Estradiol
Brand names: ALTAVERA, ALYACEN 1/35, ALYACEN 7/7/7, AMABELZ, APRI, AUBRA, AUROVELA Fe, AVIANE, Activella, Afirmelle, Alyacen 1/35, Amethia, Amethia Lo, Amethyst, Angeliq, Apri, Aranelle, Ashlyna, Aubra EQ, Aurovela 1.5/30, Aurovela 1/20, Aurovela 24 Fe, Aurovela Fe 1/20, Aviane, Ayuna, Azurette, BLISOVI FE 1.5/30, BLISOVI FE 1/20, BRIELLYN, Balcoltra, Balziva, Bekyree, Beyaz, Bijuva, Blisovi 24 Fe, Blisovi Fe 1.5/30, Blisovi Fe 1/20, Brevicon, CHATEAL, CRYSELLE, CYCLESSA, CYRED, Camrese, Caziant, Charlotte 24Fe, Chateal EQ, Cryselle, Cyclafem 1/35, Cyclafem 7/7/7, Cyonanz, Cyred EQ, DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM, Dasetta 1/35, Dasetta 7/7/7, Daysee, Delyla, Desogen, Desogestrel and Ethinyl Estradiol, Drospirenone and Ethinyl Estradiol, Drospirenone and ethinyl estradiol, Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, EMOQUETTE, ENPRESSE, ENSKYCE, ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL VAGINAL INSERTS, ESTROSTEP Fe, ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL, Elinest, Emoquette, Enpresse, Estarylla, Estrace, Estradiol / Norethindrone Acetate, Estradiol Valerate and Estradiol Valerate/Dienogest, Estradiol and Norethindrone Acetate, FAYOSIM, FEMCON Fe, Falessa, Falmina, Femynor, Fyavolv, GENERESS Fe, GIANVI, GILDESS FE 1.5/30, GILDESS FE 1/20, Gianvi, Gildagia, Gildess 1.5/30, Gildess 1/20, Gildess 24 Fe, HAILEY Fe 1/20, HGH Vitality, Hailey 1.5/30, Hailey 24 Fe, Hailey Fe 1.5/30, Iclevia, Introvale, Isibloom, JAIMIESS, JINTELI, Jasmiel, Jevantique Lo, Jinteli, Jolessa, Juleber, Junel, Junel 1.5/30, Junel Fe, Junel Fe 1.5/30, Junel Fe 1/20, KARIVA, Kaitlib Fe, Kalliga, Kariva, Kelnor 1/35, Kelnor 1/50, Kimidess, Kurvelo, LEVONEST, LEVONORGESTREL AND ETHINYL ESTRADIOL, LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, LO/OVRAL-28, LOESTRIN 1.5/30, LOESTRIN 1/20, LOESTRIN Fe 1.5/30, LOESTRIN Fe 1/20, LOPREEZA, LORYNA, Larin 1.5/30, Larin 1/20, Larin 24 Fe, Larin Fe 1.5/30, Larin Fe 1/20, Larissia, Layolis Fe, Leena, Lessina, Levlite, Levonest, Levonorgestrel and Ethinyl Estradiol, Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol, Levora, Lillow, Lo Loestrin Fe, Lo Minastrin Fe, Lo Simpesse, Lo-Zumandimine, Lo/Ovral-28, LoJaimiess, LoSeasonique, Loestrin, Loestrin 24 Fe, Lomedia 24 Fe, Lopreeza, Loryna, Low-Ogestrel, Lutera, Lybrel, MARLISSA, MERCILON, MICROGESTIN 1.5/30, MICROGESTIN 1/20, MICROGESTIN Fe 1.5/30, MICROGESTIN Fe 1/20, MINIVLAR 30, MYVLAR, Melodetta 24 Fe, Mibelas 24 Fe, Microgestin, Microgestin 24 Fe, Microgestin Fe, Mili, Mimvey, Mimvey Lo, Minastrin 24 Fe, Mircette, Modicon, Mono-Linyah, MonoNessa, Myzilra, NECON 1/35, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, NORGESTIMATE AND ETHINYL ESTRADIOL, Natazia, Necon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 777, Nexesta Fe, Nikki, Nordette, Norethindrone Acetate and Ethinyl Estradiol, Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate, Norethindrone and Ethinyl Estradiol and Ferrous Fumarate, Norgestimate and Ethinyl Estradiol, Norgestimate and ethinyl estradiol, Norgestrel/Ethinyl Estradiol, Norinyl, Nortrel, Nortrel 7/7/7, Nylia 1/35, Nylia 7/7/7, OCELLA, ORTHO TRI CYCLEN Lo, OVCON 35, Ogestrel, Oriahnn, Orsythia, Ortho Cept, Ortho Cyclen, Ortho Novum, Ortho Tri Cyclen, Ortho-Novum, PIMTREA, PIRMELLA 1/35, PIRMELLA 7/7/7, Philith, Portia, Prefest, Previfem, QUARTETTE, Quasense, RAJANI, Reclipsen, Rivelsa, SETLAKIN, SIMLIYA, SRONYX, Safyral, Seasonique, Simpesse, Solia, Sprintec, Sronyx, Syeda, TARINA 24 FE, TARINA Fe 1/20, TRI-LO-MARZIA, Tarina Fe 1/20 EQ, Taytulla, Tilia Fe, Tri Femynor, Tri Previfem, Tri-Estarylla, Tri-Legest Fe, Tri-Linyah, Tri-Lo- Estarylla, Tri-Lo-Mili, Tri-Lo-Sprintec, Tri-Mili, Tri-Norinyl, Tri-Previfem, Tri-Sprintec, Tri-VyLibra, Tri-VyLibra Lo, TriNessa, TriNessa Lo, Trivora, Tydemy, VIORELE, Vagifem, Velivet, Vestura, Vienva TM, Volnea, VyLibra, Vyfemla, WYMZYA FE, WYMZYA Fe, Wera, YUVAFEM, Yasmin, Yaz, Yuvafem, ZEOSA, Zarah, Zenchent, Zenchent 0.4/35, Zenchent FE, Zovia 1/35, Zovia 1/35E-28, Zovia 1/50E-28, Zumandimine, camrese Lo, desogestrel and ethinyl estradiol, drospirenone and ethinyl estradiol, femhrt, levonorgestrel and ethinyl estradiol, norethindrone acetate and ethinyl estradiol and ferrous fumarate, norgestimate and ethinyl estradiol, EstroGel, ESTRADIOL, Estradiol, Estradiol Vaginal Cream, Estradiol Transdermal System, Estradiol Gel, ESTROGEN PHENOLIC, ESTRACE, Estradiol Vaginal, DOTTI, estradiol, Climara, DIVIGEL, Estrogen 4X, LYLLANA, Minivelle, ELESTRIN, Vivelle-Dot, Evamist, Estring, Menostar, Estradiol 1557, ESTRADIOL VAGINAL
Boxed warning
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA 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, Malignant Neoplasms, Endometrial Cancer ]. Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders, and Probable Dementia ]. 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 [see CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders ]. 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 [see CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use ]. 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 [see CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders, and Probable 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 [see CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders ]. 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 CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use ]. Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see CLINICAL STUDIES and WARNINGS, Malignant Neoplasms, 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.
Warnings
BOXED WARNING: "ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER" in women with a uterus, with risk related to dose and duration of use; "close clinical surveillance of all women taking estrogens is important." The label also states "estrogens with or without progestins should not be used for the prevention of cardiovascular disease," citing Women's Health Initiative findings of "increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis" and an increased risk of dementia in women 65 and older. Contraindications include undiagnosed abnormal genital bleeding, known or suspected breast cancer, active or history of DVT/PE or arterial thromboembolic disease, liver dysfunction, known or suspected pregnancy, and known hypersensitivity.
Contraindications
CONTRAINDICATIONS Estradiol Vaginal Cream, 0.01% should not be used in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Known, suspected, or history of cancer of the breast. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of these conditions. Active arterial thromboembolic disease (for example, stroke, MI) or a history of these conditions. Known anaphylactic reaction or angioedema to Estradiol Vaginal Cream, 0.01%. Known liver dysfunction or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy.
Overdose
OVERDOSAGE 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 Vaginal Cream, 0.01% therapy together with institution of appropriate symptomatic care.
Drug interactions
D. Drug-Laboratory Test Interactions Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone levels, as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radioimmunoassay. T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Women on thyroid replacement therapy may require higher dose of thyroid hormone. Other binding proteins may be elevated in serum, i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). Increased plasma high-density lipoprotein (HDL) and HDL 2 cholesterol subfraction concentrations, reduced low-density lipoprotein (LDL) cholesterol concentration, increased triglycerides levels. Impaired glucose tolerance.
Uses
Indicated for treatment of moderate to severe vasomotor symptoms (hot flashes) and moderate to severe vulvar and vaginal atrophy associated with menopause; treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure; palliative treatment of certain cases of metastatic breast cancer and advanced androgen-dependent prostate cancer; and prevention of postmenopausal osteoporosis.
Dosage forms & strengths
DOSAGE AND ADMINISTRATION Use of Estradiol Vaginal Cream, 0.01% alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should reevaluate periodically as clinically appropriate to determine if treatment is still necessary. For treatment of vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. For women who have a uterus, adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal genital bleeding. Usual Dosage: The usual dosage range is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of 1 g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved. NOTE: The number of doses per tube will vary with dosage requirements and patient handling.
Ingredients
ACTIVE INGREDIENT: (in each drop): 24.98% of Estradiol 12X, 30X, 12C, 30C; 0.10% of Estradiol 6X.
INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.
All identified pills
EL
YELLOW ROUND · Estradiol
G 94
WHITE ROUND · Estradiol
G 16
WHITE ROUND · Estradiol
H 4
WHITE ROUND · Estradiol
H 5
WHITE ROUND · Estradiol
H 6
WHITE ROUND · Estradiol
J1
YELLOW ROUND · Estradiol
J2
YELLOW ROUND · Estradiol
L J7
ORANGE ROUND · Estradiol
2 manufacturers
L J2
WHITE ROUND · Estradiol
L J1
YELLOW ROUND · Estradiol
L2
YELLOW ROUND · Estradiol
L2
YELLOW ROUND · Estradiol
3 manufacturers
L3
YELLOW ROUND · Estradiol
L3
YELLOW ROUND · Estradiol
LU J61
PINK ROUND · Estradiol
LU K31
PINK ROUND · Estradiol
3 manufacturers
LU W33
PINK ROUND · Estradiol
3 manufacturers
LU U21
PINK ROUND · Estradiol
2 manufacturers
LU K24
PINK ROUND · Estradiol
LU L24
PINK ROUND · Estradiol
3 manufacturers
LU L25
PINK ROUND · Estradiol
4 manufacturers
LU U19
PINK ROUND · Estradiol
LU L25
PINK ROUND · Estradiol
2 manufacturers
LU J63
ORANGE ROUND · Estradiol
LU T41
ORANGE ROUND · Estradiol
2 manufacturers
LU L21
ORANGE ROUND · Estradiol
2 manufacturers
LU U31
ORANGE ROUND · Estradiol
LU I25
ORANGE ROUND · Estradiol
2 manufacturers
LU U31
ORANGE ROUND · Estradiol
2 manufacturers
LU J62
ORANGE ROUND · Estradiol
LU T22
ORANGE ROUND · Estradiol
7 manufacturers
LU I61
GREEN ROUND · Estradiol
2 manufacturers
LU F51
WHITE ROUND · Estradiol
LU K21
WHITE ROUND · Estradiol
2 manufacturers
LU T21
WHITE ROUND · Estradiol
4 manufacturers
LU N81
WHITE ROUND · Estradiol
4 manufacturers
LU E21
WHITE ROUND · Estradiol
5 manufacturers
LU L23
WHITE ROUND · Estradiol
3 manufacturers
LU W32
WHITE ROUND · Estradiol
3 manufacturers
LU U20
WHITE ROUND · Estradiol
LU M21
WHITE ROUND · Estradiol
LU U22
WHITE ROUND · Estradiol
4 manufacturers
LU V22
YELLOW ROUND · Estradiol
6 manufacturers
LU J23
YELLOW ROUND · Estradiol
2 manufacturers
LU K32
YELLOW ROUND · Estradiol
2 manufacturers
LU F52
BLUE ROUND · Estradiol
LU E22
BLUE ROUND · Estradiol
4 manufacturers
Side effects
Serious risks include endometrial and breast cancer, stroke, myocardial infarction, venous thromboembolism, gallbladder disease, and probable dementia. Commonly reported reactions include headache, breast pain/tenderness, irregular vaginal bleeding or spotting, abdominal cramping/bloating, nausea, and hair loss. Other reported effects include elevated blood pressure, liver function abnormalities, fluid retention, vaginal candidiasis, and enlargement of uterine leiomyomata.