Transcript Hormone Replacement and Medication Update

Updates in Women’s HealthFrom Adolescence to
Atrophy
Advanced Practitioners of the River Region
7th Biennial Pharmacology Update for Advanced Practitioners
Presented by : Della Fuller, RN, MSN, CRNP
OBJECTIVES:
At the end of this presentation the participant will be
able to:
Identify and differentiate the various methods of
contraception including risks, benefits and side effects.
 Formulate a working knowledge of treatment options for
menopause including hormonal and non-hormonal therapies.
 Demonstrate knowledge of updates in pharmacological
options for women from adolescence to menopause.
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Three Generations…
TODAY'S
CONTRACEPTIVE OPTIONS
Non-Hormonal Contraceptives
Prevent Pregnancy by:
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Providing a barrier against sperm
Interfering with sperm movement
Creating a difficult environment for sperm to travel
These methods do not use hormones, so they do not interfere
with your natural hormonal cycle
Barrier Methods
Male Condom
 Female Condom
 Spermicides ( foams or suppositories)
 Cervical Cap
 Diaphragm
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Quiz- Condom Knowledge ??
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Latex condoms are recommended for the prevention of unintended
pregnancies and sexually transmitted diseases. TRUE or FALSE ?
(lambskin)
Oil-Based lubricants such as baby oil and vaseline are safe to use with latex
condoms. TRUE or FALSE ?
Condoms can break if the tip is not pinched to remove air bubbles. TRUE
or FALSE?
After sex, a man should withdraw from his partner immediately, holding on
to the base of the condom. TRUE or FALSE?
If washed carefully, a condom can be used safely over and over. TRUE or
FALSE?
To be prepared, it is always a good idea to have a condom in your wallet.
TRUE or FALSE?
Condoms, like groceries, have expiration dates. TRUE or FALSE?
Quiz- Condom Knowledge ??
When it comes to condoms, one size fits all. TRUE or FALSE?
 How effective are condoms at preventing pregancy when they are not
always used correctly? TRUE or FALSE?
 An elastic band and Saran Wrap can work just as good as a condom.
TRUE or FALSE?
 BONUS QUESTION!! Which of the following condoms are not
approved by the FDA for pregancy prevention:
A) tingling pleasure condoms
B) warming condoms
C) French tickler condoms
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Hormonal Contraceptives
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Nuvaring - (etonogestrel/ethinyl estradioal vaginal ring, delivers
0.120mg/
0.015 mg per day)
Store refrigerated
Risks
Benefits
Side Effects
Usage
Hormonal Contraceptives
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Nexplanon- (etonogestrol implant 68 mg radiopaque)
Is a small, soft and flexible birth control implant 4 cm in
length. It is placed discreetly under the skin on the underside
of the upper arm. It is hidden from view and provides up to 3
years of continuous pregnancy prevention (progestin release).
No daily, weekly, or monthly dosing routine
99 % effective and considered one of the most effective birth
control options available.
Risks/Benefits
Side effects/usage
Hormonal Contraceptives
Nexplanon Side EffectsMood swings
Dysmenorrhea
Weight Gain
Mood swings
Headache
Back Pain
Acne
Nausea
Depressed mood
Dizziness
Vaginitis
Weight Gain
Breast pain
Stomach Pain
Hormonal Contraceptives
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Depo-Provera - prefilled syringe or separate vial
Progesterone Only : 104 mg subq or 150 mg IM both are dosed q 3
mos.
Given at time of menstrual cycle (window from day 1-7)
Risks
Benefits
Side Effects
Oral Contraceptives
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Work by preventing the release of an egg from your ovaries,
preventing
Fertilization.
OCP's should not be prescribed for women with uncontrolled HTN
or
HTN with vascular disease.
Women who are diabetic or pre-diabetic should be monitored while
using
OCP's.
Alternate contraceptive methods should be considered for women
with:
uncontrolled dyslipidemia.
Evaluate patients who have had recent lab changes, irregular
bleeding, or amenorrhea.
OCP's are contra-indicated with patients with migraines (with
aura).
Oral Contraceptives
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Monophasics
Biphasic
Triphasic
Lowest dose available
Always review risks, benefits, and side effects. Remember to
educate on usage!
Transdermal Contraception
Ortho-Evra Patch
Intrauterine Device
Mirena- Progestin releasing - 5 years
Intrauterine Device
Skyla- Progestin secreting device that
thins the endometrial lining.
Effective for 3 years (smaller than Mirena)
Risks Benefits Side Effects
Intrauterine Device
Liletta- Levonorgestrel releasing IUS/52 mg
Small and flexible - Greater than 99% effective
Intrauterine Device
Paraguard- Non-hormonal IUS
Permanent Methods
Tubal Ligation- Laprascopic, Post-partum or Essure
(tubal occlusion)
Vasectomy- Safest, simplest "office procedure"
Hormone Replacement and Medication Update
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Menopause is a normal transition
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Women can experience Menopause:
Most women enter Menopause in their 40’s or 50’s
Menopause is confirmed when you have not had a period for 12
months in a row
Naturally -A slowing of estrogen and progesterone production
leading to changes in how your body feels and acts
OR
By surgery -(Hysterectomy/Oophorectomy) leading to same
menopausal symptoms as experienced with
natural menopause
Menopause affects every woman differently…
Common Symptoms of Menopause●
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Change in your menstrual cycle
Hot Flashes- warmth in your face and upper body
Night sweats- hot flashes at night, often waking up with back of
neck wet, gown wet, sheets wet, did I wet on myself???
EVERYTHING IS WET!
Trouble sleeping- mostly staying asleep
Vaginal Dryness leading to dysparunia
Decreased or no libido
Mood swings and/or anxiety
Thinning bones leading to osteopenia and osteoporosis
Short-term memory loss- brain teasers
Common Symptoms of MenopauseOR
Trouble sleeping, tired
Anxiety
Wet from night sweats/hot flashes
Absence of thought process
No libido
Dysparunia
Absence of periods
The most common and effective way to replace the
estrogen that the body no longer produces is with
Hormone Therapy (HT).
Can be estrogen alone or a combined estrogen-progestin
The Women’s Health Initiative study of Post-Menopausal women
with an average age of 65 in 2002 found that taking combination
HT slightly increased the risk of breast cancer, heart disease,
stroke and blood clots. These results scared women, and many
stopped taking HT only to find their symptoms came back. As a
result, they began to look with their health care providers for
alternative ways to treat menopausal symptoms such as
bioidentical hormone therapy.
Hormone Replacement and Medication Update
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Biological hormones are sometimes called “natural” hormones even
though they are synthesized in a laboratory- because they are
identical or biologically the same as hormones that women make in
their bodies.
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Conventional hormone therapy uses estrogens or progestins that
differ slightly from the hormones made in the body, likewise
hormones purified from naturals sources are not necessarily
bioidentical.
Hormone Replacement and Medication Update
There are two types of bioidentical hormone products:
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Pharmaceutical products approved by the FDA. These
products are available as pills, patches, gels, sprays,
pellets, and vaginal inserts
Hormone Replacement and Medication Update
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Custom made products- made in a compounding
pharmacy. These contain varying amounts of one
(Estradiol E-2), two (Estradiol E-2, and Estriol E-3 – BIEST),
or three types of estrogen (Estrone E-1, Estradiol E-2,
Estriol E-3 –TRIEST)
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Dispensed in pill or transdermal form.
Pros of Natural Biologically Identical
Hormones
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Bioidentical Progesterone and Bone
Bone forming cells are physiologically influenced by Progesterone
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Bioidentical Progesterone and Breast Tissue
Progesterone at a concentration seen at the 3rd trimester of pregnancy,
exhibits a powerful anti-proliferative effect on at least two breast cancer cell
lines.
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Bioidentical Progesterone and the Heart
In studies progesterone and 19-nor-progesterone do not illustrate and
androgenic action and have no negative effect on lipid levels and vascular
reactivity in animal models or on exercised induced myocardial ischemia in
humans.
Pros of Natural Biologically Identical
Hormones
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Bioidentical Estrogen and bone
Estradiol and Estriol have both been shown to have a positive effect on
bone mineral density in both oral and transdermal forms.
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Bioidentical Estrogen and the Heart
Estrogen has many positive effects on lipid metabolism. It reduces LDL
and VLDL cholesterol levels.
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Bioidentical Estrogen and the skin
Estradiol or Estriol has been shown to improve elasticity and firmness of
the skin with a decrease in wrinkle depth and increase in collagen fibers.
Why you should choose FDA Approved
Menopausal Hormone Therapy Products over
Compounded Drugs
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FDA Approved Products have safety and efficacy data. This means they have been
tested in many clinical trials, on real women. The results of those tests have been
published in medical journals and scrutinized closely by many medical experts.
•FDA Approved Products are held to manufacturing standards.
•The American College of Obstetricians says, “Compounded hormone products have
the same safety issues as those associated with hormone therapy agents that are
approved by the FDA and may have additional risks intrinsic to compounding.”
•The North Americal Menopause Society (NAMS) says, “NAMS does not
recommend custom compounded products over well tested, government-approved
products for the majority of women-and does not recommend saliva testing to
determine hormone levels.”
Types of Hormone Therapy
Oral Estrogens
Component/Strength
Cenestin
Estrace (Estradiol)
Estinyl
Estratab, Menest
Synthetic CE 0.625 mg, 0.9 mg
Estradiol 0.5 mg, 1 mg, 2 mg
EE 0.02 mg, 0.05 mg
Esterified Estrogen 0.3 mg
0.625 mg, 1.25 mg, 2.5 mg
Estropipate 0.625 mg, 1.25 mg
2.5 mg
Estropipate 0.75 mg, 1.5 mg
CEE: 0.3 mg, 0.625 mg, 0.9 mg
1.25 mg, 2.5 mg
0.3 mg to 1.25 mg (Syn CE)
Estradil Acetate 0.45 mg to 1.8 mg
Ogen
Ortho Est
Premarin
Enjuvia
Femtrace
Route
Recommended
Starting dose
Tablet
Tablet
Tablet
Tablet
0.625 mg daily
0.5 mg daily
0.05 mg daily
0.625mg daily
Tablet
0.625 mg daily
Tablet
Tablet
0.75 mg daily
0.625 mg daily
Tablet
Tablet
0.625 mg daily
0.625 mg daily
* Estradiol Valerate ( Delestrogen) 10 to 20 mg IM every four weeks
Types of Hormone Therapy
Transdermal Estrogens
Component/Strength
Route
Alora
0.05 mg/day, 0.075 mg/day
0.1 mg/day
0.025 mg/day, 0.05 mg/day
0.075 mg/day, 0.1 mg/day
0.025 mg/day, 0.037 mg/day
0.05 mg/day, 0.075 mg/day
0.1 mg/day
0.05 mg/day, 0.1 mg/day
patch
Climara
Esclim
Estraderm
patch
patch
patch
Vivelle / Vivelle Dot
0.025 mg/day, 0.0375 mg/day patch
0.05 mg/ day, 0.075 mg/day
Fempatch
0.025 mg/day
Recommended
Starting Dose
0.05 mg/day
patch 2 x week
0.025 mg/day
patch 1 x week
0.025 mg/day
patch 2 x week
0.05 mg/day
patch 2 x week
0.025 mg/day
patch 2 x week
0.025 mg/day
patch 1 x week
Types of Hormone Therapy
Transdermal Estrogens Component/Strength
Route
Recommended
Starting Dose
Evamist
1.53 mg Estradiol
Spray
Estragel
1.25 mg gel= 0.75 mg estradiol
Gel
Estrasorb
1.74 mg lotion= 2.5 mg estradiol Lotion
Elestrin
1 pump = 0.0125 mg estradiol
2 pumps = 0.0375 mg estradiol
Gel
1-2-3 times a day
on forearm
Applied to legs
and thighs daily
2 packs of lotion a
day= 0.05 mg patch
1 pump daily
Applied to upper
arm or shoulder
Divigel
0.25 mg, 0.5 mg, 1 mg
Gel
0.25 mg, Applied to
upper thigh size of
5 x 7 card
* Estrogen and Testosterone pellets are available in doses ranging from 25 mg and up depending on
clinician’s choice.
Types of Hormone Therapy
Estrogen/Testosterone Component/Strength
Estratest
Estratest HS
Route
Recommended
Starting Dose
1.25 mg esterified estrogen
Tablet
1 daily
plus 2.5 mg of methyltestosterone
0.625 mg esterified estrogen Tablet
1 daily
plus 1.25 mg of methyltestosterone
Estrogen/Progesterone
Component/Strength
Route
Recommended
Starting Dose
Activella
1 mg E + 0.5 mg NE
0.5 mg E + 0.1 mg NE
5 mcg EE + 1 mg NE
Tablet
Tablet
Tablet
1 daily
1 daily
1 daily
Tablet
daily in order
Fem HRT
Ortho Prefest
1 mg E, 1 mg E + 0.09mg N
Prempro
0.625 mg CEE + 2.5 mg MPA
0.625 mg CEE + 5 mg MPA
0.625 mg/ 5 mg
0.625 mg/ 2.5 mg
0.45 mg/ 1.5 mg
0.3 mg/ 1.5 mg
Premphase
Tablet
Tablet
Tablet
1 daily
1 daily
1 daily
Types of Hormone Therapy
Estrogen/Progesterone Component/Strength
Route
Angeliq
Tablet
Climara Pro
Combipatch
1 mg estradiol/ 0.5 mg drospirone
0.045mg/0.015 mg estradiol/levonorgestril Patch
0.05 mg estradiol/ 0.14 mg Norinthindrone Patch
0.05 mg estradiol/ 0.25 mg Norinthindrone
Recommended
Starting Dose
1 daily
1 patch weekly
1 patch 2 x week
Types of Hormone Therapy
Vaginal Estrogens
Component/Strength
Route
Estrace
Estradiol 0.1 %
Cream
Estring
Premarin
Estradiol 7.5 mcg/ day
CEE 0.625 mg per gram
Vagifem
Estradiol 10 mcg
Femring
Estradiol Acetate 0.05 mg day
Estradiol Acetate 0.1 mg day
Ring
Cream
Vaginal Tablet
Ring
Recommended
Starting Dose
Daily, then 1-3
times a week
Change q 90 days
1 gm daily (for AV)
0.5 mg for
dysparunia
1 x daily for
2 weeks, then 2 x
week
Insert and replace q
3 months
Types of Hormone Therapy
Testosterone Hormone
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Multiple forms- Transdermal (creams/gels) implants, oral
Especially effective if you like your partner!
Addyi (flibanserin) – The New Pink Persuasion
Addyi (100mg) is a new medication indicated for female hypoactive sexual
desire disorder (HSSD).
Indications: treatment of pre-menopausal women with acquired, generalized, hypoactive sexual
desire as characterized by low sexual desire that causes marked distress or interpersonal
difficulty and is NOT due to:
• A co-exisiting medical or psychiatric condition
• Problems within the relationship
• Effects of another medication or other drug substance.
Acquired HSSD refers to HSDD that develops in the patient
Who previously had no problems with sexual desire.
Generalized HSSD refers to HSDD that occurs regardless of the
type of situation, stimulation, or partner.
Limitations: not indicated for post-menopausal women or in
men. Addyi is not indicated to enhance sexual performance.
https://youtu.be/9fJyGUKihyQ
Non- Hormonal Therapy Options
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Osphena (contains Ospemiphene) 60 mg tablet
A medicine that works like Estrogen in the lining of the uterus, but can work
differently in other parts of the body. Used after menopause for women with or
without a uterus to treat moderate to severe pain during sexual intercourse due
changes in and around the vagina.
Who should not take Osphena?
• Anyone who has had unusual vaginal bleeding
• Currently have or have had certain cancers
• Currently have or have had blood clots
• History of stroke or heart attack
• Allery to Osphena
• Think you may be pregnant
Serious side effects may include: Stroke, blood clots, endometrial cancer
Less serious side effects may include: hot flashes, unexplained vaginal bleeding, muscle spasms
and increased sweating.
Non- Hormonal Therapy Options
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Brisdelle (contains Paroxetine) 7.5 mg capsule
Brisdelle is indicated for moderate to severe vaso-motor symptoms consistent
with menopause. One 7.5 mg capsule is taken at bedtime. Paroxetine is a
selective serotonin receptor inhibitor (CYP20646) and is contraindicated with
certain medications.
Who should not take Brisdelle?
• Anyone who is currently prescribed an SSRI
Adverse side effects may include: Increased risk of suicidal ideation, serotonin syndrome,
abnormal bleeding, narrow angle glaucoma, bone fracture risk.
Most common side effects include: fatigue, malaise, lethargy, headache, nausea and vomiting.
Deciding If Estrogen Is Right For You:
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Estrogen therapy is the most effective, FDA approved medicine proven to treat
moderate to severe hot flashes.
Estrogen therapy helps to improve and maintain vaginal health.
Estrogen therapy is proven to help prevent post-menopausal osteoporosis.
In general, an appropriate candidate for estrogen therapy is a healthy,
symptomatic, menopausal woman who has undergone a hysterectomy.
Benefits and risks of therapy should be weighed along with individual risk
factors, such as family history of breast cancer or stroke, and therapeutic needs,
such as severity of hot flashes.
When Considering Estrogen Therapy, talk
with your Health Care Professional About:
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The time since your menopause started
Low dose options
Your expected duration of use
Your benefit-risk profile
References
North American Menopause Society
www.menopause.org
American College of Obstetricians and Gynecologists
www.acog.org
US Food and Drug Administration/Brochure on BioIdentical Hormones
www.fda.gov/for consumers/ consumer updates/ucmofbll.htm
The Female Patient Medical Journal
www.female patient.com
Red Hot Mamas
www.redhotmamas.org
Elizabeth Lee Vliet, MD
www.herplace.com
FDA: Compounded Menopausal Hormone Therapy Question and Answers
North American Menopause Society. Understanding the Controversy: Hormone Testing and
Bioidentical Hormones.2007.Available at www.menopause.org /edu
materials/PG06monograph.pdf.
ACOG Committee on Gynecologic Practice.ACOG Committee Opinion #322: Compounded
Bioidentical hormones.Obslet gynecol.2005/106 : 1139-1140.
Hormone Foundation Menopause
www.hormone.org
National Women’s Health Resource
www.healthy women.org
References
Merck and Company, 2016
Hamilton, Richard J. Tarascon Pharmacopia, 2015.
Actavis Pharma, Inc. 2015
Sprout Pharaceuticals, Inc. 2016