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EstroGel

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EstroGel

Indications
Dosage
How Supplied

INDICATIONS

Treatment Of moderate To Severe Vasomotor Symptoms Due To Menopause

Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Aatrophy Due To Menopause

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.

DOSAGE AND ADMINISTRATION

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].

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.

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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

EstroGel 0.06% is an estradiol transdermal gel. One pump depression delivers 1.25 g of gel that contains 0.75 mg estradiol.

EstroGel is a clear, colorless, hydroalcoholic 0.06 percent estradiol gel supplied in a non-aerosol, metered-dose pump. The pump consists of an LDPE inner liner encased in rigid plastic with a resealable polypropylene cap. Two pump sizes are available, a 50-gram (1.75 oz), and a 25-gram (0.88 oz). Each individually packaged 50-gram pump contains 50 grams of gel and is capable of delivering 32 metered 1.25-g doses. Each individually packaged 25-gram pump contains 25 grams of gel and is capable of delivering 14 metered 1.25-g doses. One pump depression (1.25 g EstroGel) contains 0.75 mg estradiol.

NDC: 17139-617-40............................. (50-gram pump)
NDC: 17139-617-20............................. (25-gram sample pump)

Storage And Handling

Keep out of reach of children.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured for: ASCEND Therapeutics® US, LLC, Herndon, VA 20170, By DPT Laboratories, San Antonio, TX 78215. Revised: 3/2014

Last reviewed on RxList: 4/4/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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EstroGel - User Reviews

EstroGel User Reviews

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