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Estradiol
Overview
What is Estradiol Vaginal?
Each gram of 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, -butylhydroquinone and polysorbate 80.
Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of CHO and molecular weight of 272.37.
The structural formula is:
What does Estradiol Vaginal look like?
What are the available doses of Estradiol Vaginal?
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What should I talk to my health care provider before I take Estradiol Vaginal?
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How should I use Estradiol Vaginal?
Estradiol Vaginal Cream, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
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.
What interacts with Estradiol Vaginal?
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What are the warnings of Estradiol Vaginal?
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What are the precautions of Estradiol Vaginal?
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What are the side effects of Estradiol Vaginal?
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What should I look out for while using Estradiol Vaginal?
Estradiol Vaginal Cream, 0.01% should not be used in women with any of the following conditions:
See .
Systemic absorption may occur with the use of Estradiol Vaginal Cream USP, 0.01%. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
What might happen if I take too much Estradiol Vaginal?
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.
How should I store and handle Estradiol Vaginal?
Estradiol Vaginal Cream USP, 0.01%NDC 0115-1518-66: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40°C (104°F).Keep Estradiol Vaginal Cream, 0.01% out of the reach of children.REFERENCESEstradiol Vaginal Cream USP, 0.01%NDC 0115-1518-66: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40°C (104°F).Keep Estradiol Vaginal Cream, 0.01% out of the reach of children.REFERENCESEstradiol Vaginal Cream USP, 0.01%NDC 0115-1518-66: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40°C (104°F).Keep Estradiol Vaginal Cream, 0.01% out of the reach of children.REFERENCESEstradiol Vaginal Cream USP, 0.01%NDC 0115-1518-66: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40°C (104°F).Keep Estradiol Vaginal Cream, 0.01% out of the reach of children.REFERENCESEstradiol Vaginal Cream USP, 0.01%NDC 0115-1518-66: Tube containing 1½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40°C (104°F).Keep Estradiol Vaginal Cream, 0.01% out of the reach of children.REFERENCES
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
Estradiol Vaginal Cream, 0.01% should not be used in women with any of the following conditions:See .
Systemic absorption may occur with the use of Estradiol Vaginal Cream USP, 0.01%. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
1. Addition of a Progestin When a Woman Has Not Had a Hysterectomy
Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.
There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer.
2. Elevated Blood Pressure
In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogens on blood pressure was not seen.
3. Hypertriglyceridemia
In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. Consider discontinuation of treatment if pancreatitis occurs.
4. Hepatic Impairment and/or Past History of Cholestatic Jaundice
Estrogens may be poorly metabolized in patients with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued.
5. Hypothyroidism
Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Women with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T and T serum concentrations in the normal range. Women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These women should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.
6. Fluid Retention
Estrogens may cause some degree of fluid retention. Women with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogen-alone is prescribed.
7. Hypocalcemia
Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
8. Exacerbation of Endometriosis
A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.
9. Exacerbation of Other Conditions
Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
See and .
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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