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Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 40 mg/ml Topical Cream

The Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 40 mg/ml Topical Cream is a compounded medication that combines the estrogen hormones estradiol and estriol with progesterone in a semisolid cream base. This formulation is specifically designed to be dispensed from a pump mechanism, which allows for easy, consistent, and controlled dosing. The cream is intended for topical application on the skin, where it can be used for localized treatment or systemic absorption of the hormones.

This hormone combination cream is commonly used in the management of menopausal symptoms, such as hot flashes, night sweats, vaginal dryness, and mood swings. It may also be prescribed for hormone replacement therapy in postmenopausal women or for other conditions as determined by a healthcare provider. The use of this cream aims to restore hormonal balance and alleviate the symptoms associated with estrogen and progesterone deficiencies.

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Topical Cream
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Formula Information

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The Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 40 mg/ml Topical Cream is a compounded medication specifically designed to deliver a combination of hormones directly through the skin. This semisolid preparation is dispensed in a pump mechanism, which ensures a convenient, hygienic, and controlled application. The pump is calibrated to dispense a consistent dose with each use, which is crucial for maintaining the precise dosing required for hormone replacement therapy (HRT).

The formulation combines estradiol and estriol, two forms of estrogen, with progesterone. Estradiol is the primary and most potent form of estrogen found in the body and is essential for many processes in women's health. Estriol, a weaker form of estrogen, is believed to offer benefits with fewer side effects and is often used in combination with other estrogens in HRT. Progesterone is added to balance the effects of estrogen and is essential for regulating the menstrual cycle and supporting pregnancy. Together, these hormones can help alleviate symptoms associated with menopause, such as hot flashes, night sweats, vaginal dryness, and mood swings. They may also be used for hormone imbalances or deficiencies in premenopausal women.

The topical route of administration allows for the hormones to be absorbed directly into the bloodstream through the skin, bypassing the gastrointestinal tract and liver, which can minimize the potential for metabolic side effects. This method can also provide a more consistent release of hormones into the body, potentially leading to more stable hormone levels and fewer fluctuations in symptoms. The cream is intended for localized treatment, which can be beneficial for patients who require targeted relief or for those who cannot tolerate oral or systemic forms of hormone therapy.

It is important for patients and prescribers to understand that this is a compounded medication, which means it is made to order based on a healthcare provider's prescription to meet the specific needs of an individual patient. The effectiveness and safety of compounded medications are highly dependent on the quality of ingredients and the precision of compounding. At Bayview Pharmacy, we ensure that each formulation is prepared with the utmost care and in accordance with the highest compounding standards.

Patients should be instructed on the proper use of the cream, including the specific area of application and the frequency of use as prescribed by their healthcare provider. Regular follow-up and monitoring are recommended to assess the effectiveness of the treatment and to make any necessary adjustments to the formulation or dosing. As with any hormone therapy, there are potential risks and side effects, and these should be discussed with a healthcare provider before starting treatment.

If you have any questions or require further information about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide support and guidance to both patients and prescribers considering the use of this customized hormone therapy.

Drug Interactions

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The topical cream containing estradiol, estriol, and progesterone is a hormone replacement therapy (HRT) that is applied to the skin. It is designed to alleviate symptoms associated with menopause, such as hot flashes, vaginal dryness, and osteoporosis prevention, by delivering hormones directly to the bloodstream through the skin. While this route of administration may reduce some risks associated with oral hormone therapy, it is important to consider potential drug interactions when using this formulation.

Estradiol and estriol are forms of estrogen, and progesterone is a progestin. These hormones can interact with a variety of medications. For instance, they may reduce the effectiveness of certain enzyme-inducing drugs, such as some anticonvulsants (e.g., phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin). Conversely, these medications may also decrease the effectiveness of the hormones in the cream. Patients using these or similar medications should be monitored closely for changes in hormone levels and therapeutic effects.

Additionally, the metabolism of estrogens and progestins can be affected by certain inhibitors of the cytochrome P450 enzyme system, such as ketoconazole, itraconazole, and grapefruit juice. These substances may increase the levels of hormones in the body, potentially leading to an increased risk of side effects. Patients should be advised to inform their healthcare provider of all medications, supplements, and dietary habits to assess for potential interactions.

Thyroid function tests may also be affected by the use of estrogen-containing products. 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 treated with thyroid replacement therapy may require increased doses of thyroid hormone when using this HRT cream.

Patients on anticoagulant therapy, such as warfarin, should be monitored as estrogens and progestins can affect coagulation parameters. The anticoagulant effect may be either increased or decreased, necessitating adjustments in anticoagulant dosage. Close monitoring of prothrombin time or other suitable coagulation tests is recommended, and patients should be advised to watch for signs of bleeding.

It is also important to note that smoking can increase the risk of serious cardiovascular side effects from estrogen-containing therapy. Patients who use this topical cream should be advised of this risk, especially if they are over 35 years old and smoke tobacco.

Lastly, the concurrent use of other topical products on the same skin area where the HRT cream is applied may alter the absorption of the hormones. Patients should discuss the use of other skin products with their healthcare provider to avoid potential interactions.

This information is not exhaustive, and other interactions may exist. Patients should be encouraged to report all medications, including over-the-counter drugs and herbal supplements, to their healthcare provider. Prescribers should consult the latest clinical guidelines and consider individual patient profiles when evaluating potential drug interactions. If you have any questions or require further information, please reach out to us at Bayview Pharmacy.

How Does it Work

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The Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 40 mg/ml Topical Cream is a compounded medication that combines three hormones commonly used in hormone replacement therapy (HRT). This formulation is designed to alleviate symptoms associated with menopause, perimenopause, and other hormonal imbalances. The cream is applied topically, which allows for the hormones to be absorbed directly through the skin, providing a more localized effect with potentially fewer systemic side effects compared to oral administration.

Estradiol is a form of estrogen, a hormone that regulates many processes in the female body. It is responsible for the development and maintenance of female reproductive tissues, but it also has important roles in bone health, brain function, and the cardiovascular system. Estriol is another form of estrogen that is weaker than estradiol but still plays a crucial role in the health of the urogenital tract, particularly in postmenopausal women. Progesterone is a hormone that balances the effects of estrogen and is essential for regulating the menstrual cycle and maintaining pregnancies. In a topical cream form, these hormones can be used to treat symptoms such as hot flashes, vaginal dryness, mood swings, and osteoporosis prevention.

The cream is formulated to be applied to the skin, where it is absorbed into the bloodstream. The pump mechanism ensures that a consistent and accurate dose is delivered with each use, which is important for maintaining stable hormone levels. The cream base is designed to facilitate the absorption of the active ingredients and to provide a moisturizing effect, which can be beneficial for skin health, especially in areas that may become dry or atrophic due to decreased estrogen levels.

For patients, it is important to understand that this medication should be used as directed by a healthcare provider. The site of application, frequency, and duration of use will be determined based on individual needs and response to therapy. For prescribers, it is crucial to tailor the hormone therapy to the patient's specific symptoms and health profile, monitoring for efficacy and any adverse effects. Regular follow-up is necessary to adjust the dose or formulation as needed.

If you have any questions about this formulation or how it can be integrated into a patient's treatment plan, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide support and guidance to ensure the best possible outcomes for your patients.

Other Uses

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The formulation containing Estradiol 0.16 mg, Estriol 0.64 mg, and Progesterone 40 mg/ml is primarily indicated for hormone replacement therapy, particularly in addressing symptoms related to menopause such as hot flashes, night sweats, vaginal dryness, and osteoporosis prevention. These active ingredients aim to replenish the decreased levels of estrogen and progesterone in postmenopausal women, thereby alleviating the associated conditions. However, beyond these common indications, this topical cream may have additional applications due to the actions of its component hormones.

For instance, some anecdotal evidences and limited studies suggest that such hormone creams may improve skin elasticity and thickness, potentially helping reduce the appearance of fine lines and wrinkles associated with aging skin. It can also be used for managing menstrual cycle irregularities or premenstrual syndrome (PMS) symptoms in premenopausal women under the guidance of a healthcare professional. There is also the therapeutic potential in the alleviation of fibrocystic breast changes and in some cases may contribute to the improvement of mood and libido concerns resulting from hormone imbalances.

Moreover, due to the absorption of hormones through the skin, the topical route of administration may avoid first-pass metabolism in the liver, possibly resulting in fewer side effects compared to oral hormone replacement therapy. However, any off-label and additional uses of this formulation must be approached with caution and under strict medical supervision, particularly considering the varied individual responses to hormone therapy, and the potential risks of hormone-dependent conditions or breast cancer history in patients.

Research is ongoing to explore the full scope of potential uses for this hormone cream. Health care providers considering this formulation for other uses should do so based on a thorough review of the patient's medical history, current medications, and the balance of potential benefits against risks. It is also essential to monitor hormone levels and clinical responses when using this cream for both indicated and off-label purposes. Likewise, patients using this formulation should report any unusual symptoms or side effects to their providers promptly.

If you are a patient or a prescriber and have questions about this formulation or its extended uses, please don't hesitate to reach out to us at Bayview Pharmacy. Our compounding pharmacist team is dedicated to providing personalized information and support to ensure safe and effective use of compounded medications.

Frequently Asked Questions

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What is this compounded formulation used for?

This compounded formulation is a hormone replacement therapy that combines Estradiol, Estriol, and Progesterone. It is used to alleviate symptoms associated with menopause or hormone imbalances by providing localized or systemic hormone delivery through the skin.

How do I use this topical cream?

Gently press the pump to dispense the prescribed amount of cream onto your skin. Apply it to an area of the skin as directed by your healthcare provider, usually to the inner arms or thighs, and rub it in until it is fully absorbed. Avoid applying the cream to broken or irritated skin.

How often should I apply this cream?

Use this cream exactly as prescribed by your healthcare provider. The frequency and dosing schedule may differ depending on individual needs and hormone levels.

Are there any side effects associated with this formulation?

Like all medications, this compounded cream can have side effects. Common side effects include skin irritation at the site of application, headaches, breast tenderness, or changes in mood. If you experience any severe side effects or symptoms of hormonal imbalance, contact your healthcare provider immediately.

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

No, the cream should only be applied to areas recommended by your healthcare provider—typically the inner arms or thighs. Avoid applying the cream to the breasts or near the vagina unless specifically instructed by your healthcare provider.

How long does it take for this cream to work?

Some effects may be noticed shortly after starting treatment, but it could take a few weeks to feel the full benefits of the hormone cream. It's important to use it consistently and as directed by your healthcare provider.

Should I use this cream if I am pregnant or breastfeeding?

This medication should not be used during pregnancy or while breastfeeding unless specifically prescribed by your healthcare provider. Be sure to discuss all potential risks with your doctor.

How should this cream be stored?

Store the cream at room temperature, away from direct sunlight and heat. Do not freeze the cream and keep it out of reach of children.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and proceed with your regular dosing schedule. Do not double doses.

Can I use other skin products on the same area where I applied the cream?

It is best to avoid using other topical products on the same area where you have applied the hormone cream to prevent interaction and ensure proper absorption. If you must use other products, consult with your healthcare provider on how to appropriately space out the applications.

Is this formulation safe to use with other medications?

Hormone therapies can interact with other medications, possibly altering their effects. It is important to inform your healthcare provider of all medications, supplements, and herbal products you are using to ensure safety and avoid interactions.

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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.