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Estradiol (Vivelle-Dot)

Trade Name : Vivelle-Dot

Novartis Pharmaceuticals Corporation

PATCH, EXTENDED RELEASE

Strength 0.0375 mg/d

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 (Vivelle-Dot) which is also known as Vivelle-Dot and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 0.0375 mg/d per ml. Read more

Estradiol (Vivelle-Dot) 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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About GNH

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
  • No data
  • 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 Warnings and Precautions (5.2)].
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia n- [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.3, 14.4)].
  • 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- [see Warnings and Precautions (5.1), and Clinical Studies (14.3)].
  • 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 n- [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.4)].
  • 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- [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.3, 14.4)].
  • 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- [see Warnings and Precautions (5.1), and Clinical Studies (14.3)].
  • 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 n- [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.4)].
  • Breast Cancer
  • The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer n- [see Warnings and Precautions (5.2), and Clinical Studies (14.3)].
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE plus 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
  • Vivelle-Dot is indicated for:
  • Vivelle-Dot is an estrogen indicated for:
  • Limitations of Use
  • Limitations of Use
  • Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should 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 the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be reevaluated periodically as clinically appropriate to determine whether treatment is still necessary.
  • The adhesive side of Vivelle-Dot should be placed on a clean, dry area of the trunk of the body (including the abdomen or buttocks). .
  • Vivelle-Dot should be replaced twice weekly. The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the same system cannot be reapplied, a new system should be applied to another location. In either case, the original treatment schedule should be continued. If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. The new patch should be applied on the original treatment schedule. The interruption of treatment in women taking Vivelle-Dot might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.
  • Start therapy with Vivelle-Dot 0.0375 mg/day. Dosage adjustment should be guided by the clinical response (, , )
  • For the prevention of postmenopausal osteoporosis, start therapy with Vivelle-Dot 0.025 mg/day ()
  • Vivelle-Dot should be placed on a clean, dry area on the lower abdomen or buttocks. Vivelle-Dot should not be applied to the breasts ()
  • Transdermal system: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.
  • Transdermal system: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day ()
  • Vivelle-Dot is contraindicated 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 a history of these conditions (, )
  • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (, )
  • Known anaphylactic reaction or angioedema or hypersensitivity with Vivelle-Dot (, )
  • Known liver impairment or disease (, )
  • Known protein C, protein S, or antithrombin deficiency, 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 (, , , )
  • Monitor thyroid function in women on thyroid replacement therapy (, )
  • The following serious adverse reactions are discussed elsewhere in labeling:
  • Most common adverse reactions (u226510 percent) with Vivelle are: headache, breast tenderness, nasopharyngitis, sinusitis, sinus headache, upper respiratory tract infection, back pain, depression, and irregular vaginal bleeding or spotting. ()
  • No drug interaction studies have been conducted with Vivelle-Dot.
  • 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. Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogens ()
  • Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the WHIMS ancillary studies of the WHI (, )
  • 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 Vivelle-Dot therapy with institution of appropriate symptomatic care.
  • Vivelle-Dot (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin.
  • Five dosage strengths of Vivelle-Dot are available to provide nominal delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical.
  • Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)- triene-3,17u03b2-diol.
  • The structural formula is:
  • The molecular formula of estradiol is CH0. The molecular weight is 272.39.
  • Vivelle-Dot is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used.
  • The active component of the system is estradiol. The remaining components of the system 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
  • How Supplied
  • Vivelle-Dot (estradiol transdermal system), 0.025 mg per day
  • Patient Calendar Pack of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0365-42
  • Carton of 3 Patient Calendar Packs of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0365-45
  • Vivelle-Dot (estradiol transdermal system), 0.0375 mg per day
  • Patient Calendar Pack of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0343-42
  • Carton of 3 Patient Calendar Packs of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0343-45
  • Vivelle-Dot (estradiol transdermal system), 0.05 mg per day
  • Patient Calendar Pack of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0344-42
  • Carton of 3 Patient Calendar Packs of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0344-45
  • Vivelle-Dot (estradiol transdermal system), 0.075 mg per day
  • Patient Calendar Pack of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0345-42
  • Carton of 3 Patient Calendar Packs of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0345-45
  • Vivelle-Dot (estradiol transdermal system), 0.1 mg per day
  • Patient Calendar Pack of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0346-42
  • Carton of 3 Patient Calendar Packs of 8 Systemsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0346-45
  • [*see DESCRIPTION (11)]
  • Storage and Handling
  • Store at controlled room temperature at 25u00baC (77u00b0F).
  • Do not store unpouched. Apply immediately upon removal from the protective pouch.
  • See FDA-approved patient labeling (Patient Information and Instructions for Use)
  • Advise patients to read the Patient Information and Instructions for Use. The complete text of the Patient Information and Instructions for Use is reprinted at the end of this document.
  • Vaginal Bleeding
  • Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare providers as soon as possible .
  • Possible Serious Adverse Reactions with Estrogen-Alone Therapy
  • Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia n
  • Possible Less Serious but Common Adverse Reactions with Estrogen-Alone Therapy
  • Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting.
  • T2017-86August 2017
  • PATIENT INFORMATION
  • Vivelle-Dot (vu012b-VEL-dot)
  • nttttttt(estradiol transdermal system)ntttttt
  • Read this Patient Information before you start using Vivelle-Dot 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 medical condition or your treatment.
  • What is Vivelle-Dot?
  • Vivelle-Dot is a prescription medicine patch (Transdermal System) that contains estradiol (an estrogen hormone). When applied to the skin as directed below, Vivelle-Dot releases estrogen through the skin into the bloodstream.
  • What is Vivelle-Dot used for?
  • Vivelle-Dot is used after menopause to:
  • Who should not use Vivelle-Dot?
  • Do not start using Vivelle-Dot if you:
  • What should I tell my healthcare provider before I use Vivelle-Dot?
  • ntttttttBefore you use Vivelle-Dot, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • How should I use Vivelle-Dot?
  • For detailed instructions, see the step-by-step instructions for using Vivelle-Dot at the end of this Patient Information.
  • How to Change Vivelle-Dot
  • What are the possible side effects of Vivelle-Dot?
  • 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 Vivelle-Dot. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Novartis Pharmaceuticals Corporation (1-888-NOW-NOVA or 1-888-669-6682).
  • What can I do to lower my chances of getting a serious side effect with Vivelle-Dot?
  • How should I store and throw away used Vivelle-Dot patches?
  • Keep Vivelle-Dot and all medicines out of the reach of children.
  • General information about safe and effective use of Vivelle-Dot
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Vivelle-Dot for conditions for which it was not prescribed. Do not give Vivelle-Dot to other people, even if they have the same symptoms you have. It may harm them.
  • This leaflet provides a summary of the most important information about Vivelle-Dot. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about Vivelle-Dot that is written for health professionals. For more information, call the toll-free number Novartis Pharmaceuticals Corporation (1-888-NOW-NOVA or 1-888-669-6682).
  • What are the ingredients in Vivelle-Dot?
  • Active ingredient:
  • Inactive ingredients:
  • T2017-36March 2017
  • INSTRUCTIONS FOR USE
  • Vivelle-Dot (vu012b-VEL-dot)
  • (estradiol transdermal system)
  • 1.n- nttu00a0u00a0u00a0u00a0u00a0ntDetermine Your Schedule for Your Twice-a-Week Application
  • 2.n- nttu00a0u00a0u00a0u00a0u00a0ntWhere to Apply Vivelle-Dot
  • 3. n- nttu00a0u00a0u00a0u00a0u00a0ntBefore You Apply Vivelle-Dot
  • 4. n- How to Apply Vivelle-Dot
  • Note:
  • 5.u00a0u00a0u00a0u00a0u00a0Throwing Away Your Used Patch
  • This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • Distributed by:nttttttNovartis Pharmaceuticals CorporationnttttttEast Hanover, NJ 07936
  • u00a9 Novartis
  • T2014-78July 2014
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.025 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0365-42
  • Vivelle-Dotu00ae (estradiol transdermal system)
  • Delivers 0.025 mg/day
  • Includes 8 Systems
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.0375 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0343-42
  • Vivelle-Dotu00ae (estradiol transdermal system)
  • Delivers 0.0375 mg/day
  • Includes 8 Systems
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.05 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0344-42
  • Vivelle-Dotu00ae (estradiol transdermal system)
  • Delivers 0.05 mg/day
  • Includes 8 Systems
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.075 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0345-42
  • Vivelle-Dotu00ae (estradiol transdermal system)
  • Delivers 0.075 mg/day
  • Includes 8 Systems
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 0.1 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0346-42
  • Vivelle-Dotu00ae (estradiol transdermal system)
  • Delivers 0.1 mg/day
  • Includes 8 Systems

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