Femhrt Indications, Dosage, Storage, Stability - Norethindrone acetate and ethinyl estradiol

Femhrt Indications, Dosage, Storage, Stability - Norethindrone acetate and ethinyl estradiol

INDICATIONS AND USAGE

femhrt 1/5 is indicated in women with an intact uterus for the:

1. Treatment of moderate to severe vasomotor symptoms associated with 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 and non-estrogen medications should be carefully considered.

Since estrogen administration is associated with risks as well as benefits, selection of patients ideally should be based on prospective identification of risk factors for developing osteoporosis. Unfortunately, there is no certain way to identify those women who will develop osteoporotic fractures. Thus, patient selection must be individualized based on the balance of risks and benefits.

Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Case-control studies have shown an approximately 60% reduction in hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen may prevent further loss of bone mass for as long as the treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to that in the immediate postmenopausal period. There is no evidence that estrogen therapy restores bone mass to premenopausal levels.

Early menopause is one of the strongest predictors for the development of osteoporosis.

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 1500mg/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.

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.

femhrt 1/5 therapy consists of a single tablet taken once daily.

1. For the Treatment of Vasomotor Symptoms femhrt 1/5 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. Prevention of Osteoporosis femhrt 1/5 should be given once daily to prevent postmenopausal osteoporosis (see Clinical Studies: Effect on Bone Mineral Density). Response to therapy can be assessed by measurement of bone mineral density.

femhrt 1/5 tablets are white and available in the following strength and package sizes:

N 0430-0544-23 Bottle of 90 D-shaped tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol

N 0430-0544-14 Blister card of 28 D-shaped tablets with 1 mg norethindrone acetate and 5 mcg ethinyl estradiol

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

Marketed by: Warner Chilcott, Inc. Rockaway, NJ 07866, Revised January 2004, Revision Number