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estradiol vaginal
generic
Black Box Warnings .
Estrogen Alone Tx Risk
Endometrial Cancer: unopposed estrogen use incr. endometrial CA risk in pts w/ intact uterus; adding progestin may decr. risk of endometrial hyperplasia, a possible precursor to endometrial CA; use adequate diagnostic measures such as endometrial sampling to rule out malignancy if undiagnosed persistent or recurrent abnormal genital bleeding; Cardiovascular and Probable Dementia: do not use estrogen-alone tx for cardiovascular dz or dementia prevention; incr. risk of stroke and DVT in postmenopausal women 50-79 yo (WHI estrogen-alone substudy regimen = conjugated estrogens 0.625 mg/day x7y); incr. risk of probable dementia in postmenopausal women 65 yo and older (WHIMS estrogen-alone substudy regimen = conjugated estrogens 0.625 mg/day x5y); risk unknown in younger postmenopausal women; other doses and routes of conjugated estrogens or other estrogen-alone products not studied, therefore adverse cardiovascular events and dementia relevance is unknown; weigh risk/benefit; use lowest effective estrogen dose, shortest duration based on individual tx goals and risks
Estrogen Plus Progestin Tx Risk
Cardiovascular and Probable Dementia: do not use estrogen + progestin tx for cardiovascular dz or dementia prevention; incr. risk of MI, stroke, and PE/DVT in postmenopausal women 50-79 yo (WHI estrogen/progestin substudy regimen = conjugated estrogens 0.625 mg/day w/ medroxyprogesterone 2.5 mg/day x6y); incr. risk of probable dementia in postmenopausal women 65 yo and older (WHIMS estrogen/progestin substudy regimen = conjugated estrogens 0.625 mg/day w/ medroxyprogesterone 2.5 mg/day x4y); risk unknown in younger postmenopausal women; Breast CA: estrogen + progestin tx may incr. risk of invasive breast CA in postmenopausal women (WHI estrogen/progestin substudy regimen = conjugated estrogens 0.625 mg/day w/ medroxyprogesterone 2.5 mg/day x6y); doses and routes of other estrogen progestin combos not studied, therefore adverse cardiovascular events, dementia, and breast CA relevance is unknown; weigh risk/benefit; use lowest effective estrogen dose, shortest duration based on individual tx goals and risks
Adult Dosing .
Dosage forms: TAB: 10 mcg; CRM: 0.01%
vulvovaginal atrophy, menopausal
- [tablet form]
- Dose: 10 mcg PV 2x/wk; Start: 10 mcg PV qd x2wk; Info: consider adding progestin x10-14 days/4wk cycle if intact uterus; use shortest effective tx duration
- [cream form]
- Dose: 1 g PV 1-3x/wk; Start: 2-4 g PV qd x2wk, then taper dose gradually over 1-2wk to maint. dose; Info: 1 g cream = 0.1 mg estradiol; consider adding progestin x10-14 days/4wk cycle if intact uterus; use lowest effective dose, shortest effective tx duration
renal dosing
- [see below]
- renal dz: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- hepatic impairment: contraindicated
Peds Dosing .
- Dosage forms: CRM: 0.01%
fusion of labia (off-label)
- [1 mo and older]
- Dose: apply bid for up to 6wk; Info: use lowest effective dose, shortest effective tx duration
renal dosing
- [see below]
- renal dz: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance