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ANDROGENS AND ESTROGENS (Systemic)
Some commonly used brand names are:
In the U.S.—
Androgens and estrogens (AN-droe-jens and ESS-troe-jens) are hormones. Estrogens are produced by the body in greater amounts in females. They are necessary for normal sexual development of the female and for regulation of the menstrual cycle during the childbearing years. Androgens are produced by the body in greater amounts in males. However, androgens are also present in females in small amounts.
The ovaries and adrenal glands begin to produce less of these hormones after menopause. This combination product is prescribed to make up for this lower production of hormones. This may relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.
Androgens and 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 (contained in this combination medicine) 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 the menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes.
A paper called “Information for the Patient” should be given to you with your prescription. Read this carefully . Also, before you use an androgen and estrogen product, you and your doctor should discuss the good that it will do as well as the risks of using it.
This medicine is available only with your doctor"s prescription, in the following dosage forms:
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 androgen and estrogen combination products, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to androgens, anabolic steroids, or estrogens. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy—Estrogens (contained in this combination medicine) are not recommended for use during pregnancy, since some estrogens have been shown to cause serious birth defects in humans. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina and/or uterine cervix when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.
Androgens (contained in this combination medicine) should not be used during pregnancy because they may cause male-like changes in a female baby.
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. It is not known if androgens pass into breast milk. However, androgens may cause unwanted effects in nursing babies such as too early sexual development in males or male-like changes in females.
Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older women than it does in younger females.
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 an androgen and estrogen combination product, it is especially important that your health care professional know if you are taking any of the following:
Other medical problems—The presence of other medical problems may affect the use of androgen and estrogen combination products. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine
For patients taking any of the androgen and estrogen products by mouth:
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 depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking combinations of androgen and estrogen .
Missed dose—If you miss a dose of this medicine and your dosing schedule is:
If you have any questions about this, check with your doctor.
Storage—To store this medicine:
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 6 to 12 months, but many doctors require them more often.
It is not yet known whether the use of estrogen increases the risk of breast cancer in women. Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. You should also have a mammogram (x-ray picture of the breasts) done if your doctor recommends it.
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.
For diabetic patients:
If you think that you may have become pregnant, check with your doctor immediately . Continued use of this medicine during pregnancy may cause birth defects or future health problems in the child.
In studies with oral contraceptives (birth control pills) containing estrogens, cigarette smoking during the use of estrogens was shown to cause an increased risk of serious side effects affecting the heart or blood circulation, such as dangerous blood clots, heart attack, or stroke. The risk increased as the amount of smoking and the age of the smoker increased. Women aged 35 and over were at greatest risk when they smoked while using oral contraceptives containing estrogens. It is not known if this risk exists with the use of androgens and estrogens for symptoms of menopause. However, smoking may make estrogens less effective.
Do not give this medicine to anyone else. Your doctor has prescribed it specifically for you after studying your health record and the results of your physical examination. Androgens and estrogens may be dangerous for some people because of differences in their health and body chemistry.
Side Effects of This Medicine
Discuss these possible effects with your doctor:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Yellow eyes or skin
Uncontrolled jerky muscle movements; vomiting of blood (with long-term use or high doses)
Also, check with your doctor as soon as possible if any of the following side effects occur:
Acne or oily skin (severe); breast pain or tenderness; changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding); enlarged clitoris; enlargement or decrease in size of breasts; hoarseness or deepening of voice; swelling of feet or lower legs; unnatural hair growth; unusual hair loss; weight gain (rapid)
Less common or rare
Confusion; dizziness; flushing or redness of skin; headaches (frequent or continuing); hives (especially at place of injection); shortness of breath (unexplained); skin rash, hives, or itching; unusual bleeding; unusual tiredness or drowsiness
With long-term use or high doses
Black, tarry, or light-colored stools; dark-colored urine; general feeling of discomfort or illness (continuing); hives (frequent or continuing); loss of appetite (continuing); lump in, or discharge from breast; nausea (severe); pain, swelling, or tenderness in stomach or upper abdomen (continuing); purple- or red-colored spots on body or inside the mouth or nose; sore throat or fever (continuing); unpleasant breath odor (continuing); vomiting (severe)
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:
Bloating of abdomen or stomach; cramps of abdomen or stomach; loss of appetite (temporary); nausea (mild); stomach pain (mild); unusual increase in sexual desire; vomiting (mild)
Constipation; diarrhea (mild); dizziness (mild); headaches (mild); infection, redness, pain, or other irritation at place of injection; migraine headaches; problems in wearing contact lenses; trouble in sleeping
Also, many women who are taking a progestin (another type of female hormone) with this medicine will begin to have monthly vaginal bleeding again, similar to menstrual periods. This effect will continue for as long as this medicine is used. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
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