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Estradiol 0.75 mg/Estriol 2.5 mg/Estrone 0.25 mg/g Topical Gel

The Estradiol 0.75 mg/Estriol 2.5 mg/Estrone 0.25 mg/g Topical Gel is a compounded medication designed for the management of menopausal symptoms, such as hot flashes, vaginal dryness, and osteoporosis prevention. This hormone replacement therapy (HRT) combines three estrogens to mimic the body's natural hormonal levels, potentially offering a more balanced approach to symptom relief. The semisolid gel formulation is engineered for transdermal delivery, ensuring consistent and controlled dosing with each application through a pump mechanism. The gel's texture allows for easy skin application and rapid absorption, targeting the systemic circulation to exert its therapeutic effects. This personalized medication is intended for use under the guidance of a healthcare professional.

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Estradiol
Estriol
Estrone
Topical Gel
655e5d22b461497b25f53655
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Formula Information

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The Estradiol 0.75 mg/Estriol 2.5 mg/Estrone 0.25 mg/g Topical Gel is a compounded medication specifically designed to deliver a combination of estrogens directly through the skin. This semisolid formulation is dispensed through a pump mechanism, which ensures that patients can apply a consistent and precise dose with each use. The gel base provides a favorable medium for the hormones to be absorbed into the skin, offering an alternative to oral or parenteral routes, which may be associated with higher systemic side effects.

The combination of estradiol, estriol, and estrone in this gel aims to address symptoms associated with estrogen deficiency, which is commonly experienced during menopause. Estradiol is the most potent form of estrogen and can alleviate vasomotor symptoms such as hot flashes and night sweats, as well as urogenital symptoms like vaginal dryness and atrophy. Estriol, being a weaker estrogen, is thought to offer benefits with a potentially lower risk of side effects, and it is particularly noted for its effectiveness in improving urogenital health. Estrone, the least potent estrogen in this formulation, is included to provide a more comprehensive estrogen replacement therapy, mimicking the natural spectrum of estrogen hormones found in the body.

This topical gel may also be used in managing conditions such as atrophic vaginitis, vulvar atrophy, and certain cases of osteoporosis, where estrogen plays a role in maintaining bone density. Additionally, it may be beneficial for skin health, as estrogens have been shown to improve skin elasticity, hydration, and thickness. The topical route of administration allows for localized treatment with reduced systemic exposure, which may be advantageous for patients who are at risk for or wish to avoid systemic side effects associated with oral estrogens, such as thromboembolic events or changes in lipid profiles.

It is important for prescribers to consider the individual patient's health history, including any contraindications for estrogen therapy, such as a history of hormone-sensitive cancers, undiagnosed vaginal bleeding, or active thromboembolic disorders. Regular monitoring and follow-up are essential to ensure the safety and efficacy of the treatment. Patients should be instructed on the proper application of the gel, which typically involves applying it to clean, dry skin on areas such as the arms, thighs, or abdomen, avoiding the breasts and face.

As with any compounded medication, this formulation is prepared in a compounding pharmacy where pharmacists ensure the quality and consistency of the product. Bayview Pharmacy is committed to providing high-quality, customized medications to meet the unique needs of each patient. If you have any questions or require further information about this formulation, please do not hesitate to reach out to us. Our team of knowledgeable compounding pharmacists is here to assist you.

Drug Interactions

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The estradiol, estriol, and estrone topical gel is a hormone replacement therapy (HRT) that combines three forms of estrogen. It is important to consider potential drug interactions when using this formulation. Estrogens can interact with a variety of medications, potentially altering their effects or increasing the risk of adverse reactions. For instance, estrogens may reduce the metabolism of drugs that are substrates of cytochrome P450 enzymes, particularly CYP3A4. This can lead to increased levels of medications such as cyclosporine, theophylline, and corticosteroids, necessitating close monitoring and possible dose adjustments.

Conversely, some drugs can affect the metabolism of estrogens, thereby altering their effectiveness. Substances that induce CYP3A4, such as St. John's Wort, phenobarbital, carbamazepine, and rifampicin, can decrease estrogen levels and reduce the efficacy of the HRT. Patients should be advised to inform their healthcare provider of all medications, including over-the-counter drugs and herbal supplements, they are taking to avoid potential interactions.

Additionally, estrogens can interact with thyroid hormone replacement therapy. Estrogens increase the concentration of thyroid-binding globulin, which may reduce the amount of free thyroid hormone, potentially necessitating an adjustment in the dose of thyroid medication. Patients on anticoagulant therapy, such as warfarin, should also be closely monitored as estrogens can potentiate the effects of anticoagulants, increasing the risk of bleeding. It is crucial to regularly check prothrombin time or international normalized ratio (INR) in these patients.

Furthermore, estrogens may interfere with the metabolism of other hormones, such as insulin or oral hypoglycemic drugs, leading to changes in blood glucose control. Diabetic patients may require more frequent blood glucose monitoring and possible adjustments in their antidiabetic medication when starting or changing doses of estrogen therapy.

It is also important to note that smoking can increase the metabolism of estrogens and reduce their clinical effects, in addition to significantly increasing the risk of cardiovascular side effects, especially in women over 35 years of age. Patients are strongly advised to avoid smoking while using this HRT formulation.

This topical gel is used to treat symptoms associated with menopause, such as hot flashes, vaginal dryness, and osteoporosis prevention. It may also be used for hormone replacement in conditions of estrogen deficiency or as part of transgender hormone therapy. The combination of different estrogens aims to mimic the natural variation in estrogen levels in the body, potentially reducing side effects and optimizing therapeutic outcomes.

Patients and prescribers should be aware that while topical application minimizes some risks associated with oral estrogens, such as first-pass metabolism effects on the liver, it does not eliminate the potential for systemic side effects and interactions. Therefore, it is essential to use this medication under the guidance of a healthcare professional who can monitor for interactions and adjust therapy as needed. If you have any questions or concerns regarding this formulation or its interactions with other drugs, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The Estradiol 0.75 mg/Estriol 2.5 mg/Estrone 0.25 mg/g Topical Gel is a compounded medication designed to deliver a combination of estrogen hormones directly through the skin. This semisolid formulation is dispensed through a pump mechanism, which ensures that each dose is measured accurately, providing consistent delivery of the hormones with each application. The gel base is designed to facilitate the absorption of the active ingredients into the skin, where they can then enter the bloodstream and exert their effects on target tissues.

The three estrogens in this formulation—estradiol, estriol, and estrone—are naturally occurring hormones that play a crucial role in the female reproductive system and overall health. Estradiol is the most potent form of estrogen and is primarily responsible for the development and maintenance of female reproductive tissues and secondary sexual characteristics. Estriol, the weakest estrogen, is thought to have protective effects on the skin and urogenital tract. Estrone, which is produced in the body from estradiol and androstenedione, has weaker estrogenic activity compared to estradiol but still contributes to the overall estrogenic effect.

When applied topically, the hormones in the gel are absorbed through the skin and into the systemic circulation. This method of delivery bypasses the first-pass metabolism in the liver, which can occur with oral administration, potentially reducing the risk of certain side effects. The hormones then bind to estrogen receptors in various tissues, including the reproductive system, bones, and cardiovascular system, to exert their biological effects. This can help alleviate symptoms associated with menopause, such as hot flashes, vaginal dryness, and osteoporosis, by supplementing the body's declining natural estrogen levels.

Additionally, the use of a combination of estrogens aims to mimic the natural balance of estrogens in the body, which may provide benefits over using a single estrogen type. This balance is thought to be important for optimal therapeutic outcomes and may reduce the risk of side effects associated with estrogen therapy. The precise dosing and combination of estrogens in this formulation can be tailored to the individual needs of the patient, based on their symptoms and response to therapy.

It is important for patients and prescribers to understand that hormone replacement therapy, including the use of this topical gel, should be used at the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be regularly monitored for their response to treatment and any potential adverse effects. If you have any questions or require further information about this formulation and its use in treating specific disease states, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide support and guidance.

Other Uses

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The estradiol, estriol, and estrone topical gel formulation provided by Bayview Pharmacy is designed primarily for hormone replacement therapy in women, particularly for managing symptoms associated with menopause, such as hot flashes, vaginal dryness, and osteoporosis prevention. This hormone combination is often selected due to the different roles that each estrogen plays in the body, with estradiol being the most potent, estriol considered less potent with some potential anti-cancer properties, and estrone serving as an intermediate form of estrogen. Considering the different degrees of estrogenic activity, this compounded gel facilitates a more individualized approach to hormone therapy.

Beyond the primary indication in managing menopausal symptoms, this gel formulation may have other uses. For instance, it could potentially be applied as part of a strategy to manage certain skin conditions linked to hormonal deficiencies or imbalances, such as skin aging or thinning that can occur after menopause. Additionally, it may be considered for off-label uses in improving skin elasticity, moisture, and overall appearance, although these applications should be approached cautiously and always under the guidance of a healthcare professional. It is important to note that such off-label uses should not replace conventional treatments and any potential benefits need to be weighed against the risks of systemic estrogen exposure.

Further, while the primary route of administration is through the skin, the precise dosing pump mechanism allows for consistent application, which can be advantageous for patients requiring stable and accurate dosing over time. Since this medication is a compounded product, it may be tailored to fit specific needs as determined by a healthcare provider, which allows for a degree of flexibility not typically available with commercially manufactured products.

Nevertheless, prescribers and patients should exercise caution, as estrogen therapy can come with increased risks of blood clots, stroke, and certain types of cancer. It is crucial that individuals considering this type of therapy be screened and monitored by their healthcare provider to maximize benefits and minimize potential risks. If you have any questions regarding the formulation, potential uses, or specific health concerns, do not hesitate to reach out to us here at Bayview Pharmacy for further information and personalized advice.

Frequently Asked Questions

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What is this topical gel used for?

This topical gel is a hormone replacement therapy used to relieve symptoms of menopause, such as hot flashes, vaginal dryness, and osteoporosis prevention. Its combination of estradiol, estriol, and estrone is designed to provide a balanced approach to replenishing estrogen levels.

How do I use this compounded topical gel?

The gel should be applied to clean, dry skin as directed by your healthcare provider. Upon dispensing the gel from the pump, apply it to an area of skin with relatively thin epidermis, such as the inner forearm or behind the knee, and rub it in until fully absorbed.

Are there any specific areas of the body where I should apply the gel?

It is generally recommended to apply the gel to areas with thin skin and good blood flow to facilitate absorption. Common areas include the inner forearm, behind the knee, or the upper chest. Avoid applying the gel to the breasts or vaginal area unless directed by your healthcare provider.

Can I apply moisturizer or sunscreen over the gel?

Yes, you can apply moisturizer or sunscreen, but it's essential to allow the gel to dry completely and be absorbed into your skin before applying any other products. Typically, waiting for about 5 to 10 minutes should be sufficient.

What is the dosing schedule for this medication?

The dosing schedule for this medication is specific to the individual and should be provided by your healthcare provider. Follow the prescribed regimen strictly, as hormone replacement therapy requires precise dosing for optimal effectiveness and safety.

How does the pump mechanism work?

The pump is designed to dispense a measured dose of gel with each press. Before the first use, you may have to prime the pump by pressing it several times until the product is dispensed. Afterwards, each press should deliver the same amount of gel, ensuring consistent dosing for each application.

Is this formulation safe for long-term use?

Long-term use of hormone replacement therapy should be regularly evaluated by your healthcare provider. While beneficial for many, it is associated with potential risks, and its use should be tailored to an individual's needs and health profile.

What should I do if I miss a dose?

If you miss a dose, apply the gel as soon as you remember unless it is close to the time of your next scheduled dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Are there any side effects associated with this gel?

As with any medication, side effects can occur. Common side effects may include skin irritation where the gel is applied, headaches, breast tenderness, and nausea. More serious side effects should be reported to your healthcare provider immediately.

Can I shower or swim immediately after applying the gel?

It is advisable to wait at least one to two hours after applying the gel before showering, bathing, or swimming to ensure that the medication has been properly absorbed by the skin.

How should I store this medication?

Store the medication at room temperature away from sunlight and moisture. Keep it out of reach of children and pets, and make sure the cap is secured tightly to prevent the gel from drying out.

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Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.