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Basic Drug Info
Drug Name:ClimaraPro
Manufacturer:BERLEX
Other Info:

What is Climara Pro?Climara Pro is a medicine that contains two kinds of hormones, estrogen and a progestin.

What is Climara Pro used for?Climara Pro is used after menopause to: reduce moderate to severe hot flashes.

Estrogens are hormones made by a woman's ovaries.

The ovaries normally stop making estrogens when a woman is between 45 to 55 years old.

This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods).

Sometimes, both ovaries are removed during an operation before natural menopause takes place.

The sudden drop in estrogen levels causes "surgical menopause." When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes").

In some women, the symptoms are mild, and they will not need estrogens.

In other women, symptoms can be more severe.

You and your health care provider should talk regularly about whether you still need treatment with Climara Pro.

help reduce your chances of getting osteoporosis (thin weak bones).

Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break.

If you use Climara Pro only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

You and your healthcare provider should talk regularly about whether you should continue with Climara Pro.

Weight-bearing exercise, like walking or running, and taking calcium and vitamin D supplements may also lower your chances of getting postmenopausal osteoporosis.

It is important to talk about exercise and supplements with your healthcare provider before starting them.

Who should not use Climara Pro?Do not use Climara Pro if you have had your uterus removed (hysterectomy).Climara Pro contains a progestin to decrease the chances of getting cancer of the uterus.

If you do not have a uterus, you do not need a progestin and you should not use Climara Pro.

Do not start using Climara Pro if you:have unusual vaginal bleedingcurrently have or have had certain cancers.

Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus.

If you have or had cancer, talk with your healthcare provider about whether you should use Climara Pro.

had a stroke or heart attack in the past yearcurrently have or have had blood clots.

currently have or have had liver problemsare allergic to Climara Pro or any of its ingredients.

See the end of this leaflet for a list of ingredients in Climara Pro.

think you may be pregnantTell your health care provider:if you are breastfeeding.

The hormones in Climara Pro can pass into your milk.

about all of your medical problems.

Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Some medicines may affect how Climara Pro works.

Climara Pro may also affect how your other medicines work.if you are going to have surgery or will be on bed rest.

You may need to stop using estrogens.

How should I use Climara Pro?Climara Pro is a patch that you wear on your skin.

The Climara Pro patch releases two hormones, estradiol and levonorgestrel.

See the end of this leaflet for complete instructions on how to use Climara Pro.

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.

Estrogens should be used at the lowest dose possible for your treatment only as long as needed.

You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are using and whether you still need treatment with Climara Pro.

What are the possible side effects of estrogens?Less common but serious side effects include: Breast cancer Cancer of the uterus Stroke Heart attack Blood clots Dementia Gallbladder disease Ovarian cancer These are some of the warning signs of serious side effects:Breast lumps Unusual vaginal bleeding Dizziness and faintness Changes in speech Severe headaches Chest pain Shortness of breath Pains in your legs Changes in vision Vomiting Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:Headache Breast pain Irregular vaginal bleeding or spotting Stomach/abdominal cramps, bloating Nausea and vomiting Hair loss Other side effects include:High blood pressure Liver problems High blood sugar Fluid retention Enlargement of benign tumors of the uterus ("fibroids") Vaginal yeast infection These are not all the possible side effects of Climara Pro.

For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with Climara Pro?Talk with your healthcare provider regularly about whether you should continue using Climara Pro.

See your healthcare provider right away if you get vaginal bleeding while using Climara Pro.

Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.

If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.

If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease.

Ask your healthcare provider for ways to lower your chances for getting heart disease.Have an annual gynecologic exam  General information about safe and effective use of Climara Pro Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use Climara Pro for conditions for which it was not prescribed.

Do not give Climara Pro to other people, even if they have the same symptoms you have.

It may harm them.

Keep Climara Pro out of the reach of children.This leaflet provides a summary of the most important information about Climara Pro.

If you would like more information, talk with your healthcare provider or pharmacist.

You can ask for information about Climara Pro that is written for health professionals.

You can get more information by calling the toll free number (1-888-237-5394).

What are the ingredients in Climara Pro? The active ingredients in Climara Pro are estradiol and levonorgestrel.

Climara Pro also contains acrylate copolymer adhesive and polyvinylpyrrolidone/vinyl acetate copolymer.

Do not store above 86°F (30°C).

Do not store unpouched.

Instructions for UseHow and Where do I apply the Climara Pro PatchTalk to your healthcare provider or pharmacist if you have questions about applying the Climara Pro patch.

Each Climara Pro patch is individually sealed in a protective pouch.

To open the pouch, hold it up with the Climara Pro name facing you.

Tear left to right using the top tear notch.

Tear from bottom to top using the side tear notch.

Pull the pouch open.

Carefully remove the Climara Pro patch.

You will notice that the patch is attached to a thicker, hard-plastic liner and that the patch itself is oval.Apply the adhesive side of the Climara Pro patch to a clean, dry area of the lower abdomen.

Do not apply the Climara Pro patch to your breasts.

The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site.

The area selected should not be oily, damaged, or irritated.

Avoid the waistline, since tight clothing may rub and remove the patch.

Application to areas where sitting would dislodge the patch should also be avoided.

Apply the patch immediately after opening the pouch and removing the protective liner.

Press the patch firmly in place with the fingers for about 10 seconds, making sure there is good contact, especially around the edges.The Climara Pro patch should be worn continuously for one week.

You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.

The Climara Pro patch should be changed once weekly.

Remove the used patch.

Carefully fold it in half so that it sticks to itself because used patches still contain active hormones and discard it.

Any adhesive that might remain on your skin can be easily rubbed off.

Then place the new Climara Pro patch on a different skin site.

(The same skin site should not be used again for at least 1 week after removal of the patch.) Contact with water when you are bathing, swimming, or showering may affect the patch.

If the patch falls off, the same patch may be reapplied to another area of the lower abdomen.

Make sure that there is good contact, especially around the edges.

If the patch will not stick completely to your skin, put a new patch on a different area of the lower abdomen.

Do not apply two patches at the same time.

Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time.

© 2006, Berlex.

All rights reserved.

Made In USA Manufactured for: BERLEXBerlex, Montville, NJ 07045 Manufactured by: 3M Pharmaceuticals St.

Paul, MN 55144 6050704 (3M # 632801) May 2006



Clinical Trials:


Indications and Usage

In women with an intact uterus, Climara Pro is indicated in the:Treatment of moderate to severe vasomotor symptoms associated with menopause.

Prevention of postmenopausal osteoporosis.

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.

The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy.

Postmenopausal women require an average of 1500mg/day of elemental calcium.

Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake.

Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake.

Response to therapy can be predicted by pre-treatment serum estradiol, and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.
Osteoporosis, Postmenopausal -- Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.

Osteoporosis -- Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

Contraindications

Climara Pro should not be used in women with any of the following conditions: Undiagnosed abnormal genital bleeding.

Known, suspected, or history of cancer of the breast.

Known or suspected estrogen-dependent neoplasia.

Active deep vein thrombosis, pulmonary embolism or a history of these conditions.

Active or recent (e.g.

within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).

Liver dysfunction or disease.

Known hypersensitivity to its ingredients of Climara Pro.

Known or suspected pregnancy.

There is no indication for Climara Pro in pregnancy.

There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

(See PRECAUTIONS)
Malignant Neoplasms -- A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread through the bloodstream and lymphatic system to other parts of the body.

Primary malignant neoplasm --

Deep Vein Thrombosis -- A blood clot (thrombus) in a deep vein in the thigh or leg.

Deep vein thrombosis of lower limb --

Pulmonary Embolism -- Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.

Thromboembolism -- Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Arteriopathic disease -- An impairment of the structure or function of the blood vessels which carry blood away from the heart.

Cerebrovascular accident -- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.

Liver Dysfunction --

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Little's Disease --

Warnings
See BOXED WARNINGS.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.