Climara Pro

Generic Name: Estradiol and levonorgestrel transdermal system

  • What is Climara Pro?

    Climara Pro is a medicine containing the two hormones estrogen and progestin. It is used to reduce the symptoms of menopause, such as hot flashes and osteoporosis (thin and weak bones).
  • What is the most important information I should know about Climara Pro?

    Do not use Climara Pro (estrogen/progestin) to prevent heart disease, heart attacks, or strokes, or dementia. Using it may increase your chances of having heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your doctor should talk regularly about whether you still need treatment with this drug.

    Climara Pro may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

    Talk to your doctor before you take Climara Pro if you drink more than 3 alcoholic drinks per day.

    Climara Pro may cause dark skin patches on your face. Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.

    Climara Pro may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke, especially if you are older than 35 years.

    Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention. Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Climara Pro. 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, contact your doctor.

    If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Climara Pro.

    Climara Pro may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

    Climara Pro may affect certain lab test results. Make sure laboratory personnel and your doctors know you take Climara Pro.

    Grapefruit and grapefruit juice may increase the risk of side effects of this medication. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Climara Pro.

  • Who should not take Climara Pro?

    Do not use Climara Pro if you have had your uterus removed (hysterectomy) or if you have had unusual vaginal bleeding, cancer, heart attack or stroke within the year, blood clots, liver problems, or are allergic to any of the drug's ingredients.
  • What should I tell my doctor before I take the first dose of Climara Pro?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Climara Pro. Also, talk to your doctor about your complete medical history, especially if you have a family history of breast cancer, high blood pressure, vaginal infection or womb problems, abnormal vaginal bleeding, asthma, cancer, heart disease or other heart problems, kidney or liver disease, disease of the pancreas, seizures, lupus, or low thyroid hormone levels. Also, tell your doctor if you are pregnant, plan to become pregnant, breastfeeding, will have surgery, or will be on bed rest.
  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (3-month to 6-month intervals) to determine if treatment is still necessary.

    Adults: Climara Pro is applied weekly. The patch delivers 0.045 milligrams (mg) of estradiol per day and 0.015 mg of levonorgestrel per day. The lowest effective dose of this medication has not been determined.

    Women not currently using continuous estrogen or combination estrogen/progestin therapy may start therapy with Climara Pro at any time. However, women currently using continuous estrogen or combination estrogen/progestin therapy should complete the current cycle of therapy before initiating Climara Pro therapy. Women often experience withdrawal bleeding at the completion of the cycle. The first day of this bleeding would be an appropriate time to begin therapy.

  • How should I take Climara Pro?

    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. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the patch lifts up, press down to reapply. Wear only one patch 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. Should any of the adhesive remain on the skin after removal of the patch, allow the area to dry for 15 minutes and then gently rub the area with an oil-based cream or lotion.

    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 promptly.

  • What should I avoid while taking Climara Pro?

    Avoid exposing the patch to sunlight for extended periods of time. Water contact and tight clothing may cause the patch to fall off. If this occurs, re-apply the same patch; if Climara Pro does not adhere, apply a new patch to a different area of the lower abdomen.

    Do not eat grapefruit or drink grapefruit juice while you use Climara Pro without first speaking with your doctor.

    Do not drive or perform other possibly unsafe tasks until you know how you react to Climara Pro; this medication may cause drowsiness.

  • What are possible food and drug interactions associated with Climara Pro?

    If Climara Pro is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Climara Pro with the following: anticoagulants, barbiturates, corticosteroids, phenytoin, rifampin, succinylcholine, and tacrine.
  • What are the possible side effects of Climara Pro?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: breast pain, hair loss, headache, irregular vaginal bleeding/spotting, nausea, stomach cramps/bloating, vomiting, calf pain or tenderness, change in vision or speech, dizziness

  • Can I receive Climara Pro if I am pregnant or breastfeeding?

    Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. Hormones are not indicated for use during pregnancy or immediately after birth. Increased risk of fetal reproductive tract disorders and other birth defects have been observed. Do not use during pregnancy. Use caution in breastfeeding.
  • What should I do if I miss a dose of Climara Pro?

    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.
  • How should I store Climara Pro?

    Store at room temperature in the original sealed pouch. Store away from heat, moisture, and light. Do not store in the bathroom.