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Prometrium
progesterone micronized
Black Box Warnings .
Cardiovascular and Probable Dementia Risks
estrogen + progestin tx should not be used 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 Cancer Risk
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); other doses or estrogen/progestin combos not studied, but assume similar risk; use lowest effective estrogen dose, shortest duration based on individual tx goals and risks
Adult Dosing .
Dosage forms: CAP: 100 mg, 200 mg
amenorrhea, secondary
- [400 mg PO qhs x10 days]
endometrial hyperplasia prevention, postmenopausal
- [200 mg PO qhs x12 days q4wk]
- Info: for women w/ intact uterus receiving continuous estrogen
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- hepatic impairment/dz: contraindicated
Peds Dosing .
- Dosage forms: CAP: 100 mg, 200 mg
delayed puberty, female (off-label)
- [100-200 mg PO qd x10-12 days q4wk]
- Info: start after breakthrough bleeding on unopposed estrogen occurs or 2y of estrogen tx; give on last 10-12 days of menstrual cycle
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [see below]
- hepatic impairment/dz: contraindicated