Product Description.:
M72
tablet , film-coated , yellow , oblong oblong
Close clinical surveillance of all women taking estrogens is important.Adequate diagnostic measures,including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)
CARDIOVASCULAR AND OTHER RISKS
Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women's Health Initiative Memory Study (WHIMS), a sub-study of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of conjugated estrogens with medroxyprogesterone acetate,and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and,in the absence of comparable data,these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
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.
INDICATIONS
Menest is indicated in the:
1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
3. Femalehypogonadism.
4. Female castration.
5. Primary ovarian failure.
6. Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
7. Prostatic carcinoma - palliative therapy of advanced disease.
SIDE EFFECTS
See BOXED WARNINGS, WARNINGS and PRECAUTIONS.
The following additional adverse reactions have been reported with estrogens and/or progestin therapy.
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.
Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea fibrocystic breast changes breast cancer.
Cardiovascular
Deep and superficial venous thrombosis pulmonary embolism thrombophlebitis myocardial infarction stroke increase in blood pressure.
Gastrointestinal
Nausea, vomiting abdominal cramps, bloating cholestatic jaundice increased incidence of
