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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.
Prepared to a prescriber's order for one patient. Not FDA-approved.
This is a compounded topical cream containing estradiol, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
FDA-approved products containing estradiol are listed in cream, tablet, patch, gel, injection and insert forms. It is also a component of FDA-approved kits.
This dose form is water-containing (aqueous). Under USP <795>, aqueous preparations carry shorter default beyond-use dates than nonaqueous ones, and a preservative in the base allows a longer date than no preservative. The date printed on the label is the one to follow.
Estradiol is the body's main and most potent estrogen hormone, commonly compounded in topical creams and gels, vaginal creams and suppositories, and oral capsules.
Estradiol (E2) is the principal estrogen made by the ovaries and the most potent estrogen in the human body. As a steroid hormone it crosses cell membranes, binds nuclear estrogen receptors in responsive tissues and regulates gene transcription; it also feeds back on the pituitary to lower LH and FSH. Manufactured estradiol products include oral tablets, transdermal patches such as Vivelle-Dot, gels, vaginal creams such as Estrace, vaginal inserts and rings. Vivelle-Dot is FDA-approved for moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause, hypoestrogenism due to hypogonadism, castration or primary ovarian failure, and prevention of postmenopausal osteoporosis. Estrace vaginal cream is FDA-approved for vulvar and vaginal atrophy due to menopause.
A prescriber may order estradiol compounded when a patient needs a strength or vehicle that is not manufactured, a preparation free of a specific allergen, or a combination with another hormone in one vehicle. Compounded estradiol preparations are not FDA-approved and require a prescription.
FDA-approved estradiol products carry a boxed warning: estrogen alone increases the risk of endometrial cancer in women with a uterus, estrogens increase the risk of stroke and deep vein thrombosis, estrogen plus progestin increases the risk of invasive breast cancer, and estrogens increase the risk of probable dementia in women 65 and older. Estrogens should not be used to prevent heart disease or dementia and should be used at the lowest dose that relieves symptoms, for the shortest time. Federal law exempts compounded drugs from this labeling, but the warnings describe the estrogen class. Do not use estradiol if you have undiagnosed vaginal bleeding, current or past breast cancer or other estrogen-dependent cancer, active or past blood clots, stroke or heart attack, liver disease, a known clotting disorder or a known allergy to it, or if you are pregnant. Tell your prescriber or pharmacist if you take St. John's wort, rifampin, carbamazepine, ketoconazole, clarithromycin or thyroid medicine, or drink grapefruit juice. The label states estrogens pass into breast milk and can reduce milk production; LactMed reports vaginal use produces measurable amounts in milk while transdermal patches do not. Report unexpected vaginal bleeding, a breast lump, leg swelling, chest pain or sudden severe headache right away.
Estradiol is the principal and most potent endogenous estrogen. It acts through nuclear estrogen receptors in estrogen-responsive tissue and suppresses pituitary LH and FSH by negative feedback. Circulating estradiol is largely bound to SHBG and albumin, is metabolized hepatically mainly by CYP1A2 and CYP3A4, and undergoes enterohepatic recirculation. Transdermal delivery produced a half-life of roughly 6 to 8 hours in the Vivelle-Dot pharmacokinetic studies; the Estrace cream label notes that systemic absorption may occur with vaginal use, so systemic estrogen warnings apply. Compounded preparations are not routinely assessed for bioavailability, and FDA's commissioned 2020 NASEM review found a lack of rigorous evidence of safety and effectiveness for compounded bioidentical hormones.
Labeled indications: see Vivelle-Dot and Estrace above. Prescribers have ordered compounded estradiol as topical creams and gels in strengths or vehicles not manufactured, as vaginal preparations, and combined with estriol or progesterone in a single vehicle (FDA 2019 presentation on compounded bioidentical hormone therapy). Dose, route, whether to add a progestogen in a patient with a uterus, and duration are per prescriber. Monitoring per class labeling: evaluate undiagnosed bleeding, breast examination and mammography as appropriate, thyroid status on thyroid replacement, and thromboembolic symptoms. CYP3A4 inducers lower and inhibitors raise estradiol exposure. Estradiol is not a controlled substance.
Wash your hands. Apply the amount on your label to clean, dry skin and rub it in gently. For a metered pump, each press delivers a set amount; your label states how many presses. For transdermal creams, apply to the area your label names and let it dry before dressing. Wash your hands afterward and avoid skin-to-skin contact with others at the application site until it has absorbed. Do not apply to broken skin unless told to.
Creams are aqueous. Under USP <795>, a preserved cream usually carries a beyond-use date of up to 35 days at room temperature or refrigerated, and an unpreserved one 14 days refrigerated. Follow the storage line on your label, keep from freezing, keep out of reach of children, and discard after the beyond-use date.
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.
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.
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.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
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.
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.
Apply topically to affected area(s)
