Estradiol vaginal

FDA label

Read the full label on DailyMed ↗

Renal Undefined

Hepatic Undefined

Instructions

• Administer intravaginally with calibrated applicator
• Use lowest effective dose for shortest duration; taper to maintenance and discontinue as soon as possible

Available strengths

• cream 0.01 %
• tab 10 mcg
• tab 0.5, 1, 2 mg
• gel 0.06, 0.1 %
• insert 4, 10 mcg
• insert 0.0075, 0.05, 0.1 mg/24 hr
• patch 0.014, 0.025, 0.0375, 0.05, 0.06, 0.075, 0.1 mg/24 hr
• ring 0.05, 0.1 mg/d
• + 2 other marketed forms not shown

Contraindications

• Undiagnosed abnormal genital bleeding
• Known, suspected, or history of cancer of the breast
• Known or suspected estrogen-dependent neoplasia
• Active DVT, PE or history of these conditions
• Active arterial thromboembolic disease (for example, stroke, MI) or a history of these conditions
• Known liver dysfunction or disease
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
• Known or suspected pregnancy

Cautions

• Cardiovascular disorders: increased risk of stroke, DVT/PE, MI — discontinue if occurs
• Malignant neoplasms: endometrial, breast, and ovarian cancer
• Probable dementia in women ≥65
• Gallbladder disease
• Severe hypercalcemia in breast cancer with bone metastases
• Retinal vascular thrombosis / visual abnormalities
• Hypertriglyceridemia may lead to pancreatitis
• Hypothyroidism (increased thyroid-hormone requirement); fluid retention
• Anaphylaxis/angioedema; exacerbation of hereditary angioedema

Adverse reactions

• Abnormal uterine bleeding/spotting, vaginitis, vulvovaginal burning/irritation
• Breast tenderness/enlargement/pain
• Nausea, abdominal cramps, bloating
• Headache, migraine, dizziness, mood changes
• Venous/arterial thrombotic events; increased blood pressure

Pregnancy Contraindicated in pregnancy (should not be used).

Lactation Should not be used during lactation; estrogens can decrease quantity and quality of breast milk.