8
Rheumatoid arthritis (RA) affects more than one million Americans and leads to deformity and disability. It is an au- toimmune disease which means that the immune system of the body mistakenly attacks healthy tissue. The disease is characterized by inflammation of joint synovium, which is the membrane that lines and produces the fluid that lubricates the joint. This inflammation leads to destruction of the soft and bony joint tissues with weakening of muscles and tendons and then deformity. Systemic inflammation includes not only joints, but also blood vessels (vasculitis), nerves (myelopathy, myopa- thy, neuropathy, etc) and the heart (coronary heart disease). Factors linked to the disease include infec- tion, family history, environmental exposures and hormone changes. The age of onset ranges between 50-75 years, with the 60’s being the most common. Women are three times more likely to have RA than males. Ciga- rette smoking is a strong risk factor along with obesity and increased birth weight. Symptoms typically affect joints on both sides of the body equally. Fingers, wrists, knees, feet, elbows, ankles, hips and shoulders are the most commonly affected. Patients typically have joint pain, stiffness and fatigue. They may complain of morning stiffness, which lasts more than one hour. Joints may be swollen, warm, tender and stiff par- ticularly when not used for an hour. Other symptoms may include pleurisy, dry eyes and mouth (Sjogren syndrome), and itchy, burning eyes. With severe disease, there may be nodules under the skin, numbness, tingling or burning in the hands and feet and possibly insomnia. Abnormal lab tests along with X-rays can help determine if a pa- tient has RA. Tests may include CBC, C- reactive protein (CRP), erythrocyte sedimenta- tion rate (ESR), anti- CCP antibody and rheumatoid factor (RF). Depending upon the stage of disease, lab tests may be falsely- negative and x-rays may not show joint changes in the early stages; therefore a diag- nosis must be based upon a combination of signs, symptoms, blood tests and x-rays. The chart on page 4 explains the symptoms and findings with mild to severe dis- ease. The exact cause of RA is unknown but we do know that there are many pro-inflammatory substances which contrib- ute to joint destruction such as tumor necrosis factor (TNF), interleukin (IL)-6 and others. It is important to understand the targeted area for drug therapy used to treat this debilitat- ing disease. ACUTE PAIN RELIEF MEDICATIONS NSAIDs provide fast symptomatic relief because of their anti -inflammatory properties but they do not modify disease pro- gression. Doses of 3200mg/day of ibuprofen, 1000mg/day of naproxen, 20mg/day of piroxicam, or 200mg/day of celecox- ib are typical. Benefits must outweigh risks associated with possible gastrointestinal damage, renal disease and heart fail- ure. The medications with the lowest GI Rheumatoid Arthritis: An Overview A Publication of Neil Medical Group, The Leading Pharmacy Provider in the Southeast January/February 2019 PHARM NOTES Volume 22, Issue 1 Continued on page 4 Inside this issue: Rheumatoid Ar- thritis: An Over- view 1 Andexenet Alfa 2 Drug Update: Toujeo Max SoloStar® 3 Conclusion: Rheumatoid Ar- thritis 4-5 Adrenal Fatigue: A Real Disease? 6-7 Neil Medical Group Contact Information 8

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Page 1: PHARM NOTES - neilmedical.comneilmedical.com/pdf_forms/PharmNotes/PharmNotes Jan... · Drug Update: Toujeo Max 3 SoloStar® Conclusion: thritis 4-5 Adrenal Fatigue: A Real Disease?

Rheumatoid arthritis (RA) affects more than one million

Americans and leads to deformity and disability. It is an au-

toimmune disease which means that the immune system of

the body mistakenly attacks healthy tissue. The disease is

characterized by inflammation of joint synovium, which is

the membrane that lines

and produces the fluid

that lubricates the joint.

This inflammation

leads to destruction of

the soft and bony joint

tissues with weakening

of muscles and tendons

and then deformity.

Systemic inflammation

includes not only joints,

but also blood vessels

(vasculitis), nerves

(myelopathy, myopa-

thy, neuropathy, etc)

and the heart (coronary

heart disease).

Factors linked to the

disease include infec-

tion, family history, environmental

exposures and hormone changes. The

age of onset ranges between 50-75

years, with the 60’s being the most

common. Women are three times more

likely to have RA than males. Ciga-

rette smoking is a strong risk factor

along with obesity and increased birth

weight.

Symptoms typically affect joints on

both sides of the body equally. Fingers,

wrists, knees, feet, elbows, ankles, hips

and shoulders are the most commonly

affected. Patients typically have joint

pain, stiffness and fatigue. They may

complain of morning stiffness, which

lasts more than one hour. Joints may

be swollen, warm, tender and stiff par-

ticularly when not used for an hour. Other symptoms may

include pleurisy, dry eyes and mouth (Sjogren syndrome),

and itchy, burning eyes. With severe disease, there may be

nodules under the skin, numbness, tingling or burning in the

hands and feet and possibly insomnia.

Abnormal lab tests

along with X-rays can

help determine if a pa-

tient has RA. Tests may

include CBC, C-

reactive protein (CRP),

erythrocyte sedimenta-

tion rate (ESR), anti-

CCP antibody and

rheumatoid factor (RF).

Depending upon the

stage of disease, lab

tests may be falsely-

negative and x-rays

may not show joint

changes in the early

stages; therefore a diag-

nosis must be based

upon a combination of

signs, symptoms, blood tests and x-rays. The chart on page 4

explains the symptoms and findings with mild to severe dis-

ease.

The exact cause of RA is unknown but we do know that

there are many pro-inflammatory substances which contrib-

ute to joint destruction such as tumor necrosis factor (TNF),

interleukin (IL)-6 and others. It is important to understand

the targeted area for drug therapy used to treat this debilitat-

ing disease.

ACUTE PAIN RELIEF MEDICATIONS

NSAIDs provide fast symptomatic relief because of their anti

-inflammatory properties but they do not modify disease pro-

gression. Doses of 3200mg/day of ibuprofen, 1000mg/day of

naproxen, 20mg/day of piroxicam, or 200mg/day of celecox-

ib are typical. Benefits must outweigh risks associated with

possible gastrointestinal damage, renal disease and heart fail-

ure. The medications with the lowest GI

Rheumatoid Arthritis: An Overview

A Publication of Neil Medical Group, The Leading Pharmacy Provider in the Southeast

January/February 2019

PHARM NOTES

Volume 22, Issue 1

Continued on page 4

Inside this issue:

Rheumatoid Ar-

thritis: An Over-

view

1

Andexenet Alfa 2

Drug Update:

Toujeo Max

SoloStar®

3

Conclusion:

Rheumatoid Ar-

thritis

4-5

Adrenal Fatigue:

A Real Disease?

6-7

Neil Medical

Group Contact

Information

8

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Andexenet Alfa: An Antidote

Page 2

PHARM NOTES

Anticoagulant drugs are used for the treatment and prevention

of venous thromboembolism (VTE) and embolic stroke pre-

vention. Although very beneficial and life-saving, these agents

increase the risk of bleeding events that may be minor or life-

threatening. In long term care facilities, it is estimated that

34,000 adverse events from warfarin use (Coumadin) occur

each year. In clinical trials of pa-

tients receiving Factor Xa anticoag-

ulants, there is a 2.1-3.5% chance of

major bleeding per year. Oral Factor

Xa inhibitors, such as apixaban

(Eliquis) and rivaroxaban (Xarelto),

are some of the newer anticoagu-

lants that have been developed

within the past few years. Unlike

Coumadin, whose reversal agent is

vitamin K, Factor Xa inhibitors

have not had a reversal agent availa-

ble until very recently. Andexenet

alfa (Andexxa) was approved in May 2018 under accelerated

approval for the reversal of anticoagulation in patients taking

Eliquis or Xarelto who have uncontrolled or life-threatening

bleeding. It has not been approved for any Factor Xa drugs

other than Eliquis and Xarelto. Its continued approval will be

based on the completion of post-marketing trials. It is manu-

factured by Portola Pharmaceuticals.

In the normal clotting process, Factor Xa is a protein that is

responsible for converting prothrombin into thrombin. Throm-

bin then activates clot formation. Factor Xa inhibitors bind to

Factor Xa and inhibit this process, resulting in no clot for-

mation. When this happens, bleeding can occur since the

blood cannot clot to stop the bleeding. Andexxa is a recombi-

nant modified human Factor Xa protein decoy that works by

binding to and inhibiting Eliquis and Xarelto. It is available as

a powder in a single-use vial of 100 mg of the drug. It has to

be reconstituted prior to intravenous (IV) administration. Dos-

ing depends on the dose of Eliquis or Xarelto that a patient is

on. If a patient is on < 5 mg of Eliquis, <10 mg of Xarelto, or

if the last dose was given more than 8 hours ago, then the pa-

tient should receive low dose Andexxa. High dose Andexxa

should be used if the patient is on >5 mg of Eliquis, > 10 mg

of Xarelto, or if the last dose was given less than 8 hours ago.

The dosing regimen for low dose Andexxa is: 400 mg IV bo-

lus administered at a rate of 30 mg/minute, followed by a 4

mg/minute IV infusion up to 120 minutes. The dosing regimen

for high dose Andexxa is: 800 mg IV bolus administered at 30

mg/minute, followed by 8 mg/minute IV infusion up to 120

minutes.

There are no contraindications to Andexxa; however, warn-

ings include: thromboembolic, ischemic, and cardiac events,

including sudden death within 30 days after administration.

These can occur since clots are allowed to form again in the

blood. Patients should restart their anticoagulant therapy as

soon as medically appropriate after being treated with An-

dexxa. Per the American College of Cardiology, patients with

gastrointestinal bleeds should resume their oral anticoagula-

tion medications within 7 or more days after withholding ther-

apy. The most common side effects are urinary tract infec-

tions, pneumonia, and injection site reactions. There have

been no drug interactions reported

so far. Andexxa has a rapid onset

with an effective half-life of about 1

hour. It is eliminated rapidly from

the body at a clearance of 4.3 L/h

and has an elimination half-life of

around 5-7 hours. The safety and

response to treatment is the same

for older patients as compared to

adults.

The two clinical trials that paved the

way for Andexxa to be approved are

the ANNEXA-A and ANNEXA-R trials. They were conduct-

ed in healthy volunteers aged 50-75 years old. In ANNEXA-

A, participants were treated with Eliquis before receiving An-

dexxa or placebo. In ANNEXA-R, participants were treated

with Xarelto before receiving Andexxa or placebo. The prima-

ry outcome in both studies was the percentage change in anti-

Factor Xa enzyme activity from baseline to the smallest value

measured within 5 minutes after the end of treatment. In AN-

NEXA-A, anti-factor Xa activity was reduced by 94% in An-

dexxa-treated patients versus 21% in the placebo group

(P<0.001). In ANNEXA-R, anti-factor Xa activity was re-

duced by 92% in the Andexxa group versus 18% in the place-

bo group (P<0.001).

ANNEXA-4 is an ongoing clinical trial in which Andexxa is

being given to patients on factor Xa inhibitors who are experi-

encing acute major bleeding. Preliminary data so far shows a

reduction of 93% in anti-Factor Xa activity in the Eliquis

group and 89% reduction in the Xarelto group. The trial

should be completed in 2019.

To recap, Andexxa is a newly approved drug used to treat seri-

ous, life-threatening bleeding events in patients who are taking

Eliquis or Xarelto. It is administered intravenously, so there

could be injection site reactions. Infections such as pneumonia

and urinary tract infections can occur as well. In general, it is

important to keep a cautious eye on elderly patients who are

on anticoagulants for signs/symptoms of bleeding, especially

if they have renal impairment. If they are treated with An-

dexxa, they should be monitored for any signs/symptoms of

clot formation, stroke, or heart attack. Additionally, patients

should resume their anticoagulation therapy after treatment

with Andexxa. Close follow up of when to restart anticoagula-

tion treatment is warranted to prevent patients from experienc-

ing harm. Article by Linda Xiong, PharmD Candidate Wingate University School of Pharmacy

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Page 3

Volume 22, Issue 1

Drug Update: Toujeo Max SoloStar® Introduction

The latest statistics from the Center for Disease Control (CDC) shows that more than 30.3 million people are diagnosed with

diabetes, and 84.1 million have prediabetes. With an increasing trend of diabetes each year, proper management of diabetes

is of utmost importance for better health outcomes of the patients and also to reduce the healthcare cost. Among many diabe-

tes medications that are available on the market, insulin is a common agent that is widely used for both Type 1 and Type 2

diabetes. Different from some other disease states where the treatment regimen may be more static, diabetes requires close

monitoring and fine adjustments to care in order to keep the blood glucose at a targeted range. Patient’s different meals and

fluctuating weight can all contribute to requiring fine adjustments of insulin requirements on a daily, weekly, and monthly

basis. Too much insulin can cause the patient to be hypoglycemic while not enough insulin can cause the patient to be hyper-

glycemic and at increased risk for complications. While some patients may be well controlled with small amounts of insulin,

other patients require more units of insulin to keep their blood glucose controlled.

Toujeo Max SoloStar® (Insulin glargine 300 units/mL; 900-unit pen)

The newest insulin that has been introduced to the market is the brand name of insulin glargine, Toujeo Max SoloStar® by

Sanofi. The Toujeo Max SoloStar® should not be confused with the brand’s Toujeo SoloStar®. Although the name is quite

similar, the Toujeo Max SoloStar® is the highest capacity pen on the market with a total of 900 units available in each pen.

The original Toujeo SoloStar® contains a total of 450 units of insulin in each pen. The insulin found in Toujeo Max So-

loStar® is still the same insulin glargine found in the original Toujeo SoloStar®. However, because there are two times

more units of insulin in the Toujeo Max SoloStar®, each dial represents 2 units of insulin compared to 1 unit of insulin per

dial for the original Toujeo SoloStar®. It is important to notice this difference between the two pens in order to administer

the correct amount of insulin to patients as it may be easy to get them confused, especially if there are multiple pens in the

cart for multiple patients. In a single injection, Toujeo Max SoloStar® can deliver up to 160 units per dose while the original

Toujeo SoloStar® delivers 80 units per dose.

The Toujeo Max SoloStar® is recommended for patients who require more than 20 units of insulin per day. Higher capacity

in the pen means that patients may go through fewer pens per month, resulting in potentially less cost spent on copays for

some patients. In the past, if a patient required a dose greater than 80 units, then two or more injections had to be given.

However, with the Toujeo Max SoloStar®, patients may need less injections since each dose can deliver up to 160 units

which is an added benefit of this product.

The Toujeo Max SoloStar® still has the smallest injection volume when compared to other basal insulins on the market.

Therefore, for both the Toujeo Max SoloStar® and the Toujeo SoloStar® the pen should be held in the injection spot for 5

seconds after the knob has been pushed down for injection instead of 10 seconds. Both pens should be stored in the refriger-

ator prior to opening but kept at room temperature at least 1-hour prior to first injection and then thereafter. Both pens are

good for 6 weeks (42 days) after the first injection and a new needle should be used in place with each injection.

The Toujeo Max SoloStar® may be beneficial for patients who require higher units of basal insulin to reduce the number of

pens and number of shots given. The original Toujeo SoloStar® may be more suitable for those who require less units of

insulin to prevent wasting of product if it is not used up on time, and it also allows adjustment of units by a single unit op-

posed to two units. Because the pens look very similar and are of equal size, familiarizing with the pen and always double

checking the pen before administration will help to minimize any potential errors.

Toujeo Max SoloStar® U-300 Toujeo SoloStar® U-300

mL in 1 pen 3 mL 1.5 mL

Units in 1 pen 900 units 450 units

Unit(s) per 1 dial 2 units 1 unit

Max # of units in 1

injection

160 units 80 units

Article by Ji-Young Park, Pharm D Candidate

Wingate University School of Pharmacy

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Page 4

Rheumatoid Arthritis: An Overview…………………….………continued from page 1

PHARM NOTES

risks are ibuprofen and celecoxib. Extended use longer than

six months or use of aspirin may increase GI risk also. PPIs

should be considered for preventing NSAID-induced ulcers

and risks. If pain is not relieved with one NSAID, a trial of a

different NSAID would be appropriate as patients may benefit

from a different agent.

Glucocorticoids may also be used for acute pain in every stage

of RA and they have disease modifying benefits. Low doses

( ≤ 10mg/day of prednisone or equivalent) should be used for

the shortest duration possible in order to minimize adverse

effects. High doses (up to 60mg/day with a rapid taper) may

also be used short-term. Adverse effects may include elevated

blood pressure, elevated blood sugars, and bone loss. For use

more than a month, calcium and vitamin D supplementation is

appropriate. For osteoporosis prevention, bisphosphonates

should be considered for corticosteroid use beyond 3 months.

Other medications used to treat RA include DMARDS, which

are disease-modifying anti-rheumatic drugs. These medica-

tions treat pain by suppressing symptoms and slow joint dam-

age which leads to improved quality of life and decreased dis-

ability. There are three main classes of DMARDS: traditional,

biologic, and targeted DMARDs. It may take a few months to

see the full benefits of these medications.

TRADITIONAL DMARDS

Traditional DMARDS include methotrexate, leflunomide, hy-

droxychloroquine and sulfasalazine. Methotrexate is the pre-

ferred and gold standard for RA. Dosage is typically 7.5mg to

15mg orally once weekly. Adverse effects include stomatitis,

nausea, diarrhea and alopecia. The use of folic acid is recom-

mended to decrease side effects.

Leflunomide (Arava) is usually used for those

who do not tolerate or respond to methotrex-

ate and can not take biologic DMARDS. Side

effects are similar with the addition of periph-

eral neuropathy which may occur about six

months after starting this medication. Moni-

tor patients for symptoms such as tingling,

burning, numbness or weakness and discon-

tinue medication within 30 days for improved

outcome.

Sulfasalazine (Azulfidine) or hydroxychloro-

quine (Plaquenil) are other DMARDS. Coun-

sel patients regarding increased sun sensitivity

with sulfasalazine. A longer onset of action

(at least 2-3 months) occurs with hy-

droxychloroquine with side effects including

rash, GI issues, and retinal toxicity. Other

non-preferred DMARDS which are exempt

from the most recent guidelines are gold, D-

penicillamine, azathioprine, cyclophospha-

mide, minocycline and cyclosporine.

Remember, combination therapy may be more effective than

monotherapy and aggressive treatment is now recommended.

Typically, methotrexate is the base drug therapy with one or

two other DMARDS added depending on prognosis, disease

activity and drug response. The next consideration for treat-

ment includes targeted DMARDS and biological DMARDS.

The following diagram shows treatment modalities based on

severity of RA.

Mild disease Less than six inflamed joints No other systemic signs of disease (e.g. rheumatoid nodules) No joint erosions or cartilage loss

Moderate disease

Patient doesn't meet criteria for mild or severe disease Between 6 and 20 inflamed joints May have…

Elevated ESR or CRP Positive rheumatoid factor Evidence of bone loss in joints (joint osteopenia) Small erosions Slight joint space narrowing

Severe Disease

More than 20 inflamed joints Signs of systemic inflammation such as an elevated ESR or CRP and

at least one of the following: Anemia of chronic disease and/or a low albumin Positive rheumatoid factor and/or anti-CCP antibodies X-rays showing bony erosions and loss of cartilage Disease that extends beyond the joints such as vasculitis,

pericarditis, peripheral neuropathy, scleritis, etc

MILD RA

NSAIDS

PLAQUENIL

SULFASALAZINE

MINOCYCLINE

METHOTREXATE

MODERATELY

SEVERE RA

SINGLE OR COMBO

DMARDS including:

Methotrexate

Anti-TNF Agents

Anti-IL-1 Agents

Leflunomide

Azathioprine

Gold

Cyclosporine

Agents for Mild

RA

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Page 5

Volume 22, Issue 1

SEVERE or

REFRACTORY RA

COMBINATION

DMARDS

ORAL STEROIDS

PROSORBA

COLUMN

CYTOXAN

TARGETED DMARDS

Tofacitinib (Xeljanz) is a targeted DMARD and is considered

as another class of drug therapy. It exerts its anti-inflammatory

effect by targeting the intracellular enzyme, Janus kinas

(JAK). It is generally reserved for moderately to severely ac-

tive RA, those who had inadequate responses to MTX or those

who could not tolerate MTX. It can be used in combination

with traditional DMARDS, but not biologic DMARDS. It also

has a black box warning for cancer, may increase cholesterol

and liver enzymes and decrease blood cell counts. Usual dos-

age is 5mg twice daily but it requires dose reduction if taking

liver enzyme inhibitors of CYP3A4 and CYP2C19.

BIOLOGIC DMARDS

Biologics work in specific areas of the immune system and are

divided into 2 classes based on their mechanism of action, anti

-tumor necrosis factor alpha agents (anti-TNF) and non-TNF

biologics. Because of their anti-inflammatory actions, these

medications are also used for other inflammatory diseases such

as psoriatic or juvenile arthritis, Crohn's or ulcerative colitis,

ankylosing spondylitis and psoriasis. Anti-TNF agents work

on TNF, a protein produced by white blood cells, which causes

inflammation. In healthy individuals, increased levels of TNF

are blocked naturally, but those with RA have higher than nor-

mal levels. Anti-TNF agents include etanercept, infliximab,

adalimumab, certolizumab and golimumab. Brand names and

maintenance doses are listed in the table below.

The non-TNF biologics act on other inflammatory processes

such as Interleukin-1 (IL-1), IL-6, and T-cells. These include

abatacept (Orencia), rituximab (Rituxan), and tocilizumab

(Actemra). Doses may vary depending on weight and admin-

istration is SQ or IV, although Rituxan is only available for IV

infusions.

Biologics, including both anti-TNF and non-TNF, are used

after inadequate response to monotherapy or combination ther-

apy with non-biologic DMARDS. Biologics may be used

with or without traditional DMARDS. They are generally

very expensive and require insurance approval. Most are given

as injections and the most common problem is injection site

reactions although allergic reactions may be severe. The caveat

of biologic DMARDS is that there is an increased risk for seri-

ous infections (including tuberculosis and fungal) as well as

increased cancer risk. Prior to start of therapy, patients should

have TB screens and receive recommended vaccinations as

infections may worsen during treatment. Live vaccines (i.e.

Zostavax or nasally administered FluMist) should not be given

to patients on biologics or Tofacitinib. Inactivated vaccines

(injectable flu, pneumococcal, etc) are recommended on RA

meds, even though they may not respond as well.

With long term use, there is possibly increased risk of

cancers such as lymphoma and skin cancer as well as

neurologic complications. Contraindications for TNF

-alpha blockers include patients with multiple sclero-

sis or moderate to severe heart disease.

Drug therapies are paramount to both pain relief and

quality of life for those with rheumatoid arthritis.

Current guidelines recommend more aggressive treat-

ment to stop the progression of the disease. Other non

-drug therapies that may help with joint pain include

heat/cold treatments, splints or orthotic devices or

joint protection techniques. Frequent rest periods be-

tween activities as well as 8-10 hours of sleep each

night are also recommended. Excess alcohol and

smoking should be avoided.

ANTI-TNF DRUGS BRAND NAMES MAINTENANCE DOSE

Infliximab Remicade® IV infusions every 4- 8

weeks at clinic

Etanercept Enbrel® 50mg SQ/week or 25mg

twice weekly

Adalimumab Humira® 40mg every other week SQ

Golimumab Simponi® 50mg SQ once a month

Golimumab Simponi Aria® IV infusions every 8 weeks at

clinic

Certolizumab pegol Cimzia® 200mg SQ every 2 weeks or

400mg every 4 weeks

Article by Melodie Seagle, Pharm D, BCGP

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Adrenal Fatigue: A Real Disease?

Page 6

PHARM NOTES

Do you feel like you are tired all the time, even after getting a

full night of sleep? Do you feel as if you need multiple cups of

coffee to get you through the day? Do you ever wonder what

is wrong with your body? Adrenal fatigue is a possible expla-

nation, however, many medical professionals do not believe it

is a true medical condition.

The adrenal glands are composed of the outer adrenal cortex

and the inner adrenal medulla. Our body has 2 adrenal glands,

each sitting on top of a kidney. The adrenal cortex secretes

many hormones including glucocorticoids (ex. cortisol), min-

eralocorticoids (ex. aldosterone), and androgens (ex. DHEA).

Glucocorticoids help regulate carbohydrate, protein and fat

metabolism. Mineralocorticoids help regulate fluid volume

and sodium and potassium balance. The inner adrenal medulla

regulates the secretion of catecholamines (ex. epinephrine,

norepinephrine and dopamine).

Adrenal fatigue has been known by many other names

throughout the past century such as: non-Addison’s hypoadre-

nia, subclinical hypoadrenia, neurasthenia, adrenal neurasthe-

nia and adrenal apathy. Adrenal fatigue is the term used to

explain a group of symptoms that occur most commonly in

people who are under long-term mental, emotional or physical

stress. This includes those who have a stressful job, are a

working student, single parents or those with severe infec-

tions. The hallmark complaint is fatigue that is unrelieved by

sleep. Other symptoms are common and non-specific includ-

ing tiredness, trouble waking up in the morning, GI distress

and the need for stimulants such as caffeine to get you through

the day. When the body is under a high amount of stress, hor-

mones are released to regulate energy production and storage,

immune function, heart rate, muscle tone and other processes

that enable you to cope with the stress. In those that face long-

term stress, the body is unable to keep up with the demands

for hormone production by the adrenal glands. Overstimula-

tion of these glands results in a diminished output and occur-

rence of symptoms. In adrenal fatigue, the body is still able to

produce adrenal hormones, just to a lesser extent to satisfy the

body’s demands. Compared to Addison’s disease, also known

as adrenal insufficiency, the body is unable to produce any of

one or more of the adrenal hormones. This could be caused by

direct damage to the adrenal glands by an autoimmune disease

or excess use of exogenous steroids (ex. prednisone). Addi-

tional severe symptoms that are seen in Addison’s disease in-

clude: skin discoloration, weight loss, dehydration and loss of

body hair. Adrenal fatigue is essentially a minor form of ad-

renal insufficiency and hormone levels are still within normal

ranges.

Currently, adrenal fatigue is not accepted as a medical condi-

tion, which makes it difficult to diagnose because many physi-

cians do not believe this condition exists. There is no test that

detects adrenal fatigue, and diagnosis is most often based on

symptoms alone. Some medical doctors may test adrenal hor-

mone levels by collecting saliva but these tests are not based

on scientific evidence so the accuracy of these tests is ques-

tionable. Since stress is a key factor in the cause of adrenal

fatigue, recommendations for treatment includes reducing

triggers. Physicians who support the diagnosis of adrenal fa-

tigue may advise lifestyle improvements such as smoking ces-

sation, exercise, healthy diet, and routine sleep schedule to aid

in stress management. B vitamins as well as vitamins C and E

may be beneficial to aid in adrenal hormone production since

they are essential in the adrenal cascade. Magnesium before

bedtime may help promote sleep and relaxation. Other recom-

mended dietary supplements include Siberian ginseng

(Eleutherococcus senticosus), Ashwagandha (Withania som-

nifera), Maca (Lepidium meyenii), and Licorice (Glycyrrhiza

glabra) to promote calmness during the day and sleep at

night. Dosing recommendations for these dietary supplements

can be found in Table 1. Keep in mind that dietary supple-

ments are not regulated by the Food and Drug Administration

(FDA), which means that that is no guarantee that what is

written on the label is what is actually inside the bottle. The

dose being taken may have no active ingredients or the dose

may be too high. It is important that if dietary supplements are

taken that they have an United States Pharmacopeia (USP)

seal, which means the product was evaluated for quality. This

does not mean that the product was evaluated for safety or

efficacy. Even with treatment, it takes about 6 months to fully

recover from mild adrenal fatigue, 12-18 months for moderate

adrenal fatigue and up to 2 years for severe adrenal fatigue.

Adrenal fatigue can be very debilitating if symptoms are not

under control. It is important that if you or someone you know

is experiencing these symptoms that you talk with your doctor

right away. Adrenal fatigue may be a possibility, but because

the symptoms are non-specific, other serious health conditions

could be the cause such as adrenal insufficiency or depression,

which should both be managed under the supervision of a li-

censed healthcare provider.

Article by Kayla Barker, Pharm D Candidate

Wingate University School of Pharmacy

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Page 7

Volume 22, Issue 1

Table 1: Dosing Recommendations for Dietary Supplements in Adrenal Fatigue

Dietary Supplement Dose

B Vitamins

Niacin (B3) 125-150 mg/day

Pyridoxine (B6) 50 mg/day

Pantothenic acid 1,200-1,500 mg/day

Vitamin C 2,500-4,000 mg/day

Magnesium citrate 400 mg before bedtime

Vitamin E 400-800 IU/day

Siberian ginseng 500 mg four times daily

Ashwagandha 300 mg twice daily

Maca 1.5 grams twice daily

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PHARM NOTES

Kinston Pharmacy

2545 Jetport Road

Kinston, NC 28504

Phone 800 735-9111

Louisville Pharmacy

13040 East Gate Parkway

Suite 105

Louisville, KY 40223

Phone 866-601-2982

Mooresville Pharmacy

947 N. Main Street

Mooresville, NC 28115

Phone 800 578-6506

To all the Pharm Notes Family,

I read something recently that really gave me

cause to think. It is by Molly Fletcher, CEO of the Molly Fletcher Company as well as keynote

speaker and author. She has graciously allowed me to share it with you. (To read this Article in its entirety,

please go to: www.mollyfletcher.com)

10 Things that Require Zero Talent

How often do we equate success with talent? All the time. But the reality is, success isn’t created by talent

alone. Just like we might see immense talent squandered, we also see underdogs unexpectedly overachieve.

Here are 10 behaviors that we can always control that require zero talent, yet have a huge impact on our

success.

1. Being on time: Punctuality is a keystone habit.

2. Work ethic: The discipline of showing up consistently & making the best decisions that lead to

peak performance.

3. Effort: A mindset as much as a behavior.

4. Body language: Shapes how we are perceived by others.

5. Energy: Be conscious about where yours goes.

6. Attitude: Maximizes the talent that you do have and offsets what you lack.

7. Passion: The single most important way to suffocate the fear that keeps us from peak performance.

8. Being coachable: Become a better listener, learn from feedback, & embrace the success of others.

9. Doing extra: Go the extra mile.

10. Being prepared: Failing to prepare is preparing to fail.

Remember that talent is never enough. The best of the best don’t rest on

what they were born with—they dig down to get the most they can. Try

these 10 things (or just one!) and over time…. it will pay off.

Till next time……..

Cathy Fuquay

Pharm Notes Editor

Pharm Notes is a bimonthly publication by Neil

Medical Group Pharmacy Services Division.

Articles from all health care disciplines pertinent

to long-term care are welcome. References for

articles in Pharm Notes are available upon request.

Your comments and suggestions are appreciated.

Contact: Cathy Fuquay ([email protected])

1-800-735-9111 Ext 23489

...a note from the Editor

Thank you for allowing Neil Medical Group to partner with

you in the care of your residents!