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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 metoclopramide hydrochloride, 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 metoclopramide are listed in tablet, injection, solution and spray forms. No metoclopramide 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.
Metoclopramide is a dopamine-blocking prokinetic and antinausea drug that compounding pharmacies prepare by prescription in several dosage forms.
Metoclopramide is a prokinetic drug that speeds the movement of food through the stomach and intestines. It blocks dopamine D2 receptors in the brain and gut, and StatPearls also describes 5-HT3 antagonist and 5-HT4 agonist activity. Reglan tablets are FDA-approved for 4 to 12 weeks of treatment of documented, symptomatic gastroesophageal reflux in adults who do not respond to conventional therapy, and for relief of symptoms of acute and recurrent diabetic gastroparesis in adults. Gimoti nasal spray is FDA-approved for adult diabetic gastroparesis, and MedlinePlus also lists orally disintegrating tablets and an oral solution. StatPearls notes that parenteral metoclopramide is approved to control chemotherapy-related nausea and vomiting. A prescriber might order metoclopramide compounded for a strength, dosage form or allergen-free vehicle that is not manufactured. Compounded preparations are not FDA-approved and require a prescription.
Metoclopramide carries a boxed warning for tardive dyskinesia, a potentially irreversible movement disorder whose risk rises with treatment duration and total cumulative dose. The label advises the shortest possible treatment, says Reglan has not been shown safe for reflux treatment beyond 12 weeks, and says to stop it if signs of tardive dyskinesia appear. Do not use it with a history of tardive dyskinesia or a dystonic reaction to metoclopramide, when stimulating gut motility could be dangerous (bleeding, blockage or perforation), with pheochromocytoma or other catecholamine-releasing paragangliomas, or with epilepsy. Other warnings include other movement side effects, neuroleptic malignant syndrome, depression, high blood pressure, fluid retention and raised prolactin. Avoid antipsychotics and other CNS depressants with it. Reglan tablets are not recommended for children. LactMed says it passes into milk in variable amounts and some breastfed infants have had raised prolactin. Talk to your prescriber or pharmacist about side effects.
Metoclopramide antagonizes central and peripheral D2 receptors, including in the chemoreceptor trigger zone. The Reglan label says it raises the tone and amplitude of upper GI contractions without stimulating gastric, biliary or pancreatic secretion. Absolute oral bioavailability is about 80% relative to intravenous dosing, plasma protein binding is about 30%, volume of distribution is about 3.5 L/kg, and mean elimination half-life is 5 to 6 hours with normal renal function. The label calls for dosage reduction in CYP2D6 poor metabolizers, with strong CYP2D6 inhibitors (the gastroparesis regimen avoids bupropion, fluoxetine and paroxetine), in moderate or severe hepatic or renal impairment, and in older adults, and advises avoiding it with MAO inhibitors. Labeled indications: Reglan tablets for short-term treatment of documented symptomatic GERD in adults who fail conventional therapy and for adult diabetic gastroparesis; Gimoti nasal spray for adult diabetic gastroparesis. Metoclopramide injection is also labeled for prophylaxis of postoperative nausea and vomiting when nasogastric suction is undesirable. StatPearls lists acute migraine in the emergency department as an off-label use; this is not an FDA-approved indication. Dosing is per prescriber. Monitor for abnormal movements, mood changes, blood pressure and fluid status, and periodically reassess the need to continue.
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.
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
