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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 gel containing progesterone, 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 progesterone are listed in capsule, injection, vaginal insert and vaginal gel forms.
Gel bases can be aqueous or nonaqueous, and USP <795> classifies the preparation by its water activity. Aqueous preparations carry shorter default beyond-use dates than nonaqueous ones. The date printed on the label is the one to follow.
Progesterone is a progestin hormone, manufactured as oral capsules and other products, that compounding pharmacies prepare in oral, topical, vaginal and other dosage forms.
Progesterone is a hormone made by the ovary and, during pregnancy, the placenta. It belongs to the progestin class. In plain terms, it converts the uterine lining from a growing state to a secretory state and opposes estrogen's effect on that lining. The manufactured oral capsule (Prometrium and generics) contains micronized progesterone chemically identical to ovarian progesterone and is FDA-approved to prevent endometrial hyperplasia in postmenopausal women with a uterus who are taking conjugated estrogens, and to treat secondary amenorrhea. The capsule is formulated in peanut oil. Prescribers may order progesterone compounded when they want a strength that is not manufactured, a preparation free of peanut oil or another excipient, a different base or route, or a combination with another hormone. Compounded progesterone is not FDA-approved and requires a prescription.
The manufactured capsule carries a boxed warning from the Women's Health Initiative studies: estrogen plus progestin therapy should not be used to prevent cardiovascular disease, and the combination studied raised the risk of heart attack, stroke, invasive breast cancer, blood clots, and probable dementia in women 65 and older. The capsule contains peanut oil and must not be used by people with peanut allergy. Do not use progesterone with known or suspected breast cancer, unexplained vaginal bleeding, current or past blood clots, stroke or heart attack, liver disease, or during pregnancy. Dizziness and drowsiness are common; take care when driving. CYP3A4 blockers such as ketoconazole may raise progesterone levels. LactMed reports milk levels are low and no adverse effects are expected in breastfed infants. For sudden leg or chest pain, shortness of breath, vision changes or stroke symptoms, talk to your prescriber or pharmacist.
Progesterone acts at the progesterone receptor to induce secretory transformation of an estrogen-primed endometrium; its reduced metabolites act as GABA-A receptor agonists, which accounts for the sedation seen with oral dosing. Orally, micronized progesterone reaches peak levels within about 3 hours, food increases bioavailability, it is 96 to 99 percent protein-bound to albumin and transcortin, and it undergoes extensive hepatic metabolism to pregnanediol and pregnanolone conjugates with excretion of conjugated metabolites in urine and bile. Oral progesterone undergoes extensive hepatic first-pass metabolism; in a comparative pharmacokinetic study, vaginal and oral administration of the same capsule produced different concentration profiles, with vaginal dosing giving lower peak but more sustained levels. Prometrium capsules are labeled for prevention of endometrial hyperplasia in postmenopausal women receiving conjugated estrogens and for secondary amenorrhea. The NASEM report on compounded bioidentical hormone therapy documents that prescribers have ordered compounded progesterone as creams, gels, capsules, sublingual forms and lozenges, often in combination with estrogens, and concludes that reliable bioavailability data for these preparations are lacking, which the report says makes an accurate characterization of their safety profile impossible. Dosing, cycle schedule and route per prescriber. Monitoring per label: evaluate unexplained bleeding, discontinue if a thromboembolic event or hormone-sensitive malignancy occurs, and consider stopping before surgery with prolonged immobilization. Not a controlled substance.
Wash your hands. Apply the amount on your label to clean, dry skin and spread it in a thin layer. For a metered pump, your label states the number of presses. For a dosing syringe, push the plunger to the mark. Let the gel dry before covering with clothing. Wash your hands afterward and keep the site from touching other people until it has dried. Do not apply to broken skin unless told to.
A gel can have a nonaqueous or a water-based base, and USP <795> sets its default beyond-use date by water content, not by the word gel. A nonaqueous gel usually carries a beyond-use date of up to 180 days at room temperature or refrigerated. A water-based gel carries up to 35 days with a preservative, or 14 days refrigerated without one. Your label states which applies. Keep the container closed, away from heat and open flame if it contains alcohol, out of reach of children, and discard after the beyond-use date on your label.
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)
