Estradiol (Elestrin)

Trade Name : ELESTRIN

Meda Pharmaceuticals

GEL, METERED

Strength 0.52 mg/.87g

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

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 (Elestrin) which is also known as ELESTRIN and Manufactured by Meda Pharmaceuticals. It is available in strength of 0.52 mg/.87g per ml. Read more

Estradiol (Elestrin) 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

Warnings and Precautions, Malignant Neoplasm ()u00a0u00a0u00a0u00a0u00a008/2017

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 [see Warnings and Precautions ()].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (, ), and Clinical Studies (, )].
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 [see Warnings and Precautions (), and Clinical Studies ()].
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the 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 [see Warnings and Precautions (), Use in Specific Populations (), and Clinical Studies ()].
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other 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 [see Warnings and Precautions (, ), and Clinical Studies (, )].
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 [see Warnings and Precautions (), and Clinical Studies ()].
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 [see Warnings and Precautions (), Use in Specific Populations (), and Clinical Studies ()].
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (), and Clinical Studies ()].
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.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
Estrogen-Alone Therapy
Estrogen Plus Progestin Therapy

u00a0u00a0u00a0
ELESTRIN is an estrogen indicated for:

u2022
1.1

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 [].
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.
The gel is applied onto the skin in a thin layer. The recommended area of application is the upper arm to shoulder (approximately 320 cm).
ELESTRIN is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms due to menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel (0.52 mg estradiol) per actuation (1 pump).
Patients should be started with the lowest effective dose of ELESTRIN, which is one pump per day (0.87 g per day, which contains 0.52 mg of estradiol). Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.
Daily administration ofn

Elestrin (estradiol gel) 0.06% is available in a metered dose pump which delivers 0.52 mg of estradiol in 0.87 g of gel per pump actuation
Elestrin 0.06% is available in a metered dose pump which delivers 0.52 mg of estradiol in 0.87 g of gel per pump actuationn

ELESTRIN should not be used in women with any of the following conditions:

4n- 5.2
4n- 5.2
4n- 5.1
4n- 5.1
4n- 5.10
4n- 8.1

No data

5.5n- 5.6n- 5.9n- 5.10
5.11n- 5.21

The following serious adverse reactions are discussed elsewhere in the labeling:
In a placebo-controlled trial that included a total of 484 postmenopausal women, the most common adverse reactions (u2265 5 percent) are breast tenderness, metrorrhagia, nasopharyngitis, and upper respiratory tract infections. ()
To report SUSPECTED ADVERSE REACTIONS, contact Meda at 1-877-999-8401 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No drug interaction studies have been conducted for ELESTRIN.

u2022
7.1

No data

5.3n- 8.5

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 ELESTRIN therapy with institution of appropriate symptomatic care.

ELESTRIN (estradiol gel) contains 0.06% of estradiol, an estrogen, in a colorless, non-staining hydroalcoholic gel base. One pump actuation delivers ELESTRIN in a unit dose of 0.52 mg of estradiol in 0.87 g of gel. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17-diol, (17u03b2)-. It has a molecular formula of CHOu2022u00bdHO and molecular weight of 281.4.
The structural formula is:
The active component of ELESTRIN is estradiol. The remaining components of the gel (ethanol, propylene glycol, diethylene glycol monoethyl ether, carbomer homopolymer type C, triethanolamine, edetate disodium, and purified water) are pharmacologically inactive.

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 .

ELESTRINn n- (estradiol gel)
Read this PATIENT INFORMATION before you start using ELESTRIN and read what you get each time you refill your ELESTRIN 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.
What is ELESTRIN?
ELESTRIN is a medicine in a colorless gel that contains an estrogen hormone (estradiol) which is absorbed through the skin into the bloodstream.
What is ELESTRIN used for?
ELESTRIN is used after menopause to:
Estrogens are hormones made by a womanu2019s ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the u201cchange of lifeu201d or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes u201csurgical menopause.u201d
When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (u201chot flashesu201d or u201chot flushesu201d). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with ELESTRIN.
Who should not use ELESTRIN?
Do not start using ELESTRIN if you:
How should I use ELESTRIN?
ELESTRIN comes in a metered-dose pump. One dose of ELESTRIN is released each time the pump is depressed (pressed down).
Use ELESTRIN exactly how your healthcare provider tells you.
The ELESTRIN pump contains enough of the medicine to let you prime the pump (get the pump ready) before you use it the first time. To prime the pump, push the head of the pump down slowly, then remove your finger from the pump head and allow it to spring back automatically (by itself). Repeat this until the gel comes out. Throw away this first amount of gel as it will not be a full dose. Once the pump head has come all the way back up, the pump is now primed and ready to use. With each dose, remember to push the pump head down slowly and allow it to spring back automatically. Let the pump head come all the way back up before you push it down again. If using more than 1 dose, wait 5 seconds before pumping the next dose. This will make sure that the pump works correctly and gives your full dose of ELESTRIN. Use the pump a total of 30 times (30 pushes) as your healthcare provider tells you. After you have initially primed the pump and have used a total of 30 doses of ELESTRIN, you will need to throw the pump away and use a new one. The correct amount of medicine in each dose cannot be assured after 30 doses have been used, even though the pump container is not completely empty.
Important things to remember when using ELESTRIN
Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people.
Allow the gel to dry for five minutes or more before dressing. Try to keep the area dry for as long as possible. Do not allow others to come in contact with the area of skin where you applied the gel for at least two hours after you apply ELESTRIN.
Always move the spout into locked position and place the cap over the top of the pump after each use. Never apply ELESTRIN to the breast. Never apply ELESTRIN in or around the vagina.
Do not allow others to apply the gel for you.
Do not apply sunscreen to the area where the gel was applied for at least 25 minutes.
Do not apply sunscreen to the area where the gel was applied for 7 or more consecutive days.
Avoid fire, flame or smoking until the gel has dried. ELESTRIN contains alcohol. Alcohol based gels are flammable.
It is important that you read and follow the detailed u201cPatient Instructions for Useu201d at the end of this leaflet on how to use the ELESTRIN pump and apply the dose.
What should I do if someone else is exposed to ELESTRIN?
If someone else is exposed to ELESTRIN by direct contact with the gel, that person should wash the area of contact with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater is the chance that the other person will absorb some of the estrogen hormone. This is especially important for men and children.
What should I do if I get ELESTRIN in my eyes?
If you get ELESTRIN in your eyes, rinse your eyes right away with warm clean water to flush out any ELESTRIN. Seek medical attention if needed.
What should I do if I miss a dose?
If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day.
What are the possible side effects of ELESTRIN?
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 ELESTRIN. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to Meda Pharmaceuticals Inc. at 1-877-999-8401 or to FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with ELESTRIN?
The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while using ELESTRIN.
If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
Ask your healthcare provider for ways to lower your chances of getting heart disease.
General information about safe and effective use of ELESTRIN
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ELESTRIN for conditions for which it was not prescribed. Do not give ELESTRIN to other people, even if they have the same symptoms you have. It may harm them.
Keep ELESTRIN out of the reach of children
This leaflet provides a summary of the most important information about ELESTRIN. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ELESTRIN that is written for health professionals. You can get more information by calling 1-877-999-8401 (toll free).
Patient Instructions for Use.
1. Remove the cap.
2. Activate the pump.
3. Prime the pump (get the pump ready) before using the pump for the first time.
4. Apply ELESTRIN.
Figure 1
5. Wash your hands with soap and water.
ELESTRIN should not be used after the date printed on the container (expiration date).n n
Active ingredient: estradiol.
Inactive ingredients: purified water, ethanol, propylene glycol, diethylene glycol monoethyl ether, carbomer homopolymer type C, triethanolamine, and edetate disodium.
MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks and ELESTRIN is a registered trademark of Meda AB or a related entity.
Distributed by:n n Somerset, New Jersey 08873-4120
u00a92017 Meda Pharmaceuticals Inc.
U.S. Pat. No. 7,198,801 and U.S. Pat. No. 7,470,433
Rev. 10/2017IN-0480-05140893

NDC 0037-4801-70
Elestrinn n- (estradiol gel) 0.06%n- 0.52 mg of estradiol per pump actuationn
FOR TOPICAL USE ONLY
Total Contents: 35g x 2
Rx Only
Metered dose pumpn- container deliveringn- 26 grams gel asn- 30 metered actuations.
*Each actuation delivers 0.87g of gel
Attention pharmacist:
Important:
Contents:
Usual Dose:
The metered dose pumpmust be primed before first use.After initial priming, each actuationdelivers 0.87 grams of gel whichcontains 0.52 mg of estradiol.
Net weight 35 gramsper pump container
WARNINGS
Keep out of the reach of children;n- this container is not child-resistant.
Gels are flammable. Avoid fire,n- flame, or smoking during application.
Store at 20u00ba to 25u00baC (68u00ba to 77u00baF);excursions permitted to15u00ba to 30u00baC (59u00ba to 86u00baF)
Distributed by:n n Somerset, New Jersey 08873-4120
u00a9 2017 Meda Pharmaceuticals Inc.
www.meda.usn- www.elestrin.com
MEDA PHARMACEUTICALS and the MEDAPHARMACEUTICALS logo are trademarks andELESTRIN is a registered trademark of Meda AB or arelated entity.
U.S. Pat. No. 7,198,801 andU.S. Pat. No. 7,470,433
UC-048002-03u00a0u00a0u00a0u00a0u00a0Rev. 10/2017

NDC 0037-4802-35
Elestrinn n- (estradiol gel) 0.06%n- 0.52 mg of estradiol per pump actuationn
FOR TOPICAL USE ONLY
Total Contents: 35g x 2
Rx Only
Metered dose pumpn- container deliveringn- 26 grams gel asn- 30 metered actuations.
*Each actuation delivers 0.87g of gel
Attention pharmacist:
Important:
Contents:
Usual Dose:
The metered dose pumpmust be primed before first use.After initial priming, each actuationdelivers 0.87 grams of gel whichcontains 0.52 mg of estradiol.
Net weight 35 gramsper pump container
WARNINGS
Keep out of the reach of children;n- this container is not child-resistant.
Gels are flammable. Avoid fire,n- flame, or smoking during application.
Store at 20u00ba to 25u00baC (68u00ba to 77u00baF);excursions permitted to15u00ba to 30u00baC (59u00ba to 86u00baF)
Distributed by:n n Somerset, New Jersey 08873-4120
u00a9 2014 Meda Pharmaceuticals Inc.
www.meda.usn- www.elestrin.com
MEDA PHARMACEUTICALS and the MEDAPHARMACEUTICALS logo are trademarks andELESTRIN is a registered trademark of Meda AB or arelated entity.
U.S. Pat. No. 7,198,801 andU.S. Pat. No. 7,470,433
UC-048002-01u00a0u00a0u00a0u00a0u00a0Rev. 2/2014

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Estradiol (Elestrin)

Trade Name : ELESTRIN

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)

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?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Estradiol (Elestrin)

Trade Name : ELESTRIN

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)

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?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?