Estradiol Valerate And Estradiol Valerate/Dienogest

Strong CYP3A4 inducer. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation due to risk of decreased contraceptive efficacy.

Strong CYP3A4 inducer. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation due to risk of decreased contraceptive efficacy.

Strong CYP3A4 inducer causing 83% decrease in dienogest AUC and 44% decrease in estradiol AUC. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation.

Strong CYP3A4 inducer. Should not use Estradiol Valerate/Dienogest while taking or for 28 days after discontinuation due to risk of decreased contraceptive efficacy.

CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.

CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.

[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.

CYP3A4 inhibitor that increases serum concentrations of estradiol and dienogest.

[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. In a multiple dose study investigating the effect of CYP3A4 inhibitors (ketoconazole and erythromycin) on Natazia, steady state estradiol and dienogest exposures were increased when co-administered with ketoconazole or erythromycin [see Clinical Pharmacology ( 12.3 )] .

CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.

[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.

CYP3A4 inhibitor that increases serum concentrations of estradiol and dienogest.

CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.

[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.

[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. In a multiple dose study investigating the effect of CYP3A4 inhibitors (ketoconazole and erythromycin) on Natazia, steady state estradiol and dienogest exposures were increased when co-administered with ketoconazole or erythromycin [see Clinical Pharmacology ( 12.3 )] .

CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.

CYP3A4 enzyme inducer that may decrease the effectiveness of the contraceptive or increase breakthrough bleeding.

CYP3A4 inhibitor that increases serum concentrations of estradiol and dienogest.

[See Clinical Pharmacology (12.3).] Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest.

May cause significant changes (increase or decrease) in plasma concentrations of estrogen and progestin.

May cause significant changes (increase or decrease) in plasma concentrations of estrogen and progestin.