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Femhrt (Norethindrone Acetate / Ethinyl Estradiol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Prevention of Postmenopausal Osteoporosis

 Limitation of Use

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

DOSAGE AND ADMINISTRATION

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. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

femhrt therapy consists of a single tablet to be taken orally once daily.

Prevention of Postmenopausal Osteoporosis

femhrt therapy consists of a single tablet taken orally once daily.  

DOSAGE FORMS AND STRENGTHS

The following two strengths of femhrt are available:

femhrt (0.5 mg/2.5 mcg): Each oval white tablet contains 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol; imprinted with WC on one side and 145 on the other

femhrt (1 mg/5 mcg): Each D-shaped white tablet contains 1 mg norethindrone acetate and 5 mcg ethinyl estradiol; imprinted with WC on one side and 144 on the other

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

femhrt (norethindrone acetate/ethinyl estradiol tablets) is available in the following strengths and package sizes:

N 0430-0145-23  Bottle of 90 oval white tablets containing 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol; imprinted with WC on one side and 145 on the other.

N 0430-0145-14  Blister card of 28 oval white tablets containing 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol; imprinted with WC on one side and 145 on the other.

N 0430-0544-23  Bottle of 90 D-shaped white tablets containing 1 mg norethindrone acetate and 5 mcg ethinyl estradiol; imprinted with WC on one side and 144 on the other.

N 0430-0544-14 Blister card of 28 D-shaped white tablets containing 1 mg norethindrone acetate and 5 mcg ethinyl estradiol; imprinted with WC on one side and 144 on the other.

Storage and Handling

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

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