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Formulas

Estradiol 0.125 mg/Estriol 0.125 mg/ml Topical Cream

The Estradiol 0.125 mg/Estriol 0.125 mg/ml Topical Cream is a compounded medication that combines two forms of estrogen, estradiol and estriol, in a semisolid dosage form. This cream is specifically designed to be dispensed from a pump mechanism, which allows for convenient, controlled, and consistent application to the skin. The formulation is intended for localized treatment and is absorbed through the skin to deliver the active ingredients directly to the affected area.

This topical cream is commonly used in the management of menopausal symptoms such as hot flashes, vaginal dryness, and atrophy. Additionally, it may be prescribed for conditions related to estrogen deficiency and for the support of general skin health in postmenopausal women. The dual-estrogen combination aims to provide a balanced approach to hormone therapy, potentially offering benefits in terms of efficacy and safety profiles.

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Topical Cream
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Formula Information

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The Estradiol 0.125 mg/Estriol 0.125 mg/ml Topical Cream is a compounded medication that combines two forms of estrogen, estradiol and estriol, in a semisolid cream base. This preparation is specifically designed to be dispensed from a pump mechanism, which allows for precise dosing and ease of application. The cream is intended for topical use, where it can be applied directly to the skin, providing localized treatment or facilitating the systemic absorption of the active ingredients.

Estradiol is a potent form of estrogen, the primary female sex hormone, and is identical to the hormone produced by the human body. It plays a crucial role in the regulation of the menstrual cycle and the development of female secondary sexual characteristics. Estriol, on the other hand, is a weaker form of estrogen, which is produced in significant amounts during pregnancy. The combination of estradiol and estriol in this formulation aims to provide a balanced estrogenic effect, which can be beneficial in managing symptoms associated with menopause, such as hot flashes, vaginal dryness, and atrophy.

By applying the cream topically, patients may experience fewer systemic side effects compared to oral hormone replacement therapies. This is because the hormones are absorbed directly into the local tissue, which can lead to lower circulating levels of estrogen in the body. The topical route of administration also allows for the hormones to bypass first-pass metabolism in the liver, potentially reducing the risk of certain adverse effects associated with oral estrogens.

This compounded cream may be prescribed for patients who are experiencing symptoms of menopause or for those who require hormone replacement therapy due to low estrogen levels. It is important to note that hormone replacement therapy should be tailored to the individual patient's needs, and the risks and benefits should be thoroughly discussed with a healthcare provider. Patients with a history of hormone-sensitive cancers, thromboembolic disorders, or unexplained vaginal bleeding should be evaluated carefully before considering this treatment.

For prescribers considering this formulation for their patients, it is essential to provide comprehensive counseling on the proper use of the cream, including the site of application, frequency, and duration of treatment. Monitoring for therapeutic effectiveness and potential side effects is also crucial to ensure patient safety and treatment efficacy.

If you have any questions or require further information about the Estradiol 0.125 mg/Estriol 0.125 mg/ml Topical Cream, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing support and guidance to both patients and healthcare providers to ensure optimal treatment outcomes.

Drug Interactions

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The estradiol and estriol topical cream is a hormone replacement therapy that combines two forms of estrogen, estradiol and estriol, in a semisolid preparation. This formulation is designed to be applied to the skin, where it can be absorbed locally or systemically to treat conditions associated with estrogen deficiency such as menopausal symptoms, vulvar and vaginal atrophy, and certain cases of osteoporosis. It is important to be aware of potential drug interactions when using this cream.

When using this estradiol/estriol topical cream, it is crucial to consider interactions with other medications. Concurrent use of other topical products on the same area of skin may alter the absorption of the hormones. Patients should discuss the use of any other skin products with their healthcare provider. Additionally, substances that induce or inhibit cytochrome P450 enzymes, particularly CYP3A4, may affect the metabolism of estrogens. For example, certain anticonvulsants, antifungals, and antibiotics can either decrease the effectiveness of the hormones or increase the risk of side effects.

Patients should also be aware that the use of this cream in combination with oral corticosteroids may increase the risk of edema, especially in patients with cardiac or renal impairment. Thyroid function may also be affected, as estrogens can increase thyroid-binding globulin (TBG) levels, leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay), or T3 levels (by radioimmunoassay). T3 resin uptake is decreased, reflecting the elevated TBG. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.

Additionally, estrogens may diminish the effectiveness of anticoagulant, antidiabetic, and antihypertensive medications. Patients using these medications may require dosage adjustments. Estrogens may also interfere with the metabolism of other hormones, such as progestins, androgens, and corticosteroids, potentially altering their effects. It is important to monitor patients for signs of adverse effects when these medications are used concurrently.

Patients with a history of hormone-sensitive cancers or thromboembolic disorders should use this medication with caution, as estrogens can increase the risk of certain types of cancers and thrombotic events. It is also advised to avoid smoking while using this medication, as it may further increase the risk of cardiovascular side effects, especially in women over 35 years of age.

It is essential for patients to inform their healthcare provider of all medications, supplements, and herbal products they are taking to avoid potential interactions. If you have any questions or concerns about using this estradiol/estriol topical cream or its interactions with other medications, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The Estradiol 0.125 mg/Estriol 0.125 mg/ml Topical Cream is a hormone replacement therapy (HRT) designed to deliver a combination of estrogen hormones directly through the skin. Estradiol and estriol are forms of estrogen, a hormone produced by the ovaries, which regulates many processes in the female body. As women approach menopause, the natural production of estrogen decreases, leading to symptoms such as hot flashes, vaginal dryness, and osteoporosis. This topical cream aims to replenish the levels of estrogen locally or systemically, depending on the site of application, to alleviate these symptoms.

The cream is formulated to ensure that the active ingredients, estradiol and estriol, are uniformly distributed throughout the preparation. When applied to the skin, the cream releases the hormones, which then penetrate the skin layers. The hormones can exert their effects locally, for example, when applied to the vaginal area to relieve dryness, or they can be absorbed into the bloodstream to have a more systemic effect, such as reducing hot flashes or protecting bone density.

The semisolid preparation is dispensed in a pump mechanism, which is designed to provide a convenient and controlled method of application. Each pump delivers a measured dose of the cream, ensuring consistent dosing and minimizing the risk of over-application. The pump also helps to protect the integrity of the formulation by limiting its exposure to air and contaminants, which can be particularly important for maintaining the stability of hormones like estradiol and estriol.

This topical cream is used in the treatment of various conditions associated with menopause and estrogen deficiency. For instance, it can be prescribed for the management of menopausal symptoms, such as vasomotor symptoms (hot flashes), urogenital symptoms (vaginal atrophy, dryness, itching, burning, and dyspareunia), and for the prevention of postmenopausal osteoporosis. Additionally, it may be used in cases where systemic hormone replacement therapy is contraindicated or not preferred by the patient.

It is important for both patients and prescribers to understand that while this formulation provides the benefits of estrogen therapy, it also carries risks similar to other forms of HRT. These may include an increased risk of blood clots, stroke, and certain types of cancer, among others. Therefore, it is crucial to use the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual woman.

For any questions or further information regarding the Estradiol 0.125 mg/Estriol 0.125 mg/ml Topical Cream, or to discuss whether this formulation is appropriate for you or your patient, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to ensure safe and effective treatment outcomes.

Other Uses

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While primarily prescribed for hormone replacement therapy in postmenopausal women, the Estradiol 0.125 mg/Estriol 0.125 mg/ml Topical Cream may serve several off-label uses. It's important to note that these uses should always be considered and supervised by a healthcare provider. The combination of estradiol and estriol in this topical cream formulation can potentially aid in managing various skin conditions associated with aging, such as thinning skin, dryness, and reduced elasticity because estrogens can promote skin hydration and increase collagen production.

Another emergent use is in the management of localized symptoms of vulvovaginal atrophy, where patients may experience relief from dryness, itching, and inflammation. While this is commonly associated with menopause, non-menopausal women or transgender individuals may also benefit from this hormone combination, under a physician's guidance. Furthermore, the compounded formulation in a pump mechanism facilitates precise dosing and localized application, which could be advantageous for targeting specific affected skin areas without systemic side effects.

There have also been exploratory discussions in the scientific community about the role of topical estrogens in wound healing. Estrogens have been implicated in enhancing the repair of the skin barrier, reducing the duration of the inflammatory phase of wound healing, and promoting better scar formation. While not a standard treatment, healthcare providers might consider this application in cases of chronic wounds or ulcers that are not responding to conventional therapies; however, more research is needed.

It is crucial to acknowledge that off-label uses of hormone therapies are not FDA-approved and should always be embarked upon with caution. Monitoring and evaluation by healthcare professionals are indispensable to safeguard against potential adverse effects. If you have any questions about the use of this formulation, its potential benefits, or how it can be integrated into patient care, please do not hesitate to reach out to us at Bayview Pharmacy. As compounding pharmacists, we are committed to ensuring the safe and effective use of compounded medications.

Frequently Asked Questions

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What is Estradiol/Estriol Topical Cream used for?

This compounded formulation of Estradiol/Estriol Topical Cream is used as a hormone replacement therapy to alleviate symptoms associated with menopause, such as hot flashes, vaginal dryness, and osteoporosis prevention. It may also be used for other conditions as determined by a healthcare provider.

How should I use this Estradiol/Estriol Topical Cream?

Apply the cream as directed by your healthcare provider. Typically, a small amount of cream is applied to the skin by pressing the pump mechanism. The exact dosage and location of application (such as the arms, legs, or abdomen) will depend on your individual treatment plan.

How does the pump mechanism work?

The pump is designed to deliver a controlled amount of topical cream with each press. Before the first use, you may need to prime the pump by pressing it several times until the cream is dispensed. Follow instructions for priming provided by the pharmacy, and always use the pump as instructed to ensure you get the correct dose.

Can I apply the cream to any area of my body?

No, you should only apply the cream to the areas recommended by your healthcare provider. Common application sites include the lower abdomen, inner thighs, or inner arms, but your healthcare provider will specify the best area for your treatment.

What should I do if I miss a dose?

If you miss a dose of your Estradiol/Estriol Topical Cream, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not double doses.

Are there any side effects I should be aware of?

Like all medications, this cream may cause side effects. Common side effects include skin irritation at the application site, headache, breast tenderness, and nausea. Contact your healthcare provider if you experience any severe or persistent side effects.

How should I store the Estradiol/Estriol Topical Cream?

Store the cream at room temperature, away from light and moisture. Keep it out of reach of children and pets. Do not refrigerate or freeze the cream unless instructed by the pharmacy.

Can I apply other products on the same skin area where I've applied the Estradiol/Estriol cream?

It's best to avoid applying other topical products to the same area of skin where you've applied the hormone cream, as this may alter absorption or cause irritation. Consult with your healthcare provider or pharmacist before using other skin products in conjunction with this treatment.

What should I do if the cream gets in my eyes or is ingested accidentally?

If the cream gets in your eyes, rinse them thoroughly with water. If ingested accidentally, contact a poison control center or seek emergency medical attention promptly. Keep the contact details for your local poison control center readily available in case of an emergency.

Can men use this Estradiol/Estriol Topical Cream?

This compounded formulation is typically prescribed for women; however, if a healthcare provider determines that it is appropriate for a male patient's condition, it could be prescribed. It's important for men to consult with their healthcare provider before using this medication.

Should I avoid sun exposure while using this product?

There are no specific instructions to avoid sun exposure while using Estradiol/Estriol Topical Cream; however, it's generally recommended to protect your skin from excessive sun exposure. If you have concerns or specific questions regarding sun exposure while on this medication, consult with your healthcare provider.

Can I swim or shower immediately after applying the cream?

It's advisable to allow the cream to be fully absorbed into the skin before swimming or showering. Waiting for 1-2 hours after application is typically recommended, but follow any specific instructions given by your healthcare provider.

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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.