t h i n 12months. This medication is normally t a k e n along wi t h testosterone. Normal ranges for DHTlevels are (40-575)Directions: Take 1 pill by mouth 3 times a weekCommon side effects: Decreased sexual a b i l i t y /desire. In some m e n , t hi s m e d i c a t i o ncan decrease the amount of semen released duri n g sex.Serious side effects: Lump in the breast, nipple discharge, breast enlargement/tenderness/pain,pain in the testicles, inability to urinate. 19
  • 20. General Information: Various brands o f this medication are used for the treatment of one of thefollowing m e di c a l c o n d i t i o n s : growth failure, growth h o r m o n e deficiency. Intestinaldisorder (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/unexplainedweight gain. Persistent cold i ntol erance , persistent slow he a rt be a t , fast h e a r t b e a t , e a rpain/itching.Hearing problems, joint/hip/knee pain. Numbness/tingling, unusual increase int h i r s t or urination, swelling h a n d s /ankles/feet. Change i n the a ppe a ra nc e or size of anymole, severe headache, persistent nausea/vomiting, severe stomach/abdominal pain, visionproblems or changes, seizure.GhrelinGeneral I n f o r m a t i o n : Ghrelin i s a p o t e nt stimulator of growth hormone from t h eanterior pituitary g l a n d . This medication c a n be taken every day; inject medication a t bed timebecause your body secrets growth hormone while sleeping. This medication m a y also causedrowsiness.Mixing instructions: Depressurize Ghrelin vial first. Slowly inject 3ml of bacteriostatic waterinto Ghrelin vial do not shake vial gently swirl vial between h a n d s to dissolve medication. Oncethe medication h a s been mixed store me dica ti on i n refrigerator. Inject 300- 600 mcg per day atbed time. Every 10 on insulin syringe is 100 units.Directions: Inject .25 ml sub-q every day at bed time.Side effects: Increased appetiteGeneral I n f o r m a t i o n : HCG works b y causing t h e t e ste s t o release m a l e sex hormones.This medication i s also used in women t o treat fertility problems. So both male and femalepatients should take extra precautions w h e n on this medication to prevent a n y unwantedp r e g n a n c y . It is recommended that you take this medication while taking testosterone; 4-5weeks after starting testosterone your body starts to recognize the free flowing testosteronewhich in turn causes your body to stop production of its natural LH hormone. HCG helps toprevents t h i s so your LH levels do not plateau and everything s t a ys in balance. It is alsorecommended 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 correctamount of bacteriostatic water (depending the amount of units per vial normally 1:1 followdoctors sig) slowly inject water into HCG vial, do not shake vial you gently swirl vial betweenhands to dissolve medication once the medication has been mixed it is to be stored inrefrigerator. 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. 20
  • 21. Common side e f f e c t s : Headache. restlessness, tiredness, mild swelling or water weightgain; 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-TropinGeneral Information: Various brands of this medication are used for the treatment of one of thefollowing 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 2days off. HGH contains 191 amino acids. Tev-Tropin contains 192 amino acids.Mixing Instructions: Depressurize Tev-Tropin vi a l first. Slowly inject 1 . 5 m l of bacteriostaticwater into vial do not shake vial gently swirl vial between ha nd s to dissolve medication. Once themedication ha s been mixed store medication i n refrigerator. Inject at bed time on empty stomach.Every 10 on insulin syringe is 1 unit.Common si de effects: Headache, Nausea, vomiting, fatigue, muscle, pain, orweakness.Serious side effects: Development of a limp, persistent fatigue, unusual/unexplained weightgain, persistent cold intolerance, persistent slow heartbeat, fast h e a rt b e a t , and ea rp a i n /itching. Hearing problems, joint/hip/knee pain, numbness/tingling, unusual increase in t h i r s tor urination, swelling h a n d s /ankles/feet. Change i n the a ppe ara nce or size of any mole, severeheadache, persistent nausea/vomiting, severe stomach/abdominal pain, vision problems orchanges, seizure.HydrocortisoneGeneral I n f o r m a t i o n : Hydrocortisone is a natural subst a nc e (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, cancerand severe allergies. It decreases y o u r immune system’s response t o various diseases t o reducesymptoms s u c h as pain, swelling and allergic-type reactions. Hydrocortisone i s also used to treatlow 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 functionwell. They are important f o r salt and water balance and keeping blood pressure normal. Becausethis drug works b y weakening t h e immune s yst e m , 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 i n oral thrush or a yeastinfection. This medication may infrequently m a k e your blood sugar level rise, which can cause orworsen 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 youalready have diabetes, be sure to check your blood sugars regularly. 21
  • 22. Common side effects: Nausea, heartburn, h e a d a c h e , dizziness, menstrual p e r i o d change,trouble sleeping, increased s w e a t i n g , acne.Serious side effects: Unusual tiredness, swelling ankles/feet, unusual weight gain, Visionproblems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes, muscleweakness/pain, thinning skin, slow wound healing, bone pain, black/bloody stools, vomit thatlooks like coffee grounds, stomach/abdominal pain.LetrozoleGeneral Inf or mati on : Letrozole d e c r e a s e s the amount o f estrogen t h e body makes. It isthe 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 p e n s i v e . Used when A n a s t r o z o l eis 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 vi sion .General Information: If patient has sulfa allergies this medication ca nnot be taken.Methionine: it assists in the breakdown of fats and thereby prevents the build-up of fat in thearteries, as well as assisting with the digestive system and removing heavy metals from the bodysince it can be converted to cytosine, which is a precursor to gluthione, which is of primeimportance in detoxifying the liver.Inositol: helps to m a i n t a i n proper electrical energy and nutrient transfer across thecell 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 v e l s , keeping cell membraneshealthy a n d in preventing gallstones. It is also most useful in the maintenance of the nervoussystem, assisting memory and learning, and may help to fight infections, including hepatitis andAIDS. 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 waterbalance and by the liver as a source of methyl-groups for methionine formation. It is also used toproduce 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 22
  • 23. MinocyclineGeneral 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 thegrowth o f bacteria. Swallow this medication whol e . Take each dose with a full glass of water ( 8ounces) u n l e s s your doctor directs yo u otherwise. Do not lie down for 10 minutes a f t e r takingthis medication. For this reason, d o not take it right before bedtime. You may take minocyclinewith 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/browndiscoloration of the skin/lips/tongue/gums, numbness/tingling of the hands/feet.Unusual fatigue, new signs of infection, hearing changes, easy bruising/bleeding, headache, visionchanges.Nandrolone DeconateGeneral Information: Known c o m m o n l y as “ Deca” flushes estrogen through yours y s t e m lubricating j o i n t and aiding in muscle repair. This is a short acting medication ifused for long periods of time it can cause muscle wasting. This medication should b etaken in 3 month increments.Side effects: Estrogen build up, Fluid buildup (edema), low libido.OxandroloneGeneral Information: This medication i s used to help people regain weight they have lost due tocertain medical conditions (such as s u r g e r y , chronic infection, trauma, long t e r m useo f corticosteroid medication such as hydrocortisone/prednisone). It is also used to relieve bonepain due to bone loss (osteoporosis) and muscle wasting. Oxandrolone belongs to a class of drugsknown as anabolic steroids. These drugs are similar to male hormones made by the body. Thismedication can cause your body to hold on to extra body water (edema). This can increase yourrisk of heart failure. Tell your doctor immediately if any of these unlikely but serious signs ofwater retention or heart failure occur, decreased exercise ability, hands/ankles/feet swelling,unusual tiredness, shortness of breath while lying down. This medication can also decreasesperm production in males.Common side effects: Nausea, vomiting, skin color changes, oily skin, acne, hair loss,increased/decreased sexual interestSerious side effects: Mental/mood changes, trouble sleeping/snoring, signs of serious liverdisease (persistent abdominal pain/nausea, unusual tiredness, yellowing of the eyes/skin, dark 23
  • 24. urine), trouble urinating (male only), breast swelling/tenderness (male only), tofrequent/prolonged erections (male only)In females: Deepening of the voice, hoarseness, unusual facial/body hair growth, enlargedClitoris, and irregular menstrual.Oxytocin Nasal SprayGeneral Information: Oxytocin is best known for its roles in sexual reproduction, in particularduring and after childbirth. It is released in large amounts after distension of thecervix 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 investi gate oxytocin’s role invarious behaviors, including orgasm. Social recognition, pair bonding. Anxiety. Andmaternal behaviors. For this reason, it is sometimes r e f e r r e d t o as the “love hormone". Oxytocincauses a euphoria effect increasing y o u r l i bi do . Oxytocin is destroyed in the gastrointestinalt 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 thePhosphatidylserineGeneral Information: Phosphatidylserine is a chemical. The body can make phosphatidylserine,but gets most of what it needs from foods. Phosphatidylserine supplements were once made fromcow brains, but now are commonly manufactured from cabbage or soy. Phosphatidylserine isused for Alzheimers disease, age-related decline in mental function, improving thinking skills inyoung people, attention deficit-hyperactivity disorder, depression, preventing exercise-inducedstress, and improving athletic performance.Side effects: Insomnia and stomach upset, particularly at doses over 300 mg.ProgesteroneGeneral Information: Progesterone is a type of female hormone ( progestin). This medication issimilar to the progesterone that your body naturally makes and is given to replace the hormonewhen your body is not making enough of it. In women who are not pregnant and not goingthrough menopause, this medication is used to restore normal menstrual periods that havestopped for several months (amenorrhea). Progesterone is also used as part of combinationhormone replacement therapy with estrogens to reduce menopause symptoms. Progesterone isadded to estrogen r e pl a c e m e nt t h e r a p y t o reduce the risk of cancer of the uterus.Common side effects: Nausea, bloating, breast tenderness, headache, change inv a g i n a l discharge, mood swings, blurred vi si on , dizziness, or drowsiness.Serious side effects: Unusual vaginal bleeding, mental/mood changes, swelling of thehands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face, 24
  • 25. Yellowing eyes /skin, stomach/abdominal pain, persistent nausea/vomiting, dark urine,unusual tiredness.Sermorelin GHRPGeneral Information: Stimulates your pituitary to produce your own natural HGH. Sermorelin,which was first developed in the 1970s is a peptide which contains a total of 29 amino acids andencourages the pituitary gland to produce more Human Growth hormone. Today, Sermorelin iscombined 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 yourpituitary gland to secrete HGH at a much higher rate.Mixing instructions: Depressurize Ghrelin vial first. Slowly inject 3ml of bacteriostatic waterinto Ghrelin vial do not shake vial gently swirl vial between hands to dissolve medication. Oncethe medication has been mixed store medication in refrigerator. Inject 300- 600 mg per day atbed time. Every 10 on an insulin syringe is 100 unitsSide effects: Headache. Flushing, increase in activity (hyperactivity). GHRP: Increased appetiteSerious side effects: Trouble swallowing, vomiting, tightness i n the chest.Triamterene H C T ZGeneral i n f o r m a t i o n : This d r u g i s used t o treat high bl ood p r e s s u r e . Lowering h i g hblood pressure helps prevent stroke s , heart attac ks and kidney problems. This combination i s usedby people who have developed or are at risk for having low potassium levelson hydrochlorothiazide. It causes you to make more urine, which helps your body get rid of extrasalt and water. This medication a l s o reduces e x t r a fluid in the body caused by conditions s u c has heart f a i l u r e , liver disease or kidney disease. This can lessen symptoms s u c h as shortnesso f breath o r swelling in your ankles or feet. It is best to avoid taking this medication w i t h i n 4hours 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 i n vision, eye pain.TamoxifenGeneral 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 o fsexual 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/moodchanges, swelling of ankles/feet. Unusual tiredness, s t o m a c h /abdominal pain, persistentnausea/vomiting, dark urine, yellowing eyes/skin, s i g n s of infection. 25
  • 26. Testosterone General Information: This medication is used in men who do not make enough of a naturalsubstance called testosterone. In males, t e s t o s t e r o n e is responsible for many normalfunctions, including growth and development of the genitals, m u s c l e s , and bones. It also helpsc a u s e no r m a l sexual development (puberty) in b o y s . Testosterone belongs to a c l a s s ofd 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 bo d y c a ndevelop and f unct i o n normally. This medication can cause y o u r b o d y to hold o n to extra b o d ywater (edema). This can increase your risk o f heart failure (signs of water retention/heartfailure; decreased exercise ability, hands/ankles/feet swelling, unusual tiredness, shortness of breathwhile 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 maximus, 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 shouldn o t go over 6 0 0 mg a week.Common side effects: Nausea, vomiting, skin color changes (red can mean Bop is up), oilyskin, 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 s e r io usliver 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 timesAqueous suspension: 1- days fast actingCypionate: 3-5 days slow actingProprionate: 1-2 days fast acting (increase swelling and soreness)Enanthate: 5-7 days slow actingProplonate /Cypicnate: (Bi-mix) Fast/slow actingEnanthate/Propionate: 200/50mg Fast/slow actingEnanthate /Cyplonate/Propionate: 100/100/50 (higher risk of side effects, patient must be on all3 types oftestosterone before they can go on this mix)Testosterone cream: Available from 1 - 25% Female 2% average Male 5 - 20% average 26
  • 27. Viagra SildenafilGeneral Information: Sildenafil (active ingredient) i s used to treat male sexual functionproblems ( impotence or erectile dysfunction) by blocking a certain enzyme (phosphodiesterase-PDE5) in the body. In combination wit h sexual stimulation, s i l d e n a f i l works by helpingthe blood flow into the penis to achieve and maintain an erection. If you have erections lastinglonger than four hours go directly to the emergency room. Epinephrine counteracts the effects ofprolonged erections.Common side effects: Dizziness, lightheadedness, headache, flushing, heartburn, nosebleeds. Troublesleeping, or swollen hands/ankles/feet. Vision changes such as increased sensitivity to light,blurred vision, or trouble telling blue and green colors apart.Vitamin D3General Information: Vitamin D is a vitamin. It can be found in small amounts i n a few foods,including fa t t y fish such as herring, m a c k e r e l , sardines a n d tuna. But most vitamin D - 80%to90% of what the body gets - is obtained through exposure to sunlight. Vitamin D is used forpreventing and treating rickets, a disease that is caused by not having enough vitamin D. VitaminD is also used for treating weak bones (osteoporosis), bone pain (osteomalacia), bone loss inpeople with a condition called hyperparathyroidism, and an inherited disease (osteogenesisimperfecta) in which the bones are especially brittle and easily broken. It is also used forpreventing falls and fractures in people at risk for osteoporosis, and preventing low calcium andbone loss (renal osteodystrophy) in people with kidney failure. Vitamin D is used for conditionsof the heart and blood vessels, including high blood pressure and high cholesterol. It is also usedfor diabetes, obesity, muscle weakness, lubricating joints, multiple sclerosis, rheumatoid arthritis,chronic obstructive pulmonary disease, asthma, bronchitis, premenstrual syndrome and toothand gum disease.Recommended: 50000 units weeklyCommon side effects: (when taking too much) weakness, fatigue, sleepiness, headache, loss ofappetite, dry mouth, metallic taste, nausea, vomiting.Kidney disease: Vitamin D may increase calcium levels and increase the risk of "hardening of thearteries” in people with serious kidney disease. This must be balanced with the need to preventrenal osteodystrophy, a bone disease that occurs when the kidneys fail to maintain the properlevels of calcium and phosphorus in the blood. Calcium levels should be monitored c a r e f u l l y inpeople 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 tokidney stones and other problems. Use vitamin D cautiously. 27
  • 28. Histoplasmosis: Vitamin D may increase calcium levels in people with histoplasmosis. This couldlead to kidney stones and other problems. Use vitamin D cautiously.Over-active parathyroid gland ( hyperparathyroidism): Vitamin D may increase calciumlevels in people with hyperparathyroidism. Use vitamin D cautiously.Lymphoma: Vitamin D may increase calcium levels in people with lymphoma. This could lead tokidney stones and other problems. Use vitamin D cautiouslyL-ArginineGeneral Information: L-arginine is a chemical b u i l d i n g b l o c k ca lled “ an amino a c i d .” Itis obtained f r o m the diet and is necessary f o r the body to make proteins. L-arginine is found inred meat, poultry, fish, and dairy products. It can also be made in a laboratory a n d used asmedicine L-arginine i s used for heart and blood vessel conditions i n c l u d i n g congestive h e a r tf a i l u r e . Chest pain. High blood pressure a n d coronary artery di sease. L-arginine is also usedfor 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 theelderly, erectile dysfunction and m a l e infertility. Some people u s e L-arginine f o r preventing thecold, high blood pre ssure , improving a t h l e t i c pe rform a nc e , boosting t he immune s yst e m . Youcan also apply L-arginine to the skin to speed wound healing and for increasing blood flow to coldhands and feet. Especially in people with diabetes. It is also used as a cream for sexual problems inboth men and women and to stimulate IGF-levels. Patients who have HSV should not take L-arginine; it can sometimes c a use an outbreak.Side effects: Abdominal pain, bloating, diarrhea, gout, blood abnormalities, allergies, airwayinflammation, w o r s e n i n g of asthma, and low blood pressure.L-CarnitineGeneral Information: L-carnitine is an amino acid (a building block for proteins) that isnaturally 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, andsperm. 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, andreduce fatigue, which may contribute t o weight loss in some people. Some people use L-carnitinefor 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-hyperactivitydisorder, 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 i m prove m a l e s e x u a lfuncti on . One study found that carnitine improved the effectiveness of sildenafil (Viagra) inmen with diabetes who had not previously responded to Viagra. In another study, acombination of propionyl-L carnitine and acetyl-I-carnitine improved the effectiveness of Viagrain 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. 28
  • 29. 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 s e i z u r e s . Itcan also cause the urine, breath, and sweat to have a "fishy" odor.L- Glutamine PowderGeneral Information: Glutamine i s an amino acid, found naturally i n the body. It is the mostabundant f r e e amino acid in the body. Glutamine is produced i n the muscles and is distributed b ythe blood to the organs that need it. Glutamine might help gut function, the immune system, andother essential processes in the b o d y , e speciall y i n times o f stress. It is also importantfor providing “ fuel" (nitrogen a n d carbon) to many different cells in the body. Glutamine is neededto make other c he m i c a l s in the body such as other a m i n o acids and glucose (sugar). Glutamineis used to counter s o m e of the side effects of medical treatments. For example, it is used forside effects of cancer chemotherapy including diarrhea, pain and swelling inside themouth (mucositis), nerve pain (neuropathy), and muscle and joint pains caused by the cancerdrug Taxo!. Glutamine is also used to protect the immune system and digestive system inpeople undergoing radio chemotherapy for cancer of the esophagus. Additionally, glutamine isused for improving recovery after bone marrow transplant or bowel surgery, increasing well-being in people who have suffered traumatic injuries, and preventing infections in criticallyill people. Some people use glutamine for digestive system conditions such as stomach ulcers,ulcerative colitis, and Crohns disease. It is a l so u s e d f o r d e p r e s s i o n , moodiness,irritability, anxiety, insomnia, and e nha nci ng exercise p e r f o r m a n c e . People who haveHIV (AIDS) sometimes use glutamine to p r e v e n t weight loss. Glutamine is also used forattention deficit-hyperactivity disorder, a urinary condition called cystinuria, sickle cellanemia, and for alcohol withdrawal support.Side effects: Potential side effects of glutamine are not known.Milk-ThistleGeneral Information: Milk thistle is a plant. The above ground parts and seeds are used to makemedicine 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 theseuses. Milk thistle is also used for loss o f appetite, heartburn (dyspepsia), and g a l l b l a d d e rcomplaints. Some people use milk thistle for diabetes, ha ngove r , diseases of the spleen, prostatecancer, malaria, depression, uterine complaints, increasing breast milk f l o w , a n d startingmenstrual flow. Milk thistle s e e d might protect l i ve r cells from toxic chemicals and drugs. Italso seems to have antioxidant a n d anti-inflammatory effects. Milk thistle plant extract mightenhance 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, intestinalg a s , bloating, fullness or pain and loss of appetite. 29
  • 30. Saw Palmetto General Infor mati on : Saw palmetto i s a plant. Its ripe fruit is used to make medicine. Saw palmetto is best k n o w n for its use i n decreasing symptoms of an e n l a r ge d 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, c hronic 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 se xua 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 l e ve l s 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. Somepeople have reported that saw palmetto causes impotenceAnastrozoleGeneral Information: Anastrozole h e l p s to lower estrogen l e v e l s in your body to helpprevent estrogen b u i l d up for patients w h o are taking testosterone signs of estrogen b u i l d upare a puffy face/abdomen redness o f face or gynocamastia. It is recommended t h a t you take thismedication 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 (hotflashes/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 ofinfection.AndrogelGeneral Information: This m e d i c a t e d gel c o n t a i n s testosterone. It is used forhormone replacement in men who are not able to produce enough testosterone(hypogonadism). In patients with d i a be t e s , e s p e c i a l l y t h o s e t a k i n g i n s u l i n ,t e st o st e r on e may decrease y o u r blood sugar. Symptoms of low blood sugar includeshakiness, n e r v o u s n e s s , rapid pulse and sweating. Androgel is a topical medication and it isrecommended that you apply medication to your wrist or inner thigh (rotate locations) aftershowering; avoid direct contact with other persons for at least 30 minutes after application toavoid transfer of medication to others.Common side effects: Redness/irritation at the application si te or acne may occur. 30
  • 31. Serious side e f f e c t s : Persistent nausea/vomiting, severe stomach/abdominal pain, dark urine,yellowing eyes/skin, swelling hands/ankles/feet. Breast pain/enlargement, veryslow / shallow/difficult breathing (possibly while sleeping), difficulty urinating, increasedurination ( especially at night), change in the amount o f urine, pain/swelling/redness in the legs,mental/mood change, testicle pain/tenderness.Armor ThyroidGeneral Information: Thyroid hormone i s used to treat hypothyroidism . It is a naturalproduct made from animal thyroid gl ands (usually a pigs). It replaces or provides more thyroidhormone, which is normally produced by the thyroid gl a nd . Having enough thyroid h o r m o n e i simportant for maintaining normal m e n t a l a n d activity. This medication is also used to treatother types of thyroid disorders (such as certain types of goiters, thyroid cancer). Armourthyroid is sometimes g i v e n to patients who are on HCG because H C G has a tendency o flowering thyroid production l e v e l s . Take medication o n an empty stomach, if patient has allergiesto pork products then medication should not be taken.Common si de effects: Hair loss may occur during the first few months of treatment. This effect isusually 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-ComplexGeneral Information: The vitamin B-complex refers to all of the known essential water-solublevitamins except for vitamin C. These include thiamine (vitamin Bl, riboflavin (vitaminB2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin,folic acid and the coalmines (vitamin B 1 2 ). It is recommended that you take B-complex wheno n testosterone; testosterone can lower B-complex production. Health benefits: Support and increase the rate of metabolism, Maintain healthy skin, hairand muscle tone, Enhance immune and nervous system function, Promote cellgrowth and division, including that of the red blood cells that help prevent anemia. B vitaminshave also been hypothesized t o improve the symptoms o f attention de fi c i t hyperactivity di sorder .Caverject Impulse/Tri-MixGeneral I n f o r m a t i o n : This medication is used to treat male sexual function. It works byhelping the blood flow into the penis to achieve and maintain a n erection. This medication i s notrecommended for use in men with penile implants. This medication is given by injection into thepenis as directed by your doctor. This medication s h o u l d usually work within 5 to 20 minutes toproduce an erection that lasts for about 1 hour. The manufacturer recommends t h a t thismedication b e used no more than 3 times a week with at least 1 day between e a c h dose. Makesure your medicine is stored at room temperature. Do not use any leftover Caverject solution. Donot use other medical treatments for ED while you are using Caverject. For erections lasting formore than four hours go to emergency room. 31
  • 32. CompoundingCompounding is the method of preparing c u s t o m i z e d medications t o help meet uniquephysician and patient needs.Compounding pharmacists w o r k closely with physicians to assure that the medicines are createdand administered while providing great benefit to the patient with least amount of side-effects.Just about any kind of medication ca n be formulated a nd compounded t o meet specificmedication 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 injectionsOral suspensions and pastesCapsulesTopical creams, ointments and lotionsOphthalmic preparationsOptic solutions and non-aqueous suspensionsTransdermalFlavor specializationSugar-free formulationsCombination medicationsCustomized dosage formsLollipopsTrochesPreservative-Free MedicationsSuppositories 40
  • 33. Press in Bottle AdaptersMake measuring s i m p l e , accurate and prevents t h e mess and spillage associated with conventionaldosing tools. Adapters are available in assorted sizes and tightly screw onto the medication bottlewith a convenient flip top cap which are custom fit to oral dosing syringes (also available innumerous sizes).Creams / OintmentsTransdermal o r vaginal application to deliver a variety of medications s u c h as hormones, st e roi dsand antibiotics. Once a cream or ointment is prepared, it is then run through an ointment millwhich essentially pulverizes the powdered drug to eliminate the potential for a gritty texturemaking the preparation smooth and silky.PowdersMedication powders m a y be mixed with flavored or effervescent ba se s which are later measuredand dissolved in water, juice or applesauce f o r oral administration. Powders can also be placed inan insufflators f or "puffing" a drug directly onto a wound which requires h e a l i n g (such as adiabetic ulcer) without adding unnecessary moisture to the treatment area.SolutionsTypically are for topical use (aqueous based) although oral solutions in place of suspensions a r equite common depending on the nature of the d r u g being compounded. Bottles for dispensing areavailable in various sizes with specialized closures such as an enema tip, nasal spray tips, throatOr topical spray tips and pumps dispensers. Flip top caps, roll-on applicators a n d manymore available to solve a patients m e di c a t i on d e l i v e r y needs.Powder and Oil CapsulesMade custom to order, and are available in clear gelatin, vegetarian, o r color coded capsules in amultitude o f sizes depending o n the amount of drug required. Capsules are quality control tested foraccurate weight and even drug distribution. Various fillers are available for special needs such asdye free, lactose free, and sustained release bases can be added to prolong the metabolizationOf the medication.TransdermalsTransdermal creams, ointments, lotions, solutions and gels are available for the effective deliveryof many medications and can be dispensed in jars, tubes, syringes, roll on applicators and Bostonround bottles for example. 41
  • 34. TrochesGelatin 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 thetongue in less than a couple of minutes, Ideal for children or patients u n a b l e to swallow capsulesor tablets.COMPOUNDING DEFINTIONSCompoundingCompounding is the branch of medicine in which a pharmacist formulates and makes aMedication for his/her p a t i e n t .Compounding PharmacistA compounding p h a r m a c i s t i s a specialized healthcare profe ssi onal w h o has receivedspecial education and training in the art of pharmaceutics a n d medication p r o du c t i o n .PharmaceuticsPharmaceutics i s the science of medication d e l i ve r y forms. Capsules or injections are examples ofA medication deli ve ry form.Delivery FormA delivery form is a method or device by which a patient receives a medication.Compounding OverviewCompounding is a branch of medicine in which a pharmacist formulates and makes a medicationFor his/her patient. A compounding p h a r m a c i s t i s a specialized healthcare p r o f e s s i o n a l whohas received special education and training i n the art of pharmaceutics. Pharmaceutics i s thescience of medication de l i ve r y forms. Capsules or injections are examples of a medicationdelivery form.Compounding and HealthcareCompounding allows a patient to receive the correct drug amount in a delivery system tailoredTo 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 majorityof potential patients without regard for individual variability. Most medications come in only asmall variety of strengths a n d dosage forms so a patient that requires a strength or dosage form thatin unavailable i s forced to accept the second-best opt i on that is commercially available.Compounding provides the individual a way to receive a tailored dr ug regimen that is outside ofthe scope of the c om m e rc ia l pharmaceutical company’s domain.Compounding also allows a patient to receive a medication that is not available such as an 42
  • 35. Investigation drug or a discontinued drug. A compounding pharmacist can purchase lab testedbulk chemicals and formulate a medication in such a case.Compounding PharmacyA compounding pharmacy is a specialized pharmacy that h a s professional staff proficient in theart of compounding.Compounding PharmacistA compounding pharmacist is a healthcare provider, who is specialized in the branch ofmedicine, involved in the production of individualized medications. A compounding pharmacisthas 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 ofpharmacy to the art of compounding.Compounding InnovationCompounding innovation is the central feature of a compounding practice. Often a request ismade t h a t c a u s e s a compounding pharmacist to research and formulate a specificc o m p o u n d . The innovations made in the field of compounding are usually shared withcolleagues thus expanding the potential impact compounding has upon the lives of pharmacypatients.Compound FormulationA compound formulation is the recipe t h a t i s created to direct t h e compounding pharmacistin 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 EducationCompounding education involves the s t udy of pharmaceutics, pharmacy calculations,pharmacokinetics, continuing education and compounding seminars to improve the ef f icacyof the compounding pharmacist.Compounding resourcesCompounding resources include many p h a r m a c y publications such as Martindale’s,Remingtons, the USP, the Inter national Journal of Compounding Pharmacy and collaborativeexchanges between pharmacists specialized in the practice of compounding. Additionalcompounding resources include t h e International Academy of Compounding Pharmacists,PubMed, P C C A and various Internet sites d e v o t e d to the transferable of compoundinginformation. 43
  • 36. Compounding equipment i n c l u d e s something a s simple as an electronic balance tosomething a s complicated as an automated c a p s u l e -filling machine.Compounding SuppliesCompounding supplies are items that are indirectly necessary f or the production o f acompounded m e d i c a t i o n . Examples of such item include weight boats, spatulas and mortarand pestles.Compounding CalculationsCompounding 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 timea medication i s compounded t o ensure accuracy of the prescribed c o m p o u n d . Compoundingcalculations include weight to weight, volume to volume and weight to volume ratios.Additionally, compounding c a l c u l a t i o n s often involve calculating proper dosing, expectedyields and expected losses.Aseptic Compounding USP 797 United States Pharmacopoeia 795 and 797Aseptic 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 besterile. Current United States Pharmacopoeia guidelines in USP 797 chapter on sterile or asepticcompounding gi ve standards t h a t need to be followed to be able to fill sterile compoundedprescriptions. Along with sterile irrigation prescriptions, the Minnesota State Board of Pharmacyrequires that pharmacies compound sterile inhalation solutions, sterile baths and soaks fororgans and tissues, sterile injections, sterile powders for injection, sterile metered sprays, andsterile ophthalmic and sterile otic, ear, preparations. A pharmacy that engages in sterile asepticcompounding 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 yourPrescription• Committed to complying with the USP 795 rules and guidelines to ensure potency and qualityof your compounded p r e s c r i p t i o n• Committed to complying with the Minnesota Board of Pharmacy sterile compoundingrequirements 44
  • 37. • 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 outsideconfirmatory labs• Committed to sterility testing of both sterile compounds and procedures• Committed to accepting referrals for sterile compounding from our colleagues in Mankato andsurrounding areas• We are committed to you!Compounding Dosage FormsCompounding dosage forms are the types of delivery methods used to dose a patient. Examplesof 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 , anapplicator, a syringe, etc.Compounding TechniqueCompounding technique is the procedure and methodology that is employed by theCompounding 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 . Compoundingtechnique includes experiential judgment as to the amount of liquid needed to producecohesion while avoiding encrustation of a tablet triturate and various other learned methodsnecessary to produce a suitable compound.Compounding TriadThe compounding triad is the three-part relationship b e t w e e n the patient, physician andpharmacist. The physician prescribes t h e medication; the pharmacist c o m p o u n d s a n ddispenses the medication to the patient a f t e r a consultation. The patient receives the type ofpersonalized care they deserve and allows compounding pha rm a ci st s to provide exceptional,patient-oriented service.Compounding ReferralsCompounding referrals are guidance from a medical professional directing a patient toward anIndividualized t h e r a p y via compounding. Compounding referrals are also madethrough education a nd publications. 45
  • 38. Compounding LawCompounding law involves the regulations that govern the practice of pharmacy. Manygovernment a g e n c i e s such as the FDAoften get involved or intervene i n the practice ofcompounding when they believe the compounding p h a r m a c y or pharmacist i s acting outsidetheir realm of practice.Compounding and the PatientCompounding owes its entire existence to the satisfaction of the patient. Patients have becomeeducated through various ways as to the health benefits of compounding. Spokes people likeSuzanne Summers have explained publicly the benefits of natural hormone r e p l a c e m e n tt h e r a p y . The increased awareness a m o n g patients a nd physicians regarding the positiveeffects of compounding ha s created a desire for personalized m e d i c a t i o n s . The reality is thatpatients are driving the compounding i n d u s t r y by demanding i n d i vi d u a l i z e d therapies.Compounding and the PhysicianMany physicians have become well aquatinted w i t h the advantages of compounding a nd regularlyprescribe c o m p o u n d e d p r e s c r i p t i o n s for their patients. In todays consumer drivenhealthcare system a patient desiring to be prescribed a compounded prescription can often call acompounding pharmacy for a referral to a physician versed in compounding benefits.Compounding PharmaceuticsCompounding pharmaceutics is the science of medication delivery forms; recipients a nd devicesused in the practice of compounding t o produce an efficacious compounded m e d i c a t i o n .Definition of a generic drug and the FDA requirementsA generic drug is the chemical equivalent of a drug that has an e x p i r e d patent. When a brandname drug’s patent expires, other pharmaceutical companies can produce the same active chemicalcompound and sell the drug under its generic name. In the United States, the Food and DrugAdministration ( FDA) requires that all drugs, whether b r a n d s name drug or a generic drug, meetstandards o f safety, strength, purit y and effectiveness. A drug may be chemically exact but notbioequivalent. In other words, two different products of the same drug may not get into the bodyin exactly the same way. Bioequivalence depends on how the drug is formulated a nd how it isabsorbed 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 beformulated i n t o a pill or capsule. Factors such as a person’s age, body mass, kidney, liver andintestinal fu n c t i o n can also affect the absorption o f the drug by the body. 46
  • 39. For a drug to be marketed u n d e r a generic label, the manufacturer must comply with FDAstandards. The FDA states that generic drugs must be therapeutically equivalent to the brandname 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 brandname drugs and generic drugs. The few cases where differences exist occur mostly in drugs thathave a narrow “therapeutic index." The "therapeutic index" is the difference between the drugsEffective 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. TheFDA sets up guidelines and requires st ric t testing in order to determine w h i c h drugs act the sameway in the body. Generic drugs that have been tested and approved by the FDA to betherapeutically equivalent t o brand name drugs are published in a guide that is updated monthlyand is found in most pharmacies. The guide lists drugs classified as therapeutically equivalent toeach other, and gives them an "A"rating. If the FDA does not consider a drug therapeuticallyequivalent, it is given a "B" rating. Most pharmacies purchase drugs with an "A"rating to dispense asgeneric. Ask your pharmacist about the rating of your particular generic medication.Drug costs continue to risePrice appears to be the real difference between most brand and generic drugs. Rising health carecosts -- and the cost of drugs in particular - have received a lot of media attention. The fastestgrowing segment of health care costs is prescription benefits, which is increasing at an average rateof 11.2% annually. Senior citizens are especially at risk for rising drug costs. Drug costs for seniorsare rising faster than for any other age group. Among patients 70 years and older, drug costs rose14% 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 h e y would pull out of theMedicare program by the end of the year, affecting nearly a million senior citizens. The HMOs statethat they can no longerAfford to insure seniors. A number of factors account for these rising costs. Advances intechnology (gene therapy and biotechnology, forExample) have contributed t o the increases. People are living longer and using more drugs to doso. It is fair to add that some of the new expensive drugs are actually less costly overall thanconventional t he r a pi e s , s u c h as surgery.Generic drugs are less expensive than brand name drugsGenerally, generic drugs are less expensive than brand name drugs. On average, most genericDrugs are approximately h a l f the price of their brand name counterparts. Based on 1999 values ofthe Average Wholesale Price, the brand name blood pressure drug called Hydrodiuril® was eighttimes more expensive than its generic counterpart, hydrochlorothiazide. The anti-depressantElavil® was twice the cost of its generic amitriptyline. However, tamoxifen is an exception to therule. Here, the brand name manufacturer b o u g h t exclusive rights to the generic. Since the samecompany owns the rights to both brand and generic tamoxifen, the price for the generic is only 1cent less! Currently, the Federal Trade Commission is investigating the manufacturers actions,since they appear to have discouraged o t h e r companies from marketing ge ne r i c tamoxifen. 47
  • 40. Presently, many drug companies are merging, with larger companies acquiring smaller genericcompanies. These changes have affected the price difference between b r a n d and genericproducts. Since a company may own both the brand and generic names, it prices the generic at ahigher price to discourage sales of the generic. Because of this, people may not get the savingsbenefits 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 playeda role in the development o f more effective medications. Creation of larger manufacturersthrough mergers and buy-outs of smaller pharmaceutical companies has provided theOpportunity t o increase the cost of generic medications. Annual inflation plays a role, as does theincreased utilization of drugs by the American public. Pharmaceutical companies explain theneed for making a profit as being tied to the research and development costs for newer, moreEffective medications. The estimated c os t of research and development i n the year 2000 isestimated a t $38 billion. To put this in perspective, the budget for federal research is approximatelya third of this figure. It takes an average of seven years for a drug to go through t he FDA approvalprocess, thus delaying any potential p r o f i t s . The marketing of drugs byPharmaceutical companies a re expensive. Marketing strategies i nc l u de advertisements in all ofthe 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.) anddrug samples to physicians. These promotions a r e intended to increase physician and consumerexposure to information a b o u t a particular d r u g . This exposure to information m a y increaseconsumer 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 l so provide grants to medical groups, universities a n d hospitals todevelop educational p r o g r a m s f o r patients w i t h specific disease conditions. These grants assistin theDevelopment c o s t s and ongoing costs of programs a n d services that help patientsmaintain optimal healthy living. These funds are provided a s a part of the communitybenefit monies pharmaceutical companies d e s i g n a t e as efforts to partner wi t h 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 c a naffect how a drug acts in the body. For the most part, these changes are not cause for alarm, but itis important t o realize that a person may try the same brand or generic medication and have adifferent experience a t different times. However, in most instances, the generic and brand namedrugs are both working in the body.Without much success, a number of studies have attempted t o prove particular b r a n d drugs aremore efficacious than their generic counterparts. Of particular c on t r o ve r s y i s one well-publicized story in which a brand name manufacturer paid a university researcher to prove thebrand drug was superior to the generic. The researcher actually found the generic to be equivalentand even 48
  • 41. 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 totheir brand name drug. Seven years later, the brand manufacturer published another studyopposing the researchers results. However, the FDAis now requiring all manufacturers of thatdrug to demonstrate that their products are equivalent.To summarize, generic drugs, if they have been approved by the FDA, are as safe and effective asthe brand name product. Pharmacists, using scientific information, ensure patient safety. Thisoften means recommending alternative therapies to providers and patients. A final note to thinkabout 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 berequired to use the same material, thread, stitching and so on that higher end manufacturers useto make a pair of famous-name pants. Of course, one cannot compare a drugs effect on the bodyto the appearance and durability of a pair of jeans, but if the government required both pairs ofjeans to be exactly alike, would you still want to pay the higher price?Compounding vs. Traditional PharmacyTraditional pharmaceutical needs mean that your physician prescribes you a dose and form of aspecific medication. For example ...you are prescribed 2 capsules of your medication three timesper day with food. Now, you may not be able to tolerate the casing of the capsule, or yourSchedule may be such that you cant eat those three meals a day at the appropriate times. So, youarent as compliant with these instructions and therefore, the effect of the prescription is not aseffective.So, your physician contacts one of the compounding pharmacists at Precision CompoundingPharmacy and working together as a team, you, your physician, and our pharmacist determine abetter 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 prescriptionand made well.Lifes ProblemsSome patients do not respond to traditional methods of treatment manufactured by drugcompanies. Many patients are allergic to preservatives or dyes, or are sensitive to standard drugstrengths, or cannot tolerate a specific dosage form. These unique medical problems can besolved with the triad relationship of patient, physician, and pharmacist working closely together.With a physicians consent, a compounding pharmacist can compound preservative or dye freemedications, customized strengths of medications, or different dosage forms. Children and theelderly population often benefit the most from customized compounded medications.Common areas of compounding include: 49
  • 42. • Exercise/Sports• Acne Injuries • Oral Lesions• Alzheimers • Head Lice • Otic Infections• Andropause Hemorrhoids Parkinsons (Male Menopause)• Arthritis Disorders • Hospice Needs • Pets Needs• Autistic Spectrum • Hyperhidrosis • Postpartum Needs• Bio- Identical Hormone Replacement • Infertility • Scars & Keloids Therapy (BHRT)• Chronic Diaper Rash • Migraine Headaches • Snoring• Chronic Pain Management • Multiple Sclerosis • Warts Disorder• Chronic UIIs • Nausea & Vomiting • Wound Therapy Vaginitis• Dental Needs • Neonatal Needs • Wrinkles & Age Spots• Erectile Dysfunction • NeuropathiesIs 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 compoundingpharmaceutical 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 dosagesand/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-identicalHormone Replacement Therapy (BHRT) for menopause and andropause, Veterinary, Hospice,Pediatric, Ophthalmic, Dental, Otic, Dermatology, Medication Flavoring, Chronic Pain 50
  • 43. Management, Neuropathies, Sports medicine, Infertility, Wound Therapy, Podiatry, andGastroenterology.Will my insurance cover compounded medications?Because compounded medications are exempt by law from having the National Drug Code IDnumbers that manufactured products carry, some insurance companies will not directlyreimburse the compounding pharmacy. However, almost every insurance plan allows for thepatient to be reimbursed by sending in claim forms. While you may be paying a pharmacydirectly for a compounded prescription, most insurance plans should cover the final cost.Precision Compounding Pharmacy will provide you the proper form and documentation toprovide 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 inall areas of the industry, from hospitals to nuclear medicine. Over the last decade,Compounding resurgence has largely benefited from advances in technology, quality control, andresearch methodology. The Food and Drug Administration has stated that compoundedprescriptions are both ethical and legal as long as they are prescribed by a licensed practitioner fora specific patient and compounded by a licensed pharmacy. In addition, compounding is regulatedby state boards of pharmacy.Who can take compounded medications?Compounding medications can be taken by anyone who has difficulty with traditional forms anddosages. Often, parents have a tough time getting their children to take medicine because of thetaste. A compounding pharmacist can work directly with the physician and the patient to select amedications properties and the patients 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 topicalpreparation 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 tocreate a medicine for your pet that can be more easily administered.How does compounding benefit me? 51
  • 44. There are several reasons why pharmacists compound prescription medications. The mostimportant one is what the medical community calls "patient non-compliance." Many patients areallergic to preservatives or dyes, or are sensitive to standard drug strengths. With a physiciansconsent, a compounding pharmacist can change the strength of a medication, alter its form to makeit easier for the patient to ingest, or add flavor to it to make it more palatable. The pharmacist alsocan prepare the medication using several unique delivery systems, such as a sublingual troche orlozenge, a lollipop, or a transdermal gel. Or, for those patients who are having a difficult timeswallowing 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 intodays world of aggressive marketing by drug manufacturers, some may not realize the extent ofcompounding 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 accuracyCapsules--extended-release formulationsTroches--"lozenges" that dissolve in the mouthPopsicles--great alternative, especially during the summerGummy Gels--chewable forms are great with kidsLollipops--convenient dosage form for extended delivery and local effectTransdermal Gel, Cream, and Stick--great alternative to oral formEmollient Cream--helpful for dermatological conditionsDauber Bottle--ideal for liquid preparationsLip Balm Application’s--super for "spot" applicationsOphthalmic Preparations--for treatment of eye problemsOtic Medications--for treatment of ear problemsInjectablesSuppositories 52
  • 45. Rapid Dissolve TabletsTablet Triturates--easily dissolved tablets under the tongue.Who regulates compounding pharmacies?Compounding is regulated by individual state boards of pharmacy. The Food and DrugAdministration (FDA) has stated that compounded prescriptions are both ethical and legal as longas they are prescribed by a licensed practitioner for a specific patient and compounded by a licensedpharmacy.Compounding vs. Traditional PharmacyTraditional pharmaceutical needs mean that your physician prescribes you a dose and form of aspecific medication. For example... you are prescribed 2 capsules of your medication three times perday with food. Now, you may not be able to tolerate the casing of the capsule, or yourSchedule may be such that you cant eat those three meals a day at the appropriate times. So, youarent as compliant with these instructions and therefore, the effect of the prescription is not aseffective.So, your physician contacts one of the compounding pharmacists at Precision CompoundingPharmacy and working together as a team, you, your physician, and our pharmacist determine abetter 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 prescriptionAnd made well.History of CompoundingCompounding has been a part of pharmacy since the profession began. There is only one group ofhealth care professionals--pharmacists--possessing the knowledge and skills required tocompound and prepare medications to meet patients unique needs. Extemporaneouslycompounding safe, effective prescription products for patients who require special care in apharmacy is fundamental.Pharmacys heritage spans some 5,000 years, and centers on the provision of pharmaceuticalproducts for patients. In the early years of American pharmacy, compounded formulas were theprimary source for medications.As a medication therapy manager, pharmacists were called upon to provide alternatives to assistpatients in becoming compliant with the prescribed therapy. Because most commerciallyavailable and prescribers in overcoming non-compliance problems is to rely on customizedoptions ...a compounding pharmacist to work in conjunction with the patient and physician toform a strong triad team approach to the patients success. Using fundamental pharmacy 53
  • 46. History of CompoundingCompounding has been a part of pharmacy since the profession began. There is only one groupof health care professionals--pharmacists--possessing the knowledge and skills required tocompound and prepare medications to meet patients unique needs. Extemporaneouslycompounding safe, effective prescription products for patients who require special care in apharmacy is fundamental.Pharmacys heritage spans some 5,000 years, and centers on the provision of pharmaceuticalproducts for patients. In the early years of American pharmacy, compounded formulas were theprimary source for medications.As a medication therapy manager, pharmacists were called upon to provide alternatives to assistpatients in becoming compliant with the prescribed therapy. Because most commerciallyavailable and prescribers in overcoming non-compliance problems is to rely on customizedoptions ...a compounding pharmacist to work in conjunction with the patient and physician toform a strong triad team approach to the patients success. Using fundamental pharmacyknowledge, compounding pharmacists invested time and effort to create dosage formAlternatives to enhance therapy compliance for difficult patients and unique cases. 54
  • 47. HRT Questions and Answers1. 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 bodys natural hormones but does not reallyreplace 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, thesesynthetic hormones flood the receptor sites not only of the hormone receptor sites they are intended to attach to andalter, but also the receptor sites of many other steroid hormones which should not be effected .. As is often the case innature, more is not always better and in fact, as in this case, when these other receptor sites are over-flooded, it hasbeen found that they often shut down their function and are no longer able to act in the required manner for thenormally healthy functions required elsewhere by the body, thus causing the unwanted and sometimes seriouslyrisky 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 eitherestrone or estradiol forms of estrogen. Not to Estrone form of estrogen patients, even if they have never had breastcancer, 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 havebeen studies to show that Estriol is a protective form of estrogen. It has been found to act against the stronger formsof estrogen, those that occur naturally from the patients own body and the even more toxic xeno-estrogens, whichoriginate in increasing intensity in our modern environment. Estriol significantly decreases and sometimesEliminates the often-reported troublesome symptom of painful sexual intercourse for patients. It is possible toprescribe a weak estrogen such as Estriol to reach estrogen receptor sites in a patient, as it will then block theabsorption of the strong xeno-estrogens, thereby protecting the patient from any future reoccurrence of breastcancer. 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 discussionand counseling, and only if the patient fully understands the implications and possible risks but still chooses toproceed 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
  • 48. 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 thedose required by the bio-identical hormones. In nature, more is not necessarily better. In fact, even natural hormonesif 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 respondpositively to progesterone treatment alone, and do not require any estrogen, even bio-identical estrogen. The otherhalf 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 amild sedative effect, but the oral form of progesterone passes through the liver and has an even greater degree ofsedation. Oral progesterone is therefore used specifically as a treatment for insomnia and is prescribed to be used atnight before sleep for this reason. Natural transdermal progesterone, absorbed through the skin only, can be usedboth 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 brainsynapses seems to allow quicker cognition, alleviating this common symptom of hormone balance occurring withmenopause 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 patienttakes a few days break from the medication at monthly intervals. Continuing monthly menstruations is considered bysome to be a youth-sustaining cycle for the female body. Recurring menstruation is either desirable or necessary foradequate overall protection in bin-identical hormone therapy. Estrogen should be prescribed only transdermally, inlower doses. With these lower doses of transdermal estrogen, even a break of a week each month will not createmenstruation in patients. Most report they find it desirable to preclude menstruation while at the same time gainingall 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 andthe amount of stress that I am under. I have heard about tracking hormone levels and coming up with aprogram 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 onthe amount of cream used and prescribed dosage. In fact, the safest program of bio-identical hormone treatmentwould include abstaining from use of the transdermal cream for one week of each month. This mimics the naturalcycle in which the hormones in a womans body would naturally ebb to a lower level once a month in the normalcycle of a premenopausal woman.Some do not find it desirable to take a full week break from the transdermal cream since their flushing symptoms inparticular return on day 4 or day S. In these cases, a patient can take 5 days as a break rather than a full week, anddepending on their own unique response to cessation of the hormones, sometimes even a shorter period. There isalways a short lag period of several days once the patient restarts the transdermal bin-identical cream use before thebio-identical hormones fully rebalances the body again. For some patients, the break time needs to be shortened topreclude 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
  • 49. amount of the cream could be used at the peak of the mid-cycle to balance out and normalize the cycle. On orapproximately day 14, ovulation occurs in the normal reproductive cycle, and at this point progesterone is added bythe body to the estrogen levels. Naturally, occurring levels of progesterone elevate from day 14, peaking at day 20and 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 andsmoothly 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 toget 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 bythis method, they must first pass through and be metabolized by the liver. It is not desirable for estrogen to passthrough 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 sexdrive. The oral path of taking even bio-identical hormones can therefore result in not only a subclinical hypothyroidfunction, 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 hormonereplacement, the patient should always consider using the trans dermal route through the skin, rather than the oralroute through the liver because of the negative side effects. Using natural progesterone treatment only in theevenings, which means the patients body does not have as high levels of progesterone during the day as they wouldif taken orally.However, especially in some patients with insomnia, oral capsule intake of progesterone in the evenings only doeshelp 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 offwith dosage lines, as the cream is already blended by a compounding pharmacy and prepared to be delivered via thesyringe in equal balanced dosages10. 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 Iwould suggest are those of the late Dr. John Lee, What Your Doctor Might Not Tell You About Menopause and WhatYour Doctor Might Not Tell You About Perimenopause. Dr. Lees excellent book, What Your Doctor May Not Tell Youabout Breast Cancer, has considerable pertinent information regarding the use of progesterone in bio-identicalhormone therapy.The other book, which I would suggest, is The Hormone of Desire by Dr. Susan Reiko, a psychiatrist who writes aboutthe 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 replacementtherapy. Neither patients nor doctors have to wait 50 years for medicine to change and catch up. Physiciansthroughout the world are now beginning to realize that you cannot fool Mother Nature, and if you try to do so, thereare frequently negative consequences. Use of synthetic hormones has now been shown by many studies and by muchexperience to have adverse side effects, leading to dangerous complications such as breast cancer, heart stress andother clinical problems.The Womens Health Study of 2002 has shown that use of synthetic hormones is not the healthy way to replacewomens hormones. Human female bodies do need natural bio-identical hormones, which can be used for optimal 57
  • 50. health. The lock and key effect of natural treatment works perfectly with the body and within a 12-hour period, thebody has dissipated 50% of the hormone naturally.Natural bio-identical hormone treatment therefore appears to me to be the desirable future of hormone replacementtherapy.More and more physicians are now beginning to research, assimilate and practice natural bio-identical hormonetherapy. Within the next 25 years, this will be the ideal medical standard for hormone replacement therapy and willbe taught to new doctors in our medical schools. Current graduates of medical schools are not being given thecurrent information and updates on this emerging hormone replacement therapy alternative to synthetic treatmentSome 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 .•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• INJECTABLE LASER TREATMENT SKIN CARE HORMONE BODY CONTOURING MORE REPLACEMENT Botox Laser Hair Removal Chemical Peels Testosterone Weight- Loss Nutrition Counselling Replacement Nefertiti neck Lift Laser Tattoo Microdermabrasion GHRP Injectable Mood Management Removal Dysport Laser Vein Removal Dermal Fillers Injectable HCG Endermologie PRPTherapy Restylane IPL FotoFacial Estrogen Therapy Titan Skin Tightening Juvederm Laser Genesis Perlane 2D Rejuvenation Radiesse 3D Rejuvenation Cortisone Acne Shot Vitamin Power Shot Enderologie
  • 51. Medi- Spa & Our Many ServicesNationwide MD is a facility that operates under the full-time, on-site supervision of licensed health careprofessionals. NATIONWIDE MD operates within the scope of practice of its staff, and offers traditional, complementary, andalternative health practices and treatments in a spa-like setting. Practitioners working within our medical spa are governedby their appropriate state licensing board. Nationwide MD thus combines pampering spa treatments with medical-gradeskin care treatments and products that provide visible results. As plastic surgeons we believe wholeheartedly in theimportance of a professional scientifically-based skin care regimen.Go beautifully bare with NATIONWIDE MDs Laser Hair Removal, or zap vexing veins with our Laser Vein Removal.Banish crows feet and expression lines with wrinkle-relaxing wonders - Dysport and Botox, or freshen-up with ourselection of eager-to-please dermal fillers - Restylane, Perlane, Iuvederm and Radiesse. Beam your way to beautifulskin with IPL FotoFacial and Laser Genesis, or turn back the clock with the revolutionary Titan Skin Tightening. Skipthe lipo and consider non-surgical alternatives like Endermologie Cellulite Reduction and Zerona Fat Reduction, amp upyour weight loss with a Vitamin Shot. Indulge in our extensive menu of skin there like Chemical Peels andMicrodermabrasion. Utilize http://nationwideHRT.com for additional products and services.