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Estradiol 0.01% Vaginal Cream (Propylene Glycol Free)

The Estradiol 0.01% Vaginal Cream is a propylene glycol-free, semisolid formulation specifically compounded for the treatment of atrophic vaginitis and vulvar atrophy associated with menopause. This hormone replacement therapy is designed to alleviate symptoms such as vaginal dryness, itching, and burning by delivering a low-dose of estradiol directly to the affected area. The cream is dispensed in a tube for convenient and precise application, ensuring targeted relief and minimal systemic absorption. Its propylene glycol-free base is intended for patients who may be sensitive to this common excipient, providing a safer alternative for those with allergies or intolerances.

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Vaginal Cream
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Formula Information

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Estradiol 0.01% Vaginal Cream is a hormone replacement therapy specifically formulated to alleviate symptoms associated with menopausal changes in the vagina, such as dryness, itching, and burning. Estradiol, the active ingredient, is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen levels decline during menopause, leading to various symptoms, including those affecting the vaginal area. By applying this cream directly to the affected area, estradiol can be absorbed through the vaginal tissues, helping to replenish the diminished estrogen levels locally.

The cream is designed as a semisolid formulation, which allows for a smooth and consistent application. It is dispensed in a tube, which aids in the precise delivery of the medication to the vaginal area. This targeted approach ensures that the medication is applied directly where it is needed, minimizing systemic absorption and potential side effects. The absence of propylene glycol in this formulation is beneficial for patients who may be sensitive to this common excipient, reducing the risk of irritation or allergic reactions.

By restoring the natural estrogen levels in the vaginal tissue, this cream can help to maintain the tissue's health, elasticity, and moisture. This can lead to a reduction in the uncomfortable symptoms of vaginal atrophy and can also aid in preventing urinary problems that can arise due to thinning tissues. Additionally, the use of this cream may provide benefits in maintaining the pH balance of the vagina, which can help to prevent infections and support the overall health of the vaginal flora.

It is important for patients and prescribers to understand that while this cream can provide significant relief from menopausal symptoms, it should be used under the guidance of a healthcare professional. The dosage and duration of treatment should be tailored to the individual's needs and medical history. Regular follow-ups and monitoring for side effects or potential risks associated with hormone replacement therapy are recommended.

For those considering Estradiol 0.01% Vaginal Cream, or for healthcare providers looking for a propylene glycol-free option for their patients, Bayview Pharmacy is equipped to compound this formulation with precision and care. Our team of knowledgeable compounding pharmacists is available to answer any questions and provide additional information to ensure the safe and effective use of this medication. Please reach out to us for further assistance.

Drug Interactions

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Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estradiol medication is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis in postmenopausal women and to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. When considering the use of estradiol 0.01% vaginal cream, it is important to be aware of potential drug interactions that may affect the efficacy of the treatment or cause adverse effects.

Firstly, patients should be advised that certain medications may interfere with the metabolism of estradiol, leading to altered levels of the hormone in the body. Drugs that induce liver enzymes, such as carbamazepine, phenytoin, rifampicin, and St. John's Wort, may decrease the plasma concentrations of estradiol, potentially reducing its effectiveness. Conversely, substances that inhibit cytochrome P450 enzymes, such as ketoconazole, itraconazole, and ritonavir, may increase plasma concentrations of estradiol and increase the risk of side effects.

Additionally, concurrent use of other hormonal products, particularly progestins or other estrogens, should be approached with caution. The combination of multiple hormonal agents can amplify the risk of endometrial hyperplasia and should be monitored closely by a healthcare provider. Patients using thyroid replacement therapy may require adjustments in their thyroid dose, as estrogen-containing products can increase thyroxine-binding globulin, thereby increasing the amount of thyroid hormone that is bound and inactive.

It is also important to consider the potential for estradiol to affect the anticoagulant effects of warfarin or similar oral anticoagulants. Monitoring of the prothrombin time or INR is recommended when starting or stopping estrogen therapy in patients who are taking these medications. Additionally, the use of estradiol may influence the effectiveness of antihypertensive agents or diuretics, and blood pressure should be monitored as appropriate.

Patients should be counseled to inform their healthcare providers of all medications they are taking, including over-the-counter drugs, herbal supplements, and vitamins, to ensure that any potential interactions can be assessed and managed. It is also advisable for patients to avoid smoking while using estrogen-containing products, as smoking can increase the risk of serious cardiovascular side effects, especially in women over 35 years of age.

For any questions or concerns regarding the use of estradiol 0.01% vaginal cream or potential drug interactions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing comprehensive information to ensure the safe and effective use of this medication.

How Does it Work

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Estradiol 0.01% Vaginal Cream is a hormone replacement therapy specifically formulated to alleviate symptoms associated with menopause and other conditions that result in reduced estrogen levels in the body. Estradiol, the active ingredient, is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is essential for maintaining the health and function of the vaginal tissue. As women age, particularly during and after menopause, the body's production of estrogen decreases, which can lead to various symptoms such as vaginal dryness, itching, burning, and discomfort during intercourse. These symptoms are collectively known as atrophic vaginitis or vaginal atrophy.

The cream is designed to be applied directly to the vaginal area, where it is absorbed through the skin and mucous membranes. Once absorbed, estradiol works by replenishing the local estrogen levels, which helps to restore the normal structure and function of the vaginal tissue. This can lead to an increase in vaginal lubrication, thickness of the vaginal walls, and elasticity, which in turn can alleviate the symptoms of vaginal atrophy. Additionally, the local application of estradiol minimizes systemic absorption, which can reduce the potential for side effects that are more common with oral or systemic hormone replacement therapies.

Our Estradiol 0.01% Vaginal Cream is propylene glycol-free, which is beneficial for patients who may have sensitivities or allergies to this common excipient. Propylene glycol can act as a humectant and solvent in pharmaceutical formulations, but its absence in this cream means that alternative ingredients are used to maintain the cream's stability, efficacy, and patient comfort. The semisolid formulation is dispensed in a tube, which allows for convenient and precise application. The cream is typically administered with an applicator that measures the correct dose, ensuring consistent and accurate dosing for each use.

It is important for patients and prescribers to understand that while this cream can provide significant relief from the symptoms of vaginal atrophy, it should be used under the guidance of a healthcare professional. The prescriber will determine the appropriate dosing regimen based on the patient's specific condition and response to treatment. Regular follow-up and monitoring may be necessary to assess the effectiveness of the therapy and to make any necessary adjustments to the treatment plan.

If you have any questions about the Estradiol 0.01% Vaginal Cream or its use in treating gynecological conditions, please do not hesitate to 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 the best possible outcomes for your patients.

Other Uses

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The estradiol 0.01% vaginal cream prepared at Bayview Pharmacy provides a propylene glycol-free option primarily for the management of menopausal symptoms such as vaginal atrophy, dryness, itching, and burning. However, this formulation may also have other potential uses. Some women may find an improvement in dyspareunia (painful intercourse) due to the enhanced vaginal moisture and tissue elasticity that estradiol can promote. Additionally, there is some evidence suggesting that local estrogen therapy may positively affect urinary health, potentially reducing symptoms like urgency, recurrent urinary tract infections, and urinary incontinence, although this should be further discussed with a healthcare provider.

Moreover, estradiol plays a role in maintaining the health of the vaginal mucosa, and some clinicians consider its use in pre-procedural or post-surgical care, specifically in postmenopausal women undergoing procedures that may affect vaginal health, to improve tissue healing and resiliency. However, these are off-label uses and should be carefully considered on a case-by-case basis. It is crucial that any additional uses outside the traditional scope are guided by thorough clinical evaluation and discussion with the prescriber to weigh the benefits against potential risks.

While not a focus of this formulation, some research has hinted at a possible link between local estrogen therapy and decreased severity of pelvic floor disorders, but this is an area that requires more rigorous investigation. It is important for patients to understand that the primary indication of this estradiol 0.01% cream is for vaginal symptoms due to menopause, and any extended use should only be pursued under the consultation and prescription of a qualified healthcare professional.

If you have any questions about the potential uses of this estradiol 0.01% vaginal cream or would like to discuss the appropriateness of this medication for your particular situation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide information, support, and guidance to ensure the safe and effective use of the medications we prepare.

Frequently Asked Questions

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What is Estradiol 0.01% Vaginal Cream used for?

Estradiol 0.01% Vaginal Cream is primarily used to treat symptoms of vaginal atrophy due to menopause, such as dryness, burning, and irritation. It may also provide relief for associated pain during intercourse. As a hormone replacement therapy, it delivers estradiol, a form of estrogen, directly to the vaginal area to rejuvenate and maintain vaginal health.

How do I use Estradiol 0.01% Vaginal Cream?

The cream should be applied according to your healthcare provider's instructions. Generally, it is applied intravaginally using the applicator provided with the product. You should wash your hands before and after use, and the applicator should be cleaned with warm soapy water and rinsed well after each use.

How often should I apply the Estradiol Vaginal Cream?

The frequency of application depends on the individual medical advice provided by your healthcare professional. It can vary from once a day to a couple of times a week. Always follow the prescribing information or the directions given by your doctor.

Is Estradiol 0.01% Vaginal Cream safe for long-term use?

Long-term use of hormone replacement therapies, including vaginal estradiol creams, requires ongoing medical evaluation. Your healthcare provider will assess the benefits and risks of continued use. You should have regular check-ups and discuss any concerns or symptoms with your doctor.

Are there any side effects associated with Estradiol 0.01% Vaginal Cream?

Some common side effects may include vaginal irritation, itching, or increased vaginal discharge. Some women may experience systemic effects like headaches, breast tenderness, or nausea. If you notice any severe side effects or symptoms that concern you, contact your healthcare provider immediately.

Can I use Estradiol Vaginal Cream during my period?

It is usually recommended to avoid using vaginal cream during menstruation. Consult with your healthcare provider to confirm if you should pause the treatment during your period.

Can Estradiol Vaginal Cream affect my sexual activity?

Estradiol Vaginal Cream may actually improve sexual activity for some women by relieving symptoms of vaginal atrophy, which can cause discomfort during intercourse. However, it's worth noting that the cream can compromise the integrity of latex condoms or diaphragms, reducing their effectiveness as contraceptives or for STI protection.

Does Estradiol 0.01% Vaginal Cream contain any allergens or irritants?

This formulation is propylene glycol-free and may be suitable for those who are sensitive to this common ingredient found in many topical products. However, if you have allergies or sensitivities, you should review all the ingredients with your healthcare provider to ensure the product's safety for you.

Can I use other vaginal products while using Estradiol Vaginal Cream?

Some vaginal products can interfere with the absorption or action of Estradiol Vaginal Cream. Before starting any new vaginal products, including over-the-counter treatments or supplements, you should consult with your healthcare provider.

Should I store Estradiol Vaginal Cream in a special way?

Estradiol Vaginal Cream should be stored at room temperature. Keep it away from direct sunlight and heat sources. Do not freeze the cream, and keep it 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, unless it is closer to the time of your next dose. In that case, skip the missed dose and resume your normal dosing schedule. Do not double doses to make up for a missed one. Always follow the specific advice of your healthcare provider.

Is the Estradiol 0.01% Vaginal Cream suitable for all women?

This medication may not be suitable for all women, especially those with a history of certain types of cancer, blood clots, liver disorders, or unexplained vaginal bleeding. It's important to give a full medical history to your healthcare provider to ensure the safety and appropriateness of this treatment for your condition.

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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.