Estradiol (Estrogel)

Trade Name : EstroGel

ASCEND Therapeutics US, LLC

GEL, METERED

Strength 0.75 mg/1.25g

ESTRADIOL Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Estradiol (Estrogel) which is also known as EstroGel and Manufactured by ASCEND Therapeutics US, LLC. It is available in strength of 0.75 mg/1.25g per ml. Read more

Estradiol (Estrogel) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Warnings and Precautions, Malignant Neoplasm (n n n n ) 8/2017n nn

Arrayn- Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed, persistent, or recurring abnormal genital bleeding n n n n
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia n n n .n n n
The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo n n n n
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women n n n .n n n
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Arrayn- Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia n n n .n n n
The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo n n n n
The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women n n n n
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer n n n .n n n
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning
Estrogen-Alone Therapy
Estrogen Plus Progestin Therapy

EstroGel 0.06% is an estrogen indicated for

Treatment of moderate to severe vasomotor symptoms due to menopause (n n n )n n n
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (n n n )n n n

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 n n n .n nn
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.
Daily administration of EstroGel 0.06% 1.25 g per day (1 pump depression) to the arm (n n n , n n n )n nn

EstroGel 0.06% is an estradiol transdermal gel. One pump depression delivers 1.25 g of gel that contains 0.75 mg estradiol.
1 pump depression of EstroGel 0.06% delivers 1.25 g of gel containing 0.75 mg estradiol (n n n )n nn

EstroGel is contraindicated in women with any of the following conditions:

Undiagnosed abnormal genital bleeding (n n n )n n n
Known, suspected, or history of breast cancer (n n n , n n n )n n n
Known or suspected estrogen-dependent neoplasia (n n n , n n n )n n n
Active DVT, PE, or history of these conditions (n n n , n n n )n n n
Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (n n n , n n n )n n n
Known anaphylactic reaction or angioedema to EstroGel (n n n )n n n
Known liver impairment or disease (n n n , n n n )n n n
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (n n n )n n n
Known or suspected pregnancy (n n n , n n n ) n n n

No data

Estrogens increase the risk of gallbladder disease (n n n )n n n
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (n n n , n n n , n n n , n n n )n n n
Monitor thyroid function in women on thyroid replacement therapy (n n n , n n n )n n n

The following serious adverse reactions are discussed elsewhere in the labeling:
Most frequently occurring adverse reactions (u22655 percent) are: headache, flatulence, and breast pain (n n n )n n n n
To report SUSPECTED ADVERSE REACTIONS, contact ASCEND Therapeuticsu00ae US, LLC at 1-877-204-1013 or FDA at 1-800-FDA-1088 or

No drug-drug interaction studies have been conducted for EstroGel.
Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism (n n n )n nn

No data

Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk (n n n )n n n
Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Womenu2019s Health Initiative Memory ancillary studies of the Womenu2019s Health Initiative (n n n , n n n )n n n

Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of EstroGel together with institution of appropriate symptomatic care.

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 estrau20111,3,5(10)-triene-3,17u03b2-diol. It has an empirical formula of Cn n n Hn n n On n n and molecular weight of 272.39. The structural formula is:n nn
The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol, triethanolamine and carbomer 934P) are pharmacologically inactive.

EstroGel provides systemic estrogen therapy by releasing estradiol, the major estrogenic hormone secreted by the human ovary.

Long-term, continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.

No data

No data

No data

See n n n (Patient Information and Instructions for Use)n nn

EstroGel 0.06% (u0115su2019 tru0259 ju0115l)
(estradiol gel)
Read this Patient Information before you start using EstroGel, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
What is EstroGel?
EstroGel is a prescription medicine gel that contains estradiol (an estrogen hormone). n n n n
EstroGel is used after menopause to:
Who should not use EstroGel?
Do not start using EstroGel if you:
What should I tell my healthcare provider before I use EstroGel?
Before you use EstroGel, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,n- How should I use EstroGel?
For detailed instructions, see the step-by-step instructions for using EstroGel at the end of this Patient Information.
What are the possible side effects of EstroGel?
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
Less serious, but common side effects include:
These are not all of the possible side effects of EstroGel. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away. You may report side effects to ASCEND Therapeutics US, LLC at 1u2011877-204-1013 or to FDA at 1-800-FDA-1088. n n n n
Ask your healthcare provider for ways to lower your chances of getting heart disease. n n n n
Keep EstroGel and all medicines out of the reach of children. n n General information about the safe and effective use of EstroGel
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use EstroGel for conditions for which it was not prescribed. Do not give EstroGel to other people, even if they have the same symptoms you have. It may harm them.
This patient leaflet summarizes the most important information about EstroGel. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about EstroGel that is written for health professionals.
For more information, go to , or call ASCEND Therapeutics US, LLC at 1-877-204-1013. n n n n
Active ingredient:
Inactive ingredients:n- Instructions for Use
EstroGel 0.06% (u0115su2019 tru0259 ju0115l)
(estradiol gel)
Read this Instructions for Use before you start using EstroGel and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
You will need the following supplies to use EstroGel: See Figure A.
Figure A
EstroGel is supplied in a metered-dose pump that delivers a measured amount of estradiol to your skin each time you press the pump.
EstroGel is available in a 50-gram canister.
Step 1. Priming the EstroGel pump
Figure B
Step 2. Applying EstroGel to your skin
Figure C
Figure D
Figure E
Figure F
Step 3. After you use EstroGel
Step 4. Throwing away used EstroGel canisters
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for:
ASCEND Therapeutics US, LLC
Herndon, VA 20170
By DPT Laboratories Ltd.
San Antonio, TX 78215
140992Rev052018
Utilizes EHG Technology
u00a92018 ASCEND Therapeutics US, LLC
Revised: 5/2018

NDC 17139-617-40n n n ESTROGeln n n 0.06% n n n (estradiol gel) n n n For Topical Use Only. n n n A multiple-dose pump containing 50 grams (1.75 oz)n n n Rx only n nn

NDC 17139-617-40n n n ESTROGeln n n 0.06% n n n (estradiol gel) n n n For Topical Use Only. n n n A multiple-dose pump n n n containing 50 grams (1.75 oz)n n n Rx onlyn nn

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Estradiol (Estrogel)

Trade Name : EstroGel

GEL, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Estradiol (Estrogel)

Trade Name : EstroGel

GEL, METERED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Canadian DIN

Swiss Drugs

NZ Drugs

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