Menest Information
Menest (Esterified)
Menest (Esterified) 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. 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.
Menest (Esterified) Clinical Pharmacology
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secrets 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
Menest (Esterified) Indications And Usage
Menest (Esterified) is indicated in the:
Menest (Esterified) Contraindications
Menest (Esterified) should not be used in women with any of the following conditions:
Menest (Esterified) Warnings
See.
The use of unopposed estrogens in women who have a uterus is associated with an increased risk of endometrial cancer.
Menest (Esterified) Precautions
Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See and .)
Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
In the Women’s Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n = 3,729) were 65 to 74 while 18% (n = 803) were 75 and over. Most women (80%) had no prior hormone therapy use. Women treated with conjugated estrogens plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer’s disease was the most common classification of probable dementia in both the conjugated estrogens plus medroxyprogesterone acetate group and the placebo group. Ninety percent of the cases of probable dementia occurred in the 54% of women that were older than 70. (See .)
It is unknown whether these findings apply to estrogen alone therapy.
Menest (Esterified) Adverse Reactions
See , and .
The following additional adverse reactions have been reported with estrogens and/or progestin therapy.
Menest (Esterified) Overdosage
Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
Menest (Esterified) Dosage And Administration
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See and .) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Patients should be started at the lowest dose.
For treatment of moderate to severe vasomotor symptoms, or moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.
Administration should be cyclic (e.g., 3 weeks on and 1 week off).
Menest (Esterified) How Supplied
0.3 mg yellow, film-coated oblong tablet imprinted with M72
100’s: 61570-072-01
0.625 mg orange, film-coated oblong tablet imprinted with M73
100’s: 61570-073-01
1.25 mg green, film-coated oblong tablet imprinted with M74
100’s: 61570-074-01
2.5 mg pink, film-coated oblong tablet imprinted with M75
50’s: 61570-075-50
Prescribing Information as of September 2010
Menest (Esterified) Patient Information
(Updated June 2005)
(esterified estrogens tablets, USP)
Read this PATIENT INFORMATION before you start taking Menest (Esterified) and read what you get each time you refill Menest (Esterified) . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
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Menest (Esterified) Labelgraphics
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