estradiol - norethindrone patch
In this drug factsheet:DIN (Drug Identification Number)
|02241835 ||ESTALIS 140/50µG PATCH|
|02241837 ||ESTALIS 250/50µG PATCH|
How does this medication work? What will it do for me?
This medication belongs to a group of medications called hormone replacement therapy. It is a patch that contains an estrogen (estradiol-17ß) and a progestin (norethindrone).
It is used to manage menopausal and postmenopausal symptoms such as hot flushes, trouble sleeping, and vulvar and vaginal atrophy (e.g., dryness, itching, burning in or around the vagina, and difficulty or burning on urination).
Estrogen and progesterone are female hormones made by the ovaries. At menopause, the amount of estrogen made by the ovaries declines and symptoms such as hot flushes (sudden, extreme feeling of warmth) and vaginal dryness can occur. Most women reach menopause naturally around the age of 50, but some women may undergo menopause sooner, naturally or due to surgery.
When an estradiol patch is applied to your skin, it releases the hormones into your blood through your skin. The medication is designed for women who have not had a hysterectomy (removal of their uterus or womb). These women require progestin while using estrogen to prevent complications associated with taking estrogen alone.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
How should I use this medication?
One 28-day treatment cycle with this medication consists of 8 patches. Each patch provides 50 µg (50 micrograms) of estradiol per day plus 140 µg or 250 µg of norethindrone per day.
One patch is applied twice weekly (change the patch every 3 to 4 days). Once the recommended sequence over a 28-day period has been completed, the next cycle starts again with a fresh package of patches.
Your doctor should re-assess the need for this medication 3 to 6 months after starting it and at least yearly afterwards.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are
taking the medication without consulting your doctor.
Apply a new patch to your skin twice each week on the same days of the week. The patch should be applied to a clean, dry area of intact skin that is not oily, damaged or irritated, or exposed to the sun.
Apply the patch to the abdomen or buttocks. Do not apply the patch to your breasts. Avoid areas of the skin where clothing may rub the patch off or areas where the skin is very hairy or folded.
Talk to your doctor or pharmacist about the most appropriate site to apply the patch. Patches should not be applied to the same skin site twice in a row, but the patch should be applied to the same area of your body each time (i.e., change to the opposite side of the abdomen or from one buttock to the other). Allow a one-week period before applying the patch to a previously used spot.
To apply the patch:
- Choose a clean, dry area of intact skin that is not oily, damaged or irritated, or exposed to the sun. The skin should be free of powder, moisturizers, oils, and lotions.
- Tear open the patch at the notch rather than using scissors - if you accidentally cut the patch, you will not be able to use it.
- To separate the patch from the liner, hold the patch with the liner facing you and peel off one side of the protective liner and discard it. Using the other half of the liner as a handle, apply the sticky side of the patch to the selected area immediately and smooth down. Avoid touching the adhesive. Fold back the other side of the patch and remove the other side of the protective liner.
- Use your fingers to hold the patch in place for about 10 seconds and make sure that the patch is affixed to your skin, especially around its edges.
When changing the patch, remove the old one carefully, folding the adhesive side inwards, and throw it away safely out of the reach of children or pets. Any remaining adhesive on the skin can be removed with mineral oil, baby oil, or rubbing alcohol.
Bathing, showering, swimming, or other contact with water does not affect the patch. However, hot water or steam may cause the patch to loosen.
If your patch falls off, try to reapply it. If that doesn't work, apply a new patch and continue with your usual schedule. This may mean that the replacement patch will not be on your skin for as long as usual.
If you find the patch is falling off regularly in hot baths, saunas or whirlpools, you can consider temporarily removing the patch while you are in the water.
If you remove the patch, you must cover the adhesive with the protective liner that was removed when you applied the patch, or use a piece of wax paper to stop the medication from evaporating from the patch while you are not using it.
It is important to use this medication exactly as prescribed by your doctor. If you forget to change your patch, change it as soon as you remember. If it is close to the day when you normally change your patch, still apply it but change the patch again on your usual day and continue on with your regular schedule. Do not wear 2 patches at once. If you are not sure what to do after missing a patch, contact your doctor or pharmacist for advice.
This medication should be stored in the refrigerator until you open the package. After this time, you may store the patches at room temperature, but they must be used within 6 months or before the expiry date shown on the package, whichever comes first.
If storing them in the refrigerator, allow the patch to reach room temperature before applying.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What form(s) does this medication come in?
Each round, 9 cm2 patch contains 140 µg of norethindrone acetate and 50 µg of estradiol-17ß. Nonmedicinal ingredients: silicone, acrylic-based adhesive, povidone, oleic acid, and dipropylene glycol.
Each round, 16 cm2 patch contains 250 µg of norethindrone acetate and 50 µg of estradiol-17ß. Nonmedicinal ingredients: silicone, acrylic-based adhesive, povidone, oleic acid, and dipropylene glycol.
Who should NOT take this medication?
Do not use this medication if you:
- are allergic to estradiol-17ß, norethindrone, or any ingredients of this medication
- are breast-feeding
- are or may be pregnant
- have or have had a stroke, heart attack, or heart disease
- have or have had blood clots in the legs, lungs, or heart
- have or have had other diseases that increase the risk of blood clots
- have endometrial hyperplasia (overgrowth of the lining of the uterus)
- have migraines with aura (headache is associated with symptoms such as flashes of light, tingling sensations, blind spots, muscle weakness, difficulty speaking that occur either before or during the headache)
- have or have had breast or endometrial (uterine) cancer, or other types of cancer that depend on estrogen or progestin (e.g., ovarian cancer)
- have partial or complete loss of vision or double-vision from eye disease related to circulation problems
- have porphyria (a disease of blood pigment)
- have reduced liver function or have liver disease and abnormal liver function test results
- have unexpected or unusual genital bleeding