Estradiol Vaginal Cream .1 mg/g
estradiol · CREAM · Prasco Laboratories
Estradiol Vaginal Cream is a cream containing estradiol at .1 mg/g, taken vaginal. Manufactured by Prasco Laboratories.
Key Facts
- Brand Name
- Estradiol Vaginal Cream
- Generic Name
- estradiol
- NDC Code (Product)
66993-002- Manufacturer
- Prasco Laboratories
- Strength
- .1 mg/g
- Dosage Form
- CREAM
- Route
- VAGINAL
- Marketing Status
- Application #
- ANDA212313
- Drug Class
- Estrogen [EPC]
- Marketing Start
- 10/01/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 & Administration
DOSAGE AND ADMINISTRATION Use of Estradiol Vaginal Cream, USP, 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.
Warnings
WARNINGS See BOXED WARNINGS . 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. 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 […
Contraindications
CONTRAINDICATIONS 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 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.
Adverse Reactions
ADVERSE REACTIONS See BOXED WARNINGS , WARNINGS and PRECAUTIONS . 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. 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; ra…
Frequently Asked Questions
What is Estradiol Vaginal Cream used for?
Estradiol Vaginal Cream contains estradiol. It is a cream taken vaginal. Consult your doctor for specific uses.
Is Estradiol Vaginal Cream a controlled substance?
Estradiol Vaginal Cream is not classified as a controlled substance by the DEA.
What is the generic name for Estradiol Vaginal Cream?
The generic name for Estradiol Vaginal Cream is estradiol. There are 12 other brand versions of estradiol.
What is the NDC code for Estradiol Vaginal Cream .1 mg/g?
The NDC (National Drug Code) for Estradiol Vaginal Cream .1 mg/g is 66993-002, listed by Prasco Laboratories.