What is Estraderm (estradiol)?

From the Guidelines

Estraderm should be used with caution in postmenopausal women, as the benefits of hormone replacement therapy (HRT) may not outweigh the risks of chronic disease prevention, according to the US Preventive Services Task Force recommendation statement 1.

Key Points to Consider

• Estraderm is a transdermal patch that contains estradiol, a form of estrogen, and is used to treat moderate to severe menopausal symptoms and prevent osteoporosis in postmenopausal women.
• The standard dosage of Estraderm ranges from 0.05 to 0.1 mg per day, with patches typically changed twice weekly.
• Side effects of Estraderm may include breast tenderness, headaches, nausea, and skin irritation at the application site.
• Women with a history of certain conditions, including breast cancer, blood clots, stroke, or liver disease, should not use Estraderm.
• Regular medical check-ups are recommended for all users of Estraderm.

Important Considerations for Use

• The US Preventive Services Task Force recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women, as the harms may outweigh the benefits 1.
• The use of Estraderm should be individualized based on a woman's personal preferences, individual risks for specific chronic diseases, and the presence of menopausal symptoms.
• Alternative treatments for menopausal symptoms, such as non-hormonal therapies, should be considered before initiating HRT.

Recent Guidelines and Recommendations

• The NCCN Guidelines for Survivorship recommend that HRT be used with caution in survivors of hormonally mediated cancers, and that alternative treatments be considered first 1.
• The US Preventive Services Task Force recommends that women who are considering HRT for the primary prevention of chronic conditions discuss the potential benefits and harms with their healthcare provider 1.

From the FDA Drug Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Package Label – 0.025 mg NDC 70771-1563-8 Estradiol Transdermal System, USP (Twice-Weekly) Delivers 0.025 mg/day Includes 8 Systems Rx Only zydus pharmaceuticals PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Package Label – 0.0375 mg NDC 70771-1564-8 Estradiol Transdermal System, USP (Twice-Weekly) Delivers 0.0375 mg/day Includes 8 Systems Rx Only zydus pharmaceuticals PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Package Label – 0.1 mg NDC 70771-1567-8 Estradiol Transdermal System, USP (Twice-Weekly) Delivers 0.1 mg/day Includes 8 Systems Rx Only zydus pharmaceuticals

The Estraderm is a transdermal system that delivers estradiol. The available doses are 0.025 mg/day, 0.0375 mg/day, and 0.1 mg/day [ 2(reference_id: 2) , 2(reference_id: 2) , 2(reference_id: 2) ].

• The drug label does not provide information on the Estraderm trade name, only the estradiol (TD) drug name is mentioned.
• The Estraderm trade name is not found in the provided drug labels [ 2(reference_id: 2) , 2(reference_id: 2) , 2(reference_id: 2) ].

From the Research

Estraderm Overview

• Estraderm is a transdermal estradiol patch used to treat moderate to severe postmenopausal symptoms, including hot flashes and vaginal atrophy 3, 4.
• The patch delivers 0.05 mg of estradiol per day and is applied twice weekly 3, 4.

Efficacy

• Estraderm has been shown to be effective in reducing the number of hot flashes in postmenopausal women, with a significant reduction in hot flashes per 24 hours after 4,8, and 12 weeks of treatment 3, 4.
• The patch has also been shown to improve the Kupperman Index, a measure of menopausal symptoms, at all time points compared to placebo 3, 4.
• Estraderm has been compared to other transdermal estradiol patches, such as Menorest 50, and has been shown to be equally effective in reducing hot flashes and improving menopausal symptoms 5.

Tolerability

• Estraderm has been shown to be well-tolerated, with a low incidence of adverse events, including skin irritation and breast tenderness 3, 4.
• The patch has been shown to have good local tolerability, with a lower incidence of topical adverse events, erythema, and pruritus compared to other transdermal estradiol patches 5.
• However, estrogen therapy, including Estraderm, may increase the risk of endometrial hyperplasia and cancer in women with an intact uterus, and should be used with caution and in combination with a progestogen 6, 7.

Comparison to Other Treatments

• Estraderm has been compared to other treatments for menopausal symptoms, including hormone replacement therapy (HRT) and non-hormonal alternatives, such as low-dose paroxetine and gabapentin 6.
• While HRT, including Estraderm, is effective in reducing menopausal symptoms, it may increase the risk of breast cancer and other health problems, and should be used with caution and under the guidance of a healthcare provider 6, 7.