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Amitriptyline HCl 5 mg Oral Capsules

FDA-approved generic
Dose form
Capsules
Active ingredients
Amitriptyline Hydrochloride
For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription detailsOrder form
Controlled substance: e-prescribe (EPCS) from your EHR. Faxed and phoned prescriptions cannot be accepted for this preparation.
Send it from your EHR, or fax to (401) 284-4506. How to e-prescribe this formula
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.
To prescribe, you must be a verified prescriber.
To prescribe, you must be in a state where we hold an active out-of-state pharmacy license.
Starting at
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Requires a prescription from your own provider. Bayview is a pharmacy and does not prescribe.
Ships within 1 to 2 business days after pharmacist verification
HSA and FSA eligible
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Get a one-page sheet with everything your doctor needs to prescribe this and send it to Bayview.

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.

For prescribersSign in for prescription details and order forms.
Compounded preparations are prepared by Bayview pursuant to a prescription for an individual patient. They are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Amitriptyline Hydrochloride
Capsules
6530691c9364041c976b843b
Service area

Can we ship this formula to your state?

Bayview fills prescriptions for patients in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, Pennsylvania and Rhode Island. New York patients are served on a limited basis while nonresident pharmacy registration is pending.

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Available in

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Our current service area

Currently licensed Limited basis, registration pending Not available for this formula Not currently licensed

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Prepared to a prescriber's order for one patient. Not FDA-approved.

This formulation

This is a compounded capsule containing amitriptyline hydrochloride, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved.

FDA product listings

These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.

FDA-approved products containing amitriptyline are listed in tablet form. No amitriptyline product of any kind is listed in capsule form.

Storage category and dating

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.

Sources

Amitriptyline is a tricyclic antidepressant that also acts on nerve pain pathways, commonly compounded in topical creams and gels and in oral liquids.

About this ingredient

Amitriptyline is a tricyclic antidepressant. It blocks the reuptake of two brain signaling chemicals, norepinephrine and serotonin, and it also binds histamine, muscarinic, adrenergic and serotonin receptors and blocks voltage-gated sodium channels in nerves, which is why it has been studied for pain as well as mood. The manufactured product is amitriptyline hydrochloride tablets, FDA-approved for the relief of symptoms of depression. Amitriptyline is not approved for pediatric use.

A prescriber may order amitriptyline compounded when a patient needs a dosage form that is not manufactured, such as a topical preparation applied to a painful area or a liquid for someone who cannot swallow tablets, a strength that differs from the commercial tablets, a vehicle free of a specific dye or allergen, or a combination with other active ingredients. Compounded amitriptyline preparations are not FDA-approved and require a prescription.

Safety and interactions

The amitriptyline label carries a boxed warning: antidepressants increase the risk of suicidal thinking and behavior in children, adolescents and young adults, and anyone starting the medicine or changing a dose should be watched for new or worsening depression, agitation or unusual behavior changes. Do not use amitriptyline with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping one, with cisapride, during the acute recovery period after a heart attack, or if you are allergic to it. Other label warnings include heart rhythm problems, triggering mania in bipolar disorder, angle-closure glaucoma attacks, seizures, and withdrawal symptoms if stopped suddenly. It causes drowsiness and dry mouth, and alcohol and other sedating drugs add to this. Tell your prescriber or pharmacist if you take SSRIs, cimetidine, topiramate or any CYP2D6 inhibitor, because these can raise amitriptyline levels. The label advises use in pregnancy only if the potential benefit justifies the risk and states amitriptyline is excreted into breast milk; LactMed reports milk levels are low and adverse effects in breastfed infants would usually not be expected. If you notice a fast or irregular heartbeat, fainting, confusion or a severe rash, contact your prescriber or pharmacist right away.

Amitriptyline is a tertiary amine tricyclic antidepressant. It inhibits the norepinephrine and serotonin transporters with nanomolar affinity, has high affinity for histamine H1, muscarinic and 5-HT2A/2C receptors, binds adrenergic receptors, and produces state-dependent block of voltage-gated sodium channels via the local anesthetic receptor; NMDA receptor and potassium channel effects are also described. The label states the mechanism in humans is not known and that the drug is metabolized by N-demethylation and bridge hydroxylation. CYP2D6 poor metabolizers have higher than expected plasma concentrations, and CYP2D6 inhibitors may require lower doses. Systemic absorption from topical application is not characterized in the manufactured labeling.

Labeled indication: relief of symptoms of depression; not approved for pediatric patients or bipolar depression. Prescribers have ordered amitriptyline off label for postherpetic neuralgia, migraine prophylaxis and eating disorders (MedlinePlus), for fibromyalgia (Lawson, Biomedicines 2017), and as compounded topical amitriptyline for localized neuropathic pain, where trials of low-strength creams were negative and higher strengths showed systemic effects (Cline and Turrentine, Dermatitis 2016). Dosing and titration are per prescriber. Monitor for suicidality at initiation and dose changes, cardiac conduction in cardiovascular disease, anticholinergic burden in older adults, serotonin syndrome with serotonergic co-medication, and withdrawal on abrupt cessation. Amitriptyline is not a controlled substance.

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Using and storing

How it is used

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.

Storing it

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.

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Prescribing and ordering FAQs

Formula Information

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Frequently Asked Questions

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About this compounded preparation

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.

Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.
For prescribers

How to e-prescribe this formula

Controlled substance: e-prescribe only (EPCS). Faxed, phoned, and handwritten prescriptions cannot be filled. Rhode Island law (R.I. Gen. Laws § 21-28-3.18) requires Schedule II to V prescriptions to be transmitted electronically.
1

Find Bayview in your EHR's pharmacy directory

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.

NCPDP4106882NPI1750455143Address3844 Post Rd, Warwick, RI 02886Phone(401) 284-4505Fax(401) 284-4506
2

Enter the formula as a compound

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.

3

Copy the prescription details

RxFormula name
Dose formDose form
Quantity________
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription details

Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.

4

Send it

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.

Do not use Notes to Pharmacy for the formula. Some EHRs keep that field internal and never transmit it. A prescription that arrives without the formula is delayed while we call your office.

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.

Amitriptyline HCl 5 mg Oral Capsules
Capsules
90 capsules
controlled

Take 1 capsule by mouth

Once daily at bedtime