Prescriptions in women’s health

Prescriptions in Women’s Health
IWHIM January 2013
• Scientific Advisory Boards Integrative Therapeutics Inc Gaia Herbs Nordic Naturals Natural Health International • Lichen sclerosis• Vulvar vestibulitis• Cystitis• Bacterial vaginosis• osteoporosis• Menopause symptoms Rx: Temovate ointment (clobetasol
How to use:
• Apply a thick layer of Temovate ointment
• affected areas twice daily• Rub in gently and completely• Limit use up to 2 consecutive weeks, then daily for 2 months, then twice weekly for • May use a maintenance dose 1-2 x/week Benefits of Clobetasol
• Highly potent corticosteroid
• Anti-inflammatory
• Anti-pruritic
• Vasoconstrictive
In women previously unresponsive to therapy 76.8% complete alleviation of symptoms 17.9% partial alleviation 5.3% No response 31.5% Complete remission of gross appearance of Adverse reactions of Clobetasol Localized burning Itching Skin atrophy Cracking Fissuring Adverse reactions of ClobetasolLocalized burningItchingSkin atrophyCrackingFissuring • Bland emollients - Crisco - Petroleum jelly - Aloe - vitamin E oil• Low potency steroids - hydrocortisone 1% with pramoxine 1% (Pramasone - Hydrocortisone 25 mg suppositories (for • Mid potency steroids - betamethasone valerate 0.1% ointment • Ultra-high potency steroids - clobetasol 0.05% ointment • Local immune system modulators - Tacrolimus 0.1% ointment (Protopic) - Pimecrolimus 1% ointment (Elodel)• Antivirals - Imiquimod 5% cream (Aldara) Clobetasol 2-3x/day for 2 weeks ( up to 6-12 weeks) + licorice gel Clobetasol once daily for 2-4 weeks (up to 2 months) + licorice gel once daily + topical vitamin A once daily for up to 2 months Clobetasol once daily for 2-3 days/wk + licorice gel 1-2x/daily and topical vitamin A once daily for 2-4 weeks Clobetasol once/day for 1-2 days/week and licorice gel once daily Determine optimal maintenance plan with minimal clobetasol Other steroid options: 0.05% betamethasone dipropionate • Comfort: ice, lidocaine 2% gel prn
Topical lidocaine 5% ointment; once daily x 1
Topical estriol 1 mg/Gm-apply ½-1 gm/daily;
ok to do daily without any added progestational
agent, if they are menstruating monthly
Or Estrace cream or Premarin cream
Various physical therapy techniques- PT who
has specialized training in pelvic pain;
Other considerations
Tricyclics, corticosteroids, interferon, surgery
Topical gabapentin cream 4% apply 2-3x/day
• TMP-SMZ favored, but up to 70% of E coli • Fluoroquinolones• Nitrofurantoin macrocrystals (bacteriostatic)• Treat X 3 days in most cases• Treat X 7 days – If using nitrofurantoin – If symptoms present > 7 days– If patient is complicated (e.g., diabetes) • Clindamycin 300 mg bid x 7 days• Clindamycin cream 2% vaginally x 7 • Ampicillin, docycycline, sulfonamide • Objectives
- Prevent new fractures

improve bone strength
prevent falls
- For patients with fractures

minimize symptoms
improve function
optimize quality of life
-adequate nutrition; nutraceuticals
- regular physical activity
- avoid unhealthy lifestyle
-pharmacological therapy

• All postmenopausal women with osteoporotic • All postmenopausal women with osteoporosis on • All postmenopausal women with T scores -1.0 to -2.5 and one of the following based on one of the -10 year risk of major osteoporotic fracture of - 10 year risk of hip fracture 3% or more • Clinician’s judgment and/or patient preferences • Anti-remodeling agents - Bisphosphonates - Calcitonin - Estrogen - Estrogen agonists/antagonist (raloxifene) - RANK ligand inhibitor (denosumab)• Anabolic agents -Parathyroid hormone (teriparatide)All (except calcitonin) decrease spine fracture riskOnly alendronate,risedronate, zoledronic acid and denosumab proven to reduce non-vertebral and hip • Treatments effectively reduce vertebral fracture risk - 40-70% reduction after 3 years; 60-70% after 1 - Consistent across multiple studies with several - Early response (wi/6 months) - Persistent effect- at least to 5 years for fracture - Treatment interrupts the cycle of progressive • Bisphosphonates reduce risk of non-vertebral fracture and to a lesser extent, hip fracture • Mechanism of action
- inhibiting osteoclasts--- reducing bone
- no known beneficial effects on the body other • Most common adverse effect
- esophageal and gastric irritation, particularly
Before starting bisphosphonate therapy
- screen for secondary causes of low bone mass.
- if low serum calcium - should not receive
- Serum creatinine should be used to estimate the GFR; treatment can be initiated only if the rate is 30 • Bisphosphonates
- Decreases risk of spine, hip and other fractures
- Treatment of choice for most women with

postmenopausal osteoporosis
- hypocalcemia
- significant renal impairment-especially with IV drugs
- Upper GI intolerance with oral drugs
- Acute phase reactions with IV and high-dose oral

- Long term safety issues

• Alendronate= Fosamax• Approved for postmenopausal osteoporosis • Prevention: 5 mg/day or 35 mg/wk • Treatment: 10 mg/d or 70 mg/wk• Also, 70 mg/wk with 5,600 vitamin D • FIT trial: daily alendronate for 2.9 years= • Risedronate= Actonel• Approved for prevention and • Hip Intervention Program Study Group daily risedronate therapy reduced RR - reduces risk of vertebral fractures - no evidence for reduction of other - approved for prevention and treatment - Monthly dosing form - reduces risk of all fragility fractures - IV once yearly or less often - Very long duration of effect upon - Flu-like symptoms with first doses - Contraindicated with GFR 35 ml/min • RCTs of more than 5 years duration with • No date are available on effects > 3 years • No current evidence regarding the optimal • What about?????Osteonecrosis of the jaw (ONJ) -the cases are few; estimates 1/10,000-1/250,000 - Uncertain pathogenesis - the cases are mostly in individuals on high dose IV bisphosphanates who are being treated for their risk of fracture due to metastatic cancers to the bone. -few cases reported in patients taking bisphosphonates - Currently, there is no data to recommend the discontinuation of bisphosphonate therapy before dental extraction, although many practitioners are recommending suspending bisphosphanate therapy • What about atypical femur fractures??? Atypical features: transverse fracture of femoral shaft; minimal trauma; thickened cortices and normal or high BMD; slow or • There may be the potential for over-suppression of bone turnover with long-term therapy, resulting in • Individual cases and small case series • Research is underway to determine what is unique - No effects on BMD or markers - Very weak data about fracture risk - Recent study with new oral calcitonin - Not a good treatment option CI: none Concerns: none except lack of • Prevents bone loss in early postmenopausal women• Slows and prevents bone loss in spine• Slows bone loss in the hip• Reduces spine and hip fractures in WHI study• No longer approved for treatment• Not recommended for long-term therapy in • Low dose estrogen has efficacy
Issues in Bio-identical HRT
-Estriol???, Estradiol, Estrone
-Dose -Delivery system
in standard doses are FDA approved for prevention, but not treatment of osteoporosis.
• MOA - inhibit osteoclasts, slow bone • 3% to 6% BMD loss during the first year • Estrogen agonist/antagonist- Raloxifene - Decreases risk of spine but not other fractures - An appropriate treatment for younger postmenopausal women at risk for spine fracture - Not good choice in older patients at risk for hip CI: noneConcerns: - Increased death from stroke in women at high - 2-3 fold increase in risk of venous thrombotic - Decreases risk of spine, hip/other fx
- SubQ Q 6 months
- OK if impaired renal function
- Appropriate alternative if:

- Intolerant of oral bisphosphonate
- Concern about absorption of oral agents
- Impaired renal function
CI: hypocalcemia
- lack of long term safety
- Skin infection/rash in Phase III trial
- impaired immune function??
- Possible over suppression of bone turnover

ONJ has been observed
- activates bone formation and increases - decreases risk of spine and non-spine - SubQ dailyConsider: -high risk for spine fractures -on glucocorticoid therapy -if fractures on anti-resorptive therapy • Reduced the risk of vertebral and non-vertebral fractures in women with osteoporosis (NEJM • Not demonstrated to reduce hip fracture risk• Adverse events: nausea, dizziness, hypercalcemia• CI: hypercalcemia • Caution: In patients with conditions that might increase risk of osteosarcoma (Pagets/ skeletal irradiation, prior osteosarcome), on digoxin or with • Duration of therapy- different if EPT in • EPT- duration limited by the increased risk of breast cancer assoc with > 3-5 years of • ET- more favorable benefit-risk profile with no apparent increase in risk of breast cancer • Individualized recommendations is the key- consider woman’s health, QOL priorities, personal risk factors (clots, CVD, stroke, • Hot flashes: women with a uterus – take estrogen • Low-dose vulvo/vaginal ET if local symptoms only• Neither ET or EPT increases the risk of heart disease in healthy women under age 60 or within 10 years of menopause. The risk of stroke can be • If POF or early menopause- use HT until the average age of natural menopause (51). Longer duration of tx can be considered if needed.
• Lack of safety data supporting the use of HT in oral ET is associated with lower risks of blood clots and stroke than standard doses of oral estrogen, but confirmation of benefits in RCT is not yet available (i.e. years since menopause), i.e. therapeutic window 2. Dose of estrogen3. Route of administration • Benefits outweigh risks - initiate HT within 10 years to • 0.3 mg dose of CEE is effective for treating hot flashes and vaginal dryness and for the prevention of osteoporosis in menopausal women.
• This dose also affects cardiovascular risk. - 0.3 mg/day CEE = reduced risk of CHD and stroke compared with nonestrogen users • WHI observational study: women using low dose estrogen- defined as < 0.625 mg/day as part of estrogen plus progestin therapy had a 71% lower risk of coronary heart disease and a 69% lower risk of VTE over an average f/u of 5.5 years compared with women using a conventional dose regimen. • Among women using estrogen plus progestin, the risk of CHD was more than double in users of high- dose estrogen vs women receiving a standard dose. • No relationship was observed between estrogen dose and cardiovascular events with estrogen • Transdermal avoids the hepatic first • Oral estrogens• Oral estrogen/progestins• Oral progestogens• Oral estrogens/testosterone• Transdermal estrogens• Transdermal estrogens/progestogens• Vaginal estrogens-systemic; local• Vaginal progestogens Conventional HRT products
Oral Estrogen Only
E alone for days 1-14, followed by E + P on days 15-28• Activella (estradiol-norethindrone) • FemHRT (ethinyl estradiol-norethindrone acetate) • Prefest (estradiol-norgestimate) 1mg/0.09 mg E alone for 3 days, followed by E+P for 3 days, repeated continuously• Angeliq (estradiol-drosperinone) Oral tablet: progestin

Oral capsule: micronized progesterone (in peanut oil)

• Estratest only now available in generic= esterified estrogens 0.125mg/ 17 beta Estradiol
matrix patch
0.025 mg, 0.05 mg, 0.075 mg, 0.1
0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg, 0.1 mg 1x/wk
0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg,
0.025 mg, 0.0375 mg, 0.05 mg, 0.1
Vivelle-dot 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg, 0.1 mg
Various generics
0.1, 0.05
17 beta Estradiol

0.05 mg, 0.1 mg
reservoir patch
(patch cannot be
17 beta-Estradiol transdermal gel

daily application; 1 metered pump
delivers 1.25 g of gel containing
0.75 mg 17Bestradiol
0.0125 mg
daily application, 1-2 pumps; 1
metered pump delivers 0.87 g of
containing 0.52 mg gel
0.003 mg, 0.009 mg, 0.027 mg daily application;
3 strengths of packets provide 0.25, 0.5 or 1.0 g/gel
17 b estradiol topical emulsion

0.05 mg (2 packets)
daily application of 2 packets; 1
packet- 1.74 g emulsion
0.021/90 mcgL spray (metered-dose pump 1.5/90 mcgL
maintenance:1g/dayConjugated estrogens Premarin • Vaginal tablet Vagifem (2 strengths available) initial: 1 tablet/day for 2 weeks maintenance: 1 tablet 2x/wk (tablet contains 25.8 mcg or 10 mcg of estradiol hemihydrates equivalent to 25 mcg or 10 mcg of contains 2 mg releases 7.5 mcg/day for 90 days local effect 2 strengths contains 12.4 mg or 24.8 mg estradiol acetate releases 0.05 mg /day or 0.10 mg/day estradiol for


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