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Amitriptyline 2%/Carbamazepine 2%/Clonidine 0.1%/Ketamine 2.5% Topical Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Amitriptyline Hydrochloride
Carbamazepine
Clonidine Hydrochloride
Ketamine Hydrochloride

This Amitriptyline 2%/Carbamazepine 2%/Clonidine 0.1%/Ketamine 2.5% Topical Gel is a semisolid formulation designed for easy and precise application on the skin through a pump mechanism. Its gel-like consistency ensures targeted treatment and effective absorption of active ingredients.

This compounded gel is used to manage and alleviate symptoms associated with neuropathic pain, fibromyalgia, and other chronic pain conditions. By combining these active ingredients, the formulation aims to provide comprehensive relief from pain and discomfort.

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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.
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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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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
Carbamazepine
Clonidine Hydrochloride
Ketamine Hydrochloride
Topical Gel
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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Currently licensed Limited basis, registration pending Not available for this formula Not currently licensed

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Formula Information

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This compounded topical gel combines Amitriptyline 2%, Carbamazepine 2%, Clonidine 0.1%, and Ketamine 2.5% in a semisolid formulation designed for targeted skin application. Dispensed through a convenient pump mechanism, it allows for easy and precise dosing directly to the affected area, enhancing the local absorption of the active ingredients.

Amitriptyline is a tricyclic antidepressant that, when applied topically, may help alleviate neuropathic pain by inhibiting the reuptake of serotonin and norepinephrine, neurotransmitters involved in pain modulation. Its local action can reduce pain signals in the peripheral nerves, potentially providing relief from chronic pain conditions.

Carbamazepine is an anticonvulsant and mood-stabilizing drug that acts by blocking voltage-gated sodium channels in neural membranes, reducing excitability and transmission of pain signals. When used topically, it can target specific areas of nerve pain with minimal systemic side effects compared to oral administration.

Clonidine is an alpha-2 adrenergic agonist that can decrease sympathetic outflow and norepinephrine release, contributing to its analgesic properties. Applied topically, clonidine may help in reducing localized pain by modulating peripheral nerve activity.

Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist known for its potent analgesic effects in chronic pain management. Topical ketamine may reduce central sensitization and hyperalgesia by blocking NMDA receptors in peripheral nerves, potentially offering relief in conditions where pain amplification is a significant concern.

This combination therapy aims to provide synergistic effects by targeting multiple pain pathways, which may be beneficial for patients experiencing refractory neuropathic pain or complex regional pain syndromes. The topical route minimizes systemic absorption, thereby reducing the risk of systemic side effects associated with oral medications.

For prescribers, this tailored formulation allows for individualized patient care, especially when conventional therapies have been inadequate. It’s important to monitor patient response and adjust the formulation as needed. Patients should be instructed to apply the gel as directed, typically to intact, non-irritated skin, and to report any adverse reactions.

Patients considering this treatment should consult with their healthcare provider to discuss its appropriateness for their specific condition. Proper application techniques and adherence to dosing schedules enhance the effectiveness of the therapy while minimizing potential risks.

If you have any questions or need further information about this compounded formulation, please reach out to us at Bayview Pharmacy. We are here to support both patients and healthcare providers in optimizing pain management strategies.

Drug Interactions

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This compounded topical gel formulation contains amitriptyline, carbamazepine, clonidine, and ketamine, each of which has the potential to interact with other medications. It is crucial for both patients and prescribers to be aware of these interactions to ensure safe and appropriate use of the formulation.

Amitriptyline, a tricyclic antidepressant, can interact with a variety of medications. It may enhance the sedative effects of CNS depressants such as alcohol, benzodiazepines, and opioids, potentially leading to increased drowsiness or respiratory depression. Additionally, amitriptyline can interact with other serotonergic drugs, increasing the risk of serotonin syndrome, a potentially life-threatening condition. Patients should also be cautious when using amitriptyline with medications that affect cardiac conduction, such as certain antiarrhythmics, as this can increase the risk of arrhythmias.

Carbamazepine, an anticonvulsant, is known for its enzyme-inducing properties, which can lead to decreased plasma concentrations of drugs metabolized by the cytochrome P450 system, such as warfarin, oral contraceptives, and other anticonvulsants. This can reduce the efficacy of these medications. Conversely, carbamazepine levels can be increased by inhibitors of the same enzyme system, such as certain antifungals and macrolide antibiotics, potentially leading to toxicity. Patients should be monitored for signs of carbamazepine toxicity, such as dizziness, ataxia, or diplopia, when these interactions are possible.

Clonidine, an alpha-2 adrenergic agonist, can interact with other antihypertensive agents, potentially leading to additive hypotensive effects. Patients should be monitored for symptoms of low blood pressure, such as dizziness or fainting, especially when initiating or adjusting doses of clonidine or other blood pressure medications. Additionally, abrupt withdrawal of clonidine can lead to rebound hypertension, which can be exacerbated by concurrent use of beta-blockers.

Ketamine, an NMDA receptor antagonist, can interact with other CNS depressants, enhancing their sedative effects. This can lead to increased sedation or respiratory depression, particularly when used with opioids or benzodiazepines. Ketamine may also interact with medications that affect the cardiovascular system, such as sympathomimetics, potentially leading to increased blood pressure or heart rate.

Given the potential for drug interactions, it is essential for prescribers to review a patient's complete medication list, including over-the-counter drugs and supplements, before prescribing this topical gel. Patients should be advised to inform their healthcare providers of all medications they are taking and to report any unusual symptoms or side effects promptly. If you have any questions or concerns about potential drug interactions with this formulation, please reach out to us for further guidance.

How Does it Work

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This compounded topical gel formulation combines four active pharmaceutical ingredients: Amitriptyline, Carbamazepine, Clonidine, and Ketamine, each contributing unique mechanisms of action to provide a multifaceted approach to pain management. The semisolid gel is dispensed through a pump mechanism, ensuring easy and precise application on the skin, which allows for targeted treatment and absorption of the active ingredients directly at the site of discomfort.

Amitriptyline, a tricyclic antidepressant, is included in this formulation for its ability to modulate pain pathways. It works by inhibiting the reuptake of neurotransmitters such as serotonin and norepinephrine, which are involved in the transmission of pain signals. By increasing the levels of these neurotransmitters in the synaptic cleft, Amitriptyline can help reduce the perception of pain, making it particularly useful in treating neuropathic pain conditions.

Carbamazepine, an anticonvulsant, is utilized for its efficacy in stabilizing hyperexcited nerve membranes, inhibiting repetitive neuronal firing, and reducing synaptic propagation of excitatory impulses. This action is particularly beneficial in managing neuropathic pain and conditions such as trigeminal neuralgia, where nerve hyperactivity is a primary concern. By applying Carbamazepine topically, systemic side effects are minimized while providing localized relief.

Clonidine, an alpha-2 adrenergic agonist, contributes to the formulation by reducing sympathetic outflow and enhancing the inhibitory pathways in the central nervous system. This action can lead to a decrease in pain transmission and an increase in pain threshold. The topical application of Clonidine allows for direct action on peripheral nerves, potentially reducing systemic side effects associated with oral administration.

Ketamine, an NMDA receptor antagonist, is included for its potent analgesic properties. It works by blocking the NMDA receptors in the central nervous system, which are involved in the amplification of pain signals. By inhibiting these receptors, Ketamine can help in reducing central sensitization and chronic pain states. The topical delivery of Ketamine allows for localized action, providing pain relief without the psychotropic effects associated with systemic administration.

The gel-like consistency of this formulation ensures that the active ingredients are evenly distributed and absorbed through the skin, providing a sustained release of medication at the site of application. This targeted approach not only enhances the efficacy of the treatment but also minimizes the risk of systemic side effects, making it a suitable option for patients who require localized pain management.

By combining multiple mechanisms of action, it addresses various aspects of pain, providing comprehensive relief. If you have any questions or need further information about this formulation, please reach out to us at Bayview Pharmacy.

Frequently Asked Questions

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What is the purpose of Amitriptyline 2%/Carbamazepine 2%/Clonidine 0.1%/Ketamine 2.5% Topical Gel?

This compounded topical gel is designed to provide targeted relief for pain and discomfort by delivering active ingredients directly to the affected area through the skin.

How should I apply the topical gel?

The gel should be dispensed through the pump mechanism and applied directly to the skin over the affected area. Use a small amount and gently rub it in until fully absorbed.

How often can I use this topical gel?

Usage frequency should be determined by your healthcare provider, but it is typically applied 2-3 times daily or as directed.

Can I use this gel on broken or irritated skin?

No, you should avoid applying the gel to broken, irritated, or infected skin to prevent further irritation or adverse reactions.

Are there any side effects associated with this topical gel?

Some users may experience mild skin irritation, redness, or itching at the application site. If you experience severe reactions, discontinue use and consult your healthcare provider.

Is this topical gel safe for use during pregnancy or breastfeeding?

You should consult your healthcare provider before using this gel if you are pregnant or breastfeeding to ensure it is safe for you and your baby.

Can I use this gel in conjunction with other medications?

Before using this gel with other medications, consult your healthcare provider to avoid potential interactions or side effects.

How should I store the topical gel?

Store the gel at room temperature, away from direct sunlight and moisture. Keep it out of reach of children and pets.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose.

Can this gel be used for all types of pain?

This gel is formulated for specific types of pain as determined by your healthcare provider. It may not be suitable for all pain types, so consult your provider for appropriate use.

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.

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.

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 2%/Carbamazepine 2%/Clonidine 0.1%/Ketamine 2.5% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Three times daily