Esterified Estrogens Methyltestosterone

Esterified estrogens are female sex hormones necessary for many processes in the body.

Methyltestosterone is a man-made form of testosterone, a naturally occurring 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.

The combination of esterified estrogens and methyltestosterone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

This medication may also be used for purposes not listed in this medication guide.

Do not use this medication if you have any of the following conditions: liver disease, a recent history of heart attack, stroke or circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, or if you are pregnant or breast-feeding. This medication should not be used to prevent heart disease or stroke.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor if you become pregnant during treatment.

Esterified estrogens and methyltestosterone increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using esterified estrogens and methyltestosterone may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are taking esterified estrogens and methyltestosterone.

Long-term esterified estrogens and methyltestosterone treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using esterified estrogens and methyltestosterone long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.

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

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

• liver disease;
• a recent history of heart attack, stroke or circulation problems;
• abnormal vaginal bleeding that a doctor has not checked;
• any type of breast, uterine, or hormone-dependent cancer; or
• if you are pregnant or breast-feeding.

To make sure you can safely take esterified estrogens and methyltestosterone, tell your doctor if you have any of these other conditions:

• high blood pressure, heart disease, or coronary artery disease;
• high cholesterol or triglycerides;
• kidney disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• endometriosis;
• diabetes;
• lupus;
• depression;
• gallbladder disease;
• if you smoke; or
• if you have had your uterus removed (hysterectomy).

Esterified estrogens and methyltestosterone increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using esterified estrogens and methyltestosterone may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using esterified estrogens and methyltestosterone.

Long-term esterified estrogens and methyltestosterone treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using esterified estrogens and methyltestosterone long-term. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use esterified estrogens and methyltestosterone if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Esterified estrogens and methyltestosterone can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden severe headache, confusion, problems with vision, speech, or balance;
• swelling, rapid weight gain;
• confusion, unusual thoughts or behavior;
• pain, swelling, or tenderness in your stomach;
• nausea, stomach pain, loss of appetite jaundice (yellowing of the skin or eyes);
• breast lump, nipple discharge;
• acne, skin color changes, increased facial hair, male pattern baldness, voice changes; or
• changes in your menstrual periods, break-through bleeding.

Less serious side effects may include:

• mild nausea, stomach upset;
• swollen or painful breasts;
• headache;
• hair loss;
• depression, anxiety; or
• decreased sex drive, impotence, or difficulty having an orgasm.

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.

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

Many drugs can interact with esterified estrogens and methyltestosterone. Below is just a partial list. Tell your doctor if you are using:

• a blood thinner such as warfarin (Coumadin);
• insulin;
• ketoconazole (Nizoral);
• St. John's wort;
• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• an antidepressant;
• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, Ery-Tab, Erythrocin), telithromycin (Ketek), and others; or
• HIV/AIDS medicine such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir, Kaletra).

This list is not complete and other drugs may interact with esterified estrogens and methyltestosterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.

If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking esterified estrogens and methyltestosterone.

Store at room temperature away from moisture and heat.

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

Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.