Estalis 250mcg/50 mcg

 
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Best Value On Brand Estalis 250mcg/50 mcg
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24 patches for $174.32 ($7.26 per patch)
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About Estalis

What Estalis is used for

  • ESTALIS should only be used if you have a uterus (it has not been surgically removed). To reduce moderate or severe menopausal symptoms.

  • To treat vulval and vaginal atrophy (itching, burning or dryness in or around the vagina, difficulty or burning on urination).

ESTALIS should be used only under the supervision of a doctor, with regular follow-up at least once a year to identify side effects associated with its use. Your first follow-up visit should be within 3 to 6 months of starting treatment. Your visit may include a blood pressure check, a breast exam, a Pap smear and pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your doctor. Your doctor may recommend some blood tests.

You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your doctor. You should regularly talk with your doctor about whether you still need treatment with HRT.

What Estalis does

Treatment with ESTALIS offers relief from menopausal symptoms for women with uteri. With ESTALIS used in a continuous regimen, you receive estradiol and norethindrone acetate (NETA), a progestin, throughout the entire 28-day cycle. The progestin provides important protection for your uterus (see Uses of progestins:).

Uses of estrogens

The main estrogen produced by your ovaries prior to menopause is estradiol, and this is the same estrogen that is in ESTALIS When applied to the skin, the ESTALIS patches continually release small, controlled quantities of estradiol, which pass through your skin and into your bloodstream. The amount of estrogen prescribed depends on your body's needs. By providing estradiol, ESTALIS offer relief from menopausal symptoms.

Your body normally makes estrogens and progestins (female hormones) mainly in the ovaries. Between ages 45 and 55, the ovaries gradually stop making estrogens. This leads to a decrease in body estrogen levels and a natural menopause (the end of monthly menstrual periods). If both ovaries are removed during an operation before natural menopause takes place, the sudden decrease in estrogen levels causes “surgical menopause”.

Menopause is not a disease—it is a natural life event and different women experience menopause and its symptoms differently. Not all women suffer obvious symptoms of estrogen deficiency. When the estrogen levels begin decreasing, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating (“hot flashes” or “hot flushes”). Using estrogen drugs can help the body adjust to lower estrogen levels and reduce these symptoms.

Uses of progestins

Progestins used in hormone replacement therapy have similar effects to the female sex hormone progesterone. During the child bearing years, progesterone is responsible for regulation of the menstrual cycle. The estradiol delivered by ESTALIS not only relieves your menopausal symptoms, but, like estrogens produced by your body, may also stimulate growth of the inner lining of the uterus, the endometrium. In menopausal and postmenopausal women with intact uteri, stimulation of growth of the endometrium may result in irregular bleeding. In some cases this may progress into a disorder of the uterus known as endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the uterus). The development of estrogen-mediated disorders of the uterus can be reduced if a progestin, such as norethindrone acetate, is given regularly for a certain number of days with your estrogen replacement therapy. For women receiving ESTALIS in a continuous combined regimen, it is expected that uterine bleeding will stop within a period of a few months and such treatment should also be protective of endometrial hyperplasia.

When Estalis should not be used

Certain medical conditions may be aggravated by estrogens and progestins, therefore these hormones should not be used at all under these conditions.

ESTALIS should not be used under the following conditions:

  • if you are pregnant or think you may be pregnant. Since pregnancy may be possible early in menopause while you are still having spontaneous periods, the use of non hormonal birth control should be discussed with your physician at this time. If you take estrogen during pregnancy, there is a small risk of your unborn child having birth defects.

  • if you are breast-feeding. Ask your doctor or pharmacist for advice.

  • if you currently have or have ever had cancer of the breast, or uterus or endometrium (lining of the womb) or any other estrogen-dependent cancer

  • if you have been diagnosed with endometrial hyperplasia (overgrowth of the lining of the uterus)

  • if you have unexpected or unusual genital bleeding

  • if you have active thrombophlebitis (inflamed varicose veins)

  • if you currently have a problem with blood clots forming in your blood vessels or have ever had such a problem in the past. This may cause painful inflammation of the veins (thrombophlebitis) or blockage of a blood vessel in the legs (deep vein thrombosis), lungs (pulmonary embolism) or other organs.

  • if you have ever had coronary heart disease, a heart attack or stroke

  • if you have serious liver disease

  • if you have migraine

  • if you have had partial or complete loss of vision due to blood vessel disease in the eye

  • if you have a disease of blood pigment called porphyria

  • if you have had any unusual allergic reaction to estrogens or any other component of ESTALIS (see What the medicinal ingredients are: and What the important nonmedicinal ingredients are:).

ESTALIS is not contraceptives, nor will they restore fertility.

Talk to your doctor if you have any further questions or if you think that any of the above may apply to you.

What the medicinal ingredients for Estalis are

The active components of the system are estradiol USP and norethindrone acetate (NETA) USP.

What the important nonmedicinal ingredients for Estalis are

A silicone and acrylic-based multipolymeric adhesive, povidone USP, oleic acid NF, and dipropylene glycol.

What dosage forms Estalis comes in

ESTALIS packs contain 8 patches. ESTALIS (NETA/17β-estradiol) patches are available in two strengths: ESTALIS 140/50 and ESTALIS 250/50.


Warnings and Precautions

Serious Warnings and Precautions

The Women’s Health Initiative (WHI) trial is a large clinical study that assessed the benefits and risks of oral combined estrogen plus progestin therapy and oral estrogen-alone therapy compared with placebo (a pill with no active ingredients) in postmenopausal women.

The WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women taking oral combined estrogen plus progestin.

The WHI trial indicated an increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) taking oral estrogen-alone. Therefore, you should highly consider the following:

  • There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.

  • There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.

  • Estrogens with or without progestins should not be used for the prevention of heart disease or stroke.

  • Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of time possible. Regular medical follow-up is advised.

  • Breast cancer

    The results of the WHI trial indicated an increased risk of breast cancer in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

    The results of the WHI trial indicated no difference in the risk of breast cancer in postmenopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

    Estrogens with or without progestins should not be taken by women who have a personal history of breast cancer.

    In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies or abnormal mammograms (breast x-rays) should consult with their doctor before starting hormone replacement therapy.

    Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor.

    Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women. You should review technique for breast self-examination with your doctor.

  • Overgrowth of the lining of the uterus and cancer of the uterus

    The use of estrogen-alone therapy by post menopausal women who still have a uterus increases the risk of developing endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the uterus).

    The purpose of adding a progestin medication to estrogen therapy is to reduce the risk of endometrial hyperplasia.

    You should discuss progestin therapy and risk factors for endometrial hyperplasia and endometrial carcinoma with your doctor. You should also report any unexpected or unusual vaginal bleeding to your doctor.

    If you have had your uterus removed, you are not at risk of developing endometrial hyperplasia or endometrial carcinoma. Progestin therapy is therefore not generally required in women who have had a hysterectomy.

  • Ovarian cancer

    In some studies, the use of estrogen-alone and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer.

  • Heart disease and stroke

    The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

    The results of the WHI trial indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking estrogen alone compared to women taking placebo.

  • Abnormal blood clotting

    The results of the WHI trial indicated an increased risk of blood clots in the lungs and large veins in post menopausal women taking combined estrogen plus progestin compared to women taking placebo.

    The results of the WHI trial indicated an increased risk of blood clots in the large veins, but no difference in the risk of blood clots in the lungs in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

    The risk of blood clots increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your doctor since blood clots can be life-threatening or cause serious disability.

  • Gallbladder disease

    The use of estrogens by postmenopausal women has been associated with an increase risk of gallbladder disease requiring surgery.

  • Dementia

    The Women’s Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial and indicated an increased risk of dementia (loss of memory and intellectual function) in post-menopausal women age 65 and over taking oral combined estrogen plus progestin compared to women taking placebo.

    The WHIMS indicated no difference in the risk of dementia in post-menopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

Before you use ESTALIS talk to your doctor or pharmacist if you

  • have a history of allergy or intolerance to any medications or other substances

  • have been told that you have a condition called hereditary angioedema of if you have had episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage) or digestive tract

  • have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer

  • have experienced any unusual or undiagnosed vaginal bleeding

  • have a history of uterine fibroids or endometriosis

  • have a history of liver disease or liver tumours, jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy

  • have a history of migraine headache

  • have a history of high blood pressure

  • have a personal or family history of blood clots, or a personal history of heart disease or stroke

  • phlebitis (inflamed varicose veins)

  • have a history of kidney disease or asthma

  • have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus)

  • have been diagnosed with diabetes

  • have been diagnosed with porphyria (a disease of blood pigment)

  • have been diagnosed with lupus

  • gall bladder disease

  • depression

  • have been diagnosed with hearing loss due to otosclerosis

  • epilepsy (seizures) or other neurological disorders

  • have a history of high cholesterol or high triglycerides

  • are pregnant or may be pregnant

  • are breastfeeding

  • have had a hysterectomy (surgical removal of the uterus)

  • smoke

  • are undergoing surgery or need long bed rest.

Ask your doctor and pharmacist to answer any questions you may have.


Interactions with Estalis

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products.

This particularly includes the following: anti-anxiety medicines (meprobamate), anti-epileptic medicines (e.g. phenobarbital, phenytoin or carbamazepine), an anti-inflammatory medicine called phenylbutazone, antibiotics and other anti-infective medicines (e.g. rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir), and herbal medicines (e.g. St. John’s wort).

These medicines may be affected by ESTALIS or, conversely, they may affect how well ESTALIS works. Your doctor may need to adjust the dose of your treatment.


Proper Use of Estalis

Usual dose

ESTALIS: ESTALIS packs contain 8 patches. ESTALIS (NETA/17β-estradiol) patches are available in two strengths, called ESTALIS 140/50 and ESTALIS 250/50, each containing and releasing different amounts of estradiol and norethindrone acetate, as follows:

  • ESTALIS 140/50: 9 cm2 patch, containing 0.620 mg estradiol and 2.70 mg NETA, and releasing about 50 µg estradiol and 140 µg NETA per day.

  • ESTALIS 250/50: 16 cm2 patch, containing 0.512 mg estradiol and 4.80 mg NETA, and releasing about 50 µg estradiol and 250 µg NETA per day.

    Your doctor will prescribe the patches in a continuous regimen.

Continuous regimen

The ESTALIS patch is worn continuously for the 4 weeks of the cycle (see Table 1). The ESTALIS patches are applied twice weekly on the same days of each week. Each patch should be worn continuously for 3-4 days.

Table 1: ESTALIS Continuous Regimen
Week 1 ESTALIS patch for the 4 weeks of the cycle
Week 2  
Week 3  
Week 4  

The next treatment cycle is started immediately after removal of the last ESTALIS patch. Irregular uterine bleeding may occur particularly in the first 6 months, but generally decreases with time.

It is important that you take your medication as your physician has prescribed. Do not discontinue or change your therapy without consulting your physician first.

How and where to apply ESTALIS

(See package insert for illustrations.)

It is recommended that you change the site of application each time the patch is applied. In other words, each time you apply a patch, place it on a different area of your abdomen or buttocks than used before. The same area should not be used again for at least one week. However, each time you apply a patch you should always apply it to the same area of your body (i.e., if the patch is applied to the buttocks, move the patch from right side to left side, twice a week or more if there is any redness under the patch).

Apply whole patches.

  1. Preparing the skin: In order for the patch to stick, the skin should be clean, dry and free of creams, lotions or oils. If you wish, you may use body lotion after the patch has been properly applied to the skin. The skin should not be irritated or broken, since this may alter the amount of hormone you get. Contact with water (bath, pool, or shower) should not affect the patch (see Helpful Hints:).

  2. Where to apply the ESTALIS patches: The patches may be applied to the buttocks or abdomen. Change the site of application each time you put a patch on. A one week period should elapse before applying the patch to a previously used spot.

    Avoid areas of the skin where clothing may rub the patch off or areas where the skin is very hairy or folded. Also avoid areas where the patch is likely to be exposed to the sun since this may affect how the patch works.

    DO NOT APPLY THE PATCHES TO YOUR BREAST, since this may cause unwanted effects and discomfort.

  3. Opening the pouch: The patches contained in ESTALIS are individually sealed in a protective pouch. Tear open this pouch at the indented notch and remove the patch. Do not use scissors, as you may accidentally cut and destroy the patch.

  4. Removing the liner: One side of the patch has the adhesive that sticks to your skin. The adhesive is covered by a protective liner that must be removed.

    To separate the patch from the liner, hold the patch with the protective liner facing you. Peel off one half of the protective liner and discard it. Try to avoid touching the sticky side of the patch with your fingers.

    Using the other half of the liner as a handle, apply the sticky side of the system to a dry area of intact skin on your abdomen or buttocks. Press the sticky side on the skin and smooth down.

    Fold back the remaining side of the edge of the protective liner and pull it across the skin. Avoid touching the adhesive.

  5. Applying the ESTALIS patches: Apply the adhesive side to the spot you have chosen. Press it firmly in place with the palm of your hand for about 10 seconds, then run your finger around the edge, making sure there is good contact with the skin. Apply the patch soon after opening the pouch and removing the liner.

  6. When and how to remove the patch: Continuous regimen: The ESTALIS patch should be changed twice weekly. Always change it on the same 2 days of the week. If you forget to change it at the scheduled time, there is no cause for alarm. Just change it as soon as possible and continue to follow your usual schedule.

    After you remove the patch fold it in half with the adhesive sides inwards. Throw it away, safely out of the reach of children or pets.

    Any adhesive left on your skin should rub off easily. You can also use mineral oil, baby oil or rubbing alcohol to remove adhesive from the skin. Apply a new ESTALIS patch on a different spot of clean, dry skin.

Helpful Hints

What to do if the patch falls off: Should a patch fall off in a very hot bath or shower, shake the water off the patch. Dry your skin completely and reapply the patch as soon as possible (to a different area of skin) and continue your regular schedule. Make sure you choose a clean, dry, lotion-free area of skin. If it still does not stick completely to your skin, then use a new patch. No matter what day this happens, go back to changing the patch on the same days as the initial schedule.

If hot baths, saunas or whirlpools are something you enjoy and you find that the patch is falling off, you may consider removing the patch temporarily while you are in the water. If you do remove the patch temporarily, the adhesive side of the patch should be placed on the protective liner that was removed when originally applying the patch. Wax paper may be used as an alternate to the liner. This prevents the contents of the patch from emptying by evaporation while you are not wearing it.

In addition to exposure to very hot water, there are some other causes for the patch failing to stick. If you are having patches fall off regularly, this could be happening as a result of:

  • using any type of bath oil

  • using soaps with a high cream content

  • using skin moisturizers before applying the patch

Patch adhesion may be improved if you avoid using these products, and by cleansing the site of application with rubbing alcohol before you apply the patch.

What to do if your skin becomes red or irritated under or around the patch: As with any product that covers the skin for a period of time (such as bandages), the ESTALIS patches can produce some skin irritation in some women. This varies according to the sensitivity of each woman.

Usually this redness does not pose any health concern to you, but to reduce this problem, you may change the site of application of the ESTALIS patches every time a new patch is applied.

Experience with another patch, VIVELLE, has shown that if you allow the patch to be exposed to the air for approximately 10 seconds after the protective liner has been removed, skin redness may not occur.

If redness and/or itching continues, you should consult your physician.

Always Remember

Your doctor has prescribed ESTALIS for you after a careful review of your medical needs. Use it only as directed and do not give it to anyone else.

Use ESTALIS within 6 months of purchase or before the expiry date shown on the pack, whichever comes first.

Do not use any ESTALIS pack that is damaged or shows signs of tampering.

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