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Activella
estradiol/ norethindrone acetate
Black Box Warnings .
Endometrial Cancer with Unopposed Estrogen in Patients with Intact Uterus
unopposed estrogen use incr. risk of endometrial CA in patients with intact uterus; adding progestogen has been shown to decr. risk of endometrial hyperplasia, a possible precursor to endometrial CA; perform adequate diagnostic measures (including directed or random endometrial sampling) to rule out malignancy in menopausal patient with abnormal genital bleeding of unknown etiology
Adult Dosing .
Dosage forms: TAB: 0.5 mg/0.1 mg, 1 mg/0.5 mg
vasomotor symptoms, moderate-severe menopausal
- [1 tab PO qd]
- Start: 0.5 mg/0.1 mg PO qd; Info: use lowest effective estrogen dose, shortest effective tx duration
vulvovaginal atrophy, moderate-severe menopausal
- [1 mg/0.5 mg PO qd]
- Info: use lowest effective estrogen dose, shortest effective tx duration; not preferred if local symptoms only
osteoporosis prevention, postmenopausal
- [1 tab PO qd]
- Start: 0.5 mg/0.1 mg PO qd; Info: 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 disease: 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.