estradiol and levonorgestrel (transdermal)

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Pronunciation: ess tra DY ol and LEE vo nor JESS trell

Brand: Climara Pro

What is the most important information I should know about estradiol and levonorgestrel?

Do not use if you are pregnant.

You should not use this medicine if you have had a hysterectomy, or if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Estradiol and levonorgestrel 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.

What are estradiol and levonorgestrel?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body. Levonorgestrel is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and levonorgestrel is a combination medicine used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women.

Estradiol and levonorgestrel may also be used for purposes other than those listed here.

What should I discuss with my healthcare provider before using estradiol and levonorgestrel?

You should not use estradiol and levonorgestrel if you are allergic to it, if you are pregnant, or if you have:

  • a history of stroke, heart attack, or blood clots;
  • a bleeding disorder;
  • liver disease;
  • abnormal vaginal bleeding that a doctor has not checked;
  • a history of breast, uterine, or hormone-related cancer;
  • if you have had a hysterectomy; or
  • if you are pregnant.

Estradiol and levonorgestrel 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 this medicine is safe for you, tell your doctor if you have:

  • heart disease;
  • risk factors for coronary artery disease (such as diabetes, 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);
  • hereditary angioedema (an immune system disorder);
  • kidney disease;
  • gallbladder disease;
  • asthma;
  • epilepsy or other seizure disorder;
  • migraines;
  • lupus;
  • endometriosis or uterine fibroid tumors;
  • a thyroid disorder; or
  • high levels of calcium in your blood.

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

Do not use estradiol and levonorgestrel 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 and levonorgestrel can pass into breast milk. This medication may slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use estradiol and levonorgestrel?

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

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Apply the skin patch to clean, dry skin on your lower stomach. The patch should be worn around-the-clock for one week. Choose a different place on your lower stomach 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 putting it back on to a different skin area, pressing the patch into place for 10 seconds. If the patch will not stick you may apply a new one.

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 and levonorgestrel.

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 taking estradiol and levonorgestrel.

Store at room temperature away from moisture and heat. Keep this medicine in the foil pouch until ready to use.

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 estradiol and levonorgestrel?

Avoid exposing the patch to sunlight or tanning beds while you are wearing it on your skin.

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

What are the possible side effects of estradiol and levonorgestrel?

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

Call your doctor at once if you have:

  • 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;
  • vomiting, jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding;
  • a lump in your breast;
  • fluid retention (swelling, rapid weight gain); or
  • high levels of calcium in your blood --nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common side effects may include:

  • nausea, vomiting, bloating, stomach cramps;
  • headache;
  • breast pain;
  • hair loss; or
  • vaginal itching or discharge, 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.

What other drugs will affect estradiol and levonorgestrel?

Many drugs can interact with estradiol and levonorgestrel. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • St. John's wort;
  • an antibiotic or antifungal medicine;
  • heart or blood pressure medicine;
  • antiviral medicine to treat hepatitis or HIV/AIDS;
  • seizure medicine; or
  • tuberculosis medicine.

This list is not complete and many other drugs can interact with estradiol and levonorgestrel. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about estradiol and levonorgestrel.

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.

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