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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.
DHEA (prasterone) is an adrenal steroid hormone precursor that compounding pharmacies prepare as capsules, vaginal inserts, creams and other forms by prescription.
DHEA, or dehydroepiandrosterone, is a steroid hormone made mostly by the adrenal glands, with smaller amounts from the ovaries, testes, skin and brain. It is a precursor: tissues convert it into androgens such as testosterone and estrogens as they need them. Levels peak in early adulthood and decline with age, falling to a small fraction of young-adult levels by the eighth decade. In the United States, DHEA sold over the counter is classified as a dietary supplement. The only FDA-approved prescription drug containing it is Intrarosa (prasterone) vaginal insert, approved for moderate to severe dyspareunia due to menopausal vulvar and vaginal atrophy. A prescriber may order DHEA compounded when a patient needs an oral strength, a cream, a different vaginal base, or a combination that is not manufactured. Compounded DHEA preparations are not FDA-approved and require a prescription.
The Intrarosa label carries no boxed warning. Because the body converts DHEA into estrogen, the label notes that exogenous estrogen is contraindicated in women with known or suspected breast cancer, and that Intrarosa has not been studied in women with a history of breast cancer. Undiagnosed abnormal genital bleeding is a contraindication and should be evaluated before treatment. In published trials of oral DHEA, women reported mild androgenic effects such as acne, oily skin and facial hair, and long-term safety data are lacking. Intrarosa is indicated only in postmenopausal women; there are no data in pregnancy and no information on whether prasterone is present in human milk. The label has no drug interaction section, so review every medicine and supplement with your pharmacist. The most common side effect of the insert in trials was vaginal discharge. If you notice unexpected bleeding, breast changes, or any side effect that worries you, talk to your prescriber or pharmacist.
Prasterone (DHEA) is an inactive endogenous C19 steroid converted by tissue steroidogenic enzymes into active androgens and estrogens; the exact mechanism in vulvovaginal atrophy is not fully established. With the vaginal insert, once-daily dosing for 7 days raised serum prasterone above placebo while serum testosterone and estradiol were only slightly higher than placebo, consistent with largely local conversion. Oral and transdermal DHEA in published studies were generally well tolerated across a wide dose range, but many over-the-counter products lack pharmacokinetic data. The labeled indication is moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause (Intrarosa). Prescribers have ordered compounded DHEA for age-related decline in DHEA, with studied endpoints including muscle, bone density, cardiovascular markers, sexual function and mood (Samaras et al., Rejuvenation Research 2013); the authors note trials are small and short. Dosing and monitoring are per prescriber. DHEA is not a federally controlled substance; the federal definition of anabolic steroid (21 U.S.C. 802(41)(A)) expressly excludes dehydroepiandrosterone.
Wash your hands. If the suppository is soft, chill it in its wrapper in the refrigerator or under cool water for a few minutes, then unwrap it. For rectal use, coat the tip with a water-soluble lubricant (not petroleum jelly), lie on your side with your upper knee bent, and insert it pointed end first past the muscle at the opening. For vaginal use, lie on your back with knees bent and insert it as far as it comfortably goes, by finger or applicator; bedtime use limits leakage, and a panty liner protects clothing. Stay lying down about 15 minutes. Wash your hands.
Suppositories are nonaqueous, so under USP <795> they can carry a beyond-use date of up to 180 days at controlled room temperature or in the refrigerator when no other stability data apply. Storage depends on the base: fatty bases can soften at room temperature and may be labeled for the refrigerator, while polyethylene glycol bases usually do not need refrigeration. Keep them cool so they do not melt, and refrigerate them if your label says to.
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.
Insert 1 unwrapped suppository
