Usual Adult Dose for Atrophic Urethritis

1 tablet orally once a day

Comments:

• Use at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
• Re-evaluate periodically to determine if treatment is still necessary.
• Only the estradiol 1 mg/norethindrone 0.5 mg strength is recommended for vulvar and vaginal atrophy treatment.

• Treatment of moderate to severe vasomotor symptoms due to menopause
• Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
• Prevention of postmenopausal osteoporosis

Usual Adult Dose for Atrophic Vaginitis

1 tablet orally once a day

Comments:

• Use at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
• Re-evaluate periodically to determine if treatment is still necessary.
• Only the estradiol 1 mg/norethindrone 0.5 mg strength is recommended for vulvar and vaginal atrophy treatment.

• Treatment of moderate to severe vasomotor symptoms due to menopause
• Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
• Prevention of postmenopausal osteoporosis

Usual Adult Dose for Hypoestrogenism

1 tablet orally once a day

Comments:

• Use at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
• Re-evaluate periodically to determine if treatment is still necessary.
• Only the estradiol 1 mg/norethindrone 0.5 mg strength is recommended for vulvar and vaginal atrophy treatment.

• Treatment of moderate to severe vasomotor symptoms due to menopause
• Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
• Prevention of postmenopausal osteoporosis

Usual Adult Dose for Postmenopausal Symptoms

1 tablet orally once a day

Comments:

• Use at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
• Re-evaluate periodically to determine if treatment is still necessary.
• Only the estradiol 1 mg/norethindrone 0.5 mg strength is recommended for vulvar and vaginal atrophy treatment.

• Treatment of moderate to severe vasomotor symptoms due to menopause
• Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
• Prevention of postmenopausal osteoporosis

Usual Adult Dose for Prevention of Osteoporosis

1 tablet orally once a day

Comments:

• Use at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
• Re-evaluate periodically to determine if treatment is still necessary.
• Only the estradiol 1 mg/norethindrone 0.5 mg strength is recommended for vulvar and vaginal atrophy treatment.

• Treatment of moderate to severe vasomotor symptoms due to menopause
• Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
• Prevention of postmenopausal osteoporosis

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated

Precautions

US BOXED WARNING(S):
CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, AND PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy:

• Cardiovascular Disorders and Probable Dementia
• Estrogen plus progestin therapy should not be used for prevention of cardiovascular disease or dementia.
• The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years old) taking conjugated estrogens (CE) (0.625 mg) combined with medroxyprogesterone acetate (MPA) (2.5 mg) for 5.6 years, compared to placebo.
• The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study reported an increase of developing probable dementia in postmenopausal women over 65 years old treated with daily CE (0.625 mg) with MPA (2.5 mg) compared to placebo; it is unknown if this applies to younger postmenopausal women.

• Breast Cancer
• The WHI estrogen plus progestin substudy reported an increased risk of invasive breast cancer.
• Lacking comparable data, assume the risk is similar for other doses of CE and MPA doses, and other combinations and dosage forms of estrogens and progestins.

• Endometrial Cancer
• Endometrial cancer risk is increased in a woman with a uterus using unopposed estrogens.
• Adding a progestin to estrogen therapy reduces the risk of endometrial hyperplasia, which may be an endometrial cancer precursor.
• Perform diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

• Cardiovascular Disorders and Probable Dementia
• Estrogen alone therapy should not be used for prevention of cardiovascular disease or dementia.
• The WHI estrogen-alone ancillary study reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years old) taking daily CE (0.625 mg) for 7.1 years, relative to placebo.
• The WHIMS estrogen-alone ancillary study reported an increased risk of probable dementia in postmenopausal women over 65 taking daily CE (0.625 mg) for 5.2 years, relative to placebo; it is unknown if this applies to younger postmenopausal women.
• Lacking comparable data, assume the risk is similar for other doses and dosage forms of estrogens.

• Estrogens, with or without progestins, should be prescribed at the lowest effective dose for the shortest duration consistent with treatment goals and risks.

Dialysis

Data not available