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Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.
Vivelle-Dot skin patches are used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Vivelle-Dot is also used to prevent postmenopausal osteoporosis, or to treat ovarian disorders.
Vivelle-Dot may also be used for purposes not listed in this medication guide.
You should not use estradiol if you have: undiagnosed vaginal bleeding, liver disease, coronary artery disease, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Do not use if you are pregnant.
Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.
Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol should not be used to prevent heart disease, stroke, or dementia.
You should not use estradiol if you are allergic to it, or if you have:
unusual vaginal bleeding that has not been checked by a doctor;
liver disease;
coronary artery disease;
a bleeding disorder;
a history of heart attack, stroke, or blood clot; or
a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.
Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
Using estradiol can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.
Estradiol should not be used to prevent heart disease, stroke, or dementia, because Vivelle-Dot may actually increase your risk of developing these conditions.
Tell your doctor if you have ever had:
heart disease;
liver problems, or jaundice caused by pregnancy or taking hormones;
a thyroid disorder;
gallbladder disease;
kidney disease;
asthma;
epilepsy or other seizure disorder;
migraine headaches;
lupus;
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
endometriosis or uterine fibroid tumors;
high levels of calcium in your blood; or
hereditary angioedema (an immune system disorder).
Using estradiol may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.
Estradiol can slow breast milk production. Tell your doctor if you are breast-feeding.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Apply the skin patch to clean, dry skin on your stomach or buttocks. Press the patch firmly into place for at least 10 seconds. Choose a different spot within these skin areas each time you apply a new patch. Do not use the same skin area twice within 7 days. Avoid skin that is irritated or damaged.
Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband. Never cut a skin patch.
If a patch falls off, try sticking it back into place. If it does not stick well, put on a new patch on a different skin area and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.
Remove the patch and apply a new one on the same day(s) each week to stay on your once-weekly or twice-weekly schedule.
Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.
If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.
Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using Vivelle-Dot.
Store patches at room temperature away from moisture and heat. Keep each patch in its pouch until you are ready to use it.
After removing a skin patch, fold it in half so it sticks together. Discard the folded patch in a place children and pets cannot get to.
If you forget to change your patch, change it as soon as you remember or wait until your next scheduled patch change. Do not apply two patches at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol.
Grapefruit may interact with estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.
Avoid using creams, lotions, or powders on the skin where you apply the patch, or it may not stick to your skin.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have:
heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
swelling or tenderness in your stomach;
jaundice (yellowing of the skin or eyes);
unusual vaginal bleeding, pelvic pain;
a breast lump;
memory problems, confusion, unusual behavior; or
high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.
Common side effects may include:
headache, back pain;
stuffy nose, sinus pain, sore throat;
vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
bloating, stomach cramps, nausea, vomiting;
breast pain;
redness or irritation where the patch was worn;
thinning scalp hair; or
fluid retention (swelling, rapid weight gain).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Vivelle-dot (www.drugs.com/mtm/vivelle-dot.html).
Note: This document contains side effect information about estradiol. Some of the dosage forms listed on this page may not apply to the brand name Vivelle-Dot.
Common side effects of Vivelle-Dot include: headache. Other side effects include: limb pain. See below for a comprehensive list of adverse effects.
Applies to estradiol: vaginal capsule liquid filled, vaginal cream, vaginal insert extended release, vaginal tablet
Other dosage forms:
Vaginal route (Insert, Extended Release; Cream)
Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported in women receiving estrogen alone or estrogen combined with progestins. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible.
Vaginal route (Insert, Extended Release)
Use of unopposed estrogens increases the risk of endometrial cancer, while addition of a progestin decreases the risk of endometrial hyperplasia. Rule out malignancy if abnormal vaginal bleeding develops. Do not use estrogen alone or in combination with progestin to prevent cardiovascular disease or dementia. There is an increased risk of cardiovascular disorders (ie, DVT, pulmonary embolism, stroke, myocardial infarction) with combination therapy in women 50 years or older, and an increased risk of dementia in women 65 years or older with estrogen monotherapy or combination therapy. Combination therapy also increases the risk of invasive breast cancer. Prescribe estrogens with or without progestins at the lowest effective dose and for the shortest duration consistent with risks and treatment goals.
Along with its needed effects, estradiol (the active ingredient contained in Vivelle-Dot) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking estradiol:
Less common
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking estradiol:
Symptoms of overdose
Some side effects of estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Incidence not known
Applies to estradiol: compounding powder, intramuscular solution, oral tablet, transdermal emulsion, transdermal film extended release, transdermal gel, transdermal spray, vaginal ring
Very common (10% or more): Breast pain (29%)
Common (1% to 10%): Vulvovaginal pruritus, leukorrhea, vaginal hemorrhage, vaginal discharge, vaginal discomfort, menopause symptoms, breakthrough bleeding or spotting, dysmenorrhea, breast swelling, menorrhagia, metrorrhagia, endometrial hyperplasia
Uncommon (0.1% to 1%): Urinary problems
Rare (less than 0.1%): Galactorrhea
Postmarketing reports: Vaginal irritation, vaginal pain, genital pruritus, changes in bleeding pattern, pelvic pain, breast tenderness, vaginal ulceration, uterine fibroids
Very common (10% or more): Abdominal pain (16%),
Common (1% to 10%): Flatulence, nausea, diarrhea
Uncommon (0.1% to 1%): Vomiting
Postmarketing reports: Abdominal distension
Very common (10% or more): Back pain (11%), arthralgia (11%)
Common (1% to 10%): Leg cramps
Common (1% to 10%): Varicose veins, cardiac symptoms (e.g. palpitations)
Uncommon (0.1% to 1%): Hot flush, hypertension, venous thromboembolic disease
Rare (less than 0.1%): Arterial hypertension
Postmarketing reports: Deep vein thrombosis, changes in blood pressure
Very common (10% or more): Headache (18%)
Uncommon (0.1% to 1%): Vertigo, migraine
Rare (less than 0.1%): Aggravation of epilepsy
Postmarketing reports: Migraine aggravated, paresthesia, dizziness
Uncommon (0.1% to 1%): Benign breast neoplasm, increased volume of uterine leiomyoma
Postmarketing reports: Endometrial cancer, breast cancer
Very common (10% or more): Pain (11%)
Common (1% to 10%): Edema
Uncommon (0.1% to 1%): Weight increased, asthenia
Postmarketing reports: Drug ineffectiveness, blood estrogen increase, fatigue, exacerbation of hereditary angioedema
Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Sleep disorders, nervousness, mood swings
Rare (less than 0.1%): Change in libido
Postmarketing reports: Vaginismus, insomnia, anxiety, irritability
Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Rash
Rare (less than 0.1%): Skin discoloration, acne
Postmarketing reports: Urticaria, erythematous or pruritic rash, alopecia, hyperhidrosis, night sweats, contact dermatitis, eczema
Uncommon (0.1% to 1%): Vision abnormal NOS
Postmarketing reports: Visual disturbances, contact lens intolerance
Rare (less than 0.1%): Liver function tests abnormalities
Postmarketing reports: Cholestatic jaundice
Rare (less than 0.1%): Glucose intolerance
Postmarketing reports: Fluid retention
Rare (less than 0.1%): Anaphylactic reaction (with a past history of allergic reaction)
Postmarketing reports: Anaphylactic reactions, hypersensitivity
Very common (10% or more): Upper respiratory tract infection (17%)
Common (1% to 10%): Vulvovaginal mycotic infection, pharyngitis, rhinitis, sinusitis, moniliasis genital
Uncommon (0.1% to 1%): Vaginitis/vaginal candidosis
Common (1% to 10%): Skin irritation (topical gel)
Postmarketing reports: Application site reaction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Vivelle-dot (www.drugs.com/mtm/vivelle-dot.html).
February 12, 2020
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