Estradioldosage

Daily administration of 0.25 to 1.25 grams of Divigel to the right or left upper thigh on alternating days. Women should be started with the lowest effective dose and the dose should be evaluated periodically.

2.1 Important

Use Information The timing of Divigel initiation can affect the overall benefit-risk profile. Consider initiating Divigel in women <60 years old or <10 years since menopause onset. When estrogen is prescribed for a menopausal woman with a uterus, the addition of a progestogen has been shown to reduce the risk of endometrial cancer. There are possible risks associated with the use of progestogens plus estrogens that differ from those of estrogen-alone regimens. See prescribing information for progestogens indicated for the prevention of endometrial hyperplasia in non-hysterectomized menopausal women receiving estrogens. Generally, a woman without a uterus, does not need to use a progestogen with estrogen therapy. In some cases, however, hysterectomized women with a history of endometriosis may benefit from the addition of a progestogen.

2.2 Treatment of

Moderate to Severe Vasomotor Symptoms due to Menopause Start therapy with the 0.25 grams applied once daily on the skin of either the right or left upper thigh. Adjust the dose up to a maximum of 1.25 grams, as needed. The application surface area should be about 5 by 7 inches (approximately the size of two palm prints). The entire contents of a unit dose packet should be applied each day. To avoid potential skin irritation, apply Divigel to the right or left upper thigh on alternating days. Do not apply Divigel on the face, breasts, or irritated skin or in or around the vagina. Allow gel to dry after application before dressing. Do not wash the application site within 1 hour after applying Divigel. Avoid contact of the gel with eyes. Wash hands after application.