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Estradiol Topical Dosage

Applies to the following strength(s): 25 mcg ; 2 mg ; 0.1 mg/g ; 10 mcg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Atrophic Vaginitis

Vaginal cream:
Initial dose: 2 to 4 grams intravaginally per day for 1 to 2 weeks
Maintenance dose: 1 gram intravaginally 1 to 3 times a week

Vaginal ring:
One vaginal ring should be inserted into the upper third of the vagina

Vaginal tablet:
Initial dose: One tablet inserted into the vagina once a day for two weeks
Maintenance dose: One tablet inserted into the vagina twice weekly

Comments:
-Vaginal cream: The initial dosage should be reduced to 1 to 2 grams intravaginally per day for 1 to 2 weeks.
-Vaginal cream: The number of doses per tube will vary with dosage requirements and patient handling.
-Vaginal ring: The ring should remain continuously in place for 3 months.
-Vaginal ring: If expulsion or removal occurs during a 90 day treatment period, the ring should be rinsed in lukewarm water prior to reinsertion.
-Vaginal ring: Retention of the ring beyond 90 days results in underdosage and loss of efficacy.
-Vaginal tablet: Patients should be started at the 10 mcg dose strength.

Uses:
-Treatment of atrophic vaginitis due to menopause
-Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

BOXED WARNING(S):
WARNINGS: 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 and random endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia
-Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.
-An estrogen-alone study showed 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. An ancillary estrogen-alone study showed 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.
-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.
-An estrogen plus progestin study showed 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. An ancillary estrogen plus progestin study showed 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.

Breast Cancer
-An estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.
-In the absence of comparable data, these risks should be assumed to be similar for other doses of CE plus MPA, and other combinations and dosage forms of estrogens and progestins.
-Estrogens with or without progestins should be prescribed at the lowest doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:
-Do not refrigerate
-Protect from temperatures exceeding 40C (104F)

General:
-Use of estrogen-alone, or in combination with a progestin, should be done with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual patient.
-Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Monitoring:
-Cardiovascular: Blood pressure should be monitored at regular intervals.
-Endocrine: Thyroid function should be monitored.

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