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Femring (Estradiol Acetate Vaginal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Femring therapy is indicated in the:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

DOSAGE AND ADMINISTRATION

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. 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. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS 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.

Two doses of Femring are available, 0.05 mg/day and 0.10 mg/day, for the treatment of moderate to severe vasomotor symptoms and/or moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.

Patients should be started at the lowest dose. The lowest effective dose of Femring has not been determined.

Instructions for Use

Hands should be thoroughly washed before and after ring insertion.

Femring Insertion

Insert upon removal from the protective pouch.

The opposite sides of the vaginal ring should be pressed together and inserted into the vagina. The exact position is not critical to its function. When Femring is in place, the patient should not feel anything. If the patient feels discomfort, the vaginal ring is probably not far enough inside the vagina. Gently push Femring further into the vagina.

Femring Use

Femring should remain in place for 3 months and then be replaced by a new Femring.

The patient should not feel Femring when it is in place and it should not interfere with sexual intercourse. Straining upon bowel movement may make Femring move down in the lower part of the vagina. If so, it may be repositioned with a finger.

If Femring is expelled totally from the vagina, it should be rinsed in lukewarm water and reinserted by the patient (or healthcare provider if necessary).

Femring Removal

Femring may be removed by looping a finger through the ring and pulling it out.

For patient instructions, see PATIENT INFORMATION.

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.

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

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

Keep out of reach of children.

STORAGE

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

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