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Estradiol 0.625 mg/ml Vaginal Cream

FDA-approved generic
Dose form
Vaginal Cream
Active ingredients
Estradiol

The Estradiol 0.625 mg/ml Vaginal Cream is a semisolid formulation, compounded for ease of application within the vaginal area. Packaged in a tube, this cream allows for accurate dosing and is specifically designed to deliver estradiol, a form of estrogen, directly to the site of action. This topical hormone replacement therapy is primarily used to treat symptoms associated with menopause, such as vaginal atrophy, dryness, itching, and burning. Additionally, it may be prescribed to manage conditions like kraurosis vulvae and to provide supplemental hormonal support in cases of estrogen deficiency.

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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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Requires a prescription from your own provider. Bayview is a pharmacy and does not prescribe.
Ships within 1 to 2 business days after pharmacist verification
HSA and FSA eligible
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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.

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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
Vaginal Cream
655e9555c9fdb664fc7c6cd0
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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Estradiol 0.625 mg/ml Vaginal Cream is a specially compounded semisolid formulation intended for vaginal administration. This cream is designed to deliver a consistent dose of estradiol, which is a form of estrogen, a hormone that plays a vital role in the female reproductive system. The cream is dispensed in a tube, which allows for convenient, clean, and precise application. The dosage form ensures that the medication is directly applied to the affected area, providing localized relief and treatment.

The estradiol vaginal cream is primarily used to treat symptoms associated with menopause, such as vaginal atrophy, dryness, itching, burning, and pain during intercourse. These symptoms occur due to the natural decline in estrogen levels as women age. By delivering estradiol directly to the vaginal tissue, the cream helps to replenish estrogen levels in the local area, promoting tissue regeneration, increasing lubrication, and maintaining the health of the vaginal mucosa. This can lead to a significant reduction in both the severity of symptoms and the discomfort associated with vaginal atrophy and dryness.

In addition to treating menopausal symptoms, estradiol vaginal cream may also be used in the management of certain gynecological conditions that are responsive to hormone therapy. It is important for prescribers to consider the individual needs of the patient, including their medical history and any potential risks associated with hormone therapy. Patients should be advised on the proper use of the cream, including the frequency and duration of treatment as prescribed by their healthcare provider.

It is essential for patients to understand that while estradiol vaginal cream can provide significant relief from menopausal symptoms, it may also carry risks similar to those associated with systemic hormone replacement therapy, such as an increased risk of blood clots, stroke, or breast cancer. Regular follow-ups with the healthcare provider are recommended to assess the efficacy and safety of the treatment.

For any questions or concerns regarding the use of Estradiol 0.625 mg/ml Vaginal Cream, or to discuss individualized treatment options, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing comprehensive support and guidance to both patients and prescribers to ensure the safe and appropriate use of compounded medications.

Drug Interactions

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Estradiol is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body. Estradiol vaginal cream is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol can also help to protect against osteoporosis. However, when prescribing this medication, it is important to consider potential drug interactions that may affect the efficacy of the treatment or cause adverse effects.

One of the primary concerns with estradiol is its interaction with enzyme inducers. Medications that induce liver enzymes, particularly cytochrome P450 enzymes, can increase the metabolism of estradiol, leading to reduced effectiveness. Examples of these drugs include some anticonvulsants like phenytoin and carbamazepine, and some anti-infectives like rifampicin. Patients using these medications may require a higher dose of estradiol for efficacy.

Conversely, drugs that inhibit cytochrome P450 enzymes can lead to increased levels of estradiol and potentially increase the risk of side effects. For example, certain antifungals (such as ketoconazole) and some antibiotics (like erythromycin) can inhibit the metabolism of estradiol. It is important to monitor patients for signs of estrogen excess and adjust the estradiol dose as necessary when these drugs are co-administered.

Thyroid hormone replacement therapy may also interact with estradiol. Estrogens may increase the 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, particularly warfarin, should be closely monitored as estrogen therapy can increase the risk of venous thromboembolism. Estrogens can also affect the anticoagulant's effectiveness, necessitating adjustments in the anticoagulant dosage.

Additionally, the concurrent use of other hormonal therapies, such as progestins or hormone replacement therapy, should be carefully considered as they can alter the effects of estradiol and may increase the risk of endometrial hyperplasia in women with an intact uterus. It is important to evaluate the risk-benefit ratio in each patient.

Grapefruit juice may increase plasma concentrations of estrogens and should be consumed with caution by patients being treated with estradiol. Patients should be advised to discuss their dietary habits with their healthcare provider to ensure there are no interactions with their medications.

It is also important to note that smoking can reduce the effectiveness of estradiol, as it increases the metabolism of estrogen in the liver. Patients who smoke may require a higher dose of estradiol for the same therapeutic effect.

Lastly, over-the-counter supplements and herbal products can also interact with estradiol. For example, St. John's Wort may reduce the effectiveness of estradiol by increasing its metabolism. Patients should be encouraged to inform their healthcare provider of all over-the-counter products they are taking.

Due to the complexity of drug interactions with estradiol, it is crucial for prescribers to thoroughly review the patient's current medication list, including over-the-counter drugs and supplements, before prescribing estradiol vaginal cream. Pharmacists can play a key role in identifying potential drug interactions and advising on appropriate management strategies. If you have any questions or require further information, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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Estradiol 0.625 mg/ml Vaginal Cream is a hormone replacement therapy specifically formulated to alleviate symptoms associated with menopause and other hormonal imbalances. Estradiol, the active ingredient, is a form of estrogen, a female hormone that regulates many processes in the body. As women approach menopause, their bodies produce less estrogen, which can lead to various symptoms such as vaginal dryness, itching, burning, and irritation. Additionally, low estrogen levels can contribute to the thinning of the vaginal walls, a condition known as vaginal atrophy or atrophic vaginitis.

The mechanism of action of estradiol vaginal cream involves the replenishment of estrogen levels locally within the vaginal tissue. When applied as directed, the cream releases estradiol, which is then absorbed through the vaginal walls into the surrounding tissues. This localized application allows for a direct therapeutic effect, targeting the area of discomfort and symptomatology without significantly increasing estrogen levels throughout the rest of the body. This is particularly beneficial for patients who may be concerned about the risks associated with systemic hormone replacement therapy.

The estradiol in the cream works by binding to estrogen receptors in the vaginal cells, thereby stimulating the normal growth and development of the vaginal tissue. It helps to restore the natural thickness and elasticity of the vaginal walls and increases vaginal lubrication. This can significantly reduce the symptoms of vaginal atrophy, providing relief from discomfort and improving the quality of life. Additionally, the cream can help maintain the natural acidity of the vagina, which is important for preventing infections.

The semisolid formulation of the cream is designed for ease of application. The cream is typically dispensed in a tube, often accompanied by an applicator that allows for precise dosing. Patients are instructed on how to use the applicator to insert the correct dose of cream into the vagina, usually once daily for a specified period, followed by a maintenance schedule as prescribed by their healthcare provider.

Regular follow-ups and monitoring are recommended to assess the effectiveness of the treatment and to check for any side effects or contraindications.

If you have any questions about the Estradiol 0.625 mg/ml Vaginal Cream or its use in treating specific gynecological conditions, 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 ensure appropriate treatment.

Frequently Asked Questions

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What is Estradiol 0.625 mg/ml Vaginal Cream used for?

Estradiol vaginal cream is used to treat menopausal symptoms such as vaginal dryness, itching, and burning. It works by providing a source of estrogen, which is often reduced during menopause, to improve the health and function of vaginal tissues.

How do I properly apply Estradiol Vaginal Cream?

Wash your hands thoroughly before application. Squeeze the prescribed amount of cream onto the applicator and insert it gently into the vagina, usually at bedtime as directed by your healthcare provider. Follow the specific instructions provided with your prescription for proper application.

How often should I use Estradiol Vaginal Cream?

The frequency of use for Estradiol Vaginal Cream will be determined by your healthcare provider. Always follow the prescribed treatment regimen, which is typically once daily for the first few weeks, then reduced to one to three times a week thereafter.

What side effects may I experience when using this medication?

Common side effects include local vaginal irritation or itching, increased vaginal discharge, and mild genital burning. Inform your healthcare provider if you experience any severe side effects or if symptoms persist or worsen.

Can I use Estradiol Vaginal Cream if I am pregnant or breastfeeding?

Estradiol Vaginal Cream is not recommended for use during pregnancy or while breastfeeding. If you are pregnant, planning to become pregnant, or breastfeeding, consult with your healthcare provider for alternative treatments.

Can Estradiol Vaginal Cream affect my sex life?

While it's designed to relieve symptoms of vaginal dryness and discomfort, it can sometimes cause changes in sexual sensation or libido. If you notice any changes, discuss them with your healthcare provider.

Should I be aware of any interactions with other medications?

Yes, Estradiol Vaginal Cream can interact with other medications. It is essential to inform your healthcare provider about all the medications you're currently taking, including over-the-counter drugs and herbal supplements, to avoid potential interactions.

How should Estradiol Vaginal Cream be stored?

Store the cream at room temperature, away from heat and direct light. Do not freeze it. Keep the tube tightly closed and out of reach of children and pets.

What should I do if I miss a dose of Estradiol Vaginal Cream?

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

Is there an expiration date for Estradiol Vaginal Cream?

Yes, like most medications, Estradiol Vaginal Cream has an expiration date. Do not use the cream past the expiration date marked on the tube. Expired medication may be less effective and, in some cases, unsafe to use.

Are there any other precautions I should take while using this medication?

When using Estradiol Vaginal Cream, avoid using other vaginal products without your healthcare provider's approval, as they may alter the effectiveness or increase the risk of side effects. Also, inform your healthcare provider if you have a history of hormone-sensitive conditions or are undergoing any surgeries.

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.

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 0.625 mg/ml Vaginal Cream
Vaginal Cream
30 g
controlled

Insert/apply intravaginally

Twice weekly