
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 topical gel containing mirtazapine, 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 mirtazapine are listed in tablet form. No finished mirtazapine product of any kind is listed in gel form.
Gel bases can be aqueous or nonaqueous, and USP <795> classifies the preparation by its water activity. Aqueous preparations carry shorter default beyond-use dates than nonaqueous ones. The date printed on the label is the one to follow.
Mirtazapine is a noradrenergic and specific serotonergic antidepressant that compounding pharmacies prepare as oral suspensions and capsules in strengths not manufactured, by prescription.
Mirtazapine is a tetracyclic antidepressant described as a noradrenergic and specific serotonergic antidepressant. Rather than blocking reuptake like SSRIs, it blocks presynaptic alpha-2 adrenergic autoreceptors and heteroreceptors, which increases release of norepinephrine and serotonin; it also blocks serotonin 5-HT2 and 5-HT3 receptors and histamine H1 receptors, which accounts for its sedating and antinausea effects and its tendency to increase appetite. The manufactured products are Remeron film-coated tablets, RemeronSolTab orally disintegrating tablets (Organon) and generics, FDA-approved for major depressive disorder in adults; the drug is not approved for pediatric use. No manufactured liquid exists, so a prescriber might order compounded mirtazapine as an oral suspension for a patient who cannot swallow tablets, in a strength below the smallest tablet, or for a patient who cannot take the aspartame-containing disintegrating tablet. Compounded preparations are not FDA-approved and require a prescription.
Mirtazapine carries the FDA antidepressant boxed warning: antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies, so anyone starting it, especially under 24, needs close watching for new or worsening depression, agitation or thoughts of self-harm. Do not take it with an MAO inhibitor, including linezolid or intravenous methylene blue, or within 14 days of stopping one, and do not use it after a serious reaction to it. It can cause a dangerous drop in white blood cells (report fever, sore throat or mouth sores), serotonin syndrome with other serotonergic drugs, angle-closure glaucoma, QT prolongation, low sodium in older adults and people on diuretics, seizures, mania in bipolar disorder, raised cholesterol and triglycerides, and the severe skin reaction DRESS. Drowsiness, dizziness, increased appetite and weight gain are the most common side effects; avoid alcohol and benzodiazepines. Ketoconazole, clarithromycin and cimetidine raise its levels; carbamazepine, phenytoin and rifampin lower them; watch INR with warfarin. Do not stop it suddenly. The label reports no clear risk of birth defects in human data and low milk levels (relative infant dose roughly 0.6 to 2.8 percent) with no infant effects reported; Drugs.com's breastfeeding monograph, citing primary studies, agrees. If side effects bother you, talk to your prescriber or pharmacist.
Mirtazapine antagonizes central presynaptic alpha-2 adrenergic autoreceptors and heteroreceptors, enhancing noradrenergic and serotonergic neurotransmission, and antagonizes 5-HT2, 5-HT3 and H1 receptors without monoamine reuptake inhibition. Oral bioavailability is about 50 percent with peak levels at about 2 hours and minimal food effect; protein binding is about 85 percent; the elimination half-life is 20 to 40 hours and longer in women (mean 37 versus 26 hours); metabolism is hepatic by CYP2D6, CYP1A2 and CYP3A with an active N-desmethyl metabolite; about 75 percent is excreted in urine and 15 percent in feces; clearance falls in the elderly and in renal or hepatic impairment. Labeled indication (Remeron, RemeronSolTab): major depressive disorder in adults. Prescribers have ordered compounded mirtazapine as an oral liquid and in low strengths, and the drug is used off label in palliative and oncology patients for insomnia, nausea, pruritus and anorexia; a 2024 review (Davis, Palliative Care and Social Practice) reports that single-arm studies were positive but randomized trials of appetite and nausea in advanced cancer were negative, with benefit more apparent as chemotherapy antiemetic prophylaxis and in uremic pruritus. Dosing, strength and titration are per prescriber. Monitor for suicidality early and at dose changes, CBC if infection symptoms appear, sodium in at-risk patients, lipids and weight, transaminases, QT with risk factors, and serotonin syndrome with other serotonergic agents; screen for bipolar disorder; taper on discontinuation. Not a controlled substance.
Wash your hands. Apply the amount on your label to clean, dry skin and spread it in a thin layer. For a metered pump, your label states the number of presses. For a dosing syringe, push the plunger to the mark. Let the gel dry before covering with clothing. Wash your hands afterward and keep the site from touching other people until it has dried. Do not apply to broken skin unless told to.
A gel can have a nonaqueous or a water-based base, and USP <795> sets its default beyond-use date by water content, not by the word gel. A nonaqueous gel usually carries a beyond-use date of up to 180 days at room temperature or refrigerated. A water-based gel carries up to 35 days with a preservative, or 14 days refrigerated without one. Your label states which applies. Keep the container closed, away from heat and open flame if it contains alcohol, out of reach of children, and discard after the beyond-use date on your 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.
Apply topically to affected area(s)