CYP3A4 inducer that may reduce estradiol plasma concentrations, possibly decreasing therapeutic effects and altering uterine bleeding profile.
Source: NLP:estradiol gel 0.1%
Brand names: Estradiol
Estrogen · Estrogen Receptor Agonists
Route: Topical
FDA Black Box Warning
WARNING: ENDOMETRIAL CANCER WITH UNOPPOSED ESTROGEN IN WOMEN WITH A UTERUS There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen-only therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in menopausal women abnormal genital bleeding of unknown etiology [see Warnings and Precautions ( 5.2 )]. WARNING: ENDOMETRIAL CANCER WITH UNOPPOSED ESTROGEN IN WOMEN WITH A UTERUS See full prescribing information for complete boxed warning. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens ( 5.2 )
Contraindications
4 CONTRAINDICATIONS Estradiol gel 0.1% is contraindicated in women with any of the following conditions: Abnormal genital bleeding of unknown etiology [see Warning and Precautions ( 5.2 )] Current or history of breast cancer [see Warning and Precautions ( 5.2 )] Estrogen-dependent neoplasia [see Warning and Precautions ( 5.2 )] Active DVT, PE, or history of these conditions [see Warning and Precautions ( 5.1 )] Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warning and Precautions ( 5.1 )] Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1% Hepatic impairment or disease [see Warnings and Precautions ( 5.9 )] Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Undiagnosed abnormal genital bleeding ( 4 ) Breast cancer or a history of breast cancer ( 4 , 5.2 ) Estrogen-dependent neoplasia ( 4 , 5.2 ) Active DVT, PE, or history of these conditions ( 4 , 5.1 ) Active arterial thromboembolic disease (e.g., stroke and MI), or history of these conditions ( 4 , 5.1 ) Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1% ( 4 ) Hepatic impairment or disease ( 4 , 5.9 ) Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Estradiol gel 0.1% is not indicated for use in pregnant women. There are no data with the use of estradiol gel 0.1% in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
10 interactions on record
CYP3A4 inducer that may reduce estradiol plasma concentrations, possibly decreasing therapeutic effects and altering uterine bleeding profile.
Source: NLP:estradiol gel 0.1%
CYP3A4 inhibitor that may increase estradiol plasma concentrations and result in adverse reactions.
Source: NLP:estradiol gel 0.1%
CYP3A4 inhibitor that may increase estradiol plasma concentrations and result in adverse reactions.
Source: NLP:estradiol gel 0.1%
CYP3A4 inhibitor that may increase estradiol plasma concentrations and result in adverse reactions.
Source: NLP:estradiol gel 0.1%
CYP3A4 inhibitor that may increase estradiol plasma concentrations and result in adverse reactions.
Source: NLP:estradiol gel 0.1%
CYP3A4 inhibitor that may increase estradiol plasma concentrations and result in adverse reactions.
Source: NLP:estradiol gel 0.1%
CYP3A4 inducer that may reduce estradiol plasma concentrations, possibly decreasing therapeutic effects and altering uterine bleeding profile.
Source: NLP:estradiol gel 0.1%
CYP3A4 inducer that may reduce estradiol plasma concentrations, possibly decreasing therapeutic effects and altering uterine bleeding profile.
Source: NLP:estradiol gel 0.1%
CYP3A4 inhibitor that may increase estradiol plasma concentrations and result in adverse reactions.
Source: NLP:estradiol gel 0.1%
CYP3A4 inducer that may reduce estradiol plasma concentrations, possibly decreasing therapeutic effects and altering uterine bleeding profile.
Source: NLP:estradiol gel 0.1%