Climara Pro

Generic name: estradiol and levonorgestrel (transdermal)
Drug class: Sex hormone combinations

Medically reviewed by A Ras MD.

What is Climara Pro?

Climara Pro is a prescription medicine patch (Transdermal System) that contains two kinds of hormones, an estrogen and a progestin. Climara Pro is used after menopause to Reduce moderate to severe hot flashes.

Description

Climara Pro (estradiol/levonorgestrel transdermal system) is an adhesive-based matrix transdermal patch designed to release both estradiol and levonorgestrel, a progestational agent, continuously upon application to intact skin. The 22 cm2 Climara Pro system contains 4.4 mg estradiol and 1.39 mg levonorgestrel and provides a nominal delivery rate (mg per day) of 0.045 estradiol and 0.015 levonorgestrel.

Estradiol USP has a molecular weight of 272.39 and the molecular formula is C18H24O2.

Levonorgestrel USP has a molecular weight of 312.4 and a molecular formula of C21H28O2.

The structural formulas for estradiol and levonorgestrel are:

The Climara Pro transdermal system comprises 3 layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are:

1.: A translucent polyethylene backing film.
2.: An acrylate adhesive matrix containing estradiol and levonorgestrel.
3.: A protective liner of either siliconized or fluoropolymer coated polyester film. The protective liner is attached to the adhesive surface and must be removed before the system can be used.

The active components of the transdermal system are estradiol and levonorgestrel. The remaining components of the transdermal system (acrylate copolymer adhesive and polyvinylpyrrolidone/vinyl acetate copolymer) are pharmacologically inactive.

Mechanism of Action

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.

The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.

Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.

Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

Levonorgestrel inhibits gonadotropin production resulting in retardation of follicular growth and inhibition of ovulation.

Studies to assess the potency of progestins using estrogen-primed postmenopausal endometrial biochemistry and morphologic features have shown that levonorgestrel counteracts the proliferative effects of estrogens on the endometrium.

What is the most important information I should know about Climara Pro?

Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (declines of brain function).
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia.
Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
Using estrogen-alone may increase your chances of getting strokes or blood clots.
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
Only one estrogen-alone product and dose has been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestin product and dose has been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of Climara Pro will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Climara Pro.

Who should not use Climara Pro?

Do not use Climara Pro if you have had your uterus (womb) removed (hysterectomy).

Climara Pro contains a progestin to decrease the chance 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 bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Climara Pro.
had a stroke or heart attack
currently have or have had blood clots
currently have or have had liver problems
have been diagnosed with a bleeding disorder
are allergic to Climara Pro or any of its ingredients
See the list of ingredients in Climara Pro at the end of this leaflet.
think you may be pregnant
Climara Pro is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use Climara Pro if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before using Climara Pro?

Before you use Climara Pro, tell your healthcare provider if you:

have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
have any other medical conditions
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop using Climara Pro.
are breastfeeding
The hormones in Climara Pro can pass into your breast milk.

Tell your healthcare provider 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. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Climara Pro?

For detailed instructions, see the step-by-step instructions that come with Climara Pro.

Use Climara Pro exactly as your healthcare provider tells you to use it.
Climara Pro is for skin use only.
Change your Climara Pro patch 1 time each week or every 7 days.
Apply your Climara Pro patch to a clean, dry area on your lower abdomen or buttocks. This area must be clean, dry, and free of powder, oil or lotion for your patch to stick to your skin.
Apply your Climara Pro patch to a different area of your abdomen or your buttocks each time. Do not use the same application site 2 times in the same week.
Do not apply Climara Pro to your breasts.
If you forget to apply a new Climara Pro, you should apply a new patch as soon as possible.
You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are using and whether you still need treatment with Climara Pro.

How do I change Climara Pro?

When changing Climara Pro, peel off the used patch slowly from the skin.
After removal of Climara Pro, people usually have either no adhesive residue or light adhesive residue. If any adhesive residue remains on your skin after removing the patch, allow the area to dry for 15 minutes. Then, gently rub the area with an oil-based cream or lotion to remove the adhesive from your skin.
Keep in mind, the new patch must be applied to a different skin area of your lower abdomen or buttocks. This area must be clean, dry, and free of powder, oil or lotion. The same site should not be used again for at least 1 week after removal of the patch.

What are the possible side effects of Climara Pro?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

heart attack
stroke
blood clots
dementia
breast cancer
cancer of the lining of the uterus (womb)
cancer of the ovary
high blood pressure
high blood sugar
gallbladder disease
liver problems
changes in your thyroid hormone levels
enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

new breast lumps
unusual vaginal bleeding
changes in vision or speech
sudden new severe headaches
severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less serious, but common side effects include:

headache
breast pain
irregular vaginal bleeding or spotting
stomach or abdominal cramps, bloating
nausea and vomiting
hair loss
fluid retention
vaginal yeast infection
redness or irritation at the patch placement site

These are not all the possible side effects of Climara Pro. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or does not go away.

You may report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937 or to FDA at 1-800-FDA-1088.

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 pelvic exam, 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 of getting heart disease.

General information about the 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.

This leaflet summarizes 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.

For more information, go to www.climara-us.com or call Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937.

How should I store Climara Pro?

Store at room temperature between 68°F to 77°F (20°C to 25°C).
Do not store Climara Pro patches outside of their pouches. Apply immediately after removal from the protective pouch.
Used patches still contain estrogen. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet.

Keep Climara Pro and all medicines out of the reach of children.

What are the ingredients in Climara Pro?

Active ingredient: estradiol and levonorgestrel

Inactive ingredient: acrylate copolymer adhesive, and polyvinylpyrrolidone/vinyl acetate copolymer.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

SRC: NLM .

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