The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
For the treatment of moderate to severe vasomotor symptoms associated with menopause, and the prevention of osteoporosis
femhrt 1/5 is a combination of an estrogen hormone,
ethinyl estradiol, and a progestin hormone,
norethindrone acetate. It should be used to relieve
symptoms associated with menopause, and also for the prevention of
For the treatment of menopausal symptoms:
Femhrt 1/5 will replace the dropping levels of estrogen in women
experiencing menopause. The treatment will reduce moderate to
severe symptoms, such as hot flashes or feelings of warmth in the
face, neck, and chest. Femhrt should be taken to relieve these
symptoms only as long as the symptoms persist, especially if
patient is taking hormones for other reasons.
For the prevention of osteoporosisFemhrt is most
effective in the prevention of osteoporosis (the thinning of the
bones) when taken as part of an osteoporosis-prevention regimen,
including exercise and calcium supplements.
Although the full clinical trial profile was not available by
the FDA, a study on 18 post-menopausal women tested the effects of
the femhrt hormone replacement therapy in an altered dose (1mg
NA/10mcg EE). Results indicated that the hormones were rapidly
absorbed, with the highest plasma concentrations of norethindrone
acetate and ethinyl estradiol occurring at 1 to 2 hours postdose.
The 1/10 dose were generally found to be proportional to the
marketed 1/5 dose.
Taking estrogen-containing drugs increases the risk of cancer of
the uterus, and may, under some conditions, increase the risk of
breast cancer. Although the risk is not as severe when progestins
accompany the estrogen (as in the femhrt 1/5 combination), patients
taking femhrt should get regular check-ups and perform regular
breast self-examinations. Gallbladder disease, blood clotting, and
vaginal bleeding are all also possible serious side-effects to the
Additional side-effects reported by women taking the estrogen
nausea and vomiting, breast tenderness or enlargement, headache,
retention of extra fluid (edema), runny nose, abdominal pain,
enlargement of non-cancerous tumors (fibroids) of the uterus, skin
rashes and other skin abnormalities.
Mechanism of Action
After menopause, most endogenous estrogen is produced by
conversion of androstenedione, secreted by the adrenal cortex, to
estrone by peripheral tissues. Thus, estrone and the sulphate
conjugated form, estrone sulphate, are the most abundant
circulating estrogens in postmenopausal women. The pharmacologic
effects of ethinyl estradiol are similar to those of endognous
estrogens. Circulating estrogens modulate the pituitary secretion
of the gonadotropins, luteinizing hormone (LH) and
follicle-stimulating hormone (FSH) through a negative feedback
mechanism. Estrogen replacement therapy acts to reduce the elevated
levels of these hormones seen in postmenopausal women.
Progestin compounds enhance cellular differentiation and
generally oppose the actions of estrogens by decreasing estrogen
receptor levels, increasing local metabolism of estrogens to less
active metabolites, or inducing gene products that blunt cellular
responses to estrogen. (FDA Label)
Visit the following web sites for more information about the
benefits and risks of hormone replacement therapy (HRT) and related