Climara Pro

Generic Name: estradiol and levonorgestrel (topical patches) (ess tra DY ol and LEE vo nor JESS trell)
Brand Name: Climara Pro

What are estradiol and levonorgestrel?

Estradiol is a form of estrogen, a female hormone involved in the development and maintenance of the female reproductive system. Levonorgestrel is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and levonorgestrel is used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women. This medication will not prevent dementia, heart attack, heart disease, or stroke.

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

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

This medication should not be used to prevent heart disease or dementia. Using estrogens long-term may actually increase your risk of heart attack, stroke, dementia, breast cancer, blood clots.

To be sure this medication is helping your condition, you will need to have regular physical exams every 3 to 6 months. You may also need breast mammograms. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.

Slideshow: Flashback: FDA Drug Approvals 2013

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

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

You should not use estradiol and levonorgestrel if you have had a hysterectomy, or if you have any of the following:

  • a history of stroke, heart attack, or blood clots;

  • liver disease;

  • unusual vaginal bleeding; or

  • a history of breast, uterine, or hormone-related cancer.

Before using estradiol and levonorgestrel, tell your doctor if you have:

  • high blood pressure, angina, or heart disease;

  • kidney disease;

  • a history of gallbladder disease;

  • asthma;

  • epilepsy;

  • migraines;

  • a thyroid disorder; or

  • endometriosis.

If you have any of the conditions listed above, you may not be able to use estradiol and levonorgestrel, or you may need a dosage adjustment or special tests during treatment.

You may need to stop using estradiol and levonorgestrel for a short time if you will have surgery or you become ill and must stay in bed for any length of time. Tell any doctor who treats you that you are using this medication.

This medication should not be used to prevent heart disease or dementia. Using estrogens long-term may actually increase your risk of heart attack, stroke, dementia, breast cancer, or blood clots. This risk is higher if you are overweight, if you smoke tobacco or have diabetes, high blood pressure, systemic lupus erythematosus, high cholesterol or high triglycerides. Talk with your doctor about your individual risks and benefits if you plan to use estradiol and levonorgestrel long-term.

Estradiol may increase your risk of developing endometrial hyperplasia, a condition that can lead to cancer of the uterus. Using levonorgestrel (a progestin) with estradiol can lower the risk of developing this condition.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and levonorgestrel. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.

FDA pregnancy category X: This medication can cause birth defects. Do not use estradiol and levonorgestrel if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Estradiol and levonorgestrel may cause problems with breast-feeding and can affect breast milk. Do not use estradiol and levonorgestrel without telling your doctor if you are breast-feeding a baby.

How should I use estradiol and levonorgestrel?

Use the estradiol and levonorgestrel patches exactly as your doctor has prescribed them for you. Do not use more patches than recommended or use them for longer than your doctor has prescribed.

If you have been using another form of estrogen and progestin and are switching to estradiol and levonorgestrel skin patches, finish your current cycle of treatment first. If you are not already using an estrogen or progestin, you may begin using the skin patches at any time.

To use estradiol and levonorgestrel patches:

  • Apply each patch to a clean, dry, and smooth (fold free) area of skin on the lower stomach (below the belly button). Do not use the patch on your breasts or at your waistline, where tight-fitting clothing may interfere with its use. Do not apply to broken or irritated skin.

  • Open the pouch and take out the patch. Remove one side of the protective liner, trying not to touch the sticky part. Apply the patch and then remove the second side of the liner. Press the patch firmly in place with your hand for at least 10 seconds, making sure there is good contact, especially around the edges.

  • If a patch falls off, reapply it to another place on your lower abdomen. If it will not stick, apply a new patch.

  • The patch should be worn around-the-clock for one week. Replace the patch on the same day each week as directed by your doctor. Use only one patch at a time.

  • Choose a new place on your lower abdomen each time you apply a patch. Allow at least 1 week to pass before applying a patch to the same place.

  • Do not cut the patches.

  • After one week, remove the patch and fold it in half so that it sticks to itself. Used patches still contain active hormones and should be discarded out of the reach of children and pets.

  • Remove the patch carefully and slowly to avoid irritating your skin. Any adhesive remaining on the skin can be removed with baby oil.

To be sure this medication is helping your condition, you will need to have regular physical exams every 3 to 6 months. You may also need breast mammograms. It is important that you not miss any scheduled visits to your doctor. Call your doctor at any time if you have unusual vaginal bleeding.

If you use this medication to prevent osteoporosis, your doctor may also recommend weight-bearing exercise, calcium and vitamin D supplements, and dietary changes. Follow these directions carefully and ask your doctor before using any supplements.

Store the patches in their sealed foil pouches at room temperature away from moisture, heat, and direct light.

What happens if I miss a dose?

Apply the next patch as soon as you remember. Continue to follow your regular schedule for changing the patch. Do not use extra patches to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a estradiol and levonorgestrel overdose may include nausea, vomiting, and withdrawal bleeding in females.

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.

Estradiol and levonorgestrel side effects

Stop using this medication and 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 any of the following serious side effects:

  • signs of a blood clot (sharp chest pain, coughing up blood, shortness of breath, pain in your calf);

  • signs of a heart attack (crushing chest pain, left-arm numbness);

  • signs of a stroke (sudden severe headache, problems with vision or speech, weakness, numbness);

  • nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • new or changing breast lumps.

Other less serious side effects are more likely to occur, such as:

  • nausea and vomiting;

  • tender or swollen breasts;

  • swelling of the hands or feet;

  • darkened spots on the skin of your face;

  • contact lens discomfort;

  • vaginal irritation or discomfort;

  • headache, depressed mood;

  • a skin rash or reaction where the patch is worn; or

  • changes in your menstrual periods.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect estradiol and levonorgestrel?

Before using estradiol and levonorgestrel, tell your doctor if you are taking an anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to use estradiol and levonorgestrel, or you may require a dosage adjustment or special tests during treatment.

There may be other drugs that can affect estradiol and levonorgestrel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has additional information about estradiol and levonorgestrel written for health professionals that you may read.
  • 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: 2.04. Revision Date: 2010-12-15, 5:01:39 PM.

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