Estradiol Acetate (Femring)

Trade Name : Femring

Allergan, Inc.

RING

Strength 0.05 mg/d

ESTRADIOL ACETATE 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 Acetate (Femring) which is also known as Femring and Manufactured by Allergan, Inc.. It is available in strength of 0.05 mg/d per ml. Read more

Estradiol Acetate (Femring) 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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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.

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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.

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.

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  • No data
  • Warnings and Precautions, Malignant Neoplasms ()nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt11/2017
  • 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- [see n- Arrayn- ]n- .
  • Cardiovascular n- Dn- isorders and n- Pn- robable n- Dn- ementia
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia n- [n- seen- Warnings and Precautionsn- (n- Arrayn- ,n- u00a0n- Arrayn- )n- , and Clinical Studiesn- u00a0n- (n- Arrayn- ,n- u00a0n- Arrayn- )n- ]n- .
  • Then- Womenu2019s Health Initiative (n- WHIn- )n- estrogen-alone substudy reported increased risks of stroke and n- deep vein thrombosis (n- DVTn- )n- in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) n- [n- 0.625 mgn- ]-alone, n- relative to placebon- u00a0n- [n- seen- u00a0n- Arrayn- , and n- Arrayn- ].
  • The n- WHI Memory Study (n- WHIMSn- )n- estrogen-alone ancillary study of the WHI reported n- an n- increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE n- (n- 0.625 mgn- )n- -n- alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women n- [n- seen- u00a0n- Arrayn- ,n- u00a0n- Arrayn- ,n- and n- Arrayn- ]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.
  • 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- seen- Warnings and Precautions (n- Arrayn- , n- Arrayn- ) and Clinical Studies (n- Arrayn- , n- Arrayn- ]n- .
  • The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolismn- (PE)n- , stroke and myocardial infarction n- (MI) n- in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily n- oral n- CE n- (n- 0.625 mgn- )n- combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo n- [n- seen- u00a0n- Arrayn- , and n- Arrayn- ]n- .
  • The WHIMS estrogen plus progestin ancillary study of the WHI reported 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- seen- u00a0n- Arrayn- , n- Arrayn- and n- Arrayn- ]n- .
  • Breast Cancer
  • The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer n- [n- seen- u00a0n- Arrayn- , and n- Arrayn- ]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
  • Femringu00a0is an estrogen indicated for:
  • Treatment of Moderate to Severe Vasomotor Symptoms due tou00a0Menopause ()n
  • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy 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 n n n n n n n n
  • 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.
  • One ring inserted into the vagina for 3 months. Patients should be started at the lowest dose. (, )
  • The following two strengths of Femring are available:
  • Femring (0.05 mg/day): Each off-white, soft, flexible ring has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months.
  • Femring (0.10 mg/day): Each off-white, soft, flexible ring has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months.
  • Femring (0.05 mg/day): Each off-white, soft, flexible ring has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months. ()n
  • Femring (0.10 mg/day): Each off-white, soft, flexible ring has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months. ()
  • Femringu00a0is contraindicated in women with any of the following conditions:
  • Undiagnosed abnormal genital bleeding ()n
  • Known, suspected, or history of breast cancer (, )n
  • Known or suspected estrogen-dependent neoplasia (, )n
  • Active DVT, PE,u00a0or history of these conditions (, )n
  • Active arterial thromboembolic disease (for example, stroke andu00a0MI), or a history of these conditions (, )n
  • Known anaphylactic reaction or angioedema to Femring ()n
  • Known liver impairment or disease (, )n
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ()n
  • Known or suspected pregnancy (, )
  • Femring is used only in the vagina, however, the risks associated with oral estrogens should be taken into account.
  • Estrogens increase the risk of gallbladder disease ()n
  • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (, , , )n
  • Monitor thyroid function in women on thyroid replacement therapy (, )u00a0
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • Most common adverse reactions (incidence > 5 percent) are vaginal bleeding and breast tenderness. ()
  • No drug interaction studies have been conducted for Femring.
  • Inducers and/or 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 ()n
  • Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Womenu2019s Health Initiativeu00a0Memory ancillary studies of the Womenu2019s Health Initiative (, )
  • Overdosage of estrogenu00a0may cause nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Femring with institution of appropriate symptomatic care.
  • Femring (estradiol acetate vaginal ring)u00a0is an off-white, soft, flexible ring with a central core containing estradiol acetate.
  • Femring is made of cured silicone elastomer composed of dimethyl polysiloxane silanol, silica (diatomaceous earth), normal propyl orthosilicate, stannous octoate; barium sulfate and estradiol acetate. The rings have the following dimensions: outer diameter 56 mm, cross-sectional diameter 7.6 mm, core diameter 2 mm.
  • Femring is available in two strengths: Femring 0.05 mg/day has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months. Femring 0.10 mg/day has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months.
  • Estradiol acetate is chemically described as estra-1,3,5(10)-triene-3,17u03b2-diol-3-acetate. The molecular formula of estradiol acetate is CHO and the molecular weight of estradiol acetate is 314.42.
  • 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.
  • Estradiol acetate was assayed for mutation in four histidine-requiring strains of and in one tryptophan-requiring strain of . Estradiol acetate did not induce mutations in any of the bacterial strains tested under the conditions employed.
  • No data
  • No data
  • No data
  • See FDA-approved patient labeling ( and ).
  • Patient Information
  • Femring n- (estradiol acetate vaginal ring)
  • Read this Patient Information before you start using Femring 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 Femring?
  • Femring is a prescription vaginal ring that contains estradiol (an estrogen hormone). Femring should be removed after 90 days of continuous use. If you and your healthcare provider decide you should continue using Femring, a new ring can be inserted in your vagina.
  • What is Femring used for?
  • Femring is used after menopause to:
  • Who should not use Femring?
  • Do not start using Femring if you:
  • What should I tell my healthcare provider before I use Femring?
  • Before you use Femring, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • How should I use Femring?
  • For detailed instructions, see the step-by-step instructions for using Femring at the end of this Patient Information.
  • What are the possible problems you may have when using Femring?
  • What are the possible side effects of Femring?
  • 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 Femring. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or does not go away.
  • You may report side effects to Allergan at 1-800-678-1605 or to FDA at 1-800-FDA-1088.
  • What can I do to lower my chances of a serious side effect with Femring?
  • How should I store Femring?
  • KEEP FEMRING and all other medicines out of the reach of children.
  • General information about safe and effective use of Femring.
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Femring for conditions for which it was not prescribed. Do not give Femring to other people, even if they have the same symptoms you have. It may harm them.
  • Contact with blood may cause discoloration of Femring during use. This does not affect the way in which Femring releases medicine to control your menopausal symptoms. Call your health care provider right away if you have unusual vaginal bleeding.
  • This leaflet summarizes the most important information about Femring. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Femring that is written for health professionals. You can get more information by calling the toll free number 1-800-678-1605.
  • What are the ingredients in Femring?
  • Active ingredient:
  • Inactive ingredients:
  • Instructions for Use
  • Femring n- (estradiol acetate vaginal ring)
  • Inserting Femring into your vagina:
  • Step 1.
  • Step 2.
  • Step 3.n- See Figures A and B
  • Step 4.n- Seen- Figure C
  • Step 5.n- See Figure D
  • Step 6.n- See Figure E
  • Step 7.
  • Note:
  • Removing Femring from your vagina:
  • If Femring comes out often, tell your healthcare provider. Femring may not be right for you.
  • Call your healthcare provider if you have any problems putting Femring in your vagina or taking it out.
  • You may leave Femring in place if you need to use medicine for a vaginal infection.
  • You may leave Femring in place during sex (intercourse). If you take Femring out during intercourse or it comes out, clean it with warm water and put it back in your vagina.
  • If you lose your Femring, a new Femring should be put in place for 90 days.
  • This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • Distributed by:Allergan USA, Inc.Irvine, CA 92612
  • u00a9 2017u00a0Allergan. All rights reserved.
  • FEMRINGu00ae is a registered trademark of Allergan Pharmaceuticals International Limited
  • Revised: 11/2017
  • PRINCIPAL DISPLAY PANEL
  • NDC 0023-5868-05Femring0.05 mg/dayRx only
  • PRINCIPAL DISPLAY PANEL
  • NDC 0023-5869-10Femring0.10 mg/dayRx only

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