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Vivelle (Estradiol Transdermal) - Summary

 
 



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 currently 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 or without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular Disorders.)

   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 five years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies).

   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 four years of treatment with oral conjugated equine estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

   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.

 

VIVELLE SUMMARY

Vivelle®

The Vivelle® (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin.

Vivelle is indicated in the following:

  1. Treatment of moderate-to-severe vasomotor symptoms associated with the menopause.
  2. 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.
  3. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
  4. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risks 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 1500 mg/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.


See all Vivelle indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vivelle (Estradiol Transdermal)

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial. [2014]
estradiol or venlafaxine for hot flushes... CONCLUSION: Overall sexual function among nondepressed midlife women experiencing

Effect of estradiol valerate on endometrium thickness during clomiphene citrate-stimulated ovulation. [2014]
CONCLUSIONS: We concluded that the addition of 6 mg/day EV following the CC

[Efficacy and safety of a combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 µg in the treatment of premenstrual dysphoric disorder: a randomized, double blind placebo-controlled study]. [Article in Chinese] [2014]
with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD)... CONCLUSIONS: YAZ could improve symptoms of PMDD better than placebo, while

Impact of estradiol valerate/dienogest on work productivity and activities of daily living in women with heavy menstrual bleeding. [2013]
estradiol valerate/dienogest (E2V/DNG; Qlaira(®)/Natazia(®)) compared to placebo... CONCLUSIONS: E2V/DNG was shown to have a consistent positive impact on work

Effects of tibolone or continuous combined oestradiol/norethisterone acetate on glucose and insulin metabolism. [2013]
insulin metabolism in postmenopausal women... CONCLUSIONS: Tibolone reduces insulin sensitivity. Healthy postmenopausal women

more studies >>

Reports of Suspected Vivelle (Estradiol Transdermal) Side Effects

Dysarthria (8)Hypertension (8)Mental Status Changes (6)Hypokalaemia (6)Polymedication (6)Condition Aggravated (4)Lymphadenopathy (3)Uterine Leiomyoma (3)Lymphoedema (3)Breast Cancer (3)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Vivelle has an overall score of 6. The effectiveness score is 6 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
 

Vivelle review by 39 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Total Hist
Dosage & duration:   0.1 (dosage frequency: 2 a week) for the period of 3 month's
Other conditions:   Hot flashes, severe mood swings
Other drugs taken:   Nothing
  
Reported Results
Benefits:   Decreased hot flashes, minimal mood swing and axiety.
Side effects:   Severe appetite loss and some weight loss.
Comments:   Ive been on the Vivelle patch about 3 month's now. Prior to the patch I was on a sublinqual tablet but that wasnt working so I tried the patch. Te only side affect fromthe patch is severe appetite loss. Some days I have no desire to eat at all not even a craving. This is starting to concern me considering that I'm not trying to loose weight at all. Ive lost about 3 pounds already and about 115 pounds at 5ft tall so this is a problem. Wondering if anyone else has experianced this and have any suggestions? Spoke with the pharmacist and he stated that it may go away but try it for another month. He didnt sound to sure about it either.

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Page last updated: 2015-08-10

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