Menest

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

Esterified estrogens are a man-made mixture of estrogens that are used to treat symptoms of menopause such as hot flashes, vaginal dryness, vaginal burning or irritation, or other hormonal changes in the vagina.

This medicine is also used to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body.

In some cases, esterified estrogens is used to treat symptoms of breast cancer in men and women. Esterified estrogens is also used in men to treat symptoms of advanced prostate cancer. Esterified estrogens treats only the symptoms of cancer but does not treat the cancer itself.

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

This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant, and tell your doctor right away if you become pregnant.

You should not use esterified estrogens if you are allergic to it, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• a bleeding or blood-clotting disorder;

• breast cancer (unless you are taking esterified estrogens to treat breast cancer symptoms);

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• a history of blood clots caused by taking birth control pills or hormone replacement medicine.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions.

To make sure esterified estrogens is safe for you, tell your doctor if you have:

• heart disease (coronary artery disease, chest pain, history of heart attack, stroke, or blood clot);

• gallbladder disease;

• a history of depression;

• liver disease;

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;

• a family history of breast cancer;

• diabetes;

• kidney disease;

• epilepsy;

• migraines;

• a history of jaundice caused by pregnancy or birth control pills;

• if you have had your uterus removed (hysterectomy);

• if you are pregnant or plan to become pregnant;

• if you have had a heart attack or stroke; or

• if you have ever had a blood clot (especially in your lung or your lower body).

The hormones in esterified estrogens can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding a baby.

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).
• To help prevent weakening of bones (osteoporosis) in women past menopause.
• In the treatment of selected cases of breast cancer in men and women.
• In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor's prescription.

• If you have an allergy to estrogens, esterified or any other part of Menest (estrogens, esterified).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have had any of these health problems: Bleeding disorder, blood clots, a higher risk of having a blood clot, breast cancer, liver problems or liver tumor, heart attack, stroke, or a tumor where estrogen makes it grow.
• If you have unexplained vaginal bleeding.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.

This is not a list of all drugs or health problems that interact with Menest.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Menest, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Menest. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Menest (estrogens, esterified).

Review Date: October 4, 2017

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. It contains the concomitant component, 17α-estradiol. 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.

See Boxed Warnings, WARNINGS and PRECAUTIONS.

The following additional adverse reactions have been reported with estrogens and/or progestin therapy.

1. Genitourinary system

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; premenstrual like syndrome, amenorrhea during and after treatment; cystitis like syndrome.

2. Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

3. Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

4. Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gall bladder disease; pancreatitis, enlargement of hepatic hemangiomas.

5. Skin

Chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

6. Eyes

Retinal vascular thrombosis; steepening of corneal curvature; intolerance to contact lenses.

7. Central nervous system

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

8. Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Tablets:

0.3 mg yellow, film-coated oblong tablet imprinted with M72

     100's: NDC 61570-072-01

0.625 mg orange, film-coated oblong tablet imprinted with M73

    100's: NDC 61570-073-01

1.25 mg green, film-coated oblong tablet imprinted with M74

     100's: NDC 61570-074-01

2.5 mg pink, film-coated oblong tablet imprinted with M75

     50's: NDC 61570-075-50

Rx Only

Prescribing Information as of September 2010

Pfizer

NDC 61570-075-50

Menest®
(esterified estrogens
tablets, USP)

2.5 mg

50 Tablets
Rx only

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very bad dizziness or passing out.
• Change in eyesight.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Memory problems or loss.
• Swelling in hands or feet.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.