Estratest

DRUG DESCRIPTION

ESTRATEST (esterified estrogens and methyltestosterone) ® Tablets: Each dark green, capsule shaped, sugar-coated oral tablet contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP.

ESTRATEST (esterified estrogens and methyltestosterone) ® H.S. (Half-Strength) Tablets: Each light green, capsule shaped, sugar-coated oral tablet contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP.

Esterified Estrogens

Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent.

Methyltestosterone

Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone.

Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light.

Methyltestosterone structural formula:

ESTRATEST® H.S.<sup>‡</sup> (Esterified Estrogens and Methyltestosterone) Tablets Structural Formula Illustration

C20H30O2..........302.46
Androst-4-en-3-one, 17-hydroxy-17-methyl-, (17•)-

ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets contain the following inactive ingredients: acacia, acetylated monoglycerides, calcium carbonate, carboxymethylcellulose sodium, carnauba wax NF, citric acid, colloidal silicon dioxide, gelatin, iron oxide, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, pharmaceutical glaze, povidone, propylene glycol, propylparaben, shellac glaze, sodium benzoate, sodium bicarbonate, sorbic acid, starch, sucrose, talc, titanium dioxide, and tribasic calcium phosphate.

ESTRATEST (esterified estrogens and methyltestosterone) Tablets also contain: FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, and D&C Yellow No. 10 Lake.

ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets also contain: D&C Yellow No. 10 Lake, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, FD&C Yellow No. 6 Lake, and FD&C Red No. 40 Lake.

What are the possible side effects of esterified estrogens and methyltestosterone?

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;
  • ...

Read All Potential Side Effects and See Pictures of Estratest »

What are the precautions when taking esterified estrogens and methyltestosterone (Estratest)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to methyltestosterone or estrogen; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain cancers (e.g., breast cancer, cancer of the uterus or ovaries), current/history of blood clots, history of stroke or heart attack, liver problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps...

Read All Potential Precautions of Estratest »

What are the possible side effects of esterified estrogens and methyltestosterone?

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;
  • ...

Read All Potential Side Effects and See Pictures of Estratest »

What are the precautions when taking esterified estrogens and methyltestosterone (Estratest)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to methyltestosterone or estrogen; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain cancers (e.g., breast cancer, cancer of the uterus or ovaries), current/history of blood clots, history of stroke or heart attack, liver problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps...

Read All Potential Precautions of Estratest »


Estratest Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, or breast tenderness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), breast lumps, swelling of hands/feet, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/recurrent bleeding), unusual vaginal discharge/itching/odor, changes in skin color, yellowing eyes/skin, unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, dark urine, worsening of seizures.

Women may experience signs of masculinization (male characteristics) from methyltestosterone. To prevent these changes from becoming permanent, stop taking this medication and tell your doctor immediately if any of the following occur: hoarseness, deepening of the voice, facial hair growth, new or worsening acne, an enlarged clitoris, menstrual period changes.

This medication may infrequently cause serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest pain, jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling of legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to methyltestosterone or estrogen; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain cancers (e.g., breast cancer, cancer of the uterus or ovaries), current/history of blood clots, history of stroke or heart attack, liver problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure), kidney disease, underactive thyroid (hypothyroidism), a certain hormone problem (hypoparathyroidism), mineral imbalance (low or high calcium blood level), mental/mood disorders (e.g., dementia, depression), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus problems (e.g., uterine fibroids, endometriosis), high blood cholesterol/fat (triglyceride) levels, gallbladder disease, obesity, certain blood disorder (porphyria), lupus.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and of any symptoms such as increased thirst/urination, weakness, or fainting. Your anti-diabetic medication or diet may need to be adjusted.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may worsen this darkening. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not smoke cigarettes or use tobacco. Estrogens combined with smoking further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35.

If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances (such as stopping this medication) because of the increased risk for blood clots. Consult your doctor for details.

This medication is not meant for use in children.

This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This medication is not effective for preventing a miscarriage and should not be used for this purpose.

This medication is not usually used in women of childbearing age. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.


Estratest Patient Information Including Side Effects

Brand Names: Covaryx, Covaryx HS, EEMT, Essian H.S., Estratest, Estratest H.S., Syntest DS, Syntest HS

Generic Name: esterified estrogens and methyltestosterone (Pronunciation: ess TER if fyed ESS troe jenz and METH il tes TOS te rone)

  • What is esterified estrogens and methyltestosterone (Estratest)?
  • What are the possible side effects of esterified estrogens and methyltestosterone?
  • What is the most important information I should know about esterified estrogens and methyltestosterone?
  • What should I discuss with my health care provider before using esterified estrogens and methyltestosterone?
  • How should I use esterified estrogens and methyltestosterone?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using esterified estrogens and methyltestosterone?
  • What other drugs will affect esterified estrogens and methyltestosterone?
  • Where can I get more information?

What is esterified estrogens and methyltestosterone (Estratest)?

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.

What are the possible side effects of esterified estrogens and methyltestosterone?

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.

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.

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.

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