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Estradiol 0.125 mg/Estriol 0.5 mg/ml Topical Cream

FDA-approved generic
Dose form
Topical Cream
Active ingredients
Estradiol
Estriol

The Estradiol 0.125 mg/Estriol 0.5 mg/ml Topical Cream is a compounded semisolid preparation that combines two forms of estrogen, estradiol and estriol, in a carefully measured concentration. This cream is designed to be dispensed from a pump mechanism, which allows for convenient, controlled, and consistent application to the skin. The formulation is intended for localized treatment and is absorbed through the skin to deliver the active ingredients directly to the affected area.

This topical cream is primarily used in the management of menopausal symptoms such as hot flashes, vaginal dryness, and atrophy. Additionally, it may be prescribed for conditions that result from estrogen deficiency or for the maintenance of skin elasticity and health. The combination of estradiol and estriol in this formulation aims to provide a balanced approach to hormone replacement therapy, leveraging the benefits of both estrogens while minimizing potential risks associated with estrogen therapy.

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For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription detailsOrder form
Controlled substance: e-prescribe (EPCS) from your EHR. Faxed and phoned prescriptions cannot be accepted for this preparation.
Send it from your EHR, or fax to (401) 284-4506. How to e-prescribe this formula
Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
To prescribe, you must be a verified prescriber.
To prescribe, you must be in a state where we hold an active out-of-state pharmacy license.
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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.

For prescribersSign in for prescription details and order forms.
Compounded preparations are prepared by Bayview pursuant to a prescription for an individual patient. They are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Estradiol
Estriol
Topical Cream
655ec51566cc1b4bc6552c16
Service area

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Bayview fills prescriptions for patients in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, Pennsylvania and Rhode Island. New York patients are served on a limited basis while nonresident pharmacy registration is pending.

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Formula Information

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The Estradiol 0.125 mg/Estriol 0.5 mg/ml Topical Cream is a compounded medication that combines two forms of estrogen, estradiol and estriol, in a semisolid cream base. This preparation is specifically designed to be dispensed from a pump mechanism, which allows for precise dosing and ease of application. The cream is intended for topical use, where it can be applied directly to the skin, providing localized treatment or facilitating the systemic absorption of the active ingredients.

Estradiol is a potent form of estrogen, the primary female sex hormone, and is identical to the hormone produced by the human ovaries. Estriol, on the other hand, is a weaker estrogen that is produced in significant amounts during pregnancy. The combination of these two estrogens in a topical cream allows for a balanced approach to hormone therapy, aiming to alleviate symptoms associated with estrogen deficiency or hormonal imbalances. This can include menopausal symptoms such as hot flashes, vaginal dryness, and osteoporosis prevention. Additionally, the topical route of administration may reduce the risk of systemic side effects and complications associated with oral hormone therapies.

The cream's formulation is designed to optimize the absorption of estradiol and estriol through the skin, ensuring that the hormones are delivered directly to the bloodstream, bypassing the gastrointestinal tract and liver, which can metabolize and alter the hormones. This can result in a more consistent therapeutic effect and improved patient outcomes. The pump mechanism also minimizes the risk of contamination and ensures that each dose is consistent, which is crucial for maintaining the correct hormone levels in the body.

Patients and prescribers considering this formulation should be aware that hormone replacement therapy (HRT) with estrogens, with or without a progestin, should be used at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be regularly evaluated for their need for HRT. It is also important to consider the contraindications and potential risks associated with estrogen therapy, including but not limited to cardiovascular disease, thromboembolic disorders, and certain types of cancers.

For those interested in this customized hormone therapy, Bayview Pharmacy's team of compounding pharmacists can provide additional information and guidance. We are equipped to answer any questions regarding the formulation, its administration, and its role in managing specific disease states. Our goal is to ensure that both patients and prescribers are fully informed and confident in the use of this compounded medication. If you have any questions or require further assistance, please do not hesitate to reach out to us.

Drug Interactions

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The estradiol and estriol topical cream is a hormone replacement therapy primarily used to alleviate symptoms associated with menopause, such as hot flashes, vaginal dryness, and atrophy. It may also be used for other conditions as determined by a healthcare provider. When considering drug interactions, it is important to understand that while the topical route of administration may reduce systemic exposure compared to oral forms, there is still potential for systemic absorption and interaction with other medications.

One key interaction to be aware of is with drugs that induce or inhibit hepatic enzymes, particularly cytochrome P450 enzymes such as CYP3A4. Medications that induce these enzymes, such as certain anticonvulsants (e.g., phenytoin, carbamazepine) and antibiotics (e.g., rifampicin), may decrease the effectiveness of estradiol and estriol by increasing their metabolism. Conversely, inhibitors of these enzymes, such as some antifungals (e.g., ketoconazole) and certain protease inhibitors used in HIV treatment, may increase the levels of hormones and the risk of side effects.

Thyroid function may also be affected by the use of estradiol and estriol. 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 on thyroid replacement therapy may require higher doses of thyroid hormone.

Patients taking anticoagulants, such as warfarin, should be monitored closely as estrogens can increase the effects of oral anticoagulants. Adjustments in the anticoagulant dosage may be necessary when estrogen therapy is initiated or discontinued. Additionally, estrogens may interfere with the metabolism of other compounds. Increased plasma concentrations of corticosteroids, for example, have been observed in women receiving estrogens.

It is also important to consider the potential for additive effects when used concurrently with other medications that have similar side effects or actions. For example, concurrent use with other hormonal therapies, such as progestins or androgens, should be approached with caution and under the guidance of a healthcare provider.

Patients should be advised to inform their healthcare providers of all medications they are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins, to ensure that any potential interactions can be addressed. This is particularly important for new medications or changes in therapy.

Lastly, lifestyle factors such as smoking can also affect hormone levels and the efficacy of hormone replacement therapy. Smoking increases the metabolism of estrogens, potentially reducing their therapeutic effects and increasing the risk of certain adverse effects, such as thromboembolism.

If you have any questions or require further information regarding this formulation and its interactions with other drugs or substances, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the necessary support and guidance to ensure appropriate treatment for our patients.

How Does it Work

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The Estradiol 0.125 mg/Estriol 0.5 mg/ml Topical Cream is a hormone replacement therapy (HRT) designed to deliver a combination of estrogen hormones directly through the skin. Estradiol and estriol, the active ingredients in this formulation, are naturally occurring estrogens that play a crucial role in many processes in the female body. When applied topically, the cream is absorbed through the skin and enters the bloodstream, where it can exert its effects.

Estradiol is the most potent form of estrogen and is primarily responsible for the development and maintenance of female reproductive tissues and secondary sexual characteristics. It also has important roles in bone health, cardiovascular function, and skin integrity. Estriol, on the other hand, is a weaker estrogen that is produced in significant amounts during pregnancy. It is thought to contribute to the health of the urogenital tract and may have less impact on breast tissue and the endometrium (the lining of the uterus) compared to estradiol.

This particular formulation is used to treat symptoms associated with menopause, such as hot flashes, vaginal dryness, and atrophy, as well as to prevent osteoporosis. By combining estradiol and estriol, the cream aims to provide the benefits of estrogen replacement while potentially reducing the risks associated with estrogen therapy, such as endometrial hyperplasia (thickening of the uterine lining) when used without a progestogen in women with an intact uterus.

The cream is dispensed in a pump mechanism, which allows for precise dosing and ease of application. Patients are typically instructed to apply the cream to a clean, dry area of skin, often on the lower abdomen, thighs, or arms, depending on the prescriber's instructions.

It is important for patients and prescribers to understand that while this topical cream provides localized treatment, the hormones can still have systemic effects. Therefore, it is essential to follow the prescribed dosing regimen and to be aware of potential side effects, which may include breast tenderness, nausea, bloating, and mood swings, among others. Regular monitoring and follow-up with a healthcare provider are recommended to assess the effectiveness of the treatment and to make any necessary adjustments.

If you have any questions or require further information about this formulation and its use in treating menopausal symptoms or other hormone-related conditions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide support and guidance to ensure the safe and appropriate use of this medication.

Other Uses

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The topical cream formulation containing estradiol 0.125 mg and estriol 0.5 mg per ml is primarily used for hormone replacement therapy (HRT) to alleviate symptoms associated with menopause such as hot flashes, vaginal dryness, and osteoporosis prevention. However, its usage can extend beyond these disease states. This cream can also be considered for managing symptoms of vulvar and vaginal atrophy, providing topical estrogen to improve the health and elasticity of the local tissues, which may improve sexual function and reduce discomfort during intercourse. Additionally, in some cases, it may be used as part of the management of certain skin conditions where estrogen may play a beneficial role such as in promoting skin healing or potentially improving the quality of skin affected by aging.

In practice, this formulation could also be of interest to prescribers for off-label uses where local estrogen therapy is a reasonable consideration. It's important to note, however, that the efficacy and safety of such uses may not be as thoroughly documented as the primary indications related to menopausal symptoms. Any additional uses should be under the supervision of a qualified healthcare provider who is knowledgeable about hormone therapies. As with any prescription medication, potential risks, contraindications, and the patient's overall health profile should be taken into account by healthcare providers before initiating treatment with this medication. Monitoring for adverse effects is similarly critical, as systemic absorption of hormones, while generally lower with topical applications as compared to oral forms, could still occur and lead to unwanted side effects.

Our team at Bayview Pharmacy is keen to support both patients and prescribers in understanding the full range of potential applications for this particular estradiol and estriol topical cream. We encourage an open dialogue regarding not only the intended use of HRT for menopause-related symptoms but also any investigational or supportive roles this medication might have for other conditions. If you have any questions or require detailed information about this formulation, its potential uses, or suitable candidates for treatment, do not hesitate to reach out to us for professional advice and guidance.

Frequently Asked Questions

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What is this topical cream used for?

This topical cream is a hormone replacement therapy that contains two forms of estrogen: estradiol and estriol. It is commonly used to manage menopausal symptoms such as hot flashes, vaginal dryness, and osteoporosis prevention. It can also be used in other hormone-related treatments as prescribed by a healthcare provider.

How do I use the Estradiol/Estriol topical cream?

To use this cream, pump the prescribed amount onto your finger or directly onto the skin area as instructed by your healthcare provider. Typically, it is applied once or twice daily, or as directed by your healthcare professional. Do not apply to the face unless directed to do so by your doctor.

What are the advantages of using a pump mechanism for this cream?

The pump mechanism is designed for convenient and controlled dosing. Each pump dispenses a measured dose of cream, ensuring consistent application and minimizing the risk of dosing errors. The container also minimizes contamination and maintains the integrity of the cream.

Can I apply this cream to any area of the skin?

You should apply the cream only to the areas of your skin as instructed by your healthcare provider. Different areas of skin may absorb medications at different rates, and certain areas may be more sensitive to hormones.

Are there any side effects from using this cream?

As with any medication, there can be side effects. Common side effects include skin irritation at the site of application, headaches, breast tenderness, and nausea. If you experience any severe side effects or signs of an allergic reaction, contact your healthcare provider immediately.

Will this cream affect my clothing?

The cream may leave residue on clothing if not fully absorbed. To minimize transfer, allow the cream to fully absorb into your skin before dressing. Using an appropriate amount as prescribed by your provider will also reduce the likelihood of residue.

How should I store this cream?

Store the cream at room temperature, away from direct sunlight and heat. Do not freeze. Keep the container tightly closed when not in use. Also, keep out of reach of children and pets.

Is the Estradiol/Estriol topical cream safe to use during pregnancy?

No, this cream is generally not recommended during pregnancy or while breastfeeding. Estrogens can have harmful effects on the developing fetus or infant. Always consult your healthcare provider before starting any new medication if you are pregnant or breastfeeding.

Can I use moisturizers or other skincare products with this hormonal cream?

Generally, you can use other skincare products; however, you should wait at least a few minutes to allow the hormonal cream to be absorbed into your skin before applying other products. Consult your healthcare provider on the appropriate waiting period and order of application for best results.

What should I do if I miss a dose of the Estradiol/Estriol topical cream?

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 go back to your regular dosing schedule. Do not double doses. Contact your healthcare provider if you are unsure of what to do after a missed dose.

About this compounded preparation

This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.

The conditions listed on this page are indications prescribers have ordered this preparation for. They are not FDA-approved indications, and listing them is not a statement that this preparation is effective for them.

A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice — discuss your situation with a licensed healthcare provider.

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.
For prescribers

How to e-prescribe this formula

Controlled substance: e-prescribe only (EPCS). Faxed, phoned, and handwritten prescriptions cannot be filled. Rhode Island law (R.I. Gen. Laws § 21-28-3.18) requires Schedule II to V prescriptions to be transmitted electronically.
1

Find Bayview in your EHR's pharmacy directory

Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.

NCPDP4106882NPI1750455143Address3844 Post Rd, Warwick, RI 02886Phone(401) 284-4505Fax(401) 284-4506
2

Enter the formula as a compound

Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.

Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.

3

Copy the prescription details

RxFormula name
Dose formDose form
Quantity________
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription details

Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.

4

Send it

Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.

Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.

Do not use Notes to Pharmacy for the formula. Some EHRs keep that field internal and never transmit it. A prescription that arrives without the formula is delayed while we call your office.

Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.

Estradiol 0.125 mg/Estriol 0.5 mg/ml Topical Cream
Topical Cream
30 g
controlled

Apply topically to affected area(s)

Once daily