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Estradiol/ levonorgestrel weekly patch

Generic Name: estradiol/levonorgestrel (ES-tra-DYE-ol/s LEE-voe-nor-JES-trel)
Brand Name: Climara Pro

Estrogens have been reported to increase the chance of womb (endometrial) cancer. Estrogen-containing products should not be used to prevent heart disease, heart attack, stroke, or dementia. Estrogen given alone or in combination with another hormone (progestin) for replacement therapy may increase your risk for heart disease (eg, heart attacks), stroke, serious blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), dementia, or breast cancer. These risks appear to depend on the length of time estradiol/levonorgestrel weekly patch is used and the amount of estrogen per dose. Therefore, estradiol/levonorgestrel weekly patch should be used for the shortest possible length of time at the lowest effective dose so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.


Estradiol/ levonorgestrel weekly patch is used for:

Treating certain symptoms of menopause (eg, hot flashes). It is used to prevent osteoporosis (weak bones) after menopause in certain patients. It may also be used for other conditions as determined by your doctor.

Estradiol/levonorgestrel weekly patch is a combination of progestin and estrogen hormones. It works by replacing natural progestin and estrogen in women who do not produce enough of these hormones.

Do NOT use estradiol/ levonorgestrel weekly patch if:

  • you are allergic to any ingredient in estradiol/levonorgestrel weekly patch
  • you are pregnant or think you may be pregnant
  • you have liver problems, undiagnosed abnormal vaginal bleeding, estrogen-dependent growths, or certain clotting problems (eg, protein C, protein S, or antithrombin deficiency)
  • you have or have had a history of blood clots (eg, in the lungs, legs, eyes) or breast cancer
  • you have ever had bleeding in the brain, stroke, heart attack, or other serious blood vessel problems

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using estradiol/ levonorgestrel weekly patch:

Some medical conditions may interact with estradiol/levonorgestrel weekly patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had your uterus removed (hysterectomy) or you have a history of endometrial, cervical, or vaginal cancer; endometriosis; growths in the uterus; uterine fibroids; abnormal mammograms; or lumps in the breast
  • if you have a history of angioedema, asthma, kidney problems, heart problems (eg, heart failure), high blood pressure, blood vessel problems, heart attack, stroke, high cholesterol or lipid levels, diabetes, depression, dementia, gallbladder problems, or pancreas problems
  • if you have high or low blood calcium levels or a history of cancer, growths in the liver, lupus, blood problems (eg, porphyria), migraine headaches, seizures, thyroid problems, or vision loss
  • if you have a history of fluid retention (swelling) or tobacco use, or if you are very overweight
  • if a member of your family has ever had a blood clot (eg, in the lung, leg)
  • if you have a history of jaundice (yellowing of the eyes or skin) caused by pregnancy or estrogen use
  • if you will be confined to a bed or chair for an extended period of time (eg, because of surgery or a long airplane ride)

Some MEDICINES MAY INTERACT with estradiol/levonorgestrel weekly patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, clarithromycin) because they may increase the risk of estradiol/levonorgestrel weekly patch's side effects
  • Acitretin, aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, rifampin, or St. John's wort because they may decrease estradiol/levonorgestrel weekly patch's effectiveness
  • Anticoagulants (eg, warfarin) or corticosteroids (eg, prednisone) because the risk of their side effects may be increased by estradiol/levonorgestrel weekly patch
  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased by estradiol/levonorgestrel weekly patch

This may not be a complete list of all interactions that may occur. Ask your health care provider if estradiol/levonorgestrel weekly patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use estradiol/ levonorgestrel weekly patch:

Use estradiol/levonorgestrel weekly patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet with detailed instructions for use is available with estradiol/levonorgestrel weekly patch. Talk to your pharmacist if you have questions about this information.
  • Estradiol/levonorgestrel weekly patch is for external use only. Do not get it in your mouth.
  • The patch is replaced once a week (every 7 days) or as directed by your doctor. Follow the dosing schedule carefully.
  • Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button or on the upper buttocks. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts, press down to reapply. Wear only 1 system at any one time.
  • Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.
  • When it is time to change the patch, remove it slowly, fold in half (sticky sides together), and throw it away out of the reach of children and away from pets.
  • Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor right away.
  • Eating grapefruit or drinking grapefruit juice while you are taking estradiol/levonorgestrel weekly patch may increase the amount of estradiol/levonorgestrel weekly patch in your blood, which may increase your risk for side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
  • If you forget to change the patch as scheduled, change it as soon as possible and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use estradiol/levonorgestrel weekly patch.

Important safety information:

  • Tell your doctor or dentist that you take estradiol/levonorgestrel weekly patch before you receive any medical or dental care, emergency care, or surgery. Estradiol/levonorgestrel weekly patch should be discontinued at least 4 to 6 weeks before surgery or any time you will be confined to a chair or bed for a long period of time (eg, a long plane flight). Talk to your doctor about the safe use of estradiol/levonorgestrel weekly patch if any of these conditions apply to you.
  • Estradiol/levonorgestrel weekly patch may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker. Ask your doctor whether you should use sunscreen or wear protective clothing when your skin is exposed to the sun, sunlamps, or tanning booths.
  • Estradiol/levonorgestrel weekly patch may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
  • Follow your doctor's instructions for examining your breasts and report any lumps immediately.
  • If you wear contact lenses and you develop problems with them or with your vision, contact your doctor as soon as possible.
  • Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
  • Diabetes patients - Estradiol/levonorgestrel weekly patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Estradiol/levonorgestrel weekly patch may affect certain lab test results. Make sure laboratory personnel and your doctors know you take estradiol/levonorgestrel weekly patch.
  • You should talk with your doctor regularly to determine whether or not you still need to take estradiol/levonorgestrel weekly patch.
  • Lab tests, including physical exams and blood pressure, may be performed while you use estradiol/levonorgestrel weekly patch. You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Estradiol/levonorgestrel weekly patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use estradiol/levonorgestrel weekly patch if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if estradiol/levonorgestrel weekly patch if found in breast milk after topical use. If you are or will be breast-feeding while you use estradiol/levonorgestrel weekly patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of estradiol/ levonorgestrel weekly patch:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; skin redness or irritation at the application site; stomach cramps or bloating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bulging eyes; calf or leg pain, swelling, redness, or tenderness; chest pain; confusion; coughing up blood; discharge from the nipples; fainting; lumps in the breast; memory problems; mental or mood changes (eg, depression); numbness of an arm or leg; one-sided weakness; severe or persistent breast pain; severe or persistent dizziness, headache, or stomach pain; severe, persistent, or recurring abnormal vaginal bleeding; speech changes (eg, slurred speech); sudden severe nausea or vomiting; sudden shortness of breath; sudden unusual weight gain; swelling of hands or feet; unusual tiredness or weakness; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of estradiol/levonorgestrel weekly patch:

Store estradiol/levonorgestrel weekly patch at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep estradiol/levonorgestrel weekly patch out of the reach of children and away from pets.

General information:

  • If you have any questions about estradiol/levonorgestrel weekly patch, please talk with your doctor, pharmacist, or other health care provider.
  • Estradiol/levonorgestrel weekly patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take estradiol/levonorgestrel weekly patch or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about estradiol/levonorgestrel weekly patch. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to estradiol/levonorgestrel weekly patch. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using estradiol/levonorgestrel weekly patch.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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