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Formulas

Estradiol 0.5 mg/ml Estriol 0.5 mg/ml/Testosterone 20 mg/ml Vaginal Gel

Description: This compounded vaginal gel is a unique formulation that combines estradiol (0.5 mg/ml), estriol (0.5 mg/ml), and testosterone (20 mg/ml) in a gel-like semisolid base. The gel is packaged in a tube designed for ease of use and precise application to the vaginal area. The combination of these hormones is intended to address symptoms associated with menopause, such as vaginal atrophy, dryness, and irritation. Additionally, it may be used to help manage conditions like hypoactive sexual desire disorder (HSDD) in postmenopausal women. The gel's consistency ensures that the medication is delivered directly to the affected area, providing both lubrication and the desired therapeutic effects.

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Vaginal Gel
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Formula Information

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The Estradiol 0.5 mg/ml, Estriol 0.5 mg/ml, Testosterone 20 mg/ml Vaginal Gel is a specialized compounding formulation designed to address a variety of gynecological conditions through the synergistic effects of its active ingredients. Estradiol and Estriol, both forms of estrogen, are commonly used in hormone replacement therapy to alleviate symptoms associated with menopause, such as vaginal dryness, atrophy, and irritation. These estrogens help to restore the vaginal mucosa, improve lubrication, and maintain the tissue's elasticity and health. Testosterone, included at a concentration of 20 mg/ml, is not traditionally associated with female therapies; however, recent studies have shown that it can be beneficial in improving sexual function, libido, and overall quality of life in women, particularly those experiencing menopausal symptoms.

This compounded vaginal gel is formulated to allow for precise dosing and targeted application. The gel base provides a convenient and comfortable means of delivering the active hormones directly to the affected area, ensuring optimal absorption and minimizing systemic exposure. This localized approach can lead to fewer systemic side effects compared to oral hormone therapies. The gel's consistency is designed to minimize leakage and ensure that the medication remains in contact with the vaginal tissues for an extended period, enhancing the therapeutic effects.

Patients using this formulation may experience relief from the atrophic changes associated with menopause, including improvements in vaginal tissue health, decreased discomfort during intercourse, and a reduction in urinary symptoms. Additionally, the inclusion of testosterone may contribute to an increase in sexual desire and satisfaction, which can be adversely affected by hormonal changes during menopause. It is important for prescribers to consider the individual needs of their patients, as hormone therapy should be tailored to the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual woman.

As with any hormone therapy, potential risks and side effects should be discussed with patients, including the possibility of systemic absorption and its implications. Regular monitoring and follow-up are essential to ensure the safety and efficacy of the treatment. This compounded formulation is made to order and can be adjusted according to the specific requirements of the patient, based on the prescriber's discretion and the patient's response to therapy.

For patients and prescribers interested in utilizing this compounded vaginal gel formulation, or for those seeking more information on its use and potential benefits, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is available to answer any questions and provide guidance on the best practices for prescribing and using this medication.

Drug Interactions

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The formulation you have described contains a combination of hormones: estradiol, estriol, and testosterone, which are intended for vaginal application. When considering drug interactions, it is important to note that these hormones can interact with a variety of medications and substances. For instance, certain drugs may increase the breakdown of hormones in the body, potentially reducing the effectiveness of this formulation. These include some anticonvulsants like phenobarbital and phenytoin, as well as some antibiotics such as rifampicin. Conversely, drugs that inhibit the metabolism of estrogens and testosterone, such as certain protease inhibitors and azole antifungals, may increase the levels of hormones and the risk of side effects.

Additionally, patients should be aware that the use of this formulation in conjunction with other hormonal therapies, such as oral contraceptives or hormone replacement therapy, may alter the intended effects and could potentially lead to an excess of hormones, which may increase the risk of hormone-related side effects. It is also important to consider the impact on blood clotting; estrogens can increase the risk of thromboembolic events, and when combined with drugs that affect coagulation, such as warfarin, careful monitoring is required.

Furthermore, the use of this vaginal gel may influence the effectiveness of other vaginal products due to alterations in vaginal absorption or physical interactions with the gel base. Patients should inform their healthcare provider of all medications, supplements, and herbal products they are using to ensure that potential interactions are assessed and managed appropriately.

This compounded formulation is designed to treat symptoms associated with menopause, such as vaginal atrophy, dryness, and irritation, as well as to provide local hormone replacement. Estradiol and estriol are forms of estrogen that can help replenish the diminished levels of estrogen in menopausal women, thereby alleviating these symptoms. Testosterone is included to address issues related to sexual function, such as libido and arousal, which can also be affected by menopause. The combination of these hormones aims to provide a comprehensive approach to managing menopausal symptoms with a focus on gynecological health.

It is crucial for both patients and prescribers to be aware of these potential interactions and to monitor for any adverse effects. If you have any questions or require further information regarding this formulation and its interactions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to ensure safe and effective use of this medication.

How Does it Work

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The Estradiol 0.5 mg/ml, Estriol 0.5 mg/ml, and Testosterone 20 mg/ml Vaginal Gel is a compounded medication designed to deliver a combination of hormones directly to the vaginal tissue. This gel-like semisolid formulation is dispensed in a tube, which allows for easy and controlled application. The medication is intended to be applied inside the vagina, where it can exert its effects locally with minimal systemic absorption.

Estradiol and estriol are forms of estrogen, a hormone that plays a critical role in the health and function of the vaginal tissue, as well as in the regulation of the menstrual cycle and the maintenance of the female reproductive system. In this formulation, estradiol and estriol can help alleviate symptoms of estrogen deficiency, such as vaginal dryness, itching, and irritation, which are common in menopausal and postmenopausal women. These estrogens can also aid in maintaining the thickness and elasticity of the vaginal walls, potentially improving comfort during sexual activity and reducing the risk of urinary tract infections.

Testosterone, although typically considered a male hormone, is also present in females and plays a role in sexual function and libido. The inclusion of testosterone in this formulation at a concentration of 20 mg/ml can help address issues of decreased sexual desire and arousal that some women experience, particularly during the menopausal transition. The use of testosterone in this manner is based on its ability to enhance blood flow and sensitivity in the vaginal area, which can contribute to an improved sexual response.

The combination of these hormones in a gel formulation allows for the hormones to be absorbed directly by the vaginal tissue, which can lead to a more targeted effect and potentially fewer systemic side effects compared to oral hormone replacement therapy. This is particularly beneficial for women who may not be able to tolerate systemic hormone therapy or for those who prefer a localized treatment approach.

This compounded medication is typically used to treat symptoms associated with menopause, such as atrophic vaginitis, which is the thinning, drying, and inflammation of the vaginal walls due to a decrease in estrogen. It may also be used for other gynecological conditions as determined by a healthcare provider. As with any medication, it is important to use this formulation as directed by a healthcare professional and to report any adverse effects or concerns promptly.

If you have any questions about how this formulation works or if it is appropriate for your specific condition, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide you with the information and support you need to make informed decisions about your health care.

Other Uses

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The formulation of Estradiol 0.5 mg/ml, Estriol 0.5 mg/ml, and Testosterone 20 mg/ml as a vaginal gel has primarily been used to address specific gynecological conditions such as vaginal atrophy, vulvar atrophy, and hormonal imbalance-related issues. However, the therapeutic utility of this formulation can extend to other applications beyond its primary use. In some cases, off-label uses are considered in consultation with healthcare professionals based on individual patient needs and clinical judgment.

One possible secondary use of this formulation is for the symptomatic relief of genitourinary syndrome of menopause (GSM), which encompasses a range of symptoms including dryness, burning, and irritation, often associated with estrogen deficiency. While this formulation directly delivers estrogen to the affected area, it may also provide secondary benefits by improving local blood flow and tissue elasticity, potentially alleviating discomfort during sexual activity.

Furthermore, the inclusion of testosterone in this gel could add to its therapeutic profile by possibly enhancing libido for women who experience reduced sexual desire due to hormone fluctuations or menopausal transitions. While evidence supporting the use of testosterone in women is still evolving, some prescribers may consider this combination beneficial for certain patients, especially those not responding to estrogen therapy alone.

Another potential application is in the preoperative preparation of the vaginal tissue before surgical procedures, particularly in postmenopausal women. The estrogenic components could enhance tissue quality and healing by promoting cellular proliferation and vascularization. Consequently, this could reduce the risk of complications associated with surgeries such as vaginal prolapse repairs or hysterectomies.

Despite its multifaceted applications, it is paramount to note that the use of hormone-containing products can vary in safety and effectiveness depending on the individual. Assessments are made on a case-by-case basis, taking into account the patient's medical history, current medications, and potential risks, such as hormone-sensitive cancer histories or clots. Collaboration with healthcare professionals through personalized consultation will ensure that the patient receives the appropriate guidance and monitoring while using this formulation.

If you have any questions about the potential uses of this formulation or suitability for an individual patient, please reach out to us at Bayview Pharmacy. We are dedicated to providing comprehensive support and information, empowering both patients and prescribers to make informed decisions about use and application of compounding formulations.

Frequently Asked Questions

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What is this compounded vaginal gel used for?

This compounded vaginal gel is used to deliver a combination of hormones, including Estradiol, Estriol, and Testosterone, directly to the vaginal area for therapeutic purposes. It can aid in the management of menopausal symptoms like vaginal atrophy, dryness, and possibly libido enhancement.

How should I apply the compounded vaginal gel?

Clean your hands thoroughly before use. Squeeze the prescribed amount of gel onto your fingertip or an applicator provided by your pharmacist. Gently insert into the vagina and apply the gel as directed by your healthcare provider. Usually, it is applied once daily or as prescribed.

What are the benefits of using a gel over other dosage forms?

A gel formulation provides a more direct application to the targeted area, potentially offering quicker local effects with possibly less systemic absorption compared to oral forms. It may also provide additional lubrication to alleviate symptoms of dryness.

Are there any side effects associated with using this vaginal gel?

As with any medication, there may be side effects. Common ones may include local irritation, itching, or redness. Systemic side effects due to the absorption of hormones can occur, such as breast tenderness or changes in mood. If you experience any severe side effects, contact your healthcare provider immediately.

Can I use this gel during intercourse?

It's best to consult with your healthcare provider for personal advice. Generally, the gel is intended for therapeutic purposes, and residual gel may alter the texture or pH during intercourse, potentially affecting its use as a lubricant.

How should I store the compounded vaginal gel?

Store the gel at room temperature away from direct sunlight and heat. Keep the tube tightly closed when not in use and out of reach of children and pets.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

Can I use this product if I am pregnant or breastfeeding?

This medication may not be safe during pregnancy or breastfeeding. It's essential to consult with your healthcare provider before starting any new medication, including this compounded vaginal gel, if you are pregnant or plan to become pregnant, or are breastfeeding.

How long does it take to see results from using the vaginal gel?

Response time varies from person to person, based on the condition being treated and individual hormonal levels. Some relief from vaginal symptoms may be noticed within a few weeks, whereas other effects may take longer to manifest. Consult your healthcare provider regarding what to expect in your specific case.

Are there any known interactions with other medications?

Hormones can interact with various medications, potentially altering their effects. It's important to inform your healthcare provider about all medications you're taking, including over-the-counter drugs, herbal supplements, and vitamins, to assess for interactions.

Is hormone testing necessary before using this vaginal gel?

Your healthcare provider may recommend hormone testing before prescribing the gel to determine appropriate dosages and to tailor the treatment to your individual needs. Regular monitoring might also be suggested to evaluate the efficacy and adjust dosages if necessary.

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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.