|Manufacturer:||Upsher-Smith Laboratories, Inc.|
There is a potential for drug transfer from one individual to the other following physical contact of Divigel® application sites.
In a study to evaluate transferability to males from their female contacts, there was some elevation of estradiol levels over baseline in the male subjects, however, the degree of transferability in this study was inconclusive.
Patients are advised to avoid skin contact with other subjects until the gel is completely dried.
The site of application should be covered (clothed) after drying.Washing the application site with soap and water 1 hour after application resulted in a 30 to 38% decrease in the mean total 24-hour exposure to estradiol.Therefore, patients should refrain from washing the application site for at least one hour after application.
Estrogen products, including Divigel® (estradiol gel) 0.1%, should not be used in women with any of the following conditions:Undiagnosed abnormal genital bleeding.Known, suspected, or history of cancer of the breast.Known or suspected estrogen-dependent neoplasia.Active deep vein thrombosis, pulmonary embolism, or history of these conditions.Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).Liver dysfunction or disease.Known hypersensitivity to the ingredients of Divigel®.Known or suspected pregnancy.
There is no indication for Divigel® 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.)