Menest

DRUG DESCRIPTION

Esterified estrogens 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. The content of total esterified estrogens is not less than
90 percent and not more than 110 percent of the labeled amount. Esterified estrogens
contain not less than 75 percent and not more than 85 percent of sodium estrone
sulfate, and not less than 6 percent and not more than 15 percent of sodium
equilin sulfate, in such proportion that the total of these two components is
not less than 90 percent, all percentages being calculated on the basis of the
total esterified estrogens content.

Inactive Ingredients: Ethyl cellulose, fragrances, hydroxypropyl cellulose,
hypromellose 2910, lactose, magnesium stearate, methylcellulose, polyethylene
glycol, sodium bicarbonate, shellac, starch, stearic acid, titanium dioxide,
and vanillin. Dyes in the form of aluminum lakes are contained in each tablet
strength as follows: 0.3 mg Tablet: FD&C Yellow No. 6, D&C Yellow
No. 10. 0.625 mg Tablet: FD&C Yellow No.6, D&C Yellow No.10.
1.25 mg Tablet: FD&C Yellow No.6, D&C Yellow No.10, FD&C
Blue No.1. 2.5 mg Tablet: D&C Red No.30.

What are the possible side effects of esterified estrogens (Estratab, Menest)?

If you experience any of the following serious side effects, stop taking esterified estrogens and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);


• a blood clot (pain, redness, and swelling in an arm or leg, shortness of breath, chest pain, headache, blurred vision, or confusion);


• a lump in a breast; or


• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or...

Read All Potential Side Effects and See Pictures of Menest »

What are the precautions when taking estrogens (Menest)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels,...

Read All Potential Precautions of Menest »

Menest Consumer (continued)

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell 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 right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression).

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

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking an estrogen product. You may need to stop this medication for a time or take special precautions.

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

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.

Children may be more sensitive to the side effects of this drug. It may affect their growth/development. Discuss the possible effects of this medication with the doctor, and monitor your child's growth periodically.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

Menest Patient Information Including Side Effects

Brand Names: Estratab, Menest

Generic Name: esterified estrogens (Pronunciation: ess TER ih fied ESS troe jenz)

• What are esterified estrogens (Menest)?


• What are the possible side effects of esterified estrogens (Menest)?


• What is the most important information I should know about esterified estrogens (Menest)?


• Who should not take esterified estrogens (Menest)?


• How should I take esterified estrogens (Menest)?


• What happens if I miss a dose (Menest)?


• What happens if I overdose (Menest)?


• What should I avoid while taking esterified estrogens (Menest)?


• What other drugs will affect esterified estrogens (Menest)?


• Where can I get more information?

What are esterified estrogens (Menest)?

Estrogen is a female sex hormone necessary for many processes in the body.

Esterified estrogens are naturally occurring female sex hormones that are used to treat symptoms of menopause; deficiency in ovary function (including underdevelopment of female sexual characteristics and some types of infertility); some types of breast cancer in men and in postmenopausal women; degeneration of the vagina; and urethra and prostate cancer. In addition, esterified estrogens are used to prevent osteoporosis.

Esterified estrogens may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of esterified estrogens (Menest)?

If you experience any of the following serious side effects, stop taking esterified estrogens and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);


• a blood clot (pain, redness, and swelling in an arm or leg, shortness of breath, chest pain, headache, blurred vision, or confusion);


• a lump in a breast; or


• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take esterified estrogens and talk to your doctor if you experience

• decreased appetite, nausea, or vomiting;


• swollen or tender breasts;


• acne or skin color changes;


• decreased sex drive;


• migraine headaches or dizziness;


• water retention (swollen hands, feet, or ankles);


• problems with wearing contact lenses;


• depression; or


• changes in your menstrual cycle or breakthrough bleeding.

Esterified estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with esterified estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.

It is unclear to what extent estrogen treatments may affect the risk of breast cancer.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about esterified estrogens (Menest)?

Esterified estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with esterified estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking esterified estrogens.

Do not take esterified estrogens if you are pregnant.

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