Estradiol vaginal cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
đHow to take it
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.
âšī¸Common side effects
See BOXED WARNINGS , WARNINGS and PRECAUTIONS . Systemic absorption may occur with the use of estradiol vaginal cream 0.01%. 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.
â ī¸Serious risks
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.
đInteractions & cautions
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.
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Each gram of estradiol vaginal cream USP, 0.01% contains estradiol, USP hemihydrate equivalent to 0.1 mg estradiol in a nonliquefying base containing edetate disodium, hypromellose, methylparaben, mono- and di-glycerides, propylene glycol, purified water, sodium lauryl sulfate, stearyl alcohol, tert-butylhydroquinone and white ceresin wax. Estradiol is chemically described as Estra-1,3,5(10)-triene-3,17 -diol-hemihydrate. It has an empirical formula of C18H24O2 H2O and molecular weight of 281.39. The structural formula is:
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.
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 women10 [see CLINICAL STUDIES and WARNINGS ].
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.
The WHI enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily oral CE (0.625 mg)-alone or in combination with MPA (2.5 mg) compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of coronary heart disease (CHD) (defined as nonfatal MI, silent MI and CHD death), with invasive breast cancer as the primary adverse outcome. A global index included the earliest occurrence of CHD, invasive breast cancer, stroke, PE, endometrial cancer (only in the CE plus MPA substudy), colorectal cancer, hip fracture, or death due to other cause. These substudies did not evaluate the effects of CE or CE plus MPA on menopausal symptoms.
The WHIMS estrogen-alone ancillary study of WHI enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age and older (45 percent were 65 to 69 years of age; 36 percent were 70 to 74 years of age; 19 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg)-alone on the incidence of probable dementia (primary outcome) compared to placebo. After an average follow-up of 5.2 years, the relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83-2.66). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years. Probable dementia as defined in this study included Alzheimer s disease (AD), vascular dementia (VaD) and mixed types (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see BOXED WARNINGS , WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use ]. The WHIMS estrogen plus progestin ancillary study of WHI enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent were 65 to 69 years of age; 35 percent were 70 to 74 years; 18 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) plus MPA (2.5 mg) on the incidence of probable dementia (primary outcome) compared to placebo. After an average follow-up of 4 years, the relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21-3.48). The absolute risk of probable dementia for CE plus MPA versus placebo was 45 versus 22 per 10,000 women-years. Probable dementia as defined in this study included AD, VaD and mixed types (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use ]. When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, 1.19-2.60). Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women [see WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use ].
Estradiol vaginal cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
Estradiol vaginal cream 0.01% should not be used in women with any of the following conditions: 1.Undiagnosed abnormal genital bleeding. 2.Known, suspected, or history of cancer of the breast. 3.Known or suspected estrogen-dependent neoplasia. 4.Active DVT, PE or history of these conditions. 5.Active arterial thromboembolic disease (for example, stroke, MI) or a history of these conditions. 6.Known anaphylactic reaction or angioedema to estradiol vaginal cream 0.01%. 7.Known liver dysfunction or disease. 8.Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. 9.Known or suspected pregnancy.
See BOXED WARNINGS . Systemic absorption may occur with the use of estradiol vaginal cream 0.01%. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
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.
In the WHIMS estrogen-alone ancillary study of WHI, a population of 2,947 hysterectomized women 65 to 79 years of age was randomized to daily CE (0.625 mg)-alone or placebo. After an average follow-up of 5.2 years, 28 women in the estrogen-alone group and 19 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83-2.66). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years10 [see CLINICAL STUDIES and PRECAUTIONS, Geriatric Use ]. In the WHIMS estrogen plus progestin ancillary study, a population of 4,532 postmenopausal women 65 to 79 years of age was randomized to daily CE (0.625 mg) plus MPA (2.5 mg) or placebo. After an average follow-up of 4 years, 40 women in the CE plus MPA group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21-3.48). The absolute risk of probable dementia for CE plus MPA versus placebo was 45 versus 22 cases per 10,000 women-years10 [see CLINICAL STUDIES and PRECAUTIONS, Geriatric Use ]. When data from the two populations in the WHIMS estrogen-alone and estrogen plus progestin ancillary studies were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, 1.19-2.60). Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women10 [see PRECAUTIONS, Geriatric Use ].
A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.
Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.
Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued.
Cases of anaphylaxis, which develop within minutes to hours after taking orally-administered estrogen and require emergency medical management, have been reported in the postmarketing setting. Skin (hives, pruritis, swollen lips-tongue-face) and either respiratory tract (respiratory compromise) or gastrointestinal tract (abdominal pain, vomiting) involvement has been noted. Angioedema involving the tongue, larynx, face, hands and feet requiring medical intervention has occurred postmarketing in patients taking orally-administered estrogen. If angioedema involves the tongue, glottis, or larynx, airway obstruction may occur. Patients who develop an anaphylactic reaction with or without angioedema after treatment with oral estrogen should not receive oral estrogen again.
Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.
Physicians are advised to discuss the PATIENT INFORMATION leaflet with women for whom they prescribe estradiol vaginal cream 0.01%.
Serum FSH and estradiol levels have not been shown to be useful in the management of moderate to severe symptoms of vulvar and vaginal atrophy.
1.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. 2.Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone levels, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Women on thyroid replacement therapy may require higher dose of thyroid hormone. 3.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). 4.Increased plasma high-density lipoprotein (HDL) and HDL2 cholesterol subfraction concentrations, reduced low-density lipoprotein (LDL) cholesterol concentration, increased triglycerides levels. 5.Impaired glucose tolerance.
Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer [see BOXED WARNINGS , WARNINGS and PRECAUTIONS ]. 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 vaginal cream 0.01% 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.
Estradiol vaginal cream 0.01% should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the milk of women receiving estrogen therapy. Caution should be exercised when estradiol vaginal cream 0.01% is administered to a nursing woman.
Estradiol vaginal cream 0.01% is not indicated in children. Clinical studies have not been conducted in the pediatric population.
There have not been sufficient numbers of geriatric patients involved in studies utilizing estradiol vaginal cream 0.01% to determine whether those over 65 years of age differ from younger subjects in their response to estradiol vaginal cream 0.01%.
See BOXED WARNINGS , WARNINGS and PRECAUTIONS . Systemic absorption may occur with the use of estradiol vaginal cream 0.01%. 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 System 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 Nervous System 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.
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.
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.
Estradiol Vaginal Cream USP, 0.01% contains estradiol, USP hemihydrate equivalent to 0.1 mg estradiol in a nonliquefying base. The opaque, white to off white cream is available in a tube containing 1.5 oz (42.5 g) with a calibrated plastic applicator for delivery of 1 g, 2 g, 3 g, or 4 g. It is available as follows: NDC 0378-8770-35carton containing one 1.5 oz (42.5 g) tube Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.] Protect from temperatures in excess of 40 C (104 F). Keep estradiol vaginal cream 0.01% out of the reach of children. PHARMACIST: Dispense the Patient Information Leaflet with each prescription.
1.Jackson RD, et al. Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women With Hysterectomy: Results From the Women s Health Initiative Randomized Trial. J Bone Miner Res. 2006;21:817-828. 2.Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women s Health Initiative. Circulation. 2006;113:2425-2434. 3.Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465-1477. 4.Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med. 2006;166:357-365. 5.Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med. 2006;166:772-780. 6.Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. JAMA. 2004;292:1573-1580. 7.Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. JAMA. 2006;295:1647-1657. 8.Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA. 2003;289:3234-3253. 9.Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. JAMA. 2003;290:1739-1748. 10.Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA. 2004;291:2947-2958.
Estradiol Vaginal Cream, USP(es" tra dye' ol) Read this Patient Information before you start using estradiol vaginal cream 0.01% 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. What is the most important information I should know about estradiol vaginal cream 0.01% (an estrogen hormone)? 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 estradiol vaginal cream 0.01%. 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 estradiol vaginal cream 0.01%. What is estradiol vaginal cream 0.01%? Estradiol vaginal cream 0.01% is a prescription medicine that contains estradiol (an estrogen hormone). What is estradiol vaginal cream 0.01% used for? Estradiol vaginal cream 0.01% is used after menopause to: Treat moderate to severe menopausal changes in and around the vagina. Talk regularly with your healthcare provider about whether you still need treatment with estradiol vaginal cream 0.01%. Who should not use estradiol vaginal cream 0.01%? Do not start using estradiol vaginal cream 0.01% if you: have unusual vaginal bleeding. 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. currently have or have had certain cancers. 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 estradiol vaginal cream 0.01%. currently have or have had blood clots. had a stroke or heart attack. are allergic to estradiol vaginal cream 0.01% or any of its ingredients. See the list of ingredients in estradiol vaginal cream 0.01% at the end of this leaflet. currently have or have had liver problems. have been diagnosed with a bleeding disorder. think you may be pregnant. Before you use estradiol vaginal cream 0.01%, tell your healthcare provider about all of your medical conditions, including if you: have unusual vaginal bleeding. 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. are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop using estradiol vaginal cream 0.01%. are breastfeeding. The hormone in estradiol vaginal cream 0.01% can pass into your breast milk. Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how estradiol vaginal cream 0.01% works. Estradiol vaginal cream 0.01% may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How should I use estradiol vaginal cream 0.01%? Estradiol vaginal cream 0.01% is a cream that you place in your vagina with the applicator provided with the cream. Take the dose recommended by your healthcare provider and talk to them about how well that dose is working for you. Use estrogens at the lowest dose possible for your treatment only as long as needed. Talk regularly (for example, every 3 to 6 months) with your healthcare provider about the dose you are using and whether you still need treatment with estradiol vaginal cream 0.01% Figure A Step 1. Wash and dry your hands well. Step 2. Remove the cap from the estradiol vaginal cream 0.01% tube. (There is a seal on the tube. Use the opposite end of the cap to puncture the seal.) Step 3. Hold the applicator as shown. Do not separate the plunger from applicator (Figure B). Figure B Step 4. Screw threaded end of applicator onto the open nozzle of the estradiol vaginal cream 0.01% tube until secure. Do not attach the plunger end of the applicator onto the open estradiol vaginal cream 0.01% tube (see Figure C). Figure C Step 5. Position upright to view the calibrated gram amounts. Step 6. Gently squeeze tube from the bottom to push the prescribed amount of estradiol vaginal cream 0.01% into the applicator. As estradiol vaginal cream 0.01% is squeezed out, the plunger will rise to indicate the amount of grams (see Figure D). Figure D *This Figure shows a 2 g dose for illustrative purposes only. Your prescribed dosage may vary. Step 7. Unscrew applicator from tube. Step 8. Replace cap on tube. Step 9. Lie on your back with knees bent. To deliver the medicine, gently insert applicator deeply into your vagina and press the plunger downward to its original position (see Figure E). Figure E Step 10. Remove the applicator from your vagina. Step 11. To cleanse applicator: Pull plunger to remove it from barrel. Wash with mild soap and warm water (Do not boil or use hot water) (see Figure F). Figure F What are the possible side effects of estradiol vaginal cream 0.01%? 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: stroke blood clots breast cancer dementia high or low blood calcium severe allergic reaction high blood pressure liver problems fluid retention this can make medical conditions worse in people with heart or kidney disease worsening of endometriosis changes in certain laboratory test results heart disease (such as heart attack) cancer of the lining of the uterus (womb) cancer of the ovary gallbladder disease changes in vision worsening of angioedema (swelling of face and tongue) high triglyceride (fat) levels in your blood low thyroid levels in your blood worsening of other medical conditions high blood sugar enlargement of benign tumors of the uterus ( fibroids ) Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: new breast lumps unusual vaginal bleeding changes in vision or speech sudden new severe headaches severe pains in your chest or legs with or without shortness of breath, weakness and fatigue swollen lips, tongue or face Less serious, but common side effects include: headache breast pain irregular vaginal bleeding or spotting stomach or abdominal cramps, bloating nausea and vomiting hair loss fluid retention vaginal yeast infection reactions from inserting estradiol vaginal cream 0.01%, such as vaginal burning, irritation, and itching These are not all the possible side effects of estradiol vaginal cream 0.01%. For more information, ask your healthcare provider or pharmacist for advice about side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store estradiol vaginal cream 0.01%? Store estradiol vaginal cream 0.01% at room temperature between 20 to 25 C (68 to 77 F) Protect from temperatures above 40 C (104 F) Keep estradiol vaginal cream 0.01% and all medicines out of the reach of children What can I do to lower my chances of a serious side effect with estradiol vaginal cream 0.01%? Talk with your healthcare provider regularly about whether you should continue using estradiol vaginal cream 0.01%. If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. In general, 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 estradiol vaginal cream 0.01%. Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. 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. If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease. General information about safe and effective use of estradiol vaginal cream 0.01% Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use estradiol vaginal cream 0.01% for conditions for which it was not prescribed. Do not give estradiol vaginal cream 0.01% to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about estradiol vaginal cream 0.01% that is written for health professionals. What are the ingredients in estradiol vaginal cream 0.01%? Active Ingredient: estradiol Inactive Ingredients: edetate disodium, hypromellose, methylparaben, mono- and di-glycerides, propylene glycol, purified water, sodium lauryl sulfate, stearyl alcohol, tert-butylhydroquinone and white ceresin wax. Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Manufactured by: Kavis Pharma LLC Sugar Land, TX 77478 U.S.A. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Kavis Pharma LLC Sugar Land, TX 77478 U.S.A. 1010181363.6 Revised: 6/2024KP:EVAGCR:R2
NDC 0378-8770-35 Unscented Estradiol Vaginal Cream, USP 0.01% PHARMACIST: Dispense the accompanyingPatient Information Leaflet to each patient. Rx only Net Wt 1.5 oz (42.5 g) tube INSTRUCTIONS FOR USE OF APPLICATOR: 1.Remove cap from the tube and immediately screw nozzle end of applicator on tube. 2. Gently squeeze tube to force sufficient cream into the barrel to provide the prescribed dose. 3.Unscrew applicator from tube and immediately replace cap on tube. Lie on back with knees drawn up. Gently insert the applicator deeply into the vagina. To release medication, press plunger downward to its original position. To cleanse: Pull plunger out from barrel. Wash with mild soap and warm water. DO NOT BOIL OR USE HOT WATER. NOTE: The number of doses per tube will vary with dosage requirements and patient handling. CALIBRATED APPLICATOR ENCLOSED This product also contains edetate disodium, hypromellose, methylparaben, mono- and di-glycerides,propylene glycol, purified water, sodium lauryl sulfate, stearyl alcohol, tert-butylhydroquinone andwhite ceresin wax. Each gram contains estradiol, USP hemihydrate equivalent to 0.1 mg estradiol in a nonliquefying base. Usual Dosage: See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.] Protect from temperatures in excess of 40 C (104 F). Dispense with insert. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Inc. Sugar Land, TX 77478 U.S.A. KP:8770:1C:R1 101017 1249.6
