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Formulas

Estradiol 0.4 mg/g/Estriol 1.6 mg/g Topical Cream

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

The Estradiol 0.4 mg/g/Estriol 1.6 mg/g Topical Cream is a compounded medication that combines two forms of estrogen, estradiol and estriol, in a semisolid dosage form. This cream is specifically designed to be dispensed from a pump mechanism, which allows for easy, controlled 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 commonly 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 hormone replacement therapy in postmenopausal women. The combination of estradiol and estriol in this cream aims to provide a balanced approach to estrogen therapy, potentially offering benefits in terms of efficacy and safety.

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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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This medication requires a prescription from your doctor

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
655ec4692efdc5853196d2cd

Formula Information

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The Estradiol 0.4 mg/g/Estriol 1.6 mg/g 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 body. 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 replacement therapy (HRT). This formulation is often used to manage symptoms associated with menopause, such as hot flashes, vaginal dryness, and atrophy, as well as to support skin elasticity and thickness. It may also be used in certain cases of estrogen deficiency or as part of a broader hormone replacement strategy.

The topical route of administration offers several advantages, including the ability to apply the hormone directly to the affected area, potentially reducing systemic side effects and first-pass metabolism by the liver. The cream base also provides a moisturizing effect, which can be beneficial for skin health and comfort. The pump mechanism ensures that each dose is consistent, which is crucial for maintaining the desired hormone levels and therapeutic effect.

It is important for both patients and prescribers to understand that this is a compounded medication, which means it is made to order based on individual patient needs and specifications. As such, it should be used under the guidance of a healthcare professional who can tailor the treatment to the patient's specific condition and monitor their response to therapy. Patients should follow the application instructions provided by their healthcare provider or pharmacist and report any adverse effects or concerns during treatment.

For more detailed information about this formulation, or if you have any questions regarding its use, potential side effects, or compatibility with other medications, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing personalized care and support to ensure the best possible outcomes for our patients.

Drug Interactions

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The estradiol 0.4 mg/g and estriol 1.6 mg/g topical cream is a hormone replacement therapy primarily used to alleviate symptoms associated with menopause, such as hot flashes, vaginal dryness, and osteoporosis prevention. When considering drug interactions, it is important to note that the active ingredients, estradiol and estriol, are forms of estrogen. Estrogens can interact with a variety of medications, potentially altering their effects or increasing the risk of adverse reactions.

One significant interaction is with blood thinners, such as warfarin. Estrogens can increase the risk of blood clots, potentially reducing the effectiveness of anticoagulants. Patients on blood thinners should be closely monitored for changes in their coagulation parameters, and dosage adjustments may be necessary. Additionally, estrogens can affect the metabolism of certain drugs processed by liver enzymes, particularly cytochrome P450 enzymes. This can lead to either increased or decreased levels of these drugs in the body, which may require dosage adjustments.

Estrogens can also interact with thyroid hormone replacement therapy. They may increase the amount of thyroid-binding globulin, which can reduce the amount of thyroid hormone available in the body. Patients on thyroid replacement therapy may require monitoring of thyroid function tests and potential dosage adjustments of their thyroid medication. Furthermore, estrogens can reduce the clearance of corticosteroids, potentially leading to increased effects or side effects of corticosteroids.

Grapefruit juice can increase the concentration of estrogens in the body by inhibiting certain enzymes responsible for their metabolism. Patients should be advised to avoid grapefruit and grapefruit juice while using this topical cream. Additionally, smoking can reduce the effectiveness of estrogen therapy and increase the risk of cardiovascular side effects. Patients are strongly advised to quit smoking if they are using estrogen-containing products.

It is also important to consider the potential interaction with other topical products. The application site should be clean and free from any other creams, lotions, or oils that could alter the absorption of the hormones. Patients should wait a reasonable amount of time before applying other products to the same area to ensure proper absorption of the hormones.

Lastly, patients should be aware that certain herbal products and over-the-counter supplements, such as St. John's Wort, can also interact with estrogens, potentially reducing their effectiveness or increasing side effects. It is crucial for patients to inform their healthcare provider of all medications, supplements, and herbal products they are using.

This formulation is designed for localized treatment, and while systemic absorption can occur, the extent of interactions may differ from those seen with oral or systemic hormone replacement therapies. However, caution should still be exercised, and healthcare providers should be consulted before starting any new medications or supplements. If you have any questions or concerns about potential drug interactions with this estradiol/estriol topical cream, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The Estradiol 0.4 mg/g/Estriol 1.6 mg/g Topical Cream is a compounded medication that combines two forms of estrogen, estradiol and estriol, in a cream base for topical application. Estradiol is a potent form of estrogen, the primary female sex hormone, and estriol is a weaker form of estrogen. When applied to the skin, this cream delivers a consistent dose of these hormones directly to the affected area, allowing for localized treatment.

The mechanism of action for this cream involves the absorption of estradiol and estriol through the skin and into the local tissue. Once absorbed, these hormones bind to estrogen receptors in the cells, which can influence gene expression and result in various physiological effects. For example, in the treatment of menopausal symptoms such as vaginal atrophy or dryness, the estrogens can help to restore the thickness and elasticity of the vaginal tissue by promoting cell growth and increasing blood flow. This can alleviate symptoms such as dryness, itching, and discomfort during intercourse.

In addition to local effects, a small amount of the hormones may enter the systemic circulation. However, the primary intention of this formulation is to minimize systemic exposure and focus on local relief. The cream is designed to be used with a pump mechanism, which dispenses a controlled amount of the product with each use. This ensures consistent dosing and helps to prevent overuse of the medication. The semisolid preparation is formulated to spread easily on the skin, enhancing the absorption of the active ingredients.

This topical hormone therapy can be used to treat various conditions associated with estrogen deficiency, such as atrophic vaginitis, vulvar atrophy, and some cases of lichen sclerosus. It may also be used as part of hormone replacement therapy (HRT) for menopausal symptoms. The combination of estradiol and estriol aims to provide the benefits of estrogen replacement while potentially reducing the risks associated with the use of a single estrogen type.

It is important for patients and prescribers to understand that the use of any hormone therapy should be based on a thorough evaluation of the individual's health history, current symptoms, and risk factors. The formulation and dosing of this cream can be customized by the compounding pharmacist to meet the specific needs of the patient. 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 knowledgeable compounding pharmacists is here to assist you.

Other Uses

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The topical cream formulation containing Estradiol 0.4 mg/g and Estriol 1.6 mg/g that is dispensed in a pump mechanism has been primarily compounded for the use of hormonal replacement therapy, particularly designed to address menopausal symptoms such as hot flashes, vaginal atrophy, and vulvar atrophic changes. However, aside from these primary indications, there are other potential therapeutic benefits and off-label uses for this unique hormone combination in topical administration.

In addition to relieving menopausal symptoms, this bioidentical hormone therapy formulation may be utilized as an adjunct to improve skin elasticity, thickness, and hydration, which can potentially reduce the appearance of fine lines and wrinkles. As such, it might offer cosmetic benefits for postmenopausal women seeking treatments for age-related skin changes. Furthermore, the topical route minimizes systemic absorption when compared to oral administration, which may be of particular interest to patients and prescribers who are concerned with the risks associated with systemic hormone therapy.

Other investigative uses, although less common and requiring further research, could include the management of localized symptoms of estrogen deficiency in premenopausal women who have certain conditions leading to hypoestrogenism. The formulation might also be considered in the supportive management of breast cancer survivors, for whom systemic hormone replacement therapy is contraindicated, but who suffer from severe urogenital atrophy. These patients should be closely monitored for any signs of adverse effects, particularly concerning the risk of cancer recurrence.

It is crucial to note that any off-label or secondary uses of this formulation should be approved by a healthcare provider, and based on an individual patient’s needs and risk assessment. Prescribers and patients must closely discuss the benefits and risks, as well as the available scientific evidence, before considering the use of this hormone cream for any other than its intended indication. Varying dosages and regimens may need to be tailored to suit individual conditions and preferences.

Because this is a specialized medication, Bayview Pharmacy’s compounding team ensures that each preparation meets the highest standards for quality and safety. Our team remains available for consultation with both patients and healthcare providers to answer questions regarding the formulation, potential uses, and to provide guidance on its appropriate application. Should you have any questions regarding the uses of this Estradiol and Estriol compound cream or require further information, please do not hesitate to reach out to us.

Frequently Asked Questions

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What is Estradiol/Estriol Topical Cream used for?

Estradiol/Estriol Topical Cream is a compounded formulation used for hormone replacement therapy. It may help alleviate symptoms associated with menopause or hormonal imbalance, such as hot flashes, vaginal dryness, and osteoporosis prevention. Always consult your healthcare provider for personalized advice and treatment.

How do I use this topical hormone cream?

Apply the Estradiol/Estriol Topical Cream as directed by your healthcare provider. Generally, a small amount of cream is applied to the skin, using the pump mechanism to ensure a controlled dose. The exact application site and regimen will depend on the individual treatment plan provided by your physician.

Can I apply makeup over the cream?

It is usually safe to apply makeup over the treated area, but it is best to wait until the cream has fully absorbed into the skin to prevent alteration of the cream's effects or consistency. Consult your healthcare provider for specific instructions regarding makeup use.

Where should I apply the cream on my body?

The application site for Estradiol/Estriol Topical Cream can vary depending on your specific treatment plan. Common sites include the arms, thighs, or stomach area, but avoid applying the cream directly to the breasts or face unless instructed by your doctor.

How do I store the Estradiol/Estriol Topical Cream?

Store your Estradiol/Estriol Topical Cream at room temperature, away from direct sunlight and heat. Keep the container tightly closed when not in use. Make sure to keep this medication out of reach of children and pets.

Are there any side effects associated with this cream?

As with any medication, there may be potential side effects. Common side effects include local irritation, redness, or itching at the application site. If you experience any severe side effects or signs of an allergic reaction, contact your physician immediately.

Can I bathe or swim after applying the cream?

It is advisable to allow the cream to absorb fully into the skin before bathing or swimming. Typically, you should wait at least one hour before getting the treated area wet. Follow your healthcare provider's guidance for your specific circumstances.

How long will it take to notice the effects of the cream?

The time it takes for the Estradiol/Estriol Topical Cream to show effects can vary from person to person. Generally, it might take several weeks of consistent use to notice an improvement in symptoms. Consult with your healthcare provider to discuss what to expect.

Can the Estradiol/Estriol Topical Cream affect other medications I am taking?

It is possible for the Estradiol/Estriol Topical Cream to interact with other medications. Always inform your doctor of all the medications and supplements you are taking to ensure there are no detrimental interactions.

What should I do if I miss a dose?

If you miss a dose of the Estradiol/Estriol Topical Cream, apply it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply extra cream to make up for the missed dose.

Is this cream suitable for everyone?

Not everyone is a suitable candidate for Estradiol/Estriol Topical Cream. Certain medical conditions or a history of hormone-sensitive tumors may contraindicate its use. Always consult your healthcare provider to ensure it is safe and appropriate for your specific health needs.

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 0.4 mg/g/Estriol 1.6 mg/g Topical Cream
Topical Cream
30 g
controlled

Apply topically to affected area(s)