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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 troche containing fentanyl citrate, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved. Fentanyl is a Schedule II controlled substance.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
FDA-approved products containing fentanyl are listed in patch and injection forms. No finished fentanyl product of any kind is listed in troche form.
Bases for this dose form differ, and the base used decides how USP <795> classifies the preparation for beyond-use dating. The date printed on the label is the one to follow.
Fentanyl citrate is a potent Schedule II opioid pain medicine and anesthesia aid that a pharmacy may compound when a prescriber orders it.
Fentanyl is a synthetic opioid that StatPearls calls 50 to 100 times more potent than morphine. It mainly activates mu opioid receptors in the brain, producing pain relief and sedation. Current DailyMed products are fentanyl citrate injections (intravenous or intramuscular), indicated for short-acting pain relief around anesthesia, as a pain-relief supplement in general or regional anesthesia, with a neuroleptic for premedication and induction, and with oxygen as an anesthetic in selected high-risk surgery. Transmucosal products for flares of cancer pain in opioid-tolerant patients (Actiq, Fentora, Abstral and others) are no longer marketed in the United States, according to MedlinePlus. StatPearls lists moderate to severe acute pain as an off-label use, not an FDA-approved indication. A prescriber might order fentanyl citrate compounded in a strength or form that is not manufactured. Compounded preparations are not FDA-approved and require a prescription.
Fentanyl citrate injection carries a boxed warning for addiction, abuse and misuse that can lead to overdose and death; life-threatening or fatal breathing problems, especially at the start or after a dose increase; profound sedation, coma and death when combined with benzodiazepines, other sedatives or alcohol; and higher, potentially fatal fentanyl levels with CYP3A4 inhibitors or after stopping a CYP3A4 inducer. Do not use it if you are allergic to fentanyl. Serotonergic drugs, MAOIs, mixed agonist/antagonist or partial agonist opioids and muscle relaxants also interact; MedlinePlus adds St. John's wort and grapefruit. Long use in pregnancy can cause withdrawal in the newborn. The label and LactMed agree fentanyl passes into milk; LactMed says short use around delivery is not expected to harm breastfed infants, and the label advises watching for infant sedation and breathing problems. Get emergency help for slow or shallow breathing or extreme sleepiness, and talk to your prescriber or pharmacist about side effects.
Fentanyl is a mu-selective opioid agonist that can also activate delta and possibly kappa receptors; its principal therapeutic actions are analgesia and sedation. After intravenous or intramuscular dosing, it follows a three-compartment model, with a volume of distribution of 4 L/kg, distribution time of 1.7 minutes and redistribution time of 13 minutes. It accumulates in muscle and fat and is released slowly; protein binding rises with ionization, so pH changes affect distribution. It is metabolized in the liver by CYP3A4, with high first-pass clearance; about 75% of an intravenous dose appears in urine, mostly as metabolites (under 10% unchanged), and about 9% in feces. The label gives a terminal half-life of 219 minutes; StatPearls cites 3 to 7 hours. Labeled indications: fentanyl citrate injection (NDA019101, NDA019115) for anesthesia-related analgesia and as an anesthetic adjunct. Dosing is per prescriber, with careful titration and monitoring for respiratory depression, sedation and signs of addiction or misuse; monitor closely with any CYP3A4 inhibitor or inducer. Fentanyl citrate is a Schedule II controlled substance. Under DEA rules, electronic prescribing of controlled substances is voluntary, though state requirements that are more stringent supersede DEA's. Separately, CMS requires that at least 70% of each prescriber's Part D controlled-substance prescriptions be sent electronically, with exceptions, and states may set their own requirements; Pennsylvania, for example, requires e-prescribing of Schedule II to V drugs.
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
