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What is the most important information I should know about esterified estrogens-methylTESTOSTERone?

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.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is 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 other purposes not listed in this medication guide.

Precautions

Esterified estrogens and methyltestosterone should not be used to prevent heart disease or stroke.

Do not use 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.

Before taking this medication, tell your doctor if you have:

  • 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).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

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 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.

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.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are taking this medication.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

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 any of these serious side effects:

  • 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 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.

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Interactions

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).

This list is not complete and there may be other drugs that can interact with esterified estrogens and methyltestosterone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04