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Femring (Estradiol Acetate Vaginal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

 1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

DOSAGE AND ADMINISTRATION

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.

A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.14)].

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

Start therapy with 0.05 mg/day. Dosage adjustment should be guided by the clinical response.

 Therapy should be started at the lowest effective dose and the shortest duration consistent with treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

Start therapy with 0.05 mg/day. Dosage adjustment should be guided by the clinical response.

 Therapy should be started at the lowest effective dose and the shortest duration consistent with treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

 

DOSAGE FORMS AND STRENGTHS

The following two strengths of Femring are available:

Femring (0.05 mg/day): Each off-white, soft, flexible ring has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months.

Femring (0.10 mg/day): Each off-white, soft, flexible ring has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Each Femring (estradiol acetate vaginal ring) is individually packaged in a pouch consisting of one side medical grade paper and the other side polyester/polyethylene laminate.

N 0430-6201-40 Femring 0.05 mg/day (estradiol acetate vaginal ring) is available in single units.
N 0430-6202-40 Femring 0.10 mg/day (estradiol acetate vaginal ring) is available in single units.

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].

Do not store unpouched.  Insert immediately upon removal from the protective pouch.

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