Femhrt Tablets
Company: Parke-Davis
Approval Status: October 15, 1999
Treatment for: For the treatment of moderate to severe vasomotor symptoms associated with menopause, and the prevention of osteoporosis
Areas: Endocrinology; Musculoskeletal; Obstetrics/Gynecology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
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
osteoporosis.
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.
Clinical Results
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.
Side Effects
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 hormone treatment.
Additional side-effects reported by women taking the estrogen
hormone include:
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)
Additional Information
Visit the following web sites for more information about the
benefits and risks of hormone replacement therapy (HRT) and related
subjects:
www.pslgroup.com/MENOPAUSE.HTM
www.healthyideas.com/healing/living/980623.lvg.html
www.plgrm.com/health/E/Estrogen_Replacement.HTM
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
