Esterified estrogens are female sex hormones produced by the ovaries.

Methyltestosterone is a sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.

Esterified estrogens and methyltestosterone is a combination medicine used to treat symptoms of menopause such as hot flashes or night sweats. esterified estrogens and methyltestosterone is usually given only short-term (such as 3 to 6 months).

Esterified estrogens and methyltestosterone may also be used for purposes not listed in this medication guide.

You should not use esterified estrogens and methyltestosterone if you have: undiagnosed vaginal bleeding, severe liver disease, if you will have major surgery, or if you have ever had a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant or breastfeeding.

Estrogens may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, vagina, or liver. Estrogens should not be used to prevent heart disease.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

esterified estrogens and methyltestosterone is usually taken in a cycle of 3 weeks on and 1 week off. Follow your doctor's instructions.

Estrogens may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using esterified estrogens and methyltestosterone.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while taking esterified estrogens and methyltestosterone.

When you stop using this medicine, follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Postmenopausal Symptoms:

Esterified estrogens-medroxyprogesterone 1.25 mg-2.5 mg oral tablets: one tablet orally once a day
or
Esterified estrogens-medroxyprogesterone 0.625 mg-1.25 mg oral tablets: one or two tablets orally once a day

Comments:
-Administration should be cyclic (e.g., three weeks on and one week off); women with a uterus should receive a progestin to reduce the risk of endometrial cancer.
-This drug should be used at the lowest dose that will control symptoms for the shortest duration consistent with treatment goals; attempts to discontinue or taper medication should be made at 3 to 6 month intervals.
-There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.

Use: For treatment of moderate to severe vasomotor symptoms associated with the menopause in patients not improved by estrogen alone.

You should not use esterified estrogens and methyltestosterone if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• severe liver disease;

• if you have had a stroke or blood clot;

• if you have had hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina; or

• if you are pregnant or breastfeeding.

Do not use this medicine if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Esterified estrogens and methyltestosterone should not be used to prevent heart disease or stroke because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease;

• liver problems, or jaundice caused by pregnancy or taking hormones;

• a thyroid disorder;

• gallbladder disease;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraine headaches;

• diabetes;

• depression;

• uterine fibroid tumors;

• a breast lump or abnormal mammogram; or

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Using this medicine may increase your risk of cancer of the breast, uterus, vagina, or liver. Talk with your doctor about this risk.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Overdose symptoms may include nausea and vaginal bleeding.

Do not share esterified estrogens and methyltestosterone with another person, even if they have the same symptoms you have.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Esterified estrogens and methyltestosterone may cause serious side effects. Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• swelling or tenderness in your stomach;

• nausea, vomiting, swelling, rapid weight gain;

• jaundice (yellowing of the skin or eyes);

• changes in skin color;

• a light-headed feeling, like you might pass out;

• unusual vaginal bleeding;

• a breast lump;

• memory problems, confusion, unusual behavior;

• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy; or

Methyltestosterone can cause symptoms of male features in a woman taking this medicine. Call your doctor if you develop enlarged genitals, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Common side effects of esterified estrogens and methyltestosterone may include:

• swollen or painful breasts;

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;

• pain or burning when you urinate;

• nausea, vomiting, stomach cramps;

• darkening of facial skin, increased hair growth, loss of scalp hair;

• vision changes, problems with contact lenses;

• swelling, weight gain or loss;

• increased or decreased libido;

• headache, dizziness, depression, anxiety; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• insulin; or

• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect esterified estrogens and methyltestosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.