Climara Pro

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

What is Climara Pro?

Climara Pro is a skin patch containg 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.

Climara Pro is used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women.

Climara Pro may also be used for purposes other than those listed here.

Important information

Do not use Climara Pro patches if you are pregnant.

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

Slideshow: Flashback: FDA Drug Approvals 2013

Climara Pro patches 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 of Climara Pro may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risk.

To be sure Climara Pro 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.

Before using Climara Pro

You should not use Climara Pro if you are allergic to estradiol and levonorgestrel, or if you have any of the following:

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

  • 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.

To make sure Climara Pro 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 Climara Pro may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using this medicine long term.

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

FDA pregnancy category X: Do not use Climara Pro if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

How should I use Climara Pro?

Use the Climara Pro patches exactly as your doctor has prescribed them for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Climara Pro 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 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 Climara Pro 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 medication for a short time. Any doctor or surgeon who treats you should know that you are using Climara Pro.

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 while using Climara Pro transdermal.

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?

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.

Climara Pro side effects

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

Call your doctor at once if you have:

  • chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs;

  • vomiting, jaundice (yellowing of the skin or eyes);

  • unusual vaginal bleeding; or

  • a lump in your breast.

Common Climara Pro side effects may include:

  • 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.

See also: Side effects (in more detail)

What other drugs will affect Climara Pro?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Climara Pro, especially:

  • nefazodone, St. John's wort;

  • an antibiotic--clarithromycin, erythromycin, telithromycin; antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole; heart medication--nicardipine, quinidine;

  • hepatitis C medications--boceprevir, telaprevir; HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; tuberculosis medication--isoniazid, rifabutin, rifampin, rifapentine.

This list is not complete and there are many other drugs that can interact with Climara Pro transdermal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist has additional information about Climara Pro 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 Climara Pro 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 1996-2014 Cerner Multum, Inc. Version: 3.01. Revision Date: 2013-07-17, 9:35:59 PM.

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