Estradiol (Estradiol)

Trade Name : Estradiol

Teva Pharmaceuticals USA, Inc.

INSERT

Strength 10 ug/1

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 (Estradiol) which is also known as Estradiol and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 10 ug/1 per ml. Read more

Estradiol (Estradiol) 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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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 .
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia .
The Womenu2019s 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 .
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 .
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 .
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 .
The WHIMS estrogen plus progestin ancillary study of the 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 .
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer .
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 DEMENTIAn n
Estrogen-Alone Therapy
Estrogen Plus Progestin Therapy

No data

Estradiol vaginal inserts are an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause ()

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 a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin .
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 re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Estradiol vaginal inserts should be administered intravaginally using the supplied applicator: 1 insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Tuesday and Friday).
Estradiol vaginal inserts should be administered intravaginally:

1 insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Tuesday and Friday) ()

Estradiol vaginal inserts USP are white to off-white, round, film-coated, unscored, biconvex inserts containing 10 mcg of estradiol. Each vaginal insert is 6 mm in diameter and is administered in a disposable applicator.

Estradiol vaginal inserts: One vaginal insert contains 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol ()

Estradiol vaginal inserts should not be used in women with any of the following conditions:

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

No data

Estrogens increase the risk of gallbladder disease ()
Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (, , , )
The estradiol vaginal inserts applicator may cause vaginal abrasion ()
Monitor thyroid function in women on thyroid replacement therapy (, )

The following serious adverse reactions are discussed elsewhere in the labeling:
In a prospective, randomized, placebo-controlled, double-blind study the most common adverse reactions (incidence u22655 percent) were back pain, vulvovaginal pruritus, vulvovaginal mycotic infection and diarrhea. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No drug-drug interaction studies have been conducted for estradiol.

Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism ()

No data

Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk ()
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 ()

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 estradiol therapy with institution of appropriate symptomatic care.

Estradiol vaginal inserts USP, 10 mcg are white to off-white, round, film-coated, unscored, biconvex inserts containing 10.3 mcg of estradiol hemihydrate, USP equivalent to 10 mcg of estradiol. Each 10 mcg estradiol vaginal insert contains the following excipients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, and polyethylene glycol. Each estradiol vaginal insert is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina.
Estradiol hemihydrate, USP is white to practically white crystals or powder and chemically described as estra1,3,5 (10)-triene-3,17u03b2-diol, hydrate (2:1).
The structural formula is:
CHOn 1/2 HO M.W. 281.4 (Estradiol hemihydrate, USP)
USP Dissolution Test pending.

No data

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 FDA-Approved Patient Labeling.

Estradiol (ess tra DYE ole) Vaginal Inserts
Read this PATIENT INFORMATION before you start using estradiol vaginal inserts and read what you get each time you refill your estradiol vaginal inserts prescription. 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.
Arrayn- Array
Estradiol vaginal inserts are a medicine that contains estradiol (an estrogen hormone) in a vaginal insert.
What are estradiol vaginal inserts used for?
Estradiol vaginal inserts are used after menopause to:
Who should not use estradiol vaginal inserts?
Do not start using estradiol vaginal inserts if you:
Tell your healthcare provider:
How should I use estradiol vaginal inserts?
Estradiol vaginal inserts are an insert that you place in your vagina with an applicator.
Step 1:
Step 2:
Step 3:
Step 4:u00a0
Step 5:
Step 6:
Step 7:
Step 8:
Dosage
Estradiol vaginal insert therapy consists of the following dosing regimen:
One (1) estradiol vaginal insert intravaginally once daily for the first two (2) weeks, then one (1) insert twice weekly (for example Tuesday and Friday) for as long as you use estradiol vaginal inserts.
What are the possible side effects of estradiol vaginal inserts?
Estradiol vaginal inserts are only used in the vagina; however, the risks associated with oral estrogens should be taken into account.
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 the possible side effects of estradiol vaginal inserts. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with estradiol vaginal inserts?
General information about the safe and effective use of estradiol vaginal inserts.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use estradiol vaginal inserts for conditions for which they were not prescribed. Do not give estradiol vaginal inserts to other people, even if they have the same symptoms you have. They may harm them.
Keep estradiol vaginal inserts out of the reach of children.
This leaflet provides a summary of the most important information about estradiol vaginal inserts. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about estradiol vaginal inserts that is written for health professionals. You can get more information by calling the toll free number 1-888-838-2872.
What are the ingredients in estradiol vaginal inserts?
Estradiol vaginal inserts are small, white, round, film-coated, unscored, biconvex insertsu00a0containing estradiol. Each insert also contains corn starch, hypromellose, lactose monohydrate, magnesium stearate, and polyethylene glycol.
Each estradiol vaginal insert is contained in a disposable applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset inserts.
Store at 68u00b0 to 77u00b0F (20u00b0 to 25u00b0C).
Do not refrigerate.
Teva Women's Health, Inc.
Subsidiary of Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. C 5/2019

No data

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Estradiol (Estradiol)

Trade Name : Estradiol

INSERT

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 (Estradiol)

Trade Name : Estradiol

INSERT

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

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