Vivelle-Dot is a prescription medication used to treat symptoms of menopause including hot flashes and vaginal dryness. It is used to treat conditions in which a woman's ovaries do not produce enough estrogen naturally (hypoestrogenism). It is also used to help prevent osteoporosis after menopause. The active ingredient in Vivelle-Dot, estradiol, is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes as a long acting transdermal patch. It is usually applied twice a week. 

Common side effects of Vivelle-Dot include headache and breast pain. 

Vivelle-Dot is a prescription medication used to treat treat symptoms of menopause including hot flashes and vaginal dryness. It is used to treat conditions in which a woman's ovaries do not produce enough estrogen naturally (hypoestrogenism). It is also used to help prevent osteoporosis after menopause.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported withVivelle-Dot. See the “Vivelle-Dot Precautions” section.

Common side effects of Vivelle-Dot include the following:

• headache
• breast pain or tenderness
• nausea
• vomiting
• constipation
• gas
• heartburn
• weight gain or loss
• hair loss
• redness or irritation of the skin that was covered by Vivelle-Dot
• swelling, redness, burning, irritation or itching of the vagina
• vaginal discharge
• painful menstrual periods
• anxiety
• depression
• changes in mood
• change in sexual desire
• back, neck, or muscle pain
• runny nose or congestion
• cough
• darkening of skin on face (may not go away even after you stop using Vivelle-Dot)
• unwanted hair growth

This is not a complete list of Vivelle-Dot side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate)
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Vivelle-Dot drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vivelle-Dot including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not use Vivelle-Dot if you:

• are allergic to Vivelle-Dot or to any of its ingredients
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• have a blood clot
• have a history of blood clots
• are currently having a heart attack or stroke
• have a history of heart attack or stroke
• have liver disease
• have certain bleeding disorders
• are pregnant or possibly 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.

Before taking Vivelle-Dot, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Vivelle-Dot or to any of its ingredients
• have or have ever had asthma
• have seizures
• have migraine headaches
• have endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body)
• have uterine fibroids (growths in the uterus that are not cancer)
• have or have had yellowing of the skin or eyes, especially during pregnancy or while you were using an estrogen product
• have very high or very low levels of calcium in your blood
• have porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system) or gallbladder, thyroid, pancreas, liver or kidney disease
• have had a heart attack or stroke
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• have had blood clots
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Vivelle-Dot should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while using Vivelle-Dot.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Vivelle-Dot should not be used during breastfeeding. Estradiol has been detected in human breast milk. Estradiol can decrease the quality or quantity of breast milk. A choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Use Vivelle-Dot exactly as prescribed.

This medication is available as a long acting transdermal patch. It is usually applied twice a week. 

• Apply patch to a dry area of the skin of the trunk of the body, including the lower abdomen, or buttocks. 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 1 week.
• Make sure your skin is clean (freshly washed), dry and cool. Make sure it free of any powder, oil, moisturizer or lotion. make sure your skin is free of cuts or irritations (rashes or other skin problems).
• Apply the patch immediately after removing from the pouch.
• Press the entire patch firmly into place with the palm of your hand.
• Continue to apply pressure, with the palm of your hand over the patch, for approximately 10 seconds.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Vivelle-Dot (estradiol) transdermal patches for the treatment of menopause symptoms is 0.0375 mg per day applied to the skin twice weekly. 

The recommended starting dose of Vivelle-Dot (estradiol) transdermal patches for the prevention of osetoprosis in women after menopause is 0.025 mg per day applied to the skin twice weekly.

If you use to much Vivelle-Dot, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Vivelle-Dot is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at room temperature.
• Keep this and all medicines out of the reach of children.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

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.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.

The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE plus MPA, and other 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 consistent with treatment goals and risks for the individual woman.