Estrogel
Loading...Estrogel Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
History
There is currently no drug history available for this drug.
Other Information
EstroGel (estradiol gel) contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of EstroGel delivers 1.25 g of gel containing 0.75 mg estradiol.
Estradiol is a white crystalline powder, chemically described as estra‑1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:
The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol, triethanolamine and carbomer 934P) are pharmacologically inactive.
Sources
Estrogel Manufacturers
-
Ascend Therapeutics Us, Llc
![Estrogel (Estradiol) Gel, Metered [Ascend Therapeutics Us, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Estrogel | Ascend Therapeutics Us, Llc
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 MenopauseEstroGel 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 MenopauseEstroGel 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.
-
Ascend Therapeutics Us, Llc
Estrogel | Ascend Therapeutics Us, Llc
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 MenopauseEstroGel 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 MenopauseEstroGel 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.
![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)
Login To Your Free Account