Esterified estrogens

This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant, and tell your doctor right away if you become pregnant.

You should not use esterified estrogens if you are allergic to it, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• a bleeding or blood-clotting disorder;

• breast cancer (unless you are taking esterified estrogens to treat breast cancer symptoms);

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• a history of blood clots caused by taking birth control pills or hormone replacement medicine.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions.

To make sure esterified estrogens is safe for you, tell your doctor if you have:

• heart disease (coronary artery disease, chest pain, history of heart attack, stroke, or blood clot);

• gallbladder disease;

• a history of depression;

• liver disease;

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;

• a family history of breast cancer;

• diabetes;

• kidney disease;

• epilepsy;

• migraines;

• a history of jaundice caused by pregnancy or birth control pills;

• if you have had your uterus removed (hysterectomy);

• if you are pregnant or plan to become pregnant;

• if you have had a heart attack or stroke; or

• if you have ever had a blood clot (especially in your lung or your lower body).

The hormones in esterified estrogens can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Usual Adult Dose for Osteoporosis:

0.3 mg orally once a day.

In addition to hormonal therapy, adequate calcium intake is important for postmenopausal women who require treatment or prevention of osteoporosis. The average diet of older American women contains 400 to 600 mg of calcium per day. A suggested optimal intake is 1500 mg per day. If dietary intake is insufficient to achieve 1500 mg per day, supplementation may be useful in women who have no contraindication to calcium supplementation.

Long-term therapy (for more than 5 years) is generally necessary in order to obtain substantive benefits in reducing the risk of bone fracture. Maximal benefits are obtained if estrogen therapy is initiated as soon after menopause as possible. The optimal duration of therapy has not been definitively determined.

Usual Adult Dose for Postmenopausal Symptoms:

1.25 mg orally once a day.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms should be limited. Treatment for one to five years is generally sufficient. However, long-term therapy (for the treatment/prophylaxis of osteoporosis and for risk reduction of cardiovascular disease) may be considered during the time in which the patient is being treated for postmenopausal symptoms.

Usual Adult Dose for Atrophic Urethritis:

0.3 mg to 1.25 mg orally once a day.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

Usual Adult Dose for Atrophic Vaginitis:

0.3 mg to 1.25 mg orally once a day.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

Usual Adult Dose for Hypoestrogenism:

2.5 mg to 7.5 mg orally once a day in divided doses for 21 days followed by a 10 day rest period. This schedule is repeated as necessary to product bleeding.

Usual Adult Dose for Oophorectomy:

1.25 mg orally once a day.

Usual Adult Dose for Primary Ovarian Failure:

1.25 mg orally once a day.

Usual Adult Dose for Breast Cancer:

10 mg orally three times a day for at least three months.

Estrogen therapy for breast cancer should be considered only for palliation in the treatment of metastatic disease in postmenopausal women and select male patients.

Usual Adult Dose for Prostate Cancer:

1.25 mg to 2.5 mg orally three times a day.

Estrogen therapy for prostate cancer should be considered only for palliation in the treatment of metastatic disease in select patients.

Other drugs may interact with esterified estrogens, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to esterified estrogens: oral tablet

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very bad dizziness or passing out.
• Change in eyesight.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Memory problems or loss.
• Swelling in hands or feet.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.

2.5 mg to 7.5 mg orally once a day in divided doses for 21 days followed by a 10 day rest period. This schedule is repeated as necessary to product bleeding.

1.25 mg orally once a day.

Esterified estrogens have been assigned to pregnancy category X by the FDA. There are no controlled data in human pregnancy. Esterified estrogens are contraindicated during pregnancy.

Estrogenic agents have been associated with urogenital abnormalities in offspring that manifest later in life. Vaginal adenosis, squamous cell dysplasia of the uterine cervix, and vaginal cancer have developed later in life in female offspring. In the male offspring, the risks of urogenital abnormalities and testicular cancer later in life are increased.