Usual Adult Dose for Postmenopausal Symptoms

Vasomotor symptoms:
One 0.25 mg drospirenone/0.5 mg estradiol tablet orally once a day
OR
One 0.5 mg drospirenone/1 mg estradiol tablet orally once a day

Vulvar and vaginal atrophy:
One 0.5 mg drospirenone/1 mg estradiol tablet orally once a day

Comments:

• Treatment is continuous.
• Women not on estrogens, or those on a continuous combination product may start treatment anytime.
• Women switching from continuous sequential or cyclic hormone therapy should complete their current cycle before switching.
• When used solely for vulvar and vaginal atrophy, consider using topical vaginal products.

Renal Dose Adjustments

Contraindicated

Liver Dose Adjustments

Contraindicated

Precautions

US BOXED WARNING(S): CARDIOVASCULAR DISORDERS, BREAST CANCER, AND PROBABLE DEMENTIA
Estrogen plus progestin therapy:

• Estrogen plus progestin therapy should not be used for prevention of cardiovascular disease or dementia.
• Estrogen plus progestin increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI) in postmenopausal women (50 to 79 years old) in the Women's Health Initiative (WHI) substudy.
• Estrogen plus progestin increased the risk of invasive breast cancer in the WHI substudy.
• Estrogen plus progestin therapy increased the risk of probable dementia in postmenopausal women 65 years and older in the WHI Memory Study (WHIMS) study.
• In the absence of comparable data, these risks should be assumed to be similar for other doses and combinations of estrogens and progestins.
• Prescribe at the lowest effective dose for the shortest duration consistent with treatment goals and individual risks.

• There is an increased risk of endometrial cancer in women with uteruses using unopposed estrogens.
• Adding a progestin to estrogen therapy reduced the risk of endometrial hyperplasia, a possible precursor to endometrial cancer.
• The WHI estrogen alone substudy reported increased risk of stroke and deep vein thrombosis (DVT).
• The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years and older on estrogen-alone therapy.
• Estrogen alone therapy should not be used for prevention of cardiovascular disease or dementia.

Dialysis

Contraindicated in renal insufficiency

Other Comments

Administration advice:

• Tablets should be swallowed whole with some liquid, irrespective of food intake.
• Take at the same time every day.
• This is continuous treatment, without a break.
• If a tablet is missed, it should be taken as soon as possible; if more than 24 hours late, do not take an extra tablet. If several tablets are missed, bleeding may occur.