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Amitriptyline HCl 2%/Clonidine HCl 0.1%/Ketamine HCl 4.6%/Ketoprofen 10%/Lidocaine 2% Transdermal Gel

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

This formulation is a semisolid transdermal gel containing Amitriptyline HCl 2%, Clonidine HCl 0.1%, Ketamine HCl 4.6%, Ketoprofen 10%, and Lidocaine 2%. It is dispensed through a pump mechanism, which allows for easy and precise application on the skin. The gel-like consistency ensures targeted treatment or absorption of the active ingredients.

The combination of these active ingredients is designed to treat a variety of disease states. Amitriptyline HCl is a tricyclic antidepressant used for its analgesic properties, Clonidine HCl is an alpha-2 adrenergic agonist used for its sedative and analgesic effects, Ketamine HCl is an NMDA receptor antagonist used for its analgesic and anesthetic properties, Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used for its anti-inflammatory and analgesic effects, and Lidocaine is a local anesthetic used for its numbing effect on the skin.

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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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This medication requires a prescription from your doctor

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
Clonidine Hydrochloride
Ketamine Hydrochloride
Ketoprofen
Lidocaine Hydrochloride
Topical Gel
65306e21d38a93a11408747a

Formula Information

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This formulation is a compounded transdermal gel containing Amitriptyline HCl 2%, Clonidine HCl 0.1%, Ketamine HCl 4.6%, Ketoprofen 10%, and Lidocaine 2%. It is a semisolid formulation that is dispensed through a pump mechanism, allowing for easy and precise application on the skin. The gel-like consistency ensures that the active ingredients are absorbed directly into the targeted area, providing localized treatment.

Amitriptyline HCl is a tricyclic antidepressant that is used in this formulation for its analgesic properties, particularly in neuropathic pain. Clonidine HCl is an alpha-2 adrenergic agonist that can help reduce certain types of pain, including neuropathic pain and inflammatory pain. Ketamine HCl is an NMDA receptor antagonist that provides analgesic effects, particularly for neuropathic pain. Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain in the body. Lidocaine is a local anesthetic that provides immediate relief from pain and discomfort.

This formulation is particularly useful in treating various disease states that involve chronic pain, such as fibromyalgia, neuropathic pain, and certain types of arthritis. By delivering the medication directly to the site of pain, it can provide targeted relief with fewer systemic side effects compared to oral medications. It is also beneficial for patients who have difficulty swallowing pills or who have gastrointestinal issues that may affect the absorption of oral medications.

As with any medication, it is important for patients and prescribers to be aware of potential side effects and interactions. Common side effects may include skin irritation at the application site, dizziness, dry mouth, and constipation. Serious side effects are rare but can include severe allergic reactions, slow/irregular heartbeat, mental/mood changes, and difficulty urinating. This medication may interact with other drugs, so it is important to inform your healthcare provider of all medications you are currently taking.

It is also important to note that this is a compounded medication, meaning it is made specifically for you based on a doctor's prescription. It is not a commercially available product and should be used only under the supervision of a healthcare provider. If you have any questions about this formulation, please reach out to us at Bayview Pharmacy. We are a team of knowledgeable compounding pharmacists who are here to help.

Drug Interactions

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This compounded formulation contains several active ingredients, each with its own potential for drug interactions. It's important to note that while these interactions are possible, they may not always occur. The severity and clinical significance of these interactions can vary based on individual patient characteristics, the dosages used, and the concurrent medications.

Amitriptyline HCl is a tricyclic antidepressant that can interact with monoamine oxidase inhibitors (MAOIs), leading to serious effects such as serotonin syndrome. It can also interact with anticholinergic drugs, increasing the risk of side effects such as dry mouth, constipation, and confusion. Concurrent use with other CNS depressants, including alcohol, can enhance the sedative effects.

Clonidine HCl, an alpha-2 adrenergic agonist, can interact with beta-blockers, potentially causing rebound hypertension if either drug is discontinued abruptly. It can also interact with CNS depressants, leading to additive sedative effects. Additionally, concurrent use with antihypertensive drugs can enhance the blood pressure-lowering effects.

Ketamine HCl is an NMDA receptor antagonist. It can interact with CNS depressants, leading to additive CNS and respiratory depression. Concurrent use with serotonergic drugs can increase the risk of serotonin syndrome. Additionally, it can interact with drugs that affect hepatic enzymes, potentially altering its metabolism and effects.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that can interact with anticoagulants, increasing the risk of bleeding. It can also interact with other NSAIDs, leading to additive adverse effects. Concurrent use with ACE inhibitors or ARBs can decrease their antihypertensive effects and increase the risk of renal impairment.

Lidocaine is a local anesthetic that can interact with other local anesthetics or antiarrhythmic drugs, potentially leading to additive systemic toxicity. It can also interact with drugs that affect hepatic enzymes, potentially altering its metabolism and effects.

This formulation is designed to treat various disease states, including neuropathic pain, chronic pain, and inflammatory conditions. Amitriptyline and ketamine can help manage neuropathic pain by modulating the activity of certain neurotransmitters and receptors. Clonidine can provide analgesia and sedation, potentially enhancing the pain-relieving effects. Ketoprofen can reduce inflammation and pain, while lidocaine can provide local anesthesia, numbing the treated area.

If you have any questions about this formulation or its potential drug interactions, please don't hesitate to reach out to us. We're here to help ensure the safe and appropriate use of this medication.

How Does it Work

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The formulation of Amitriptyline HCl 2%/Clonidine HCl 0.1%/Ketamine HCl 4.6%/Ketoprofen 10%/Lidocaine 2% Transdermal Gel is a unique combination of active ingredients designed to provide targeted relief for a variety of disease states. This semisolid formulation is dispensed through a pump mechanism, which allows for easy and precise application on the skin. The gel-like consistency ensures that the active ingredients are absorbed effectively into the skin for targeted treatment.

Amitriptyline HCl is a tricyclic antidepressant that works by increasing the levels of certain chemicals in the brain that help improve mood, relieve pain, and promote sleep. In this formulation, it is used for its analgesic properties to help manage chronic pain conditions.

Clonidine HCl is an alpha-2 adrenergic agonist that works by relaxing blood vessels and decreasing heart rate. It is used in this formulation for its ability to help manage neuropathic pain and certain symptoms of withdrawal from opioids.

Ketamine HCl is a powerful anesthetic that works by blocking certain receptors in the brain that are responsible for transmitting pain signals. In this formulation, it is used for its potent analgesic properties to help manage severe or chronic pain conditions.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain in the body. It is used in this formulation for its anti-inflammatory and analgesic properties to help manage pain and inflammation associated with various conditions.

Lidocaine is a local anesthetic that works by blocking nerve signals in your body. It is used in this formulation for its ability to provide temporary relief of pain and discomfort from skin irritations and localized pain conditions.

Together, these active ingredients work synergistically to provide targeted relief from pain and inflammation. The transdermal delivery system allows for the active ingredients to be absorbed directly into the affected area, providing localized treatment and minimizing systemic side effects.

If you have any questions about this formulation or how it may benefit you, please don't hesitate to reach out to us at Bayview Pharmacy. Our knowledgeable team of compounding pharmacists is here to help.

Other Uses

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This compound, which combines Amitriptyline HCl, Clonidine HCl, Ketamine HCl, Ketoprofen and Lidocaine in a transdermal gel, is primarily used as a topical pain relief solution. However, besides chronic and neuropathic pain, it may also have a range of other applications.

Providing a concentrated dose of multiple active pharmaceutical ingredients, the formulation might be useful in managing complex or multifactorial pain conditions, where the combination of ingredients targeting different pain pathways could be beneficial. These conditions can include fibromyalgia, phantom limb pain, and postherpetic neuralgia.

Besides pain management, this formulation can potentially serve as a non-invasive treatment option for autonomic nervous system disorders. The presence of Clonidine HCl, an alpha-2 adrenergic agonist, may make the formulation beneficial for conditions like hyperhidrosis (excessive sweating) and potentially hot flashes associated with menopause.

The Amitriptyline HCl component’s antidepressant properties may also be utilized for patients with dermatologic conditions characterized by chronic itch, such as eczema and psoriasis.

The local anesthetic properties of Lidocaine can potentially provide temporary relief from itching and burning sensations associated with insect bites, minor cuts, burns or abrasions, and cases of sunburn.

Individual responses to medication vary greatly, and the effectiveness of this particular formulation in the aforementioned conditions needs further clinical validation. These potential applications should be thoroughly discussed with the prescriber before initiating the treatment for any off-label uses.

Should you or your healthcare provider have more questions or require additional information about this compounded medication and its potential therapeutic applications, please contact our team of expert pharmacists at Bayview Pharmacy. We're here to assist you to maximize the benefits of this formulation.

Frequently Asked Questions

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What is the Amitriptyline HCl 2%/Clonidine HCl 0.1%/Ketamine HCl 4.6%/Ketoprofen 10%/Lidocaine 2% Transdermal Gel?

This is a semisolid compounded formulation that consists of numerous active ingredients. The gel is dispensed through a pump mechanism for a precise application on the skin. It is used for targeted treatment or absorption.

How is this compounded formulation applied?

The gel is intended for topical use. It is applied to the skin via a specialized pump mechanism that allows for easy and precise treatment or absorption of the active ingredients.

What does the percentage in the formulation denote?

The percentage represents the amount of each active ingredient in the total formulation. For instance, Lidocaine makes up 2% of the total formulation, while Ketoprofen constitutes 10%.

What is the purpose of the active ingredients in this formulation?

Each active ingredient serves a unique therapeutic function. Amitriptyline HCl is typically used for its mood enhancing effects, Clonidine HCl may decrease heart rate and blood pressure, Ketamine HCl is known for its pain relieving and anesthetic properties, Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID), and Lidocaine is used as a local anesthetic.

Who can use this compounded formulation?

This medication is typically prescribed by a healthcare professional based on the individual patient's needs and health status. Always consult with your healthcare provider to determine if this is a suitable option for you.

Are there any side effects associated with this formulation?

Yes, side effects can occur with any medication. Common side effects may include redness, itching, or mild irritation at the application site. Should you experience any severe reactions or symptoms, contact your healthcare provider immediately.

How should this formulation be stored?

This gel should be stored in a cool place, away from direct sunlight. It should not be exposed to extreme temperatures. Always check the package for specific storage instructions.

What should I do in case I miss a dose?

If you have missed a dose, apply it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular dosing schedule. It's not advisable to use a double dose to make up for the missed one.

Can this formulation be used with other medications?

It's always important to discuss your full medication list and any potential interactions with your healthcare provider. Certain drugs may interact with the active ingredients in this formulation, so it's crucial to provide your healthcare professional with this information.

How long does it take for this formulation to work?

The time taken for the formulation to work can vary between individuals and depends on the purpose of its application. However, on average, patients typically begin to experience relief within a few hours of application. Your healthcare provider will provide more specific guidance based on your individual circumstances.

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.

The conditions listed on this page are indications prescribers have ordered this preparation for. They are not FDA-approved indications, and listing them is not a statement that this preparation is effective for them.

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 HCl 2%/Clonidine HCl 0.1%/Ketamine HCl 4.6%/Ketoprofen 10%/Lidocaine 2% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)