Estradiol

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

• Pediatric Use Estradiol Vaginal Cream, 0.01% is not indicated in children
• Clinical studies have not been conducted in the pediatric population

I. Geriatric Use 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%. …

• Patient Information Physicians are advised to discuss the PATIENT INFORMATION leaflet with women for whom they prescribe Estradiol Vaginal Cream, 0.01%
• PATIENT INFORMATION Estradiol (es-tra-DYE-ole) Vaginal Cream USP, 0.01% 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. …

• 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. …

D. Drug-Laboratory Test Interactions 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. …

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. 1. Cardiovascular Disorders 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. …

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 h …

F. Pregnancy 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.

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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.