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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 hydromorphone hydrochloride, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved. Hydromorphone 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 hydromorphone are listed in tablet, injection and solution forms. No hydromorphone 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.
Hydromorphone is a Schedule II opioid pain reliever that a pharmacy may compound when a prescriber orders it.
Hydromorphone is an opioid analgesic, a full opioid agonist that is relatively selective for the mu-opioid receptor and changes how the brain and nervous system respond to pain. Manufactured products include Dilaudid oral solution and tablets and Dilaudid injection, which are indicated for pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, and generic extended-release tablets, which are indicated only for opioid-tolerant patients with severe and persistent pain that cannot be adequately treated with alternative options, including immediate-release opioids. The labels reserve opioids for patients whose alternative treatment options are ineffective, not tolerated or otherwise inadequate. A prescriber might order hydromorphone compounded when a patient needs a strength, dosage form or vehicle that is not manufactured. Compounded preparations are not FDA-approved and require a prescription. Hydromorphone is a federally controlled Schedule II substance.
Dilaudid carries a boxed warning covering medication errors with the oral solution, addiction, abuse and misuse, life-threatening breathing problems, fatal accidental ingestion, especially by children, profound sedation, coma or death with benzodiazepines, alcohol or other CNS depressants, neonatal opioid withdrawal syndrome, and the opioid REMS program. Do not use it with significant breathing problems, acute or severe asthma without monitoring, known or suspected bowel blockage, or allergy to hydromorphone or sulfite-containing medicines. It is not recommended with MAO inhibitors or within 14 days of stopping one, and serotonergic drugs can cause serotonin syndrome. Long-term use in pregnancy can cause withdrawal in the newborn. LactMed notes newborns are particularly sensitive to opioids; watch a breastfed baby for unusual sleepiness, feeding or breathing trouble, or limpness. Ask about having naloxone or nalmefene on hand, and talk to your prescriber or pharmacist about side effects.
Hydromorphone is a full opioid agonist, relatively selective for the mu receptor, with no ceiling effect for analgesia. Per the Dilaudid label, oral bioavailability is about 24% because of extensive first-pass metabolism, peak concentrations occur within half an hour to an hour, plasma protein binding is about 8 to 19%, and the terminal half-life after an intravenous dose is about 2.3 hours. More than 95% of a dose is glucuronidated to hydromorphone-3-glucuronide, excreted in urine. Exposure rises about fourfold in moderate hepatic impairment and two- to threefold in moderate to severe renal impairment, so the label advises lower starting doses with close titration. StatPearls lists intramuscular, intravenous, subcutaneous, rectal and oral routes, and off-label use for refractory cough, which is not an FDA-approved indication. Labeled indication: pain severe enough to require an opioid when alternatives are inadequate (Dilaudid oral and injection); opioid-tolerant severe and persistent pain (extended-release tablets). Dosing is per prescriber. Monitor respiratory status, sedation, misuse and bowel function. Hydromorphone is Schedule II. Electronic prescribing of controlled substances is voluntary under federal DEA rules, CMS applies a prescriber-level threshold for Part D, and a number of states mandate it.
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
