ESTRING (Estradiol) vaginal ring is indicated for the treatment of urogenital symptoms associated with post-menopausal atrophy of the vagina (such as dryness, burning, pruritus and dyspareunia) and/or the lower urinary tract (urinary urgency and dysuria). ESTRING (Estradiol) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. ESTRING (Estradiol), silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING (Estradiol) releases estradiol, approximately 7.5 mcg/24 hours, in a consistent stable manner over 90 days. ESTRING (Estradiol) Has the Following Dimensions: Outer diameter 55 mm; cross-sectional diameter 9 mm; core diameter 2 mm. One ESTRING (Estradiol) should be inserted into the upper third of the vaginal vault, to be worn continuously for three months. One ESTRING (Estradiol) vaginal ring is to be inserted as deeply as possible into the upper one-third of the vaginal vault. The ESTRING (Estradiol) ring is to remain in place continuously for 3 months, after which ESTRING (Estradiol) ring is to be removed and, if appropriate, replaced by a new ESTRING (Estradiol) ring. The need to continue treatment should be assessed at 3 or 6 month intervals. Should the ESTRING (Estradiol) ring be removed or fall out at any time during the 90-day treatment period, the ESTRING (Estradiol) ring should be rinsed in lukewarm water and re-inserted by the patient, or, if necessary, by a physician or nurse. Retention of the ESTRING (Estradiol) 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. 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 the ESTRING (Estradiol) vaginal ring is in place, the patient should not feel anything. If the patient feels discomfort, the ESTRING (Estradiol) vaginal ring is probably not far enough inside. Gently push the ESTRING (Estradiol) vaginal ring further into the vagina. ESTRING (Estradiol) Vaginal Ring Use: The ESTRING (Estradiol) vaginal ring should be left in place continuously for 90 days and then, if continuation of therapy ESTRING (Estradiol) is deemed appropriate, replaced by a new ESTRING (Estradiol) vaginal ring. The patient should not feel the ESTRING (Estradiol) vaginal ring when ESTRING (Estradiol) is in place and ESTRING(Estradiol) should not interfere with sexual intercourse. Straining at defecation may make the ESTRING (Estradiol) vaginal ring move down in the lower part of the vagina. If so, ESTRING (Estradiol) may be pushed up again with a finger. If the ESTRING (Estradiol) vaginal ring is expelled totally from the vagina, ESTRING (Estradiol) should be rinsed in lukewarm water and reinserted by the patient (or doctor/nurse if necessary). ESTRING (Estradiol) Vaginal Ring Removal: The ESTRING (Estradiol) vaginal ring may be removed by hooking a finger through the ring and pulling it out.

Estring Vaginal Ring Side Effects:

The biological safety of the silicone elastomer has been studied in various in vitro and in vivo test models. The results show that the silicone elastomer is non-toxic, non-pyrogenic, non-irritating, and non-sensitizing. Long-term implantation induced encapsulation equal to or less than the negative control (polyethylene) used in the USP test. No ESTRING side effects like toxic reaction or tumor formation was observed with the silicone elastomer. In general , no estradiol side effects were reported. In the two pivotal controlled studies, discontinuation of treatment due to an adverse event was required by 5.4% of patients receiving the estradiol vaginal ring and 3.9% of patients receiving conjugated estrogens vaginal cream. The most common reasons for withdrawal from estradiol vaginal ring treatment due to ESTRING side effects like vaginal discomfort and gastrointestinal symptoms.

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