Ascend Therapeutics Us, Llc
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Ascend Therapeutics Us, Llc Drugs
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![Estrogel (Estradiol) Gel, Metered [Ascend Therapeutics Us, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=762ac371-bb8b-47e7-b48f-e80d452c9dd4&name=5f346be7-1b1c-4b9d-84a5-960844c11dfb-09.jpg)
Estrogel
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 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 reevaluated periodically as clinically appropriate to determine if treatment is still necessary.
2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
EstroGel 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe vasomotor symptoms due to menopause. The lowest effective dose of EstroGel 0.06% for this indication has not been determined.
Before using the canister for the first time, it must be primed. Remove the large canister cover, and fully depress the pump 3 times. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash. After priming, the pump is ready to use.
The recommended area of application is the arm. Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder.
2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
EstroGel 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. The lowest effective dose of EstroGel 0.06% for this indication has not been determined. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Before using the canister for the first time, it must be primed. Remove the large canister cover, and fully depress the pump 3 times. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash. After priming, the pump is ready to use.
The recommended area of application is the arm. Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder.
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![Estrogel (Estradiol) Gel, Metered [Ascend Therapeutics Us, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=87bb0e2f-9fa6-438b-9d5f-d0a90af770ed&name=92f8e342-081c-4e2c-bf02-2d2710e260e7-09.jpg)
Estrogel
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 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 reevaluated periodically as clinically appropriate to determine if treatment is still necessary.
2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
EstroGel 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe vasomotor symptoms due to menopause. The lowest effective dose of EstroGel 0.06% for this indication has not been determined.
Before using the canister for the first time, it must be primed. Remove the large canister cover, and fully depress the pump 3 times. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash. After priming, the pump is ready to use.
The recommended area of application is the arm. Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder.
2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
EstroGel 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. The lowest effective dose of EstroGel 0.06% for this indication has not been determined. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Before using the canister for the first time, it must be primed. Remove the large canister cover, and fully depress the pump 3 times. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash. After priming, the pump is ready to use.
The recommended area of application is the arm. Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder.
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