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Formulas

Estradiol 0.125 mg/Estriol 0.5 mg/Progesterone 2.5 mg Oral Capsules

Description: This compounded formulation consists of Estradiol 0.125 mg, Estriol 0.5 mg, and Progesterone 2.5 mg contained within oral capsules. The capsules are solid dosage forms made from either gelatin or vegetarian shells, designed to be easily swallowed. Each capsule provides a precise dose of the active ingredients, ensuring consistent and accurate delivery of medication. This particular combination of hormones is commonly used in hormone replacement therapy (HRT) to treat symptoms associated with menopause, such as hot flashes, night sweats, vaginal dryness, and osteoporosis prevention. Additionally, it may be prescribed to address hormonal imbalances in premenopausal women and for certain conditions of hormone-dependent tissue atrophy.

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Formula Information

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Estradiol 0.125 mg/Estriol 0.5 mg/Progesterone 2.5 mg Oral Capsules are a compounded bioidentical hormone replacement therapy (BHRT) designed to alleviate symptoms associated with hormonal imbalances or deficiencies in women, particularly those occurring during menopause. This custom formulation combines three naturally occurring hormones: estradiol, estriol, and progesterone, in a solid dosage form. The capsules are made from two halves of either gelatin or vegetarian material that encapsulate the powdered hormones, ensuring a consistent and accurate dose is delivered with each administration. This is particularly important for maintaining the delicate balance required for effective hormone therapy.

Estradiol is a potent form of estrogen and is identical to the hormone produced by the ovaries. It is often prescribed to treat symptoms of menopause such as hot flashes, vaginal dryness, and osteoporosis. Estriol, a weaker estrogen, is thought to offer benefits for vaginal and urinary health without the risks associated with stronger estrogens. Progesterone is included to counterbalance the effects of estrogen and reduce the risk of endometrial hyperplasia, which can occur with estrogen therapy alone. The combination of these hormones aims to mimic the natural hormone levels in the body, providing relief from menopausal symptoms, while also potentially offering protective effects against certain diseases such as osteoporosis and heart disease.

The precise dosing of each hormone in this formulation is critical, as it allows for the tailoring of therapy to the individual needs of the patient. This personalized approach can help in minimizing side effects and optimizing therapeutic outcomes. The oral capsule form is a convenient and non-invasive route of administration, preferred by many patients over other forms such as creams, gels, or patches. However, it is important to note that hormone replacement therapy may not be suitable for everyone and requires careful consideration of the patient's medical history, risks, and benefits. Regular monitoring and follow-up with a healthcare provider are essential to ensure the safety and efficacy of the treatment.

Patients and prescribers considering this compounded hormone therapy should be aware of the potential side effects, which can include but are not limited to, breast tenderness, spotting or bleeding, bloating, mood swings, and gallbladder disease. It is also important to discuss the risk of hormone-sensitive cancers with a healthcare provider before starting treatment. For those interested in this custom-compounded formulation, Bayview Pharmacy's team of knowledgeable compounding pharmacists is available to answer any questions and provide guidance on the appropriate use of this medication. We are committed to working closely with both patients and prescribers to ensure optimal care and treatment outcomes.

Drug Interactions

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The formulation you have described contains a combination of hormones: estradiol, estriol, and progesterone. These hormones are commonly used in hormone replacement therapy (HRT) to treat symptoms of menopause such as hot flashes, vaginal dryness, and osteoporosis prevention. It is important to note that hormone therapy can interact with a variety of medications, which may alter the effectiveness of the hormones or the concomitant medication, or increase the risk of adverse effects.

One significant interaction is with drugs that induce hepatic enzymes, particularly cytochrome P450 enzymes such as CYP3A4. Medications such as carbamazepine, phenytoin, rifampicin, and St. John's Wort can increase the metabolism of hormones, potentially reducing their effectiveness. Conversely, inhibitors of these enzymes, such as ketoconazole, erythromycin, and grapefruit juice, can increase hormone levels and the risk of side effects.

Thyroid function may be affected by estrogen therapy, which 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 on thyroid replacement therapy may require higher doses of thyroid hormone.

Estrogens can also interfere with the metabolism of other hormones, such as corticosteroids, necessitating dosage adjustments of the latter. They may also reduce the plasma concentrations of certain anticoagulants like warfarin, leading to a decreased anticoagulant effect. Close monitoring and possible dose adjustments of the anticoagulant may be necessary.

Progesterone can interact with benzodiazepines, which are metabolized by CYP3A4, potentially leading to increased sedative effects. Additionally, progesterone may affect the pharmacokinetics of certain antidepressants, antiepileptics, and antihypertensive agents. It is crucial to monitor patients for altered therapeutic effects or side effects when these medications are used concurrently with hormone therapy.

Furthermore, smoking can increase the risk of serious cardiovascular side effects from oral contraceptive use and hormone replacement therapy, especially in women over 35 years old. This risk increases with age and with heavy smoking and is quite marked in women over 35 years of age. Women who use hormone therapy are strongly advised not to smoke.

It is also important to consider the potential for increased risk of thromboembolic events, breast cancer, and endometrial cancer with hormone therapy, which may be influenced by the concurrent use of other medications. Patients with a history of these conditions or those at high risk should be closely monitored.

Patients and prescribers should be aware that this is not an exhaustive list of all potential drug interactions. It is essential to review all medications, including over-the-counter drugs and herbal supplements, with a healthcare provider to ensure safety and efficacy. If you have any questions or concerns about this formulation and its interactions with other drugs, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The Estradiol 0.125 mg/Estriol 0.5 mg/Progesterone 2.5 mg Oral Capsules are a form of hormone replacement therapy (HRT) that combines two estrogens, estradiol and estriol, with progesterone. This medication is designed to alleviate symptoms associated with menopause, such as hot flashes, night sweats, vaginal dryness, and mood swings, by replenishing the hormones that the body no longer produces in sufficient quantities after menopause.

Estradiol is a form of estrogen that is identical to the hormone naturally produced by the ovaries. It is the most potent estrogen and is primarily responsible for the development and maintenance of female reproductive tissues. Estriol, another form of estrogen, is weaker than estradiol and is thought to offer some protective effects on the tissues of the vagina and urinary tract. The combination of estradiol and estriol aims to provide a balanced estrogenic effect, targeting a broad range of menopausal symptoms while potentially reducing the risks associated with estrogen therapy.

Progesterone is included in this formulation to counterbalance the effects of estrogen on the endometrium, the lining of the uterus. In women with an intact uterus, unopposed estrogen can lead to endometrial hyperplasia, which can increase the risk of endometrial cancer. Progesterone helps to maintain a healthy endometrium by causing it to shed during the menstrual cycle, thus reducing the risk of hyperplasia and cancer.

The oral capsules are a solid dosage form consisting of two gelatin or vegetarian shells that encapsulate the active ingredients. This form of delivery ensures that patients receive a precise dose of each hormone with each capsule. The capsules are designed for oral administration, which allows for the systemic absorption of the hormones through the digestive tract. Once absorbed, the hormones enter the bloodstream and are distributed throughout the body to target tissues, where they exert their therapeutic effects by binding to specific hormone receptors and modulating gene expression and cellular function.

This HRT formulation is typically prescribed for postmenopausal women or those experiencing menopausal symptoms due to a hysterectomy or other medical conditions that lead to decreased hormone production. It is important to note that hormone replacement therapy is not suitable for everyone, and a thorough evaluation by a healthcare provider is necessary to determine if this treatment is appropriate. Factors such as personal and family medical history, current health status, and the specific symptoms being treated are all considered when deciding to use HRT.

If you have any questions about this formulation or how it may benefit you or your patients, 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 hormone replacement therapy.

Other Uses

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The Estradiol 0.125 mg/Estriol 0.5 mg/Progesterone 2.5 mg Oral Capsules you are inquiring about are primarily used in hormone replacement therapy (HRT) for the management of symptoms associated with menopause such as hot flashes, vaginal dryness, and prevention of osteoporosis. However, these capsules have also been utilized off-label for a variety of other potential indications that are based on the properties of their constituent hormones.

Estradiol and estriol, both forms of estrogen, in conjunction with progesterone may be used for improving skin elasticity and thickness, which can have cosmetic benefits such as reducing the appearance of wrinkles. This combination may also support mood regulation, potentially benefiting patients experiencing mood swings or depressive symptoms associated with hormonal imbalances during perimenopause or after menopause. Furthermore, some prescribers may consider this formulation to address symptoms of premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) in certain cases.

In addition to these potential uses, there is ongoing research investigating the cognitive benefits of hormone replacement, with some studies suggesting that there might be a reduced risk of cognitive decline when HRT is initiated near the onset of menopause. However, it is essential for both patients and prescribers to approach these alternative uses with caution, as they are not universally accepted indications, and the benefits and risks must be weighed on a case-by-case basis.

It is critical to note that hormone therapy can be associated with various risks, including an elevated risk of blood clots, stroke, and certain types of cancer, among others. Therefore, it is crucial for patients to engage in a thorough discussion with their healthcare provider about the potential risks and benefits of this therapy. Additionally, consideration should be given to the lowest effective dose for the shortest duration necessary to accomplish treatment goals in alignment with individual patient risk profiles.

For patients and prescribers interested in exploring the use of Estradiol 0.125 mg/Estriol 0.5 mg/Progesterone 2.5 mg Oral Capsules for any indication outside of the established HRT uses, we recommend a thorough review of current evidence and clinical guidelines. We at Bayview Pharmacy are dedicated to providing evidence-based information and high-quality compounding services to support patient care. If you have any questions about this formulation or its potential uses, please do not hesitate to reach out to us for more detailed information.

Frequently Asked Questions

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What is the purpose of this compounded medication?

This compounded formulation is designed to provide a precise dose of hormones – Estradiol, Estriol, and Progesterone – for hormone replacement therapy (HRT) which is often used to manage symptoms of menopause or other hormonal imbalances.

How should I take these oral capsules?

These capsules should be taken orally with a glass of water. It is important to follow your healthcare provider's instructions on when and how to take this medication for best results. Do not chew or open the capsules.

What are the benefits of using capsules for hormone therapy?

Capsules provide an accurate dosage and ensure the consistent delivery of hormones into the body. They are also convenient to take, easy to swallow, and the encapsulation protects the active ingredients from degradation.

Can I take this medication with food?

It is best to follow your doctor's advice on whether to take this medication with or without food. The presence of food can affect the absorption of some medications.

Are these capsules made with gelatin or a vegetarian alternative?

The composition of the capsules can be either gelatin or vegetarian based. If you have dietary restrictions or preferences, please consult with your pharmacist or healthcare provider to ensure you receive the appropriate type of capsule.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. However, if it's nearly time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Are there any side effects associated with this medication?

As with all medications, there can be side effects. Common side effects of hormone replacement therapy may include bloating, breast tenderness, headaches, mood swings, and fatigue. If you experience any severe side effects or signs of an allergic reaction, contact your healthcare provider immediately.

How should I store the capsules?

Store the capsules at room temperature away from light and moisture. Keep them out of reach of children and pets. Do not store them in the bathroom or fridge unless specifically instructed by your pharmacist.

Is it safe to use this medication if I am pregnant or breastfeeding?

No, this medication is typically not recommended for use during pregnancy or while breastfeeding. Consult your healthcare provider for guidance specific to your situation before starting any new medication.

How long do I need to take this medication?

The duration of treatment with this compounded formulation will depend on your individual treatment plan and health needs. Your healthcare provider will determine the best treatment duration based on your response and any side effects.

Can I request a custom dosage different from the 0.125mg Estradiol / 0.5mg Estriol / 2.5mg Progesterone?

Yes, compounding pharmacies can tailor the dosage to meet specific patient needs. If you require a different dosage, consult with your healthcare provider about adjusting your prescription.

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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.