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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 capsule containing doxepin 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 doxepin are listed in capsule, tablet, cream and solution forms.
This is a solid, nonaqueous dose form. Under USP <795>, nonaqueous preparations carry longer default beyond-use dates than water-containing ones. The date printed on the label is the one to follow.
Doxepin is a tricyclic antidepressant with strong antihistamine activity that compounding pharmacies prepare by prescription in topical and oral forms.
Doxepin is a tricyclic antidepressant that blocks reuptake of serotonin and norepinephrine and also blocks histamine H1 and H2, alpha-1 adrenergic and muscarinic receptors (StatPearls). Doxepin hydrochloride capsules (for example Mylan) are FDA-approved for major depressive disorder in adults. Silenor (doxepin tablets, Currax) is approved for insomnia marked by difficulty staying asleep, and doxepin hydrochloride cream (for example Sun Pharma) is approved for short-term management of moderate itching in adults with atopic dermatitis or lichen simplex chronicus. A prescriber may order doxepin compounded when a patient needs a topical base, strength or combination that is not manufactured. Compounded preparations are not FDA-approved and require a prescription.
Doxepin capsules carry a boxed warning that antidepressants increase the risk of suicidal thoughts and behaviors in children and young adults; watch closely for worsening mood, especially early in treatment. Do not use doxepin with glaucoma, current or past urinary retention, an allergy to doxepin or related dibenzoxepines, or within 14 days of an MAO inhibitor, including linezolid or IV methylene blue. Other label warnings include serotonin syndrome, angle-closure glaucoma, drowsiness, mania, seizures and psychosis. Alcohol, sedatives, cimetidine, CYP2D6 inhibitors, serotonergic drugs and tolazamide can interact. The cream can also cause drowsiness because significant amounts reach the bloodstream. Babies exposed late in pregnancy may have trouble adapting after birth. The capsule label says breastfeeding is not recommended; LactMed calls oral doxepin a poor choice but says cream applied away from the breast is unlikely to pose a problem. Talk to your prescriber or pharmacist about side effects.
Per the Mylan capsule label, peak doxepin levels occur at 2 to 4 hours, apparent volume of distribution is about 20 L/kg, protein binding is about 76%, and 55% to 87% of an oral dose undergoes first-pass hepatic metabolism to the active metabolite nordoxepin. Mean half-life is 17 hours for doxepin and 51 hours for nordoxepin, with urinary excretion mainly as metabolites. The capsule label states that doxepin is metabolized mainly by CYP2D6 and/or CYP2C19 and recommends lower dosing in CYP2D6 and CYP2C19 poor metabolizers and with strong CYP2D6 inhibitors; StatPearls also suggests therapeutic drug monitoring in CYP2D6 poor metabolizers. Topical doxepin is absorbed systemically, and StatPearls advises against use under occlusion. Labeled indications: capsules for MDD in adults; Silenor for insomnia with difficulty in sleep maintenance; doxepin cream for up to 8 days of moderate pruritus in atopic dermatitis or lichen simplex chronicus. StatPearls lists off-label topical doxepin for pain, urethral irritation and dysuria, and oral use for refractory chronic urticaria, neuropathic pain and migraine prophylaxis. Dosing is per prescriber. Screen for bipolar disorder before starting; monitor mood, suicidality, sedation, anticholinergic effects and QT-prolonging combinations. Doxepin is not a controlled substance.
Swallow each capsule whole with a glass of water, unless your label says otherwise. Do not crush, chew or open the capsule unless your pharmacist tells you it is safe to do so. Take it at the times shown on your prescription label. If you miss a dose or are unsure how to take it, call the pharmacy.
Capsules are nonaqueous, so under USP <795> they usually carry a beyond-use date of up to 180 days when no other stability data apply. Keep the vial tightly closed at room temperature, away from heat, moisture and direct light, and out of reach of children. Discard any capsules left 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.
Take 1 capsule by mouth
