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Formulas

Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 12.5 mg Oral Capsules

Description: This compounded formulation consists of Estradiol 0.16 mg, Estriol 0.64 mg, and Progesterone 12.5 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 to treat symptoms associated with menopause, such as hot flashes, vaginal dryness, and osteoporosis prevention. Additionally, it may be prescribed to address hormonal imbalances or deficiencies in female patients.

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Formula Information

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Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 12.5 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. The formulation combines three hormones—estradiol, estriol, and progesterone—in a solid dosage form, which consists of two halves of either gelatin or vegetarian capsules that are filled with the precise amount of medication. This form of encapsulation ensures the stability of the hormones, facilitates ease of administration, and aids in consistent dosing.

Estradiol, a potent form of estrogen, is essential for managing menopausal symptoms such as hot flashes, night sweats, and vaginal dryness. It also plays a role in bone density maintenance, thereby helping to prevent osteoporosis. Estriol, a weaker estrogen, offers similar benefits but with a potentially reduced risk of estrogen-related side effects. The combination of estradiol and estriol aims to provide a balanced estrogenic effect. Progesterone is included to counterbalance the effects of estrogen on the endometrium, reducing the risk of endometrial hyperplasia and cancer, which can be associated with unopposed estrogen therapy. It also contributes to the overall balance of hormones and can improve sleep quality and mood.

This customized formulation is tailored to meet the specific hormonal needs of individual patients, as determined by their healthcare provider. It is important to note that hormone replacement therapy should be personalized and closely monitored due to the potential risks and side effects associated with hormone use, including cardiovascular disease, breast cancer, and thromboembolic events. Patients should be thoroughly evaluated, and the risks and benefits of hormone therapy should be discussed before initiating treatment.

For prescribers considering this formulation for their patients, it is crucial to assess the patient's medical history, current symptoms, and hormone levels. Regular follow-up and monitoring of hormone levels are recommended to ensure the effectiveness of the therapy and to make any necessary adjustments to the dosage. Patients should be advised to report any side effects or concerns promptly to their healthcare provider.

At Bayview Pharmacy, we are committed to providing high-quality compounded medications tailored to the unique needs of each patient. Our team of knowledgeable compounding pharmacists is available to answer any questions and provide guidance on the use of this formulation. If you have any questions or require further information, please do not hesitate to reach out to us.

Drug Interactions

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The formulation containing Estradiol 0.16 mg, Estriol 0.64 mg, and Progesterone 12.5 mg in oral capsules is a hormone replacement therapy (HRT) primarily used to treat symptoms of menopause such as hot flashes, vaginal dryness, and osteoporosis prevention. It is important to consider potential drug interactions when prescribing or taking this medication.

Estradiol and estriol are forms of estrogen, and progesterone is a progestin. These hormones can interact with a variety of medications. For instance, certain enzyme inducers such as carbamazepine, phenytoin, and St. John's Wort can increase the metabolism of estrogens and progestins, potentially reducing their effectiveness. Conversely, enzyme inhibitors like ketoconazole, itraconazole, and ritonavir may increase the levels of hormones and the risk of side effects.

Thyroid function tests may be altered by the use of estrogens and monitoring is advised for patients on thyroid hormone replacement therapy. Estrogens can also potentiate the effects of corticosteroids, so dosage adjustments may be necessary. Patients taking anticoagulants like warfarin should be closely monitored as estrogens can affect coagulation parameters. Additionally, estrogens may reduce the clearance of certain benzodiazepines and tricyclic antidepressants, leading to increased effects or side effects of these drugs.

Progesterone can interact with benzodiazepines that are metabolized by the liver, such as lorazepam, leading to increased sedative effects. It can also interact with certain antifungal medications, increasing the risk of liver enzyme elevations. Progesterone's metabolism may be affected by inhibitors of CYP3A4, such as erythromycin or clarithromycin, potentially leading to increased progesterone levels and side effects.

It is also important to note that smoking can decrease the effectiveness of this hormone therapy and increase the risk of cardiovascular side effects. Patients should be advised to avoid smoking while taking this medication. Additionally, concurrent use with other hormonal therapies, such as oral contraceptives, should be approached with caution and under the guidance of a healthcare provider.

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 safe and effective use of this HRT formulation. If you have any questions or concerns regarding potential drug interactions with this formulation, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 12.5 mg Oral Capsules are a form of hormone replacement therapy (HRT) that combines two estrogens, estradiol and estriol, with progesterone. This medication is specifically compounded to address the hormonal imbalances or deficiencies that may occur during menopause or other hormonal disturbances. The capsules are a solid dosage form, consisting of two halves of either gelatin or vegetarian material that are sealed together to enclose the powdered hormones. This design ensures that patients receive a consistent and precise dose of each hormone with each capsule.

Estradiol is a form of estrogen, a hormone produced by the ovaries, which is responsible for the development and maintenance of female reproductive tissues and secondary sexual characteristics. It also has important functions in many other systems of the body, including the cardiovascular and skeletal systems. Estriol is another form of estrogen, which is considered to be weaker than estradiol but still plays a role in supporting menopausal symptoms. The combination of estradiol and estriol in this formulation aims to provide a balanced estrogenic effect, which can alleviate symptoms such as hot flashes, vaginal dryness, and mood swings.

Progesterone is included in the formulation to counterbalance the effects of estrogen. In a woman's body, progesterone is produced after ovulation by the corpus luteum and plays a key role in regulating the menstrual cycle and supporting early stages of pregnancy. When used in combination with estrogen in postmenopausal women, progesterone can help prevent the overgrowth of the lining of the uterus (endometrial hyperplasia) that can occur with estrogen therapy alone, thereby reducing the risk of endometrial cancer.

This particular combination of hormones is often prescribed for women who are experiencing symptoms of menopause or who have had a hysterectomy and are in need of hormone replacement. The precise dosing and the combination of estrogens with progesterone mimic the body's natural hormonal rhythms, aiming to restore balance and provide relief from menopausal symptoms while minimizing potential risks associated with HRT.

It is important for patients and prescribers to understand that hormone therapy should be tailored to an individual's specific needs and health profile. Regular monitoring and adjustments may be necessary to ensure the best therapeutic outcomes. If you have any questions or require further information about this formulation and its use in treating hormonal imbalances or menopausal symptoms, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support.

Other Uses

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The Estradiol 0.16 mg/Estriol 0.64 mg/Progesterone 12.5 mg oral capsules you mentioned are primarily indicated for use in hormone replacement therapy (HRT) in peri-menopausal or menopausal women. Specifically, they are often prescribed to help alleviate symptoms such as hot flashes, night sweats, and vaginal dryness, while also aiming to prevent bone loss that can occur rapidly in the first few years after menopause. However, beyond their application in treating menopausal symptoms, this particular combination of hormones may be utilized off-label for additional purposes as decided by the prescribing healthcare provider based on individual patient needs.

Some women suffering from premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) may also benefit from the use of these hormone capsules. Progesterone, in particular, can play a role in balancing the effects of estrogen and may help alleviate some of the mood-related symptoms associated with these conditions. Furthermore, patients with irregular menstrual cycles or estrogen dominance might find symptom relief through a controlled dosage of hormones found in this formulation.

In selected cases, the combination of estradiol, estriol, and progesterone may also support skin health, as estrogen has been known to have a beneficial impact on collagen production and skin elasticity. These effects, however, are secondary and should not be the primary indication for the use of this medication. It's always important to note that the use of hormone therapy should be individualized and closely monitored by a healthcare provider, considering the potential risks and benefits associated with prolonged hormone exposure.

This oral capsule format is designed for ease of administration and consistent dosing. The encapsulation in either gelatin or vegetarian capsules helps to ensure the stability of the hormones and assists in the proper absorption of the medication. As with all medications, proper storage and handling of these hormone capsules are essential to maintain their efficacy.

Patients or prescribers considering the use of this formulation for indications other than those officially approved should do so only under the guidance and strict supervision of a healthcare provider knowledgeable in hormone therapy. If you have any questions about this formulation or its potential uses, we at Bayview Pharmacy would be more than happy to provide additional information and support.

Frequently Asked Questions

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What is the composition of Estradiol/Estriol/Progesterone oral capsules?

The capsules are a compounded formulation containing 0.16 mg of Estradiol, 0.64 mg of Estriol, and 12.5 mg of Progesterone in each capsule.

What is the purpose of the different hormones in this compounded capsule?

Estradiol and Estriol are forms of estrogen used for hormone replacement therapy, while Progesterone is a natural progestogen, all of which work together to help balance hormones in the body, especially during menopause or for other hormone-related issues.

How should these oral capsules be stored?

These medications should be stored at room temperature away from light and moisture. Keep the bottle tightly closed when not in use, and keep out of reach of children and pets.

Are these capsules safe for everyone?

Compounded hormone therapies are not suitable for everyone. Use should be individualized and discussed with a healthcare provider, who will consider your medical history and the potential risks and benefits of treatment.

How are these capsules taken?

These capsules should be taken orally with a full glass of water, usually as directed by your healthcare provider. It is important not to alter the dosage or frequency without consulting your doctor.

Can these capsules be opened or chewed?

No, the capsules should not be opened, chewed or crushed. They are designed to be swallowed whole to ensure that the medication is released at the correct rate and at the correct location in the digestive system.

What are the potential side effects of taking this compounded medication?

Possible side effects may include nausea, headache, breast tenderness, or spotting. If you experience any severe side effects or symptoms of an allergic reaction, contact your healthcare provider immediately.

Is it possible to have an allergic reaction to this medication?

Yes, an allergic reaction is possible. If you notice symptoms such as rash, itching, severe dizziness, or trouble breathing, seek medical attention promptly.

What should I do if I miss a dose?

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

Are these capsules gluten-free?

Compounded medications can be made with gluten-free ingredients. However, you should confirm with your pharmacist that the specific capsules you will receive are free from gluten and any other allergen that may concern you.

Can the dosage of Estradiol/Estriol/Progesterone be adjusted?

Yes, the dosage of these hormones can be adjusted, but any changes should be made under the supervision of your healthcare provider based on your treatment needs and response to therapy.

Can I take these capsules with other medications?

You should discuss all medications, including prescription drugs, over-the-counter medications, and herbal supplements, with your healthcare provider to ensure that there are no interactions with this compounded hormone therapy.

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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.