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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 pts 50-79 yo (WHI estrogen-alone substudy regimen = conjugated estrogens 0.625 mg/day x7y); incr. risk of probable dementia in postmenopausal pts 65 yo and older (WHIMS estrogen-alone substudy regimen = conjugated estrogens 0.625 mg/day x5y); risk unknown in younger postmenopausal pts; 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 pts 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 pts 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 pts; Breast CA: estrogen + progestin tx may incr. risk of invasive breast CA in postmenopausal pts (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 1-2 patches (0.1-0.2 mg) 2x/wk]
- Info: for hypogonadism, oophorectomy, or primary ovarian failure; titrate to lowest effective maint. dose; add 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
puberty induction, female (off-label)
- [associated w/ hypogonadism, 11 yo and older]
- Dose: apply 1-2 patches (0.1-0.2 mg) 2x/wk; Start: cut patch to appropriate dose; start 3-7 mcg dose 2x/wk x6-12mo, then incr. to 14 mcg dose 2x/wk x6-12mo, then incr. to 25 mcg dose 2x/wk x6-12mo, then incr. by 25 mcg per dose 2x/wk x6-12mo; Info: add progesterone micronized or medroxyprogesterone after breakthrough bleeding occurs w/ at least 2y of estrogen tx if intact uterus; after puberty induction, titrate to lowest effective maint. dose for hypoestrogenism until menopausal age
- [associated w/ constitutional causes, 13 yo and older]
- Dose: apply partial patch (0.014 mg) 2x/wk x3-6mo; Info: cut patch to appropriate dose; may incr. dose after 6mo if spontaneous puberty progression not achieved; reassess tx need q3-6mo
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance