Estradiol Transdermal
Generic Name: estradiol transdermal
Brand Names:
Estradiol
11 DESCRIPTION Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol, USP when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1, and 1.25 mg estradiol USP, respectively).
Overview
11 DESCRIPTION Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol, USP when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1, and 1.25 mg estradiol USP, respectively).
Uses
1 INDICATIONS AND USAGE Estradiol gel, 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1) . 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Dosage
2 DOSAGE AND ADMINISTRATION Daily administration of 0.25 to 1.25 grams of estradiol gel, 0.1% to the right or left upper thigh on alternating days. Women should be started with the lowest effective dose and the dose should be evaluated periodically (2) . 2.1 Important Use Information The timing of estradiol gel, 0.1% initiation can affect the overall benefit-risk profile. Consider initiating estradiol gel, 0.1% in women <60 years old or <10 years since menopause onset [see Warnings and Precautions (5) , Use in Specific Populations (8.5) and Clinical Studies (14) ] . When estrogen is prescribed for a menopausal woman with a uterus, the addition of a progestogen has been shown to reduce the risk of endometrial cancer.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.1) ] . Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.2) ] . The most common adverse reactions (incidence >5 percent and greater than placebo) in any estradiol gel treatment group are metrorrhagia, breast tenderness, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John's wort ( Hypericum perforatum ) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice, may increase plasma concentrations of estrogens and result in adverse reactions.
Warnings
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. 5 WARNINGS AND PRECAUTIONS Cardiovascular Disorders: Increased risk of PE, DVT, and stroke with estrogen-alone therapy. Discontinue if an arterial or venous thrombotic or thromboembolic event occurs. (5.1) Estrogens increase the risk of gallbladder disease (5.4) Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.5 , 5.6 , 5.8 , 5.9) Monitor thyroid function in women on thyroid replacement therapy (5.10 , 5.21) 5.1 Cardiovascular Disorders Estradiol gel is contraindicated in women with active DVT, PE, stroke, or a history of these conditions [see Contraindications (4) ] . Immediately discontinue estradiol gel if a PE, DVT, or stroke, occurs or is suspected. 4 CONTRAINDICATIONS Estradiol gel 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...
Pregnancy
8.1 Pregnancy Risk Summary Estradiol gel is not indicated for use in pregnant women. There are no data with the use of estradiol gel 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Estradiol gel, 0.1% is a clear, colorless, smooth, opalescent gel free from lumps and foreign matter filled in single-dose foil packets of 0.25, 0.5, 0.75, 1, and 1.25 grams, corresponding to 0.25, 0.5, 0.75, 1, and 1.25 mg estradiol USP, respectively.
Frequently Asked Questions
What is Estradiol Transdermal used for?▼
1 INDICATIONS AND USAGE Estradiol gel, 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1) . 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
What are the side effects of Estradiol Transdermal?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.1) ] . Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.2) ] . The most common adverse reactions (incidence >5 percent and greater than placebo) in any estradiol gel treatment group are metrorrhagia, breast tenderness, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Estradiol Transdermal during pregnancy?▼
8.1 Pregnancy Risk Summary Estradiol gel is not indicated for use in pregnant women. There are no data with the use of estradiol gel 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.
What are the important warnings for Estradiol Transdermal?▼
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. 5 WARNINGS AND PRECAUTIONS Cardiovascular Disorders: Increased risk of PE, DVT, and stroke with estrogen-alone therapy. Discontinue if an arterial or venous thrombotic or thromboembolic event occurs. (5.1) Estrogens increase the risk of gallbladder disease (5.4) Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.5 , 5.6 , 5.8 , 5.9) Monitor thyroid function in women on thyroid replacement therapy (5.10 , 5.21) 5.1 Cardiovascular Disorders Estradiol gel is contraindicated in women with active DVT, PE, stroke, or a history of these conditions [see Contraindications (4) ] . Immediately discontinue estradiol gel if a PE, DVT, or stroke, occurs or is suspected. 4 CONTRAINDICATIONS Estradiol gel 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...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.