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|Conjugated Estrogens And Medroxyprogesterone For Ovarian Hormone Therapy

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CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE FOR OVARIAN HORMONE THERAPY (OHT) (Systemic)

Some commonly used brand names are:

In the U.S.—

Premphase ¹
Prempro ²

In Canada—

Premplus ²

Note:

For quick reference, the following estrogens are numbered to match the corresponding brand names.

This information applies to the following medicines
1.	Conjugated Estrogens, and Conjugated Estrogens and Medroxyprogesterone (CON-ju-gate-ed ES-troe-jenz, and CON-ju-gate-ed ES-troe-jenzand me-DROX-ee-proe-JES-te-rone)†
2.	ConjugatedEstrogens and Medroxyprogesterone (CON-ju-gate-ed ES-troe-jenz and me-DROX-ee-proe-JES-te-rone)
† Not commercially available in Canada

Description

Conjugated estrogens and medroxyprogesterone (CON-ju-gate-ed ES-troe-jenz and me-DROX-ee-proe-JES-te-rone) are estrogen and progestin hormones. Along with other effects, estrogens help females develop sexually at puberty and regulate the menstrual cycle. Progestin lowers the effect of estrogen on the uterus and keeps estrogen-related problems from developing.

Around the time of menopause, the ovaries produce less estrogen. Estrogens are given to:

Relieve the signs of menopause (vasomotor symptoms of menopause), such as hot flashes and unusual sweating, chills, faintness, or dizziness.
Treat inflammation of the vagina (atrophic vaginitis) and of the genital area (atrophy of the vulva) by keeping these areas from becoming too dry, itchy, or painful.
Prevent the loss of bone that begins at the time of menopause. Keeping bones strong decreases the chance of developing weak bones that easily break (osteoporosis). Estrogen use is most effective when it is taken for more than 7 years while you are getting regular exercise and extra calcium. Protection from bone loss can then last for many years after you stop taking the medicine.

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 related to the menopausal symptoms, such as hot flashes.

Progestins are not needed if the uterus has been removed (by a surgical method called hysterectomy). In that case, it may be better to receive estrogens alone without the progestin.

Conjugated estrogens and medroxyprogesterone are available only with your doctor"s prescription, in the following dosage forms:

Oral
Conjugated Estrogens; Conjugated Estrogens and Medroxyprogesterone
- Tablets (U.S. )
Conjugated Estrogens and Medroxyprogesterone
- Tablets (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 conjugated estrogens and medroxyprogesterone, the following should be considered:

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

Pregnancy—Conjugated estrogens and medroxyprogesterone are not recommended for use during pregnancy. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause. Tell your doctor right away if you suspect you are pregnant.

Breast-feeding—Conjugated estrogens and medroxyprogesterone pass into the breast milk. This medicine is not recommended for use during breast-feeding.

Older adults—Conjugated estrogens and medroxyprogesterone may increase your chance of having a stroke, memory problems, or breast cancer that spreads to other parts of your body.

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 conjugated estrogens and medroxyprogesterone, 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
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
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
Plicamycin (e.g., Mithracin)—Use of these medicines with conjugated estrogens and medroxyprogesterone may increase the chance of problems occurring that affect the liver

Aminoglutethimide (e.g., Cytadren) or
Barbiturates, especially phenobarbital or
Carbamazepine (e.g., Tegretol) or
Phenytoin (e.g., Dilantin) or
Rifampin (e.g., Rifadin) or
St. John"s wort (Hypericum perforatum —These medicines may decrease the effect of conjugated estrogens or medroxyprogesterone

Cyclosporine (e.g., Sandimmune)—Conjugated 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 conjugated estrogens and medroxyprogesterone. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or
Heart problems or
Epilepsy or
High blood pressure or
Kidney problems, severe or
Migraine headaches—Rarely, water retention caused by conjugated estrogens or medroxyprogesterone may worsen these conditions; on the other hand, blood pressure and some heart or blood vessel problems can improve for most patients

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

Bone cancer or
Breast cancer or
Cancer of the uterus (active or suspected) or
Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer, worsen cancer of the uterus, or increase the size of fibroid tumors

Changes in genital or vaginal bleeding of unknown causes—Estrogens may make these conditions worse; some irregular vaginal bleeding may be a sign that the lining of the uterus may be growing too much or is a sign of cancer of the uterus lining

Changes in vision—This medicine may make cause changes in vision; your medicine may need to be stopped if these conditions become worse

Diabetes mellitus (sugar diabetes)—Conjugated estrogens or medroxyprogesterone may slightly change the amount of blood sugar for some patients, but for most patients with sugar diabetes, there is no change in blood sugar

Endometriosis or
Gallbladder disease or gallstones (or history of) or
High cholesterol or triglycerides (or family history of) or
Jaundice (yellow skin) or
Liver disease, including jaundice (or history of) or
Pancreatitis (inflammation of pancreas) or
Porphyria (liver problem)—Conjugated estrogens or medroxyprogesterone may worsen these conditions; using estrogens can lower blood cholesterol in many patients with high cholesterol

Low blood calcium, severe—Estrogens should be used with caution in patients with this condition

Underactive thyroid—A change in dose of thyroid medication may be needed. Your doctor will watch for this.

Proper Use of This Medicine

Conjugated estrogens and medroxyprogesterone usually come with patient 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 it for a longer period of time than your doctor ordered . The length of time you take the medicine will depend on the medical problem for which you are taking conjugated estrogens and medroxyprogesterone. Discuss with your doctor how long you will need to take these medicines.

If you are taking the estrogen or progestin hormones in a certain order (i.e., conjugated estrogens tablets followed by conjugated estrogens and medroxyprogesterone tablets), be sure you know in which order you need to take the medicines . If you have questions about this, ask your health care professional.

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.

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.

For conjugated estrogens, and conjugated estrogens and medroxyprogesterone
For oral dosage form (tablets):
- To prevent loss of bone (osteoporosis) or for treating itching or dryness of the genital area (atrophy of the vulva), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—One tablet (containing 0.625 mg conjugated estrogens) once a day on Days 1 through 14; then, one tablet (containing 0.625 mg conjugated estrogens and 5 mg medroxyprogesterone) once a day on Days 15 through 28. Repeat cycle.

For conjugated estrogens and medroxyprogesterone
For oral dosage form (tablets):
- To prevent loss of bone (osteoporosis) or for treating itching or dryness of the genital area (atrophy of the vulva), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—One tablet (containing 0.3 mg conjugated estrogens and 1.5 mg medroxyprogesterone) once a day for twenty-eight days. Repeat cycle. If vaginal bleeding or spotting continues and it is undesired, your doctor may increase your dose to the next highest strength tablet (0.45 mg conjugated estrogens and 1.5 mg medroxyprogesterone). It should be taken once a day for twenty-eight days. Repeat cycle.

Missed dose—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.

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, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
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.

Although the risk for developing breast problems or breast cancer is low, it is still important that you regularly check your breasts for any unusual lumps or discharge, and report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) and breast examination done by your doctor whenever your doctor recommends it.

If your menstrual periods have stopped, they may start again once you begin taking this medicine. 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 test results may be affected.

You may need to stop taking this medicine before having some kinds of surgery or while your doctor has ordered a long period of bedrest. Talk with your doctor about this.

Side Effects of This Medicine

Healthy women rarely have severe side effects from taking conjugated estrogens or medroxyprogesterone to replace estrogen.

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

More common

Itching of the vagina or genital area; menstrual periods beginning again, including changing menstrual bleeding pattern for up to 6 months (spotting, breakthrough bleeding, prolonged or heavier vaginal bleeding, or vaginal bleeding completely stopping by 10 months); pain during sexual intercourse; thick, white vaginal discharge

Less common

Blurred vision; breast lumps; chest pain; discharge from breast; dizziness; feeling faint, dizzy, or light-headed; feeling of warmth or heat; flushing or redness of skin, especially on face and neck; headache; heavy nonmenstrual vaginal bleeding; nervousness; pounding in the ears; severe cramping of the uterus; skin rash; slow or fast heartbeat; sweating

Rare

Change in vaginal discharge; pain or feeling of pressure in pelvis; pain or tenderness in stomach, side, or abdomen; yellow eyes or skin

Unknown

acid or sour stomach; belching; backache; full or bloated feeling or pressure in the stomach; heartburn; indigestion; loss of appetite; stomach discomfort, upset or pain; swelling of abdominal or stomach area; abdominal bloating; pelvic pain; stomach pain

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:

More common

Abdominal cramps; back pain; body aches or pain; breast pain or tenderness; congestion; chills; cough; crying; diarrhea; depersonalization; dryness or soreness of throat; dysphoria; enlarged breasts; euphoria; feeling faint, dizzy, or light-headedness; feeling of warmth or heat; fever; flushing or redness of skin, especially on face and neck; general feeling of discomfort or illness; headache, severe and throbbing; hoarseness; increase in amount of clear vaginal discharge; itching; joint pain; lack or loss of strength; mental depression; muscle aches and pains; nausea; pain; pain or tenderness around eyes and cheekbones; painful menstrual periods; painful or difficult urination; paranoia; passing of gas; quick to react or overreact emotionally; rapidly changing moods; runny nose; shivering; shortness of breath or troubled breathing; sneezing; sore throat; stuffy nose; stomach discomfort following meals; tender, swollen glands in neck; tightness of chest or wheezing; trouble sleeping; trouble in swallowing; unusual tiredness; voice changes; vomiting

Less common

Acne; bloating or swelling of face, ankles, or feet; cervix disorder; crying; depersonalization; dysphoria; euphoria; increase in sexual desire; leg cramps; mental depression; paranoia; quick to react or overreact emotionally; rapidly changing moods; sleeplessness; tense muscles; trouble sleeping; unable to sleep; unusual weight gain or loss

Unknown

light vaginal bleeding between periods and after intercourse; bloody vaginal discharge; bloody or cloudy urine; difficult, burning, or painful urination; frequent urge to urinate; abdominal cramping

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

Revised: 06/25/2004

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