femhrt (norethindrone acetate, ethinyl estradiol) is indicated in women with an intact uterus for the:

1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered.

The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Response to therapy can be predicted by pre-treatment serum estradiol, and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.

Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Studies have shown a risk ratio of about 0.4 for hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause, compared to women taking calcium and vitamin D alone. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen reduces further loss of bone mass for as long as treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.

Data from the Women's Health Initiative study showed that use of estrogen plus progestin (dose equivalent to 0.625 CE and 2.5 mg MPA) resulted in about 5 less hip fractures per 10,000 women-years, compared to use of placebo (risk ratio about 0.66).

Use of estrogen, alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3 to 6 month intervals) to determine if treatment is still necessary (See BOXED WARNING and WARNINGS.) 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 evaluated for breast abnormalities in accordance with good clinical practice. Patients should be started at the lowest dose. femhrt (norethindrone acetate, ethinyl estradiol) therapy consists of a single tablet taken once daily.

1. For the Treatment of Moderate to Severe Vasomotor Symptoms associated with the menopause
   femhrt (norethindrone acetate, ethinyl estradiol) should be given once daily for the treatment of moderate to severe vasomotor symptoms associated with the menopause. Patients should be reevaluated at 3 to 6 month intervals to determine if treatment is still necessary.
2. For Prevention of Postmenopausal Osteoporosis.
   When prescribing solely of the prevention of postmenopausal osteoporosis, femhrt (norethindrone acetate, ethinyl estradiol) should only be prescribed to postmenopausal women who are at significant risk of osteoporosis. Non-estrogen medications should be carefully considered. Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Patients should be treated with the lowest effective dose. This dose should be periodically reassessed by the healthcare provider. Response to therapy can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.

femhrt® (norethindrone acetate, ethinyl estradiol) tablets are available in the following strength and package sizes:

N 0430-0145-23 Bottle of 90 oval white tablets with 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol
N 0430-0145-14Blister card of 28 oval white tablets with 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol
N 0430-0544-23 Bottle of 90 D-shaped white tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol
N 0430-0544-14 Blister card of 28 D-shaped white tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol

Keep this drug and all drugs out of the reach of children.

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature].

Manufactured by Duramed Pharmaceuticals, Inc. Pomona, NY 10970. For Warner Chilcott Company Inc. Fajardo, Puerto Rico 00738. Marketed by Warner Chilcott, Inc. Rockaway, NJ 07866. Revised January 2005. FDA revision date: 1/14/2005

Last reviewed on RxList: 1/23/2009
This monograph has been modified to include the generic and brand name in many instances.