Recommended Topic Related To:

CombiPatch

"The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mes"...

CombiPatch

CombiPatch

PATIENT INFORMATION

CombiPatch (estradiol, norethindrone acetate transdermal system) ®

(estradiol/norethindrone acetate transdermal system)

Please read this Patient Information before you start using CombiPatch (estradiol/norethindrone acetate transdermal system) and read all the information that you get each time you refill CombiPatch (estradiol, norethindrone acetate transdermal system) . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT COMBIPATCH (estradiol, norethindrone acetate transdermal system) (a combination of estrogen and progestin hormones)?

· Do not use estrogens and progestins to prevent heart disease, heart attacks, strokes, or dementia.

Using estrogens and progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with CombiPatch (estradiol, norethindrone acetate transdermal system) .

What is CombiPatch (estradiol, norethindrone acetate transdermal system) ?

CombiPatch (estradiol, norethindrone acetate transdermal system) is a medicine that contains two kinds of hormones, estrogen and progestin. CombiPatch (estradiol, norethindrone acetate transdermal system) is available in two round sizes:

System Size
Amount of Each Drug in Each System Estradiol / NETA (mg)
Amount of Each Drug Released Every Day Estradiol / NETA (mg per day)
9 sq cm
0.62 / 2.7
0.05 / 0.14
16 sq cm
0.51 / 4.8
0.05 / 0.25

What is CombiPatch (estradiol, norethindrone acetate transdermal system) used for?

CombiPatch (estradiol, norethindrone acetate transdermal system) is used after menopause to:

· reduce moderate to severe hot flashes.

Estrogens are hormones made by a womans ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 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 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 healthcare provider should talk regularly about whether you still need treatment with CombiPatch (estradiol, norethindrone acetate transdermal system) .

· treat moderate to severe dryness, itching and burning in or around the vagina.

You and your healthcare provider should talk regularly about whether you still need treatment with CombiPatch (estradiol, norethindrone acetate transdermal system) to control these problems. If you use Combipatch (estradiol, norethindrone acetate transdermal system) only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

· treat certain conditions in which a young womans ovaries do not produce enough estrogens naturally.

Who should not use CombiPatch (estradiol, norethindrone acetate transdermal system) ?

Do not use CombiPatch (estradiol, norethindrone acetate transdermal system) if you have had your uterus removed (hysterectomy). CombiPatch (estradiol, norethindrone acetate transdermal system) 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 take CombiPatch (estradiol, norethindrone acetate transdermal system) . Do not start using CombiPatch (estradiol, norethindrone acetate transdermal system) if you:

· have unusual vaginal bleeding

· currently 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 CombiPatch (estradiol, norethindrone acetate transdermal system) .

· had a stroke or heart attack in the recent past (for example in the past year).

· currently have or have had blood clots. currently have or have had liver problems

· are allergic to CombiPatch (estradiol, norethindrone acetate transdermal system) or any of its ingredients.

See the end of this leaflet for a list of ingredients in CombiPatch (estradiol, norethindrone acetate transdermal system) .

· think you may be, or know that you are, pregnant. Tell your healthcare provider:

· if you are breastfeeding. The hormones in CombiPatch (estradiol, norethindrone acetate transdermal system) 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, or 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 CombiPatch (estradiol, norethindrone acetate transdermal system) works. CombiPatch (estradiol, norethindrone acetate transdermal system) may also affect how other medicines work.

· if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens.

How should I use CombiPatch (estradiol, norethindrone acetate transdermal system) ?

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

2. Estrogens and progestins should be used at the lowest dose possible for your treatment, only as long as needed. The lowest effective dose of CombiPatch (estradiol, norethindrone acetate transdermal system) has not been determined in clinical trials. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with CombiPatch (estradiol, norethindrone acetate transdermal system) . CombiPatch (estradiol, norethindrone acetate transdermal system) is a thin, opaque, plastic patch that sticks to the skin. Each patch is sealed in a pouch that protects it until you are ready to put it on. Do not open the pouch or remove a patch until just before you apply it.

How often should you apply CombiPatch (estradiol, norethindrone acetate transdermal system) ?

· Put on a new CombiPatch (estradiol, norethindrone acetate transdermal system) every 3 to 4 days, according to your healthcare provider's instructions

· Wear the patch all the time until it is time to replace it with a new patch

· Change the patch on the same days each week. Your CombiPatch (estradiol, norethindrone acetate transdermal system) package contains a calendar checklist to help you remember a schedule. Mark the 2-day schedule you plan to follow.

· Only one CombiPatch (estradiol, norethindrone acetate transdermal system) should be worn at any one time

Where do you apply CombiPatch (estradiol, norethindrone acetate transdermal system) ?

CombiPatch (estradiol, norethindrone acetate transdermal system) should be placed on the lower abdomen (below the panty line).

For best results, choose:

· A smooth (fold free), clean, dry area of skin

· An area that has been freshly washed and dried well (free of oils, lotions or powders that could keep the patch from sticking well to your skin)

· An area that has no cuts, rashes, or other skin problems

Every time you put on a new CombiPatch (estradiol, norethindrone acetate transdermal system) , move to a different area on your lower abdomen than used before. The same area should not be used again for at least 1 week.

Do not put CombiPatch (estradiol, norethindrone acetate transdermal system) on or near your breasts. You should not put CombiPatch (estradiol, norethindrone acetate transdermal system) on the waistline, since tight clothing may rub off the patch. To avoid disturbing the patch it may help to choose an area where your underwear will cover it all the time.

How do you apply CombiPatch (estradiol, norethindrone acetate transdermal system) ?

· Each CombiPatch (estradiol, norethindrone acetate transdermal system) is sealed in its own protective pouch. Tear open this pouch at the slit (do not use scissors) and remove the patch. The pouch should not be opened until you are ready to put the patch on

· A protective liner covers the adhesive side of the patch. Peel off one side of the protective liner. Do not touch the sticky part of the patch with your fingers

· Put the sticky side of the patch on an area of skin on your lower abdomen. Peel off the second side of the protective liner

· Press the patch firmly in place with your hand for about 10 seconds. Make sure there is good contact, especially around the edges

When changing CombiPatch (estradiol, norethindrone acetate transdermal system) , peel off the used patch slowly. Fold the used patch in half (sticky sides together) and throw it in the trash. Please remember to keep CombiPatch (estradiol, norethindrone acetate transdermal system) out of the reach of children.

If any adhesive remains on your skin after removal of the patch, let the area dry for 15 minutes. Then gently rub the area with an oil-based cream or lotion to remove the adhesive from your skin.

What if you forget to put on a new CombiPatch (estradiol, norethindrone acetate transdermal system) ?

If you are currently wearing a patch, remove it and put on a new patch in a different area of your lower abdomen. Then go back to changing the patch on the same days each week.

Can you wear CombiPatch (estradiol, norethindrone acetate transdermal system) when bathing, swimming, or in the sun?

· Bathing, swimming, or showering should not affect the patch. Make sure that the patch does not loosen during these activities

· The patch should not be exposed to the sun for long periods of time. Once in place, make sure that the patch is covered by your clothing (but remember not to apply CombiPatch (estradiol, norethindrone acetate transdermal system) on or near your breasts)

What should I do if CombiPatch (estradiol, norethindrone acetate transdermal system) comes off?

Most women find that CombiPatch (estradiol, norethindrone acetate transdermal system) seldom comes off. But if a patch should fall off, the same patch may be put on a different area of the lower abdomen (make sure you are choosing a clean, dry, lotion-free area of skin). If the patch will not stick completely to your skin, put a new CombiPatch (estradiol, norethindrone acetate transdermal system) on a different area of the lower abdomen. No matter what day this happens, go back to changing the patch on the same days each week.

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

Other side effects of CombiPatch (estradiol, norethindrone acetate transdermal system) are possible. For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with CombiPatch (estradiol, norethindrone acetate transdermal system) ?

· Talk with your healthcare provider regularly about whether you should continue using CombiPatch (estradiol, norethindrone acetate transdermal system) .

· See your healthcare provider right away if you get vaginal bleeding while using CombiPatch (estradiol, norethindrone acetate transdermal system) .

· 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.

General information about the safe and effective use of CombiPatch (estradiol, norethindrone acetate transdermal system)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use CombiPatch (estradiol, norethindrone acetate transdermal system) for conditions for which it was not prescribed. Do not give CombiPatch (estradiol, norethindrone acetate transdermal system) to other people, even if they have the same symptoms you have. It may harm them. Keep CombiPatch (estradiol, norethindrone acetate transdermal system) out of the reach of children.

This leaflet provides a summary of the most important information about CombiPatch (estradiol, norethindrone acetate transdermal system) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about CombiPatch (estradiol, norethindrone acetate transdermal system) that is written for health professionals. You can get more information by calling the toll free number (888-NOW-NOVA (888-669-6682)

What are the ingredients in CombiPatch (estradiol, norethindrone acetate transdermal system) ?

CombiPatch (estradiol, norethindrone acetate transdermal system) transdermal systems are comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film backing, (2) an adhesive layer containing estradiol, norethindrone acetate, acrylic adhesive, silicone adhesive, oleyl alcohol, oleic acid, NF povidone USP and dipropylene glycol, and (3) a polyester release protective liner, which is attached to the adhesive surface and must be removed before the system can be used. The active components of the system are estradiol USP and norethindrone acetate USP. The remaining components of the system are pharmacologically inactive.

Where should you store CombiPatch (estradiol, norethindrone acetate transdermal system) ?

Each CombiPatch (estradiol, norethindrone acetate transdermal system) is sealed in its own pouch. To protect the medication, store the patch in the pouch until you are ready to use it.

Before CombiPatch (estradiol, norethindrone acetate transdermal system) was sold to you, the pharmacist stored the package in the refrigerator. You can store CombiPatch (estradiol, norethindrone acetate transdermal system) at room temperature, below 77°F (25°C). The patch sticks best to your skin when stored at room temperature. For best results, DO NOT store CombiPatch (estradiol, norethindrone acetate transdermal system) patches in the refrigerator or in areas where the temperature can become extreme (very high or very low), such as in DIRECT SUNLIGHT or in a car.

Keep this and all medicines out of the reach of children.

Last reviewed on RxList: 10/5/2006
This monograph has been modified to include the generic and brand name in many instances.

A A A

CombiPatch - User Reviews

CombiPatch User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication CombiPatch sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations