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Vivelle-Dot
estradiol transdermal
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: PATCH: 0.025 mg per day, 0.0375 mg per day, 0.05 mg per day, 0.075 mg per day, 0.1 mg per day
vasomotor sx, mod-severe menopausal
- [apply 1 patch 2x/wk]
- Start: apply 0.0375 mg patch 2x/wk; Info: use lowest effective estrogen dose, shortest effective tx duration; may cycle 3wk on, 1wk off if intact uterus; consider adding progestin if intact uterus
vulvovaginal atrophy, menopausal
- [apply 1 patch 2x/wk]
- Start: apply 0.0375 mg patch 2x/wk; Info: not preferred if local sx only; use lowest effective estrogen dose, shortest effective tx duration; may cycle 3wk on, 1wk off if intact uterus; consider adding progestin if intact uterus
hypoestrogenism
- [apply 1 patch 2x/wk]
- Start: apply 0.0375 mg patch 2x/wk; Info: for oopherectomy, hypogonadism, or primary ovarian failure; may cycle 3wk on, 1wk off if intact uterus; consider adding progestin if intact uterus
osteoporosis prevention, postmenopausal
- [apply 1 patch 2x/wk]
- Start: apply 0.025 mg patch 2x/wk; Info: weigh estrogen tx risk/benefit; may cycle 3wk on, 1wk off if intact uterus; consider adding progestin if intact uterus
transgender hormone therapy, feminizing (off-label)
- [apply 1-2 patches (0.025-0.2 mg) 2x/wk]
- Info: adjust dose based on pt tx goals, clinical response, and estradiol levels; refer to WPATH or Endocrine Society guidelines
renal dosing
- [see below]
- renal dz: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- hepatic impairment/dz: contraindicated
Peds Dosing .
- Dosage forms: PATCH: 0.025 mg per day, 0.0375 mg per day, 0.05 mg per day, 0.075 mg per day, 0.1 mg per day
delayed puberty, female (off-label)
- [apply 1 patch 2x/wk]
- Start: apply 0.025 mg patch 2x/wk, then incr. dose q6mo prn; Info: for delay assoc. w/ hypogonadism; may cycle 3wk on, 1wk off if intact uterus; add progestin on last 10-12 days of cycle after breakthrough bleeding occurs or 2y of estrogen tx
renal dosing
- [see below]
- renal dz: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- hepatic impairment/dz: contraindicated