Vivelle-Dot (generic: estradiol) is a prescription medication used to treat the symptoms of menopause including hot flashes and vaginal dryness. It is also used to treat conditions in which a woman's ovaries do not produce enough estrogen naturally, and to prevent osteoporosis in women who have gone through menopause. Vivelle-Dot contains estradiol, a form of the hormone estrogen. It works to reduce symptoms of menopause, and to prevent osteoporosis, by replacing estrogen that the ovaries no longer produce.
Vivelle-Dot is a prescription medication used to treat the symptoms of menopause including hot flashes and vaginal dryness. It is also used to treat conditions in which a woman's ovaries do not produce enough estrogen naturally, and to prevent osteoporosis in women who have gone through menopause.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Less common but serious side effects include:
- Breast cancer
- Cancer of the uterus
- Heart attack
- Blood clots
- Gallbladder disease
- Ovarian cancer
These are some of the warning signs of serious side effects:
- Breast lumps
- Unusual vaginal bleeding
- Dizziness and faintness
- Changes in speech
- Severe headaches
- Chest pain
- Shortness of breath
- Pains in your legs
- Changes in vision
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.
Common side effects include:
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach/abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
Other side effects include:
- High blood pressure
- Liver problems
- High blood sugar
- Fluid retention
- Enlargement of benign tumors of the uterus (“fibroids”)
- Vaginal yeast infection
Other side effects of Vivelle-Dot may be possible. If you have questions, talk to your healthcare provider or pharmacist.
Lower your chances of a serious side effect with Vivelle-Dot
- Talk with your healthcare provider regularly about whether you should continue taking Vivelle-Dot.
- If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.
- See your healthcare provider right away if you get vaginal bleeding while taking Vivelle-Dot.
- Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- St. John's Wort (Hypericum perforatum)
Do not start taking Vivelle-Dot if you:
- have unusual vaginal bleeding.
- currently have or have had certain cancers.
- Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Vivelle-Dot.
- had a stroke or heart attack in the recent past (for example in the past year).
- currently have or have had blood clots.
- currently have or have had liver problems.
- are allergic to Vivelle-Dot or any of its ingredients.
- think you may be, or know that you are, pregnant.
Grapefruit and grapefruit juice may interact with Vivelle-Dot and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
- if you are breast-feeding. The hormone in Vivelle-Dot can pass into your milk.
- about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Vivelle-Dot works. Vivelle-Dot may also affect how other medicines work.
- if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens.
Vivelle-Dot should not be used during pregnancy.
Tell your doctor if you are breastfeeding or plan to breastfeed. Estrogens, when given to nursing mothers, have been shown to decrease the quantity and quality of the milk. Additionally, estrogens are excreted in human breast milk.
1. Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.
2. Estrogens should be used at the lowest dose possible for your treatment, only as long as needed. The lowest effective dose of Vivelle-Dot has not been determined for any indication. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Vivelle-Dot.
Determine Your Schedule for Your Twice-a-Week Application
- Decide upon which two days you will change your patch.
- Your Vivelle-Dot (estradiol transdermal system) individual carton contains a calendar card printed on its inner flap. Mark the two-day schedule you plan to follow on your carton’s inner flap.
- BE CONSISTENT.
- If you forget to change your patch on the correct date, apply a new one as soon as you remember.
- No matter what day this happens, stick to the schedule you have marked on the inner flap of your carton (your calendar card).
Where to Apply Vivelle-Dot
- Apply patch to lower abdomen, below the waistline. Avoid the waistline, since clothing may cause the patch to rub off.
- DO NOT APPLY PATCH TO BREASTS.
- When changing your patch, based on your twice-a-week schedule, apply your new patch to a different site. Do not apply a new patch to that same area for at least one week
Before You Apply Vivelle-Dot
Make sure your skin is:
- Clean (freshly washed), dry and cool.
- Free of any powder, oil, moisturizer or lotion.
- Free of cuts and/or irritations (rashes or other skin problems).
- Contact with water while bathing, swimming or showering will not affect the patch.
- In the event that a patch should fall off, AVOID TOUCHING THE STICKY SIDE WITH YOUR FINGERS. Put the same patch back on a different site, making sure to press the patch firmly into place for at least 10 seconds.
- Continue to follow your original twice-a-week schedule you have marked on the inner flap of your individual carton (your calendar card).
- If necessary, if the same patch cannot be reapplied, apply a new patch at another location but continue to follow your original schedule. 5.
How to Change and Discard Vivelle-Dot
- When changing the patch, peel off the used patch slowly.
- Fold the used patch in half (sticky sides together) and discard appropriately, in the trash.
- PLEASE KEEP OUT OF THE REACH OF CHILDREN.
- If any adhesive residue remains on your skin after removing the patch, allow the area to dry for 15 minutes. Then, gently rub the area with oil or lotion to remove the adhesive from your skin.
- Keep in mind, the new patch must be applied to a different area of your abdomen. This area must be clean, dry, cool and free of powder, oil or lotion.
Apply Vivelle-Dot exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. Dosage must be individualized.
If you apply too much Vivelle-Dot (overdose) call your local Poison Control Center right away.
Vivelle-Dot is available in the following strengths: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.
Vivelle-Dot is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used.
The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.
Do not store above 25°C (77°F). Do not store outside of their pouches. Apply immediately upon removal from the protective pouch.
Keep this and all medicines out of reach of children.
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.
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease.
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 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.
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 or to women taking estrogen alone therapy.
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.