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Estradiol 0.2 mg/Estriol 0.8 mg/Progesterone 25 mg/Testosterone 0.25 mg/ml Topical Cream

Description: This topical cream is a compounded formulation that combines estradiol (0.2 mg), estriol (0.8 mg), progesterone (25 mg), and testosterone (0.25 mg) per milliliter. The cream is designed to be applied to the skin, where the active ingredients can be absorbed locally or systemically. The semisolid preparation is dispensed in a pump mechanism, which allows for convenient and controlled dosing. This formulation is typically used in the management of menopausal symptoms, hormone replacement therapy, and may also be used to address conditions related to hormonal imbalances such as certain types of amenorrhea, dysmenorrhea, and androgen deficiency. The specific combination of hormones aims to provide a balanced approach to treating these disease states, with the goal of alleviating symptoms and restoring hormonal equilibrium.

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Topical Cream
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Formula Information

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The Estradiol 0.2 mg/Estriol 0.8 mg/Progesterone 25 mg/Testosterone 0.25 mg/ml Topical Cream is a compounded formulation 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 deliver a specific dose with each actuation, allowing for consistent dosing and ease of use for the patient.

The formulation combines estradiol and estriol, both forms of estrogen, which can be beneficial in managing symptoms of menopause such as hot flashes, vaginal dryness, and bone loss. Estrogen therapy is also used to treat conditions like atrophic vaginitis, female hypogonadism, and certain types of breast cancer under professional guidance. Progesterone is included to counterbalance estrogen's effects on the endometrium, thus reducing the risk of endometrial hyperplasia and cancer in women with an intact uterus. It also has a role in treating menopausal symptoms and may aid in improving sleep and protecting against bone loss.

Testosterone in this formulation is used in smaller quantities and may help address sexual dysfunction, such as low libido, which can occur in women during menopause or due to other hormonal imbalances. Additionally, testosterone has been found to have a positive effect on mood, energy levels, and muscle mass maintenance.

This topical cream is intended for localized treatment, which may reduce systemic side effects compared to oral hormone therapies. The transdermal route allows the hormones to be absorbed directly into the bloodstream, bypassing the liver and potentially resulting in a more favorable safety profile. However, it is crucial to use this medication under the supervision of a healthcare provider, as hormone therapy can be associated with risks and should be tailored to an individual's specific health needs and risk factors.

Patients and prescribers should be aware that this is a compounded medication, which means it is made to order based on a healthcare provider's prescription to meet the unique needs of a patient. Compounded medications are not FDA-approved but are created in compounding pharmacies that adhere to strict guidelines to ensure quality and safety. It is essential to discuss the potential benefits and risks of hormone therapy with a healthcare provider, considering the patient's medical history, current health status, and personal preferences.

If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide guidance and support to both patients and prescribers considering the use of this customized hormone therapy.

Drug Interactions

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The formulation you have described contains a combination of hormones: estradiol, estriol, progesterone, and testosterone, which are commonly used in hormone replacement therapy (HRT). 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 such as enzyme inducers like rifampin, carbamazepine, phenytoin, and St. John's Wort may increase the metabolism of these hormones, potentially reducing their effectiveness. Conversely, enzyme inhibitors like ketoconazole, itraconazole, and ritonavir may increase hormone levels, leading to an increased risk of side effects.

Additionally, patients should be aware that the use of these hormones may affect the metabolism of other medications. For example, estradiol and estriol can influence the metabolism of drugs metabolized by cytochrome P450 enzymes, particularly CYP3A4. This can lead to either increased or decreased levels of drugs such as cyclosporine, theophylline, and certain benzodiazepines. Progesterone can also interact with benzodiazepines and may affect the efficacy of antihypertensive agents and anticoagulants. Testosterone's interactions include alterations in the effects of oral anticoagulants, insulin, and other antidiabetic agents, necessitating close monitoring of patients on these medications.

It is also important to consider the potential for additive effects or increased risk of adverse reactions when hormones are used concurrently with other medications that have similar effects. For example, the concurrent use of testosterone with other androgens or anabolic steroids can potentiate the risk of edema, especially in patients with underlying cardiac, renal, or hepatic disease. The use of progesterone with other sedative medications may increase drowsiness and sedation.

Regarding the treatment of disease states, this topical cream formulation is designed to alleviate symptoms associated with hormonal deficiencies or imbalances, such as those experienced during menopause or as part of gender-affirming hormone therapy. Estradiol and estriol are forms of estrogen that can help manage symptoms like hot flashes, vaginal dryness, and osteoporosis. Progesterone is used to counterbalance estrogen's effects on the uterus, reducing the risk of endometrial hyperplasia and cancer in women with an intact uterus. Testosterone is included to address conditions such as hypoactive sexual desire disorder and to provide masculinizing effects in transgender hormone therapy.

Patients should be advised to inform their healthcare providers of all medications, supplements, and herbal products they are currently taking to avoid potential interactions. It is also important for prescribers to review the patient's medication history and to monitor for any adverse effects or changes in efficacy when initiating this hormone therapy. If you have any questions or require further information regarding this formulation and its interactions, please reach out to us at Bayview Pharmacy.

How Does it Work

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The formulation of Estradiol 0.2 mg/Estriol 0.8 mg/Progesterone 25 mg/Testosterone 0.25 mg/ml Topical Cream is a compounded medication that combines four hormones commonly used in hormone replacement therapy (HRT). This cream is designed to be applied topically, which allows for the hormones to be absorbed directly through the skin into the bloodstream. The use of a topical application can help to minimize first-pass metabolism by the liver, which is common with oral hormone preparations, potentially reducing the risk of certain side effects and improving the bioavailability of the hormones.

Estradiol and estriol are forms of estrogen, a hormone that plays a critical role in the regulation of the female reproductive system and secondary sexual characteristics. Estradiol is the most potent form of estrogen and is often used to alleviate symptoms of menopause such as hot flashes, vaginal dryness, and bone loss. Estriol, being a weaker estrogen, is thought to provide some of the benefits of estrogen replacement with a potentially lower risk of estrogen-related side effects. The combination of these two estrogens can offer a balanced approach to estrogen replacement, aiming to maximize benefits while minimizing risks.

Progesterone is another hormone that is important for regulating the menstrual cycle and maintaining the early stages of pregnancy. In HRT, progesterone is often used in combination with estrogen to prevent the overgrowth of the lining of the uterus (endometrial hyperplasia) that can occur with estrogen therapy alone. This can reduce the risk of endometrial cancer. Progesterone can also help to improve sleep quality and reduce anxiety and mood swings.

Testosterone, although commonly known as a male hormone, is also present in females and plays a role in muscle strength, bone density, and sexual function. In women, testosterone therapy can be used to improve libido, energy levels, and overall well-being. The inclusion of testosterone in this formulation aims to address symptoms that may be related to testosterone deficiency or imbalance.

The cream is dispensed in a pump mechanism, which allows for precise dosing and ease of use. Patients are typically instructed to apply the cream to areas of thin skin, such as the inner arms or thighs, where absorption can be maximized. The cream base is designed to facilitate the transfer of the active hormones through the skin and into the systemic circulation.

This hormone combination can be used to treat various disease states associated with hormonal imbalances or deficiencies, such as menopausal symptoms, certain menstrual disorders, and conditions resulting from low testosterone levels in women. It is important to note that hormone replacement therapy should be tailored to the individual patient's needs and should be used under the guidance of a healthcare provider. Regular monitoring and adjustments may be necessary to ensure the optimal balance of hormones and to minimize potential risks associated with HRT.

If you have any questions or require further information about this formulation and its use in treating specific disease states, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the support and guidance needed to ensure safe and effective treatment for our patients and prescribers.

Other Uses

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While the primary indication for this compounded topical cream containing estradiol, estriol, progesterone, and testosterone is often hormone replacement therapy for symptoms associated with menopause or hormonal imbalance in women, there are other potential uses for this formulation. Due to the actions of the hormones included, this compound may be considered for adjunctive use in conditions such as certain cases of premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), or for addressing symptoms of perimenopause. Some patients may also experience benefits in terms of mood stabilization, as hormonal fluctuations can influence neurotransmitter dynamics and mood disorders. Additionally, in some cases, this formulation can be used in hormone therapy for transgender individuals who may benefit from the effects of these hormones on secondary sexual characteristics.

It is important to note that testosterone in the blend may support libido and sexual function in women experiencing declines in these areas due to low androgen levels. Estriol, known for being a weaker estrogen, is sometimes favored for its potential to promote vaginal rejuvenation and urinary tract health with a potentially lower risk profile compared to stronger estrogens. Moreover, the balancing effects of progesterone can sometimes be beneficial for skin health, particularly in addressing hormonal acne or skin inflammation. Lastly, for men with a medical indication, such as male hypogonadism, while the dosage might differ, this compounded cream might be adjusted by a healthcare provider to support testosterone replacement therapy.

It’s critical for prescribers and patients to appreciate that the use of any hormone therapy must be tailored to the individual, taking into account their full medical history, current symptoms, and other medications. Close monitoring is advised to detect any side effects or adverse reactions swiftly. Furthermore, any off-label use should be based on a thorough understanding of the potential risks and benefits and should be discussed with a healthcare provider. If you have further questions regarding this formulation, or would like to explore the possibility of using it for an indication not mentioned here, do not hesitate to reach out to us at Bayview Pharmacy for additional information and professional guidance.

Frequently Asked Questions

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What is this compounded formulation used for?

This compounded formulation is a hormone replacement therapy used for managing symptoms associated with menopause, hormone deficiencies, or imbalances. It delivers specific doses of hormones, such as estradiol, estriol, progesterone, and testosterone, which may help to alleviate symptoms like hot flashes, night sweats, vaginal dryness, reduced libido, and other hormonal issues.

How do I use this topical cream?

Apply the cream as prescribed by your healthcare provider. The pump mechanism is designed to dispense a controlled amount of the cream. You should apply the cream to clean, dry skin on areas recommended by your doctor, such as the lower abdomen, inner thighs, or arms, avoiding the face, breasts, and mucous membranes.

How often should I apply the cream?

The frequency of application will be determined by your healthcare professional based on your specific hormonal needs. Always follow their instructions regarding the dosage and frequency of application. It could range from once a day to multiple times a day as advised.

Can this cream affect my menstrual cycle?

Yes, depending on your current hormonal status, this cream may affect your menstrual cycle. If you are still menstruating, it is important to discuss any changes in your cycle with your healthcare provider, as adjustments to your treatment may be necessary.

What should I do if I miss a dose?

If you miss a dose, apply the cream as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and proceed with your normal dosing schedule. Do not apply a double dose to make up for the missed one.

Are there any side effects associated with this cream?

As with any medication, this compounded cream may cause side effects. Common side effects include local irritation, redness, or itching at the application site. More serious side effects can include changes in mood, weight gain, or fluid retention. If you experience any severe side effects or signs of an allergic reaction, contact your healthcare provider immediately.

Can I apply other lotions or creams in the same area as this hormonal cream?

It is recommended to avoid using other topical products on the same area where you apply the hormonal cream unless directed by your healthcare provider. Other products may alter the absorption or effectiveness of the hormones.

How should I store the cream?

Store the cream at room temperature away from light and moisture. Always keep the pump container tightly closed when not in use to prevent contamination or degradation of the product. Do not store it in the bathroom or expose it to extreme temperatures, such as in a car during hot weather.

Can men use this topical cream?

This cream is typically formulated for women's health issues concerning hormonal imbalances or deficiencies, but it is not exclusive to female use. If a healthcare provider determines it is appropriate, men can also use this cream for specific hormone replacement needs. Always consult a healthcare professional before starting any new treatment.

Is this compounded formulation safe during pregnancy or breastfeeding?

It is not generally recommended to use this formulation during pregnancy or while breastfeeding without your healthcare provider's approval. Hormonal medications can have effects on fetal development and an infant's health. If you are pregnant, planning to become pregnant, or breastfeeding, discuss your treatment options thoroughly with 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.