Estradiol Indications and Dosage

atrophic vaginitis
breast cancer
dysfunctional uterine bleeding
hot flashes
hypogonadism
menopause
oophorectomy
osteoporosis prophylaxis
ovarian failure
prostate cancer
urethritis

Estradiol Indications and Dosage

For hormone replacement therapy for treating symptoms associated with menopause:
NOTE: Reevaluate at 3 - 6 month intervals to determine if continued HRT is appropriate. Continuous, unopposed estrogen administration is acceptable in women without a uterus. In women with an intact uterus, estrogen may be given cyclically or combined with a progestin for at least 10 - 14 days/month to minimize the risk of endometrial hyperplasia. However, taking estrogens with progestins may have additional health risks for the patient; risk must be determined individually.

for vasomotor symptoms and hot flashes; atrophic vaginitis; and/or vulvar atrophy (kraurosis vulvae):

Oral dosage:
Adult menopausal and postmenopausal females: 0.5 - 2 mg PO once daily for 21 days cyclically or continuously. Dose < 1 mg/day may suffice for vaginal/vulvar symptoms only. Initiate therapy at any time if no menses present for >= 2 months. If menstruating, initiate on cycle day 5.
Adult postmenopausal females with an intact uterus who are receiving concomitant progestin therapy: Common regimens include: Estradiol 0.5 - 2 mg PO once daily with a daily progestin (women not desiring withdrawal bleeding). Alternatively, estradiol 0.5 - 2 mg PO once daily on days 1 - 25, co-administer with a progestin on the last 10 - 14 days; no HRT on day 26 through the month’s end to allow for withdrawal bleeding.

Transdermal dosage (estradiol patch, e.g., Alora®, Estraderm®, Noven®, or Vivelle-Dot™):
Adult menopausal and postmenopausal females: 1 patch (delivering 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg, or 0.1 mg per day) to trunk or buttocks; replace twice weekly; give cyclically or continuously. Usual initial dose is 0.0375 mg/day or 0.05 mg/day.
Adult females with an intact uterus in whom concomitant progestin therapy is desired: Estradiol can be used in sequential regimen with an estradiol-progestin patch (i.e., CombiPatch™). Estradiol-patch is worn for days 1 - 14, replacing twice weekly. On days 14 - 28, CombiPatch™ (estradiol/norethindrone acetate patch) is applied, replacing twice weekly (monthly withdrawal bleeding often occurs). Usual initial dose is 0.0375 mg/day or 0.05 mg/day.

Transdermal dosage (estradiol patch, Esclim® only):
Adult females: 1 patch (delivering 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg, or 0.1 mg per day) on upper arm, upper thigh, or buttocks; replace twice weekly; give cyclically or continuously. Usual initial dose is 0.0375 mg/day or 0.05 mg/day.

Transdermal dosage (estradiol patch, Climara® only):
Adult females: 1 patch (delivering 0.025 mg, 0.0375 mg, 0.05 mg, 0.06 mg, 0.075 mg, or 0.1 mg per day) on trunk or buttocks; replace every 7 days; give cyclically or continuously. Usual initial dose is 0.0375 mg/day or 0.05 mg/day.

Transdermal dosage (estradiol patch, FemPatch® only):
Adult females: 1 patch (delivering 0.025 mg/day) on buttocks; replace every 7 days. If symptoms are not relieved after 4 - 6 weeks, increase dose to 2 patches; give cyclically or continuously.

Transdermal dosage (E2III, estradiol transdermal patch by Cygnus only):
Adult females: 1 patch (delivering 0.05 mg, 0.075 mg, or 0.1 mg per day) on the trunk, buttocks, hip, or abdomen; replace every 7 days; give cyclically or continuously. Therapy is usually initiated with 0.05 mg/day.

Topical dosage (Estrasorb™ estradiol topical emulsion only):
Adult females: Apply 2 packets every day in the morning (delivers 0.05 mg per day); 1 packet applied to the left thigh and calf and 1 packet applied to the right thigh and calf.

Topical dosage (EstroGel™ topical gel only):
Adult females: Apply 1.25 g (one-half applicatorful) to one arm every day (usually in the morning).

Intravaginal dosage (Femring™ estradiol vaginal ring only):
Adult females: Insert 1 vaginal ring (delivering either 50 or 100 mcg/24 hours) into the upper third of the vaginal vault. Initiate therapy with the lowest dosage. Keep in place continuously for 3 months, then remove. If appropriate, insert a new ring. While Femring™ may be used solely to treat vulvar/vaginal symptoms, consider other products of lower estrogen dosage first.

Intramuscular dosage (estradiol valerate in oil):
Adult females: 10 - 20 mg IM once every 4 weeks as necessary.

Intramuscular dosage (estradiol cypionate in oil):
Adult females: 1 - 5 mg IM once every 3 - 4 weeks as necessary.

for the vaginal and urogenital symptoms (e.g., dryness, pruritus, dyspareunia, atrophic urethritis, urgency, urge incontinence and dysuria) of post-menopausal atrophic vaginitis and vulvar atrophy:
Intravaginal dosage (estradiol vaginal cream):
Adult females: Initially, 2 - 4 g (200 - 400 mcg of estradiol) PV once daily for 1 - 2 weeks; then gradually reduce over 1 - 2 weeks. Usual maintenance 1 g (estradiol 100 mcg) PV 1 - 3 times per week; treatment is cyclic (3 weeks, followed by 1 week drug-free).

Intravaginal dosage (Estring™ estradiol vaginal ring):
Adult females: Insert 1 vaginal ring (delivering 7.5 mcg/24 hours) into the upper third of the vaginal vault. Keep in place continuously for 3 months, then remove. If appropriate, insert a new ring. Clinicians should note that the dosage of this ring is not effective at treating vasomotor symptoms and is used to address solely the vulvar and vaginal symptoms associated with menopause.

Intravaginal dosage (Vagifem™ estradiol vaginal tablets):
Adult females: Insert 1 vaginal tablet (25 mcg) PV once daily for 2 weeks. Insert into the upper third of the vaginal vault using the supplied applicator. After 2 weeks, maintenance dose of 1 vaginal tablet (25 mcg) PV twice weekly.

For osteoporosis prophylaxis secondary to estrogen deficiency, due to either natural or surgical menopause:
NOTE: Prophylaxis against bone loss should begin as soon as possible after menopause. Continuous, unopposed estrogen administration is acceptable in women without a uterus. In women with an intact uterus, estrogen may be given cyclically or combined with a progestin for at least 10 - 14 days/month to minimize the risk of endometrial hyperplasia. However, taking estrogens with progestins may have additional health risks for the patient; risk must be determined individually.

Oral dosage:
i: Not less than 0.5 mg PO once daily, cyclically or continuously. Dosage may be adjusted as needed to control concurrent menopausal symptoms.

Transdermal dosage (estradiol patch, e.g., Alora®, Estraderm®, or Vivelle-Dot™):
Adult females: 1 patch (delivering 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg, or 0.1 mg per day) to trunk or buttocks; replace twice weekly; give cyclically or continuously. The lowest effective dose is 0.025 mg/day.

Transdermal dosage (estradiol patch, Menostar™ only):
Adult females: 1 patch (delivering 0.014 mg/day) to the lower abdomen; replace every 7 days; give cyclically or continuously.

For estrogen replacement for those with oophorectomy, primary ovarian failure, or female hypogonadism:
NOTE: In female hypogonadism, the months of estrogen needed to produce cyclical bleeding will depend on endometrial responsiveness. A 2-month drug-hiatus usually follows establishment of cyclical menses to assess if normal menstrual cycles can be maintained. If menses does not resume, medication cycles may be repeated.

Oral dosage:
Adult females: 0.5 - 2 mg PO once daily continuously; or in cycles of 21 days on and 7 days off.

Intramuscular dosage (estradiol valerate in oil):
Adult females: Estradiol valerate 10 - 20 mg IM every 4 weeks as necessary.

Intramuscular dosage (estradiol cypionate in oil):
Adult females: Estradiol cypionate is for female hypogonadism only. Single doses of 1.5 - 2 mg IM at monthly intervals are used.

Transdermal dosage (estradiol patch, e.g., Alora®, Estraderm®, or Vivelle-Dot™):
Adult females: 1 patch (delivering 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg, or 0.1 mg per day) to trunk or buttocks; replace twice weekly (every 3 - 4 days); give cyclically or continuously. Usual initial dose is 0.0375 mg/day or 0.05 mg/day.

Transdermal dosage (estradiol patch, FemPatch® only):
Adult females: 1 patch (delivering 0.25 mg/day) on buttocks; replace every 7 days. If symptoms are not relieved after 4 - 6 weeks, increase dose to 2 patches; give cyclically or continuously.

For the treatment of dysfunctional uterine bleeding caused by hormonal imbalance in the abscence of organic pathology, and only in association with a hypoplastic or atrophic endometrium:
NOTE: While some products containing estradiol and ethinyl estradiol are FDA approved for this indication, the short-term administration of other estrogens (i.e., estrone, conjugated estrogens) is commonly recommended and preferred.

Transdermal dosage (estradiol patch, Climara® only):
Adult females: 1 patch (delivering 0.025 mg, 0.0375 mg, 0.05 mg, 0.06 mg, 0.075 mg, or 0.1 mg per day) on trunk or buttocks; replace every 7 days. Usual initial dose 0.05 mg/day. Therapy usually follows a cyclic schedule.

For the palliative treatment of inoperable, progressive breast cancer in selected men and postmenopausal women:
NOTE: In the past, estrogens have been used for the palliative management of breast cancer of selected men and postmenopausal women. While these drugs are no longer used routinely, some reference texts still list this condition as an indication.

Oral dosage:
Adults: 10 mg PO three times per day for at least 3 months.

For the treatment of advancing inoperable prostate cancer:
NOTE: Efficacy is evaluated according to patient clinical response and serial PSA levels. A response to estrogen treatment, if it will occur, will usually be noted within 3 months. If patient responds, estrogen therapy is continued until a significant advancement of the disease occurs.

Oral dosage:
Adult males: 1 - 2 mg PO twice daily or three times daily, adjusted or continuing according to patient response.

Intramuscular dosage (estradiol valerate):
Adult males: 30 mg IM every 1 - 2 weeks, according to response.

Maximum Dosage Limits:

Adults: Dependent on indication for therapy.
Elderly: Dependent on indication for therapy.
Adolescents: Dependent on indication for therapy.
Children: Not indicated in prepubescent females.

Patients with hepatic impairment:
Estradiol is contraindicated in the presence of jaundice or marked hepatic disease of any type.

Patients with renal impairment:
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Estradiol Indications and Dosage

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