CLIMARA PRO (Transdermal)
Climara Pro is a transdermal patch containing a combination of two female hormones, estradiol and levonorgestrel. As a form of hormone replacement therapy (HRT), it is designed to provide a continuous, low-dose delivery of these hormones through the skin. This once-weekly patch offers a convenient and effective treatment option for postmenopausal women with a uterus, addressing a range of symptoms associated with the decline in natural hormone production. The use of a combination of estrogen (estradiol) and a progestin (levonorgestrel) is crucial for women who still have their uterus, as the progestin helps to protect the uterine lining from the increased risk of endometrial cancer that can be associated with estrogen-only therapy.
Uses & Indications
Climara Pro is specifically indicated for the following uses in postmenopausal women with an intact uterus:
1. Treatment of Moderate-to-Severe Vasomotor Symptoms: Vasomotor symptoms, commonly known as hot flashes and night sweats, are a hallmark of menopause. These symptoms can be highly disruptive to a woman’s quality of life, affecting sleep, work, and daily activities. The estradiol in Climara Pro helps to alleviate these symptoms by supplementing the body’s declining estrogen levels, thus stabilizing the body’s temperature regulation.
2. Prevention of Postmenopausal Osteoporosis: Osteoporosis is a condition characterized by a decrease in bone mass and density, leading to an increased risk of fractures. Estrogen plays a vital role in maintaining bone density. After menopause, the rapid decline in estrogen production can accelerate bone loss. Climara Pro, by providing a steady supply of estradiol, can help to prevent bone loss and reduce the risk of osteoporosis-related fractures in postmenopausal women. While effective, it’s important to note that the use of non-estrogen medications should be considered first when the primary goal is solely the prevention of osteoporosis.
How It Works
The effectiveness of Climara Pro stems from its unique combination of hormones and its transdermal delivery system.
Estradiol: This is the primary active ingredient and is a bioidentical form of estrogen, meaning its chemical structure is identical to the estrogen naturally produced by the ovaries. By supplementing the body’s estrogen levels, estradiol acts on estrogen receptors throughout the body. In the brain, it helps to regulate the thermoregulatory center, reducing the frequency and severity of hot flashes. In the bones, it helps to slow the rate of bone resorption (breakdown), promoting the preservation of bone density.
Levonorgestrel: This is a synthetic progestin, a hormone that mimics the effects of progesterone. For postmenopausal women with a uterus, estrogen therapy alone can stimulate the growth of the uterine lining (endometrium), which can lead to a condition called endometrial hyperplasia. If left unchecked, endometrial hyperplasia can increase the risk of endometrial cancer. The levonorgestrel in Climara Pro counteracts this effect by helping to shed the uterine lining, thereby preventing excessive endometrial growth and significantly reducing the risk of endometrial cancer.
Transdermal Delivery: The transdermal patch system allows for the continuous and controlled release of estradiol and levonorgestrel directly into the bloodstream, bypassing the gastrointestinal system and the liver’s first-pass metabolism. This is a key advantage over oral hormone therapy, as it allows for a lower total dose of hormones to achieve therapeutic effects, potentially reducing some of the associated side effects and risks. The patch ensures stable hormone levels for the entire seven-day application period.
Dosage and Administration
Climara Pro is a once-weekly transdermal system. It is crucial to follow the administration instructions precisely for both safety and effectiveness.
Application Site: The patch should be applied to a clean, dry, and smooth area of skin on the lower abdomen or the upper outer quadrant of the buttock. It is important to avoid applying the patch to the breasts, a waistline where tight clothing may rub it off, or to any skin that is oily, damaged, or irritated.
Application Process:
- Open the pouch and immediately remove the patch and the protective liner.
- Press the patch firmly onto the chosen application site with your fingers for at least 10 seconds, ensuring good contact, especially around the edges.
- Rotate the application site with each new patch. Do not apply a new patch to the same spot for at least one week to prevent skin irritation.
Schedule: Climara Pro is a once-weekly patch. A new patch should be applied on the same day each week. If a patch falls off, the same patch may be reapplied to a new area. If it cannot be reapplied, a new patch should be put on, and the original treatment schedule should be maintained. Only one patch should be worn at a time.
Duration of Use: The lowest effective dose for the shortest duration is recommended. Healthcare providers should periodically re-evaluate the need for continued treatment, typically at 3- to 6-month intervals.
Side Effects
As with any medication, Climara Pro can cause side effects. These can range from mild and temporary to more serious. It is essential to be aware of the potential side effects and to consult a healthcare provider if they are persistent or severe.
Common Side Effects:
- Application site reactions: This is one of the most frequently reported side effects and may include skin redness, irritation, itching, or rash at the site of the patch.
- Breast pain or tenderness: This is a common and often mild side effect related to hormonal changes.
- Nausea, vomiting, and abdominal pain: Gastrointestinal discomfort may occur, particularly at the beginning of treatment.
- Headache: Headaches can be a side effect of hormone fluctuations.
- Weight changes: Some women may experience slight weight gain, which can be related to fluid retention.
- Irregular vaginal bleeding or spotting: This is especially common during the initial months of therapy.
- Fluid retention (edema): Swelling in the hands, ankles, or feet.
Serious Side Effects (Seek immediate medical attention if you experience any of these):
- Cardiovascular events: Increased risk of myocardial infarction (heart attack), stroke, and blood clots (e.g., deep vein thrombosis or pulmonary embolism). Symptoms may include chest pain, shortness of breath, sudden numbness or weakness on one side of the body, slurred speech, or pain and swelling in a leg.
- Breast cancer: The use of estrogen-plus-progestin therapy has been associated with an increased risk of invasive breast cancer.
- Endometrial cancer: While the progestin in Climara Pro is designed to mitigate this risk, any unusual or persistent vaginal bleeding should be reported to a doctor for evaluation.
- Gallbladder disease: Estrogen therapy can increase the risk of gallbladder problems.
- Liver problems: Symptoms may include jaundice (yellowing of the skin or eyes), severe stomach pain, or dark urine.
Warnings and Precautions
Before starting Climara Pro, a thorough medical history and physical examination should be conducted. It is essential to discuss all pre-existing conditions and medications with a healthcare provider.
Contraindications (Do not use Climara Pro if you have):
- A history of or current breast cancer.
- A history of or current endometrial cancer or other estrogen-dependent tumors.
- Undiagnosed abnormal genital bleeding.
- A history of or current blood clots (e.g., deep vein thrombosis, pulmonary embolism).
- A history of or current heart attack or stroke.
- Liver disease.
- Protein C, Protein S, or antithrombin deficiency.
- Known or suspected pregnancy.
General Precautions:
- Cardiovascular Risk: Estrogen-plus-progestin therapy should not be used to prevent heart disease or stroke.
- Breast Health: All women should have yearly breast examinations and perform monthly breast self-exams. Mammograms should be scheduled based on individual risk factors and age.
- Smoking: Cigarette smoking significantly increases the risk of serious cardiovascular events with hormone therapy. Women using Climara Pro should not smoke.
- Surgery and Immobilization: Climara Pro should be discontinued at least 4 to 6 weeks before surgeries or during periods of prolonged immobilization to reduce the risk of blood clots.
- Monitoring: Regular follow-up appointments with a healthcare provider are necessary to monitor blood pressure, lipid levels, and overall health while on Climara Pro.
- Vision Changes: Report any sudden vision changes or loss of vision to a doctor immediately, as this could be a sign of a blood clot in the eye.
Drug Interactions
Climara Pro can interact with other medications, which may alter its effectiveness or increase the risk of side effects. It is crucial to inform your healthcare provider about all prescription, over-the-counter, and herbal supplements you are taking.
Key Interactions Include:
- CYP3A4 Inducers: Medications that induce the CYP3A4 enzyme in the liver (e.g., phenobarbital, rifampin, St. John’s Wort, certain anticonvulsants like carbamazepine and phenytoin) can increase the metabolism of the hormones in Climara Pro, potentially reducing their effectiveness.
- CYP3A4 Inhibitors: Medications that inhibit CYP3A4 (e.g., erythromycin, ketoconazole, grapefruit juice) may increase the concentration of the hormones, potentially increasing the risk of side effects.
- Thyroid Hormone Replacement Therapy: Patients on thyroid hormone replacement may require an increased dose of their thyroid medication while on Climara Pro, as estrogens can affect thyroid-binding globulin levels.
- Corticosteroids: Climara Pro may increase the effects of corticosteroids, necessitating a dose adjustment of the corticosteroid.
FAQs
Q: Is Climara Pro a contraceptive? A: No, Climara Pro is not a birth control method. It does not prevent pregnancy.
Q: What should I do if a patch falls off before my scheduled change day? A: If the patch falls off and it’s still sticky, you can try to reapply it to a different area of the lower abdomen or buttock. If it does not stick, apply a new patch, but continue to follow your original weekly schedule for your next patch change.
Q: Can I swim or take a shower with the Climara Pro patch on? A: Yes, you can shower, bathe, or swim with the patch on. However, excessive heat from saunas or hot tubs has not been studied and may affect the patch’s adhesion or hormone delivery. If the patch becomes loose, press it firmly back into place.
Q: How soon will I notice a difference in my symptoms? A: Many women report a reduction in vasomotor symptoms within a few weeks of starting treatment, with full effects often seen after a few months.
Q: What is the difference between Climara and Climara Pro? A: Climara is a transdermal patch that contains only estradiol (estrogen). Climara Pro contains both estradiol and levonorgestrel (a progestin). Climara is used for women who have had a hysterectomy (uterus removed), while Climara Pro is for women with an intact uterus, as the progestin component is necessary to protect the uterine lining.
Q: Is it safe to use Climara Pro long-term? A: The decision for long-term use of Climara Pro should be made in consultation with a healthcare provider. The lowest effective dose for the shortest possible duration is recommended, and the need for continued therapy should be regularly re-evaluated to weigh the benefits against the potential risks.
References
- U.S. Food and Drug Administration. (2024). Climara Pro Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020375s049s050lbl.pdf
- Drugs.com. (n.d.). Climara Pro Dosage Guide. Retrieved August 11, 2025, from https://www.drugs.com/dosage/climara-pro.html
- RxList. (n.d.). Climara Pro Side Effects Center. Retrieved August 11, 2025, from https://www.rxlist.com/climara-pro-drug.htm
