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Vivelle-Dot

Pronunciation

Generic Name: estradiol transdermal (ES tra DYE ole tranz DERM al)
Brand Name: Alora, Climara, Estraderm, Estradiol Patch, Menostar, Minivelle, Vivelle, Vivelle-Dot

What is Vivelle-Dot (estradiol transdermal)?

Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Estradiol transdermal skin patches are used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medicine is also used to prevent postmenopausal osteoporosis, or to treat ovarian disorders.

Estradiol transdermal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Vivelle-Dot (estradiol transdermal)?

You should not use estradiol if you have: liver disease, a bleeding disorder, unusual vaginal bleeding, history of a hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer), or if you have ever had a heart attack, stroke, or a blood clot.

Slideshow: Flashback: FDA Drug Approvals 2013

Do not use if you are pregnant.

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.

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment.

What should I discuss with my healthcare provider before using Vivelle-Dot (estradiol transdermal)?

You should not use this medicine if you are allergic to estradiol, if you are pregnant, or if you have:

  • unusual vaginal bleeding that a doctor has not checked;

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • a recent history of heart attack or stroke;

  • a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

  • if you have ever had a blood clot (especially in your lung or your lower body).

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure estradiol is safe for you, tell your doctor if you have:

  • heart disease;

  • risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

  • a history of jaundice caused by pregnancy or birth control pills;

  • hereditary angioedema (an immune system disorder);

  • a thyroid disorder;

  • kidney disease;

  • asthma;

  • epilepsy or other seizure disorder;

  • migraines;

  • lupus;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • endometriosis or uterine fibroid tumors;

  • gallbladder disease;

  • high or low levels of calcium in your blood; or

  • if you have had your uterus removed (hysterectomy).

Long-term use of estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol transdermal long term.

FDA pregnancy category X. Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

Estradiol can pass into breast milk. This medicine may slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use Vivelle-Dot (estradiol transdermal)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply the skin patch to clean, dry skin on your stomach or buttocks. Choose a different spot within these skin areas each time you apply a new patch. Avoid skin that is oily, 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.

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.

Some transdermal patches contain aluminum that may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

If you need surgery or medical tests or if you will be on 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 (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estradiol transdermal.

Store 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.

What happens if I miss a dose?

Apply a skin patch as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Vivelle-Dot (estradiol transdermal)?

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Vivelle-Dot (estradiol transdermal) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unusual vaginal bleeding;

  • swelling or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes);

  • a lump in your breast;

  • skin rash;

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • 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 in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

  • low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common side effects may include:

  • headache;

  • weight gain, bloating, stomach cramps, nausea, vomiting;

  • fluid retention (swelling, rapid weight gain);

  • thinning scalp hair;

  • redness or irritation where the patch was worn;

  • breast pain; or

  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

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.

See also: Side effects (in more detail)

What other drugs will affect Vivelle-Dot (estradiol transdermal)?

Other drugs may interact with estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about estradiol transdermal.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 15.01. Revision Date: 2014-10-09, 10:19:49 AM.

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