ESTRACE estradiol .1 mg/g Cream
Other active recalls for Estradiol (different manufacturers) — 4 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Radioactive Diagnostic Agent class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Estradiol topical may be used for the following: to treat and prevent hot flushes (hot flashes; sudden strong feelings of heat and sweating) in women who are experiencing menopause (change of life; the end of monthly menstrual periods). to treat vaginal dryness, itching, and burning Estradiol is in a class of medications called estrogen hormones. It works by replacing estrogen that is normally produced by the body.
Read the full MedlinePlus article ↗- Estradiol is a form of estrogen — the main female sex hormone. When estrogen levels fall after menopause (or due to other conditions like ovarian failure), you can get symptoms lik...
- What exactly is estradiol and why has my doctor prescribed it?
- Apply the patch to a clean, dry area of skin — usually the lower abdomen. Never put it on your breasts. Press it firmly in place and leave it on for the full wear period — once a w...
- How do I use my estradiol patch correctly?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Estradiol — tap one for details:
Estradiol may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII Q1LS2UJO3A
Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII U72Q2I8C85
A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
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UNII 39J80LT57T
Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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UNII C12674942B
A synthetic antioxidant used to prevent oils and fats in medicines from breaking down and becoming rancid. It extends the shelf life and stability of products containing lipids.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.761 | $11,874.79 / 1530 g |
| Medicaid paysCMS SDUD · 12 mo | $1.10 | $1,681.93 / 1530 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Estradiol .1 mg/g 00093-3541-43 | Teva | 1 tube | $0.426 | AB | Availability likely | save 95% |
| Estradiol .1 mg/g 00378-8770-35 | Mylan | 1 tube | $0.426 | AB | Availability likely | save 95% |
| Estradiol Vaginal .1 mg/g 21922-0085-06 | Encube | 1 tube | $0.426 | AB | Availability likely | save 95% |
| Estradiol Vaginal .1 mg/g 45802-0097-35 | Padagis | 1 tube | $0.426 | AB | Availability likely | save 95% |
| Estradiol .1 mg/g 47781-0104-44 | Alvogen | 1 tube | $0.426 | AB | Availability likely | save 95% |
| Estradiol Vaginal Cream .1 mg/g 66993-0002-10 | Prasco | 1 tube | $0.426 | AB | Availability likely | save 95% |
| Estrace .1 mg/gthis 00430-3754-14 | Allergan, | 1 tube | $7.761 | AB | Availability likely | — |
| Estradiol Vaginal .1 mg/g 42291-0426-42 | AvKARE | 1 tube | — | AB | FDA listed | — |
| Estrace .1 mg/g 50090-2321-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Estradiol .1 mg/g 50090-3327-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Estradiol .1 mg/g 50090-3645-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Estradiol Vaginal .1 mg/g 50090-6811-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Estradiol Vaginal .1 mg/g 50090-7266-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Estradiol Vaginal .1 mg/g 63629-8654-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Estradiol .1 mg/g 63629-8713-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Estradiol Vaginal .1 mg/g 67296-2258-04 | Redpharm | 1 tube | — | AB | FDA listed | — |
| Estradiol Vaginal .1 mg/g 68071-3796-04 | NuCare | 1 tube | — | AB | FDA listed | — |
| Estradiol Vaginal .1 mg/g 71335-2831-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Estradiol Vaginal .1 mg/g 72162-1389-02 | Bryant | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00430-3754-14 You're viewing this | 36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR | 2001-07-01 | Active |
📄 Full prescribing information FDA SPL
🚨 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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE ESTRACE (estradiol vaginal cream USP 0.01%) is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Use of ESTRACE 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.
⛔ Contraindications ▾
CONTRAINDICATIONS ESTRACE (estradiol vaginal cream USP 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 ESTRACE (estradiol vaginal cream USP 0.01%).
Known liver dysfunction or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy.
⚠️ Warnings ▾
WARNINGS See BOXED WARNINGS . Systemic absorption may occur with the use of ESTRACE (estradiol vaginal cream USP 0.01%). The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
1. Cardiovascular D isorders An increased risk of stroke and DVT has been reported with estrogen-alone therapy. An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin therapy.
Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Stroke In the WHI estrogen-alone substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg)-alone compared to women in the same age group receiving placebo (45 versus 33 per 10,000 women-years).
The increase in risk was demonstrated in year one and persisted [see CLINICAL STUDIES ]. Should a stroke occur or be suspected, estrogen-alone therapy should be discontinued immediately. Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg)-alone versus those receiving placebo (18 versus 21 per 10,000 women-years) 3 .
In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years) [see CLINICAL STUDIES ]. The increase in risk was demonstrated after the first year and persisted 3 . Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. b.
Coronary Heart Disease In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI and CHD death) was reported in women receiving estrogen-alone compared to placebo 4 [see CLINICAL STUDIES ]. Subgroup analyses of women 50 to 59 years of age suggest a statistically non-significant reduction in CHD events (CE [0.625 mg]-alone compared to placebo) in women with less than 10 years since menopause (8 versus 16 per 10,000 women-years) 3 . In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years) 3 .
An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5 [see CLINICAL STUDIES ]. In postmenopausal women with documented heart disease (n = 2,763), average age 66.7 years of age, in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study; HERS), treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease.
There were more CHD events in the CE plus MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand, three hundred and twenty one (2,321) women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall.
Rates of CHD events were comparable among women in the CE plus MPA group and the placebo group in HERS, HERS II, and overall. c. Venous Thromboembolism In t…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS See BOXED WARNINGS , WARNINGS and PRECAUTIONS . Systemic absorption may occur with the use of ESTRACE. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
The following adverse reactions have been reported with estrogen and/or progestin therapy. 1. Genitourinary S ystem Abnormal uterine bleeding or spotting; dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in cervical secretion; cystitis-like syndrome; application site reactions of vulvovaginal discomfort including burning and irritation; genital pruritus; ovarian cancer; endometrial hyperplasia; endometrial cancer.
2. Breasts Tenderness, enlargement, pain, nipple discharge, fibrocystic breast changes; breast cancer. 3.
Cardiovascular Deep and superficial venous thrombosis; pulmonary embolism; myocardial infarction; stroke; increase in blood pressure. 4. Gastrointestinal Nausea, vomiting; abdominal cramps, bloating; increased incidence of gallbladder disease.
5. Skin Chloasma that may persist when drug is discontinued; loss of scalp hair; hirsutism; rash. 6.
Eyes Retinal vascular thrombosis, intolerance to contact lenses. 7. Central N ervous S ystem Headache; migraine; dizziness; mental depression; nervousness; mood disturbances; irritability; dementia.
8. Miscellaneous Increase or decrease in weight; glucose intolerance; edema; arthralgias; leg cramps; changes in libido; urticaria; exacerbation of asthma; increased triglycerides; hypersensitivity.
🔄 Drug / Laboratory Test Interactions ▾
D. D rug- L aboratory T est I nteractions 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.
🤰 Pregnancy ▾
F. P regnancy ESTRACE should not be used during pregnancy [see CONTRAINDICATIONS ]. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.
🧒 Pediatric Use ▾
H. P ediatric U se ESTRACE Vaginal Cream is not indicated in children. Clinical studies have not been conducted in the pediatric population.
🧓 Geriatric Use ▾
I. Geriatric Use There have not been sufficient numbers of geriatric patients involved in studies utilizing ESTRACE to determine whether those over 65 years of age differ from younger subjects in their response to ESTRACE. The Women’s Health Initiative Study In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see CLINICAL STUDIES and WARNINGS ] .
In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see CLINICAL STUDIES and WARNINGS ]. The Women’s Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see CLINICAL STUDIES and WARNINGS ].
Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women 10 [see CLINICAL STUDIES and WARNINGS ].
🆘 Overdosage ▾
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 ESTRACE therapy together with institution of appropriate symptomatic care.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle.
After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues.
To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism.
Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Pharmacokinetics Absorption Estrogen drug products are absorbed through the skin, mucous membranes, and the gastrointestinal tract after release from the drug formulation. Distribution The distribution of exogenous estrogens is similar to that of endogenous estrogens.
Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin. Metabolism Exogenous estrogens are metabolized in the same manner as endogenous estrogens.
Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite.
Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption. In postmenopausal women, a significant proportion of the circulating estrogens exist as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens. Excretion Estradiol, estrone, and estriol are excreted in the urine along with glucuronide and sulfate conjugates.
Special Populations No pharmacokinetic studies were conducted in special populations, including patients with renal or hepatic impairment. Drug Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism.
Inducers of CYP3A4 such as St. John’s Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED ESTRACE (estradiol vaginal cream USP 0.01%). N DC 0430-3754-14: Tube containing 1 ½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g. Smooth semi solid cream. White or off-white. S t o r e at r o o m t e m p er a t u r e 20° t o 25°C ( 59° t o 77° F ) . P r o t ec t f r o m t e m p er a t u re s in e x c e ss of 40°C ( 104° F ) . Keep ESTRACE Vaginal Cream out of the reach of children.
📋 Description ▾
DESCRIPTION Each gram of ESTRACE (estradiol vaginal cream USP 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary -butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.37.
The structural formula is: The structural formula for ESTRACE (estradiol vaginal cream, USP, 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary-butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.37.
💬 Information for Patients ▾
B. P atient I nformation Physicians are advised to discuss the PATIENT INFORMATION leaflet with women for whom they prescribe ESTRACE (estradiol vaginal cream USP 0.01%).
PATIENT INFORMATION EST RA C E ® C R E A M (es-trays) (estradiol vaginal cream USP 0.01%) Read this Patient Information before you start using ESTRACE Vaginal Cream and each time you refill. There may be new information. This information does not take the place of talking with your healthcare provider about your menopausal symptoms or your treatment.
W h at is t h e m ost i m p o r t a n t i n f o r m a t ion I s h o u ld kn o w a b o u t E S T RACE Vagi n al C re a m ( an e s tr o g e n h o r m o ne ) ? Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using ESTRACE Vaginal Cream.
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Have your healthcare provider check any unusual vaginal bleeding to find out the cause. Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
Using estrogen-alone may increase your chances of getting strokes or blood clots. Using estrogen-alone may increase your chance of getting dementia, based on a study of women - 65 years of age or older. Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia.
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older. Talk regularly with your healthcare provider about whether you still need treatment with ESTRACE Vaginal Cream.
W h at is EST RACE V a gi n al C re a m ? ESTRACE Vaginal Cream is a prescription medicine that contains estradiol (an estrogen hormone). W h at is EST RACE V a gi n al C re a m u s e d f o r?
EST RACE Vagi n al C re am is u s e d a f te r me n o p a u se t o: T re at m o d e r a t e t o s e v e r e m e n o p a u sal c h a n g e s in a n d a r o u n d t h e vagi n a. Talk regularly with your healthcare provider about whether you still need treatment with ESTRACE. W h o s h o u l d n ot u se E S T RACE Vagi n al C re a m ?
Do not start using ESTRACE Vaginal Cream if you: have unu s u a l vagi n al b l ee d i ng. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Have your healthcare provider check any unusual bleeding to find out the cause. c u rre n t ly h ave or h ave h ad cert ain c a n cers .
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use ESTRACE Vaginal Cream. c u rre n t ly h ave or h ave h ad b lo o d c lo t s . had a stroke or heart attack. a r e all er g i c t o EST RACE Vagi n al C re a m or a n y of i t s i n g re d i e n t s. See the list of ingredients in ESTRACE Vaginal Cream at the end of this leaflet. c u rre n t ly h ave or h ave h ad liv e r p r o b l e m s. have b ee n d iag n os e d wi t h a b l ee d i n g d iso r d e r. th i n k you m ay b e p re g n a n t.
Before you use ESTRACE Vaginal Cream, tell your healthcare provider about all of your medical conditions, including if you: h ave unu s u al va g i n al b l ee d i ng. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. have any other medical conditions.
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), diabetes, epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. a r e goi n g t o h ave s u…