|
|
Nutrilib.com
A comprihensive source of nutritional information
|
|
BOX WARNING |
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See Warnings, Malignant neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention of cardiovascular disease or dementia. (See Warnings, Cardiovascular disorders and Dementia.)
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625mg) combined with medroxyprogesterone acetate (MPA 2.5mg) relative to placebo. (See Clinical Pharmacology, Clinical Studies and Warnings, Cardiovascular disorders and Malignant neoplasms, Breast cancer).
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See Clinical Pharmacology, Clinical Studies and Warnings, Dementia and PRECAUTIONS, Geriatric use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
|
| | |
CLIMARA SUMMARY
Climara®
(Estradiol Transdermal System)
Climara® , estradiol transdermal system, is designed to release 17(beta)-estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15.0, 18.75 and 25.0 cm2) systems are available to provide nominal
in vivo
delivery of 0.025, 0.0375, 0.05, 0.060, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15.0, 18.75 or 25.0 cm2, and contains 2.0, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical.
Climara® is indicated in the:
-
Treatment of moderate to severe vasomotor symptoms associated with the menopause.
-
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
-
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
-
Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Studies have shown an approximately 60% reduction in hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen prevents further loss of bone mass for as long as treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.
Early menopause is one of the strongest predictors for the development of osteoporosis in all women. Other factors associated with osteoporosis include genetic factors, lifestyle and nutrition.
|
CLIMARA NEWS HIGHLIGHTS Media Articles Related to Climara (Estradiol)
Antiangiogenic Role Of 2ME2 Demonstrated In Rheumatoid Arthritis Models
Source: Arthritis / Rheumatology News From Medical News Today [2008.11.04]
Hormone Cream Smoothes Skin Not Damaged by Sun
Source: MedPage Today Dermatology [2008.09.15]
FDA Drug and Device Approvals: June 10, 2004
Source: Medscape Pharmacotherapy Headlines [2004.06.10]
Published Studies Related to Climara (Estradiol)
Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. [2008.10]
Luteal phase oestradiol suppression by letrozole: a pilot study in oocyte donors. [2008.09]
Does hormone therapy improve age-related skin changes in postmenopausal women? A randomized, double-blind, double-dummy, placebo-controlled multicenter study assessing the effects of norethindrone acetate and ethinyl estradiol in the improvement of mild to moderate age-related skin changes in postmenopausal women. [2008.09]
A combined oral contraceptive containing 3-mg drospirenone/ 20-microg ethinyl estradiol in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled study evaluating lesion counts and participant self-assessment. [2008.08]
Inhibitors and activation markers of the haemostatic system during hormone therapy: a comparative study of oral estradiol (2 mg)/ dydrogesterone and estradiol (2 mg)/ trimegestone. [2008.08]
Clinical Trials Related to Climara (Estradiol)
Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climaraź Transdermal System 0.025 mg/Day [Completed]
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women [Completed]
Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch [Completed]
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination [Completed]
Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer [Completed]
|
CLIMARA PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Climara has an overall score of 7. The effectiveness score is 7.20 and the side effect score is 6.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Climara review by 37 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | surgical menopause |
| Dosage & duration: | | .025 (dosage frequency: one patch per week) for the period of 2 years continually and currently |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Immediately after a complete hysterectomy, menopause set in. Night sweats and insomnia were making life difficult. Immediately after starting the Climara patch, all menopausal symptoms were relieved. |
| Side effects: | | I have not experienced any side effects except when dosage was increased. Side effects then were acne and headaches. Upon reducing the dosage to the current .025, all side effects were relieved. |
| Comments: | | Treatment entails applying one patch per week. |
|
| | Climara review by 52 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause, memory loss, night sweats, low libido |
| Dosage & duration: | | 1 patch weekly (dosage frequency: 1 patch every 7 days) for the period of week 3 |
| Other conditions: | | high blood pressure |
| Other drugs taken: | | adalat 30 MG, daily vitamin, vitamin E | | |
Reported Results |
| Benefits: | | nothing noticeable really, night sweats improved (slightly), memory, not as fuzzy |
| Side effects: | | Weight gain 4 lbs, my weight has always been stable, bloatiness/gas (uncomfortable)
hair loss (more than usual and thinner), depression (crying for no reason) |
| Comments: | | Change patch every 7 days. Very difficult keeping the patch on. I'm going to ask the Dr. for different type of patch. Heard Vivelle is smaller and stays on bettetr. |
|
| | Climara review by 51 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | hormone replacement therapy |
| Dosage & duration: | | .075mg/day taken one patch per week for the period of one week |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no positive benefits |
| Side effects: | | mood changes, weight gain (4 pounds in 3 days!) extremely emotional. depression |
| Comments: | | I had been using the trade brand of this patch, Climara for several months with positive results. One month my local pharmacy was out of the trade brand and offered to fill the prescription with the generic brand and because I was in a hurry to catch a plane to go on a vacation, I agreed, thinking they had to be similar. Wrong! To begin with, the generic patch is twice the size and thickness of the trade brand - don't even think of wearing tight clothes while sporting one of these! (I laughlingly told my husband we could always use one to patch a flat tire if needed, but soon it wasn't so funny.) Within a day or two I knew something was wrong, but hadn't yet identified the problem. I couldn't stop crying about nothing in particular. It seemed as if overnight, my world had become very sad and depressing. I immediately began to gain weight, despite no change in my dietary habits. After finally putting two and two together, I ripped it off and contacted my local pharmacist to see if anyone else had complained of similar experiences. After rechecking my prescription, the pharmacist noticed my physician had marked "no generics". Apparently, he had a good reason for this choice as this was not his usual stance on generics. The pharmacist refilled my prescription with the trade brand and all was quickly back to normal. I usually have no problem with genereic brands, but unfortunately, no more generic estradiol for me! |
|
|
|
Page last updated: 2008-11-04
|
|
-- advertisement --
|
