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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.
Testosterone is an androgen hormone and Schedule III controlled substance, manufactured as injections, gels and other forms, and compounded in topical and other dosage forms.
Testosterone is the main androgen hormone made by the testes. With its metabolite dihydrotestosterone, it drives male sexual development and secondary sex characteristics, acting through androgen receptors in tissue. Manufactured products include transdermal gels such as AndroGel, injectable esters such as testosterone cypionate, and buccal, nasal, pellet and oral capsule forms. The gel and the cypionate injection are FDA-approved for replacement therapy in adult men with testosterone deficiency from primary hypogonadism or hypogonadotropic hypogonadism; their labels state that safety and efficacy for age-related hypogonadism have not been established. Testosterone is a Schedule III controlled substance. Prescribers may order it compounded when they want a strength, base or route that is not manufactured, a preparation without a particular excipient, or a combination with another ingredient. Compounded testosterone is not FDA-approved and requires a prescription.
The manufactured gel carries a boxed warning for secondary exposure: children who touch unwashed application sites have developed signs of early puberty, so cover treated skin and wash your hands. The labels also warn of blood pressure increases, higher red blood cell counts, blood clots, worsening of enlarged prostate, possible prostate cancer risk, sleep apnea, reduced sperm production, and serious heart and mental health effects with misuse. Men with breast cancer or known or suspected prostate cancer should not use it. It is contraindicated in pregnancy because it can cause male characteristics in a female fetus; the injection label says it is not recommended for nursing mothers. It can change the effect of blood thinners, lower blood sugar with insulin, and add fluid retention with corticosteroids. For leg pain or swelling, chest pain, shortness of breath or trouble urinating, talk to your prescriber or pharmacist.
Testosterone and its 5-alpha-reduced metabolite dihydrotestosterone act at the androgen receptor; a portion is aromatized to estradiol. About 98 percent of circulating testosterone is protein-bound, roughly 40 percent to sex hormone-binding globulin and most of the rest to albumin. Transdermal gel delivers testosterone continuously over 24 hours, and transfer to partners through skin contact is documented. Intramuscular cypionate in oil is absorbed slowly from the depot with a half-life of about eight days. Inactivation is mainly hepatic, with urinary excretion of conjugates. AndroGel and testosterone cypionate injection are labeled for primary and hypogonadotropic hypogonadism in adult males. The NASEM report on compounded bioidentical hormone therapy notes that compounded testosterone is dispensed as creams, pellets, lozenges and combination preparations, and concludes that reliable pharmacokinetic and bioavailability data for these preparations are scarce; prescribers have ordered compounded testosterone in these forms. Dosing, titration and route per prescriber. Monitoring per the labels: morning serum testosterone after initiation or dose change, hematocrit at baseline, 3 to 6 months and annually, PSA, lipids, liver function and blood pressure, serum calcium in patients at risk of hypercalcemia, and INR with oral anticoagulants. DEA Schedule III.
Wash and dry your hands. Place the troche between your cheek and gum or under your tongue, as your label directs, and let it dissolve. Do not chew or swallow it whole unless told to. Dissolving can take up to 30 minutes. Follow your label about eating or drinking around the dose.
Troches are nonaqueous, so a USP <795> default beyond-use date of up to 180 days usually applies. Store in the closed container in a cool, dry place at room temperature, away from heat so they do not soften, and out of reach of children. Discard after the beyond-use date on the 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.
This preparation is a controlled substance. Additional prescribing, refill, and shipping restrictions apply, and the states Bayview can dispense it to are narrower than for non-controlled preparations.
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.
Place 1 troche between cheek and gum and let slowly dissolve
