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Estradiol 0.625 mg/ml Vaginal Cream

The Estradiol 0.625 mg/ml Vaginal Cream is a semisolid formulation, compounded for ease of application within the vaginal area. Packaged in a tube, this cream allows for accurate dosing and is specifically designed to deliver estradiol, a form of estrogen, directly to the site of action. This topical hormone replacement therapy is primarily used to treat symptoms associated with menopause, such as vaginal atrophy, dryness, itching, and burning. Additionally, it may be prescribed to manage conditions like kraurosis vulvae and to provide supplemental hormonal support in cases of estrogen deficiency.

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Vaginal Cream
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Formula Information

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Estradiol 0.625 mg/ml Vaginal Cream is a specially compounded semisolid formulation intended for vaginal administration. This cream is designed to deliver a consistent dose of estradiol, which is a form of estrogen, a hormone that plays a vital role in the female reproductive system. The cream is dispensed in a tube, which allows for convenient, clean, and precise application. The dosage form ensures that the medication is directly applied to the affected area, providing localized relief and treatment.

The estradiol vaginal cream is primarily used to treat symptoms associated with menopause, such as vaginal atrophy, dryness, itching, burning, and pain during intercourse. These symptoms occur due to the natural decline in estrogen levels as women age. By delivering estradiol directly to the vaginal tissue, the cream helps to replenish estrogen levels in the local area, promoting tissue regeneration, increasing lubrication, and maintaining the health of the vaginal mucosa. This can lead to a significant reduction in both the severity of symptoms and the discomfort associated with vaginal atrophy and dryness.

In addition to treating menopausal symptoms, estradiol vaginal cream may also be used in the management of certain gynecological conditions that are responsive to hormone therapy. It is important for prescribers to consider the individual needs of the patient, including their medical history and any potential risks associated with hormone therapy. Patients should be advised on the proper use of the cream, including the frequency and duration of treatment as prescribed by their healthcare provider.

It is essential for patients to understand that while estradiol vaginal cream can provide significant relief from menopausal symptoms, it may also carry risks similar to those associated with systemic hormone replacement therapy, such as an increased risk of blood clots, stroke, or breast cancer. Therefore, it is crucial to use the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual woman. Regular follow-ups with the healthcare provider are recommended to assess the efficacy and safety of the treatment.

For any questions or concerns regarding the use of Estradiol 0.625 mg/ml Vaginal Cream, or to discuss individualized treatment options, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing comprehensive support and guidance to both patients and prescribers to ensure the safe and effective use of compounded medications.

Drug Interactions

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Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body. Estradiol vaginal cream is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol can also help to protect against osteoporosis. However, when prescribing this medication, it is important to consider potential drug interactions that may affect the efficacy of the treatment or cause adverse effects.

One of the primary concerns with estradiol is its interaction with enzyme inducers. Medications that induce liver enzymes, particularly cytochrome P450 enzymes, can increase the metabolism of estradiol, leading to reduced effectiveness. Examples of these drugs include some anticonvulsants like phenytoin and carbamazepine, and some anti-infectives like rifampicin. Patients using these medications may require a higher dose of estradiol for efficacy.

Conversely, drugs that inhibit cytochrome P450 enzymes can lead to increased levels of estradiol and potentially increase the risk of side effects. For example, certain antifungals (such as ketoconazole) and some antibiotics (like erythromycin) can inhibit the metabolism of estradiol. It is important to monitor patients for signs of estrogen excess and adjust the estradiol dose as necessary when these drugs are co-administered.

Thyroid hormone replacement therapy may also interact with estradiol. Estrogens may increase the 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.

Patients taking anticoagulants, particularly warfarin, should be closely monitored as estrogen therapy can increase the risk of venous thromboembolism. Estrogens can also affect the anticoagulant's effectiveness, necessitating adjustments in the anticoagulant dosage.

Additionally, the concurrent use of other hormonal therapies, such as progestins or hormone replacement therapy, should be carefully considered as they can alter the effects of estradiol and may increase the risk of endometrial hyperplasia in women with an intact uterus. It is important to evaluate the risk-benefit ratio in each patient.

Grapefruit juice may increase plasma concentrations of estrogens and should be consumed with caution by patients being treated with estradiol. Patients should be advised to discuss their dietary habits with their healthcare provider to ensure there are no interactions with their medications.

It is also important to note that smoking can reduce the effectiveness of estradiol, as it increases the metabolism of estrogen in the liver. Patients who smoke may require a higher dose of estradiol for the same therapeutic effect.

Lastly, over-the-counter supplements and herbal products can also interact with estradiol. For example, St. John's Wort may reduce the effectiveness of estradiol by increasing its metabolism. Patients should be encouraged to inform their healthcare provider of all over-the-counter products they are taking.

Due to the complexity of drug interactions with estradiol, it is crucial for prescribers to thoroughly review the patient's current medication list, including over-the-counter drugs and supplements, before prescribing estradiol vaginal cream. Pharmacists can play a key role in identifying potential drug interactions and advising on appropriate management strategies. If you have any questions or require further information, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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Estradiol 0.625 mg/ml Vaginal Cream is a hormone replacement therapy specifically formulated to alleviate symptoms associated with menopause and other hormonal imbalances. Estradiol, the active ingredient, is a form of estrogen, a female hormone that regulates many processes in the body. As women approach menopause, their bodies produce less estrogen, which can lead to various symptoms such as vaginal dryness, itching, burning, and irritation. Additionally, low estrogen levels can contribute to the thinning of the vaginal walls, a condition known as vaginal atrophy or atrophic vaginitis.

The mechanism of action of estradiol vaginal cream involves the replenishment of estrogen levels locally within the vaginal tissue. When applied as directed, the cream releases estradiol, which is then absorbed through the vaginal walls into the surrounding tissues. This localized application allows for a direct therapeutic effect, targeting the area of discomfort and symptomatology without significantly increasing estrogen levels throughout the rest of the body. This is particularly beneficial for patients who may be concerned about the risks associated with systemic hormone replacement therapy.

The estradiol in the cream works by binding to estrogen receptors in the vaginal cells, thereby stimulating the normal growth and development of the vaginal tissue. It helps to restore the natural thickness and elasticity of the vaginal walls and increases vaginal lubrication. This can significantly reduce the symptoms of vaginal atrophy, providing relief from discomfort and improving the quality of life. Additionally, the cream can help maintain the natural acidity of the vagina, which is important for preventing infections.

The semisolid formulation of the cream is designed for ease of application. The cream is typically dispensed in a tube, often accompanied by an applicator that allows for precise dosing. Patients are instructed on how to use the applicator to insert the correct dose of cream into the vagina, usually once daily for a specified period, followed by a maintenance schedule as prescribed by their healthcare provider.

It is important for patients and prescribers to understand that while estradiol vaginal cream is effective for treating local symptoms of estrogen deficiency, it is not intended for use in patients with certain conditions, such as unexplained vaginal bleeding, a history of breast or uterine cancer, or a history of blood clots, unless deemed safe and necessary by a healthcare provider. Regular follow-ups and monitoring are recommended to assess the effectiveness of the treatment and to check for any side effects or contraindications.

If you have any questions about the Estradiol 0.625 mg/ml Vaginal Cream or its use in treating specific gynecological conditions, 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 ensure safe and effective treatment.

Other Uses

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Estradiol 0.625 mg/ml Vaginal Cream is typically prescribed to address menopausal symptoms such as vaginal atrophy, dryness, irritation, and related painful intercourse. However, it may have additional uses beyond these indications. Some practitioners have utilized this hormonal cream off-label for the management of vulvar atrophic changes and to assist with the maintenance of tissue elasticity and integrity in postmenopausal women. Research has also hinted at potential benefits in improving the urinary symptoms associated with the genitourinary syndrome of menopause (GSM), such as urgency and recurrent urinary tract infections, though these applications should be approached cautiously and under direct medical supervision.

Furthermore, in cases of breast cancer patients who are undergoing aromatase inhibitor therapy and suffer from atrophic vaginitis, a very low dose of vaginal estrogen such as estradiol cream might sometimes be considered, even though it is generally contraindicated. This application requires a careful balance of risks and benefits due to the sensitive nature of hormone interaction in breast cancer patients, and should only be done with the guidance of an oncologist. Moreover, it's important to be aware that while there is evidence showing minimal systemic absorption with low-dose vaginal estrogen therapy, any usage in a patient with a history of hormone-sensitive cancer needs to be closely monitored.

While less common, some studies have suggested the possible benefits of vaginal estrogen cream for premenopausal women with conditions such as lichen sclerosus, which can cause significant vulvar itching, burning, and even pain. However, since this use is not widely accepted as standard of care, it typically falls into an experimental or last-resort category, to be used when other treatments have failed. If you are considering estradiol vaginal cream for any use other than the treatment of menopausal vaginal symptoms, it is imperative to do so under the advice and observation of a healthcare provider who can monitor for side effects and assess the appropriateness of treatment for your specific condition.

Please do keep in mind that while there are additional potential applications for this medication, all off-label uses must be carefully weighed against potential risks and done under the guidance of a healthcare professional. Tailoring treatments to the specific needs of patients is a cornerstone of compounding pharmacy, and the pharmacists at Bayview Pharmacy are here to provide counsel and support. If you have any questions or need further information about the uses of Estradiol 0.625 mg/ml Vaginal Cream, please do not hesitate to reach out to us. We are committed to helping enhance your health and wellness through personalized medicine and care.

Frequently Asked Questions

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What is Estradiol 0.625 mg/ml Vaginal Cream used for?

Estradiol vaginal cream is used to treat menopausal symptoms such as vaginal dryness, itching, and burning. It works by providing a source of estrogen, which is often reduced during menopause, to improve the health and function of vaginal tissues.

How do I properly apply Estradiol Vaginal Cream?

Wash your hands thoroughly before application. Squeeze the prescribed amount of cream onto the applicator and insert it gently into the vagina, usually at bedtime as directed by your healthcare provider. Follow the specific instructions provided with your prescription for proper application.

How often should I use Estradiol Vaginal Cream?

The frequency of use for Estradiol Vaginal Cream will be determined by your healthcare provider. Always follow the prescribed treatment regimen, which is typically once daily for the first few weeks, then reduced to one to three times a week thereafter.

What side effects may I experience when using this medication?

Common side effects include local vaginal irritation or itching, increased vaginal discharge, and mild genital burning. Inform your healthcare provider if you experience any severe side effects or if symptoms persist or worsen.

Can I use Estradiol Vaginal Cream if I am pregnant or breastfeeding?

Estradiol Vaginal Cream is not recommended for use during pregnancy or while breastfeeding. If you are pregnant, planning to become pregnant, or breastfeeding, consult with your healthcare provider for alternative treatments.

Can Estradiol Vaginal Cream affect my sex life?

While it's designed to relieve symptoms of vaginal dryness and discomfort, it can sometimes cause changes in sexual sensation or libido. If you notice any changes, discuss them with your healthcare provider.

Should I be aware of any interactions with other medications?

Yes, Estradiol Vaginal Cream can interact with other medications. It is essential to inform your healthcare provider about all the medications you're currently taking, including over-the-counter drugs and herbal supplements, to avoid potential interactions.

How should Estradiol Vaginal Cream be stored?

Store the cream at room temperature, away from heat and direct light. Do not freeze it. Keep the tube tightly closed and out of reach of children and pets.

What should I do if I miss a dose of Estradiol Vaginal Cream?

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

Is there an expiration date for Estradiol Vaginal Cream?

Yes, like most medications, Estradiol Vaginal Cream has an expiration date. Do not use the cream past the expiration date marked on the tube. Expired medication may be less effective and, in some cases, unsafe to use.

Are there any other precautions I should take while using this medication?

When using Estradiol Vaginal Cream, avoid using other vaginal products without your healthcare provider's approval, as they may alter the effectiveness or increase the risk of side effects. Also, inform your healthcare provider if you have a history of hormone-sensitive conditions or are undergoing any surgeries.

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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.