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|Dienestrol Vaginal

ESTROGENS (Vaginal)

Some commonly used brand names are:

In the U.S.—

• Estrace ³
• Estring ³
• Premarin ¹

In Canada—

• Estring ³
• Oestrilin ⁴
• Premarin ¹

Other commonly used names are dienoestrol , oestradiol , and piperazine estrone sulfate .

Category

• Urogenital symptoms suppressant—Conjugated Estrogens; Dienestrol; Estradiol; Estrone; Estropipate

Description

Estrogens (ES-troe-jenz) are hormones produced by the body. Among other things, estrogens help develop and maintain female organs.

When your body is in short supply of this hormone, replacing it can ease uncomfortable changes that occur in the vagina, vulva (female genitals), and urethra (part of the urinary system). Conditions that are treated with vaginal estrogens include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), and inflammation of the urethra (atrophic urethritis).

Estrogens work partly by increasing a normal clear discharge from the vagina and making the vulva and urethra healthy. Using or applying an estrogen relieves or lessens:

• Dryness and soreness in the vagina
• Itching, redness, or soreness of the vulva
• Feeling an urge to urinate more often then is needed or experiencing pain while urinating
• Pain during sexual intercourse

When used vaginally or on the skin, most estrogens are absorbed into the bloodstream and cause some, but not all, of the same effects as when they are taken by mouth. Estrogens used vaginally at very low doses for treating local problems of the genitals and urinary system will not protect against osteoporosis or stop the hot flushes caused by menopause.

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

• Vaginal
• Conjugated Estrogens
  • Cream (U.S. and Canada)
• Estradiol
  • Cream (U.S.)
  • Insert (or ring) (U.S. and Canada)
• Estrone
  • Cream (Canada)
  • Suppositories (Canada)

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or to parabens. 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, since an estrogen called diethylstilbestrol (DES) that is no longer taken for hormone replacement has caused serious birth defects in humans and animals.

Breast-feeding—Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and may decrease the amount and quality of breast milk.

Children—Estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. Safety and effectiveness have not otherwise been established.

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. Tell your health care professional if you are taking or using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Asthma or
• Epilepsy or
• Heart problems or
• Kidney problems or
• Migraine headaches—Estrogens may worsen these conditions.

• Blood clotting problems—Although worsening of a blood clotting condition is unlikely, some doctors do not prescribe vaginal estrogens for patients with blood clotting problems or a history of these problems

• Certain cancers, including cancers of the breast, bone, or uterus (active or suspected)—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present

• Diabetes mellitus (sugar diabetes)—Estrogens may alter your body"s response to sugar in your diet.

• Endometriosis or
• Fibroid tumors of the uterus—Estrogens may worsen endometriosis or increase the size of fibroid tumors

• Gallbladder problems (gallstones)—Estrogens may increase your chance of getting a gallbladder attack.

• Hepatic hemangioma—Estrogens may worsen this this medical problem.

• Hypercalcemia (too much calcium in your blood)—Estrogens may worsen this this medical problem.

• Hypertriglyceridemia (too much triglycerides in your blood)—Estrogens may increase or chance of getting pancreatitis or other side effects.

• Hypocalcemia (too little calcium in your blood)—Your doctor should treat the low calcium in your blood before starting estrogen therapy.

• Irritation or infection of the vagina—Usually estrogens decrease infections or irritation of the vagina, but sometimes these conditions may become worse

• Liver disease, severe—Estrogens may worsen the condition in some cases; however, many doctors recommend vaginal use of estrogen because it has less effect on the liver than when estrogens are taken by mouth

• Lupus erythematosus, systemic (SLE)—Estrogens may worsen this this medical problem.

• Physical problems within the vagina, such as narrow vagina, vaginal stenosis, or vaginal prolapse—Estradiol vaginal insert may be more likely to slip out of place or cause problems, such as irritation of the vagina

• Porphyria—Estrogens may worsen this medical problem.

• Thyroid problems (underactive thyroid)—Estrogens may alter your body"s response to your thyroid medication. Your doctor may alter the amount of thyroid replacement that you take while on estrogen therapy.

• 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.

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

Proper Use of This Medicine

Vaginal estrogen products usually come with patient directions. Read them carefully before using this medicine .

Wash your hands before and after using the medicine. Also, keep the medicine out of your eyes. If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of tap water. If your eyes still burn or are painful, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it for a longer time than your doctor ordered . It can take up to 4 months to see the full effect of the estrogens. Your doctor may reconsider continuing your estrogen treatment or may lower your dose several times within the first one or two months, and every 3 to 6 months after that. Sometimes a switch to oral estrogens may be required for added benefits or for higher doses. When using the estradiol vaginal insert, you will need to replace it every 3 months or remove it after 3 months.

For vaginal creams or suppositories—Vaginal creams and some vaginal suppositories are inserted with a plastic applicator. Directions for using the applicator are supplied with your medicine. If you do not see your dose marked on the applicator, ask your health care professional for more information.

• To fill the applicator for cream dosage forms :
  • Break the metal seal at the opening of the tube by using the point on the top of the cap.
  • Screw the applicator onto the tube.
  • Squeeze the medicine into the applicator slowly until it is measured properly.
  • Remove the applicator from the tube. Replace the cap on the tube.
• To fill the applicator for suppository dosage form
  • Place the suppository into the applicator.
• To place the dose using the applicator for cream and suppository dosage forms :
  • Relax while lying on your back with your knees bent or stand with one foot on a chair.
  • Hold the full applicator in one hand. Slide the applicator slowly into the vagina. Stop before it becomes uncomfortable.
  • Slowly press the plunger until it stops.
  • Withdraw the applicator. The medicine will be left behind in the vagina.
• To care for the applicator for cream and suppository dosage forms :
  • Clean the applicator after use by pulling the plunger out of the applicator and washing both parts completely in warm, soapy water. Do not use hot or boiling water .
  • Rinse well.
  • After drying the applicator, replace the plunger.

For vaginal insert dosage form

• To place the vaginal insert
  • Relax while lying on your back with your knees bent or stand with one foot on a chair.
  • Pinch or press the sides of the vaginal insert together, between your forefinger and middle finger.
  • With one hand, part the folds of skin around your vagina.
  • Slide the vaginal insert slowly into the upper third of your vagina. Stop before it becomes uncomfortable. The exact location is not too important but it should be comfortable.
  • If it seems uncomfortable, then carefully push the vaginal insert higher into the vagina.
• To remove the vaginal insert
  • Stand with one foot on a chair.
  • Slide one finger into the vagina and hook it around the closest part of the vaginal insert.
  • Slowly pull the vaginal insert out.
  • Dispose of the vaginal insert by wrapping it up and throwing it into the trash. Do not flush it down the toilet .

Dosing—The dose of vaginal estrogens will be different for different women. 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.

• For conjugated estrogens
• For vaginal dosage form (cream):
  • For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis):
    • Adults: 0.3 to 1.25 milligrams (mg) of conjugated estrogens (one half to two grams of cream) inserted into the vagina once a day or as directed by your doctor to achieve the lowest dose possible. Usually your doctor will want you to use this medicine for only three weeks of each month (three weeks on and one week off).

• For estradiol
• For vaginal dosage form (cream):
  • For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis):
    • Adults: 200 to 400 micrograms (mcg) of estradiol (two to four grams of cream) inserted into the vagina once a day for one to two weeks, decreasing the dose by one half over two and four weeks. After four weeks, your doctor will probably ask you to use the medicine less often, such as 100 mcg (one gram of cream) one to three times a week and for only three weeks of each month (three weeks on and one week off).
• For vaginal dosage form (insert):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis) in postmenopausal women, and inflammation of the urethra (urethritis) in postmenopausal women:
    • Adults: 2 milligrams (mg) of estradiol (7.5 mcg released every twenty-four hours with continuous use) and replaced every three months.

• For estrone
• For vaginal dosage form (cream):
  • For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis) in postmenopausal women:
    • Adults: 2 to 4 milligrams (mg) of estrone (two to four grams of cream) inserted into the vagina once a day or as directed by your doctor.
• For vaginal dosage form (suppository):
  • For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis) in postmenopausal women:
    • Adults: 250 to 500 micrograms (mcg) inserted into the vagina once a day or as directed by your doctor.

Missed dose—When using the suppository or cream several times a week: If you miss a dose of this medicine and remember it within 1 or 2 days of the missed dose, use the missed dose 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.

When using the cream or suppositories more than several times a week: If you miss a dose of this medicine, use it as soon as possible if remembered within 12 hours of the missed dose. 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.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the 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 . Plan on going to see your doctor every year, but some doctors require visits more often.

It is not yet known whether the use of vaginal estrogens 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. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it.

Although the chance is low, use of estrogen may increase your chance of getting cancer of the ovary or uterus (womb). Regular visits to your health professional can help identify these serious side effects early.

If you think that you may be pregnant, stop using the medicine immediately and check with your doctor .

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

For vaginal creams

• Avoid using latex condoms, diaphragms, or cervical caps for up to 72 hours after using estrogen vaginal creams. Certain estrogen products may contain oils in the creams that can weaken latex (rubber) products and cause condoms to break or leak, or cervical caps or diaphragms to wear out sooner. Check with your health care professional to make sure the vaginal estrogen product you are using can be used with latex devices.
• This medicine is often used at bedtime to increase effectiveness through better absorption.
• Vaginal creams or suppositories will melt and leak out of the vagina. A minipad or sanitary napkin will protect your clothing. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine and make the medicine less effective.
• Avoid exposing your male sexual partner to your vaginal estrogen cream or suppository by not having sexual intercourse right after using these medicines. Your male partner might absorb the medicine through his penis if it comes in contact with the medicine.

For estradiol vaginal insert

• It is not necessary to remove the vaginal insert for sexual intercourse unless desired.
• If you do take it out or if it accidentally slips or comes out of the vagina, you can replace the vaginal insert in the vagina after washing it with lukewarm water. Never use hot or boiling water .
• If it slips down, gently push it upwards back into place.
• Replace the vaginal insert every 3 months.

Side Effects of This Medicine

The risk of any serious adverse effect is unlikely for most women using low doses of estrogens vaginally. Even women with special risks have used vaginal estrogens without problems.

Check with your doctor as soon as possible if any of the following side effects occur:

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 using 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).

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

Revised: 07/19/2004

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