ESTRING® (estradiol vaginal ring) Dosage and Administration

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Prescribing Information

ESTRING^® (estradiol vaginal ring)
Dosage and Administration


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One ESTRING (estradiol vaginal ring) is to be inserted as deeply as possible into the upper one-third of the vaginal vault. The ring is to remain in place continuously for three months, after which it is to be removed and, if appropriate, replaced by a new ring. The need to continue treatment should be assessed at 3 or 6 month intervals.

Should the ring be removed or fall out at any time during the 90-day treatment period, the ring should be rinsed in lukewarm water and re-inserted by the patient, or, if necessary, by a physician or nurse.

Retention of the ring for greater than 90 days does not represent overdosage but will result in progressively greater underdosage with the attendant risk of loss of efficacy and increasing risk of vaginal infections and/or erosions.

Instructions for Use

ESTRING (estradiol vaginal ring) insertion

The ring should be pressed into an oval and inserted into the upper third of the vaginal vault. The exact position is not critical. When ESTRING is in place, the patient should not feel anything. If the patient feels discomfort, ESTRING is probably not far enough inside. Gently push ESTRING further into the vagina.

ESTRING use

ESTRING should be left in place continuously for 90 days and then, if continuation of therapy is deemed appropriate, replaced by a new ESTRING.

The patient should not feel ESTRING when it is in place and it should not interfere with sexual intercourse. Straining at defecation may make ESTRING move down in the lower part of the vagina. If so, it may be pushed up again with a finger.

If ESTRING is expelled totally from the vagina, it should be rinsed in lukewarm water and reinserted by the patient (or doctor/nurse if necessary).

ESTRING removal

ESTRING may be removed by hooking a finger through the ring and pulling it out.

For patient instructions, see Patient Information.

PRINTER-FRIENDLY

ESTRING Safety Information

WARNINGS

ENDOMETRIAL CANCER

Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Dementia.)

The Women’s Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated estrogens (CE 0.625 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.)

The estrogen plus progestin WHI substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.)

The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Important Safety Information

ESTRING^® (estradiol vaginal ring) is indicated for the treatment of moderate to severe urogenital symptoms associated with postmenopausal atrophy of the vagina (such as dryness, burning, pruritus, and dyspareunia) and/or the lower urinary tract (urinary urgency and dysuria).

Estrogens should not be used during pregnancy. There is no indication for ESTRING in pregnancy.

Estrogens increase the risk of endometrial carcinoma. Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures should be undertaken to rule out malignancy in all cases of undiagnosed, persistent, or recurring abnormal vaginal bleeding.

Estrogens with and without progestins should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported that the use of estrogens increases the risk of stroke and deep vein thrombosis in postmenopausal women. The WHI study also reported that the use of estrogens in combination with medroxyprogesterone acetate (MPA) increases the risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women. In a substudy of WHI, estrogen alone and combined with MPA increased the risk of developing probable dementia in postmenopausal women. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

ESTRING is contraindicated in women with the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or a history of these conditions; active or recent (eg, within the past year) arterial thromboembolic disease (eg, stroke, myocardial infarction); and liver dysfunction or disease. ESTRING should not be used in patients hypersensitive to any of its ingredients.

Please see full prescribing information.

ESTRING^® (estradiol vaginal ring)

estring_safety_information.htm