Vivelle-DOT (Estradiol) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Adhesion

Based on combined data from three short-term clinical trials consisting of 471 observations, 85% of Vivelle-Dot adhered completely to the skin over the 3.5-day wear period. Three (3%) of the systems detached and were reapplied or replaced during the 3.5-day wear period. Approximately 80% of the transdermal systems evaluated in these studies were Vivelle-Dot 0.05 mg/day.

OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.

CONTRAINDICATIONS

Vivelle-Dot^® (estradiol transdermal system) should not be used in women with any of the following conditions:

1. Undiagnosed abnormal genital bleeding.
   
2. Known, suspected or history of cancer of the breast.
   
3. Known or suspected estrogen-dependent neoplasia.
   
4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions.
   
5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
   
6. Liver dysfunction or disease.
   
7. Vivelle-Dot^{should not be used in patients with known hypersensitivity to its ingredients.}
   
8. Known or suspected pregnancy. There is no indication for Vivelle-Dot in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy (see PRECAUTIONS).