Estradiol Transdermal System

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Overview

What is Estradiol Transdermal System?

The Estradiol Transdermal System is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm) systems are available to provide nominal delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15, 18.75 or 25 cm, and contains 2, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical.

Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of CH O and molecular weight of 272.38. The structural formula is:

The Estradiol Transdermal System comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are:

The active component of the transdermal system is estradiol. The remaining components of the transdermal system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive.

What does Estradiol Transdermal System look like?

What are the available doses of Estradiol Transdermal System?

What should I talk to my health care provider before I take Estradiol Transdermal System?

How should I use Estradiol Transdermal System?

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin .

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

What interacts with Estradiol Transdermal System?

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What are the warnings of Estradiol Transdermal System?

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What are the precautions of Estradiol Transdermal System?

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What are the side effects of Estradiol Transdermal System?

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What should I look out for while using Estradiol Transdermal System?

The Estradiol Transdermal System is contraindicated in women with any of the following conditions:

What might happen if I take too much Estradiol Transdermal System?

Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding in women. Treatment of overdose consists of discontinuation of the Estradiol Transdermal System therapy with institution of appropriate symptomatic care.

How should I store and handle Estradiol Transdermal System?

Store under normal lighting conditions at 20-25°C (68-77°F); excursions permitted to 15-30°C (59- 86°F) Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows:Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing.Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows:Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing.Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows:Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing.Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows:Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing.Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows:Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat. Do not autoclave. Protect from freezing.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol at the receptor level.

The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.

Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.

Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

Non-Clinical Toxicology

The Estradiol Transdermal System is contraindicated in women with any of the following conditions:

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillins, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

The concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and by iron-containing preparations.

An increased risk of stroke and DVT has been reported with estrogen-alone therapy. An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately.

Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

The following serious adverse reactions are discussed elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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