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|Ogen .625

ESTROGENS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Alora ⁴
• Climara ⁴
• Congest ¹
• Delestrogen ⁴
• Depo-Estradiol ⁴
• Depogen ⁴
• Estinyl ⁷
• Estrace ⁴
• Estraderm ⁴
• Estragyn 5 ⁵
• Estragyn LA 5 ⁴
• Estrasorb ⁴
• Estro-L.A. ⁴
• Kestrone-5 ⁵
• Neo-Estrone ⁴
• Menest ³
• Ogen .625 ⁶
• Ogen 1.25 ⁶
• Ogen 2.5 ⁶
• Ortho-Est .625 ⁶
• Ortho-Est 1.25 ⁶
• Premarin ¹
• Premarin Intravenous ¹
• Valergen-10 ⁴
• Valergen-20 ⁴
• Valergen-40 ⁴
• Vivelle ⁴
• Vivelle-Dot ⁴

In Canada—

• C.E.S. ¹
• Delestrogen ⁴
• Estradot ⁴
• Estraderm ⁴
• Ogen ⁶
• Premarin ¹
• Premarin Intravenous ¹
• Vivelle ⁴

Other commonly used names are:

• DES
• Fosfestrol
• Oestradiol
• Oestrone
• Piperazine estrone sulfate
• Stilboestrol

Category

• Antineoplastic—Conjugated Estrogens; Diethylstilbestrol; Esterified Estrogens; Estradiol; Estradiol valerate; Estrone; Ethinyl Estradiol
• Estrogen, systemic—Conjugated Estrogens; Diethylstilbestrol; Esterified Estrogens; Estradiol; Estrone; Estropipate; Ethinyl Estradiol
• Osteoporosis prophylactic—Conjugated Estrogens; Esterified Estrogens; Estradiol; Estropipate
• Ovarian hormone therapy—Conjugated Estrogens; Esterified Estrogens; Estradiol; Estropipate

Description

Estrogens (ES-troe-jenz) are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• to provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).
• to help prevent weakening of bones (osteoporosis) in women past menopause.
• in the treatment of selected cases of breast cancer in men and women.
• in the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Conjugated Estrogens
  • Tablets (U.S. and Canada)
• Esterified Estrogens
  • Tablets (U.S. and Canada)
• Estradiol
  • Tablets (U.S.)
• Estropipate
  • Tablets (U.S. and Canada)
• Ethinyl Estradiol
  • Tablets (U.S.)

• Parenteral
• Conjugated Estrogens
  • Injection (U.S. and Canada)
• Estradiol
  • Injection (U.S. and Canada)
• Estrone
  • Injection (U.S.)

• Topical
• Estradiol
  • Emulsion (U.S.)
  • Transdermal system (skin patch) (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For estrogens, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to estrogens. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast-feeding—Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

Children—Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

Adolescents—This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Older adults—Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking estrogens, it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Anti-infectives by mouth or by injection (medicine for infection) or
• Antithyroid agents (medicine for overactive thyroid) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Chloroquine (e.g., Aralen) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Isoniazid or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Oral contraceptives (birth control pills) containing estrogen or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Phenytoin (e.g., Dilantin) or
• Plicamycin (e.g., Mithracin) or
• Valproic acid (e.g., Depakene)—Use of these medicines with estrogens may increase the chance of problems occurring that affect the liver

• Cyclosporine (e.g., Sandimmune)—Estrogens can prevent cyclosporine"s removal from the body; this can lead to cyclosporine causing kidney or liver problems

Other medical problems—The presence of other medical problems may affect the use of estrogens. Make sure you tell your doctor if you have any other medical problems, especially:

• For all patients
• Blood clotting problems (or history of during previous estrogen therapy)—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use

• Asthma or
• Calcium, too much or too little in blood or
• Diabetes mellitus (sugar diabetes)
• Epilepsy (seizures) or
• Heart problems or
• Kidney problems or
• Liver tumors, benign or
• Lupus erythematosus, systemic or
• Migraine headaches—Estrogens may worsen these conditions.

• Breast cancer or
• Bone cancer or
• Cancer of the uterus or
• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present

• Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used

• Endometriosis or
• High cholesterol or triglycerides (or history of) or
• Gallbladder disease or gallstones (or history of) or
• Liver disease (or history of) or
• Pancreatitis (inflammation of pancreas) or
• Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

• Vision changes, sudden onset including
• Bulging eyes or
• Double vision or
• Migraine headache or
• Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

• For males treated for breast or prostate cancer
• Blood clots or
• Heart or circulation disease or
• Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs

Proper Use of This Medicine

Estrogens usually come with patient information or directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered . For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

For patients taking any of the estrogens by mouth or by injection:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch) form of estradiol:

• Wash and dry your hands thoroughly before and after handling the patch.
• Apply the patch to a clean, dry, nonoily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.
• Do not apply to the breasts . Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.
• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.
• If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.
• Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion) form of estradiol:

• Washing and drying hands thoroughly before each application.
• Apply while you are sitting comfortably. Apply one pouch to each leg every morning.
• Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Rub any remaining emulsion on both hands on the buttocks.
• Washing and drying hands thoroughly after application.
• To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take or the amount of injection you use depends on the strength of the medicine. Also, the number of doses you take or use each day or patches you apply each week, the time allowed between doses, and the length of time you take or use the medicine depend on the medical problem for which you are taking, using, or applying estrogen .

• For conjugated estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • For treating ovary problems (female hypogonadism or for starting puberty):
    • Adults and teenagers—0.3 to 0.625 mg a day. Your doctor may want you to take the medicine only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 mg three times a day.
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—25 mg injected into a muscle or vein. This may be repeated in six to twelve hours if needed.

• For esterified estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
    • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism):
    • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating symptoms of menopause:
    • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 mg three times a day.

• For estradiol
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
    • Adults—0.5 to 2 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1 to 2 mg three times a day.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.5 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
• For topical emulsion dosage form (skin lotion):
  • For treating symptoms of menopause:
    • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.
• For transdermal dosage form (skin patches):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
    • For the Climara patches
    • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
    • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

• For estradiol cypionate
• For injection dosage form:
  • For treating ovary problems (female hypogonadism):
    • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
  • For treating symptoms of menopause:
    • Adults—1 to 5 mg injected into a muscle every three to four weeks.

• For estradiol valerate
• For injection dosage form:
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—10 to 20 milligrams (mg) injected into a muscle every four weeks as needed.
  • For treating prostate cancer:
    • Adults—30 mg injected into a muscle every one or two weeks.

• For estrone
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.1 to 0.5 mg injected into a muscle two or three times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.1 to 1 mg a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating prostate cancer:
    • Adults—2 to 4 mg injected into a muscle two or three times a week.

• For estropipate
• For oral dosage form (tablets):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—1.5 to 9 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.75 mg a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one-day cycle.

• For ethinyl estradiol
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—1 milligram (mg) three times a day.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.05 mg one to three times a day for three to six months. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—0.15 to 3 mg a day.
  • For treating symptoms of menopause:
    • Adults—0.02 to 0.05 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.

• For ethinyl estradiol and norethindrone
• For oral dosage form (tablets):
  • For treating symptoms of menopause:
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day
  • To prevent loss of bone (osteoporosis):
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day

Missed dose—

• For patients taking any of the estrogens by mouth: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• For patients using the topical emulsion (skin lotion) form of estradiol: If you forget to apply the emulsion when you are suppose to, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed one and go back to your regular schedule. Do not apply more than once a day.
• For patients using the transdermal (skin patch) form of estradiol: If you forget to apply a new patch when you are supposed to, apply it as soon as possible. However, if it is almost time for the next patch, skip the missed one and go back to your regular schedule. Always remove the old patch before applying a new one. Do not apply more than one patch at a time.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom medicine cabinet because the heat or moisture may cause the medicine to break down.
• Keep the injection form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects . These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). . Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor . You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again . This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant .

Tell the doctor in charge that you are taking this medicine before having any laboratory test because some results may be affected.

Side Effects of This Medicine

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

• The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.
• Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

Frequency not determined

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of scalp hair in some people.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:

• Osteoporosis caused by lack of estrogen before menopause
• Turner"s syndrome (a genetic disorder)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 09/02/2004

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