Usual Adult Dose for Atrophic Vaginitis

Initial dose: 0.5 grams intravaginally in a cyclic regimen: daily for 21 days, then off for 7 days
Maintenance dose: 0.5 to 2 grams intravaginally in a cyclic regimen: daily for 21 days, then off for 7 days

Comments:

• Adjust dose based on individual response

Usual Adult Dose for Postmenopausal Symptoms

0.5 grams intravaginally twice weekly (e.g. Monday and Thursday)
OR
0.5 grams intravaginally in a cyclic regimen: daily for 21 days, then off for 7 days

Uses: Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated

Precautions

BOXED WARNINGS:
Endometrial cancer, cardiovascular disorders, breast cancer and probable dementia:

Estrogen Only Therapy:

• There is an increased risk of endometrial cancer in women with uteruses using unopposed estrogens.
• The Women's Health Initiative (WHI) estrogen along 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.

• Estrogen plus progestin increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) in the 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 WHIMS study.
• Estrogen plus progestin should not be used for prevention of cardiovascular disease or dementia.

Dialysis

Data not available

Other Comments

Administration advice:

• Generally, a postmenopausal woman with a uterus should have a progestin added to reduce the risk of endometrial cancer.
• Women without a uterus do not need progestin, except some patients with a history of endometriosis may need a progestin.
• Use at the lowest effective dose for the shortest duration consistent with treatment goals.