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Prefest
estradiol/ norgestimate
Black Box Warnings .
Cardiovascular and Other Risks
estrogens +/- progestins not indicated for cardiovascular dz or dementia prevention; incr. risk of stroke and DVT (from WHI estrogen-alone substudy) and MI, stroke, PE/DVT, and invasive breast CA (from WHI estrogen/progestin substudy) in postmenopausal women; incr. risk of probable dementia in postmenopausal women 65 yo and older on a WHI regimen x4-5y; WHI regimens = conj. estrogens 0.625 mg/day w/ or w/o medroxyprogesterone 2.5 mg/day, 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
Endometrial Cancer Risk
unopposed estrogen use incr. risk if intact uterus; adding progestin may decr. risk of endometrial hyperplasia (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
Adult Dosing .
Dosage forms: convenience pack
Special Note
- [convenience pack components]
- Info: 30-day pack contains estradiol/norgestimate 1 mg/0 mg (peach) tab x15 and estradiol/norgestimate 1 mg/0.09 mg (white) tab x15
vasomotor sx, mod-severe menopausal
- [1 tab PO qd]
- Info: repeating 6-day cycle of estradiol only (peach tab) x3 days then combo (white tab) x3 days; use lowest effective estrogen dose, shortest effective tx duration
vulvovaginal atrophy, menopausal
- [1 tab PO qd]
- Info: repeating 6-day cycle of estradiol only (peach tab) x3 days then combo (white tab) x3 days; use lowest effective estrogen dose, shortest effective tx duration; not preferred if local sx only
osteoporosis prevention, postmenopausal
- [1 tab PO qd]
- Info: repeating 6-day cycle of estradiol only (peach tab) x3 days then combo (white tab) x3 days; calcium and vitamin D supplementation recommended; weigh estrogen tx risk/benefit; fixed-dose regimen may not contain lowest effective estrogen dose
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 .
Peds dosing is currently unavailable or not applicable for this drug.