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esterified estrogens and methyltestosterone

Generic Name: esterified estrogens and methyltestosterone (ess TER if fyed ESS troe jenz and METH il tes TOS te rone)
Brand Name: Covaryx, Covaryx HS, EEMT, EEMT DS, EEMT HS, Essian, Essian H.S., Estratest, Estratest H.S., Menogen HS, Menogen, Syntest HS, Syntest DS

What is esterified estrogens and 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.

What is the most important information I should know about esterified estrogens and 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.

Slideshow: Flashback: FDA Drug Approvals 2013

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.

What should I discuss with my health care provider before 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.

How should I use esterified estrogens and methyltestosterone?

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

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

What should I avoid while using esterified estrogens and methyltestosterone?

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

Esterified estrogens and methyltestosterone 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 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.

See also: Side effects (in more detail)

Esterified estrogens and methyltestosterone dosing information

Usual Adult Dose for Postmenopausal Symptoms:

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

The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Administration should be cyclic (e.g., three weeks on and one week off). Attempts to discontinue or taper medication should be made at three to six month intervals.

What other drugs will affect esterified estrogens and methyltestosterone?

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.

Where can I get more information?

  • Your pharmacist can provide more information about esterified estrogens and methyltestosterone.
  • 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.
  • 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 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2010-12-23, 6:46:06 PM.

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