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Amitriptyline 2%/Baclofen 2%/Clonidine 0.23%/Ibuprofen 5%/Ketamine 5.75%/Ketoprofen 5%/Lidocaine 5% Transdermal Gel

Customized at Bayview Pharmacy, this transdermal gel is compounded to help manage neuropathic pain, fibromyalgia, and chronic pain syndromes. Learn more today.
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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
Ibuprofen
Ketamine Hydrochloride
Ketoprofen
Lidocaine Hydrochloride
Baclofen
Topical Gel
652f485f818a160e1790cbfc

Formula Information

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This formulation is a compounded transdermal gel containing a combination of Amitriptyline 2%, Baclofen 2%, Clonidine 0.23%, Ibuprofen 5%, Ketamine 5.75%, Ketoprofen 5%, and Lidocaine 5%. 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 relief.

Amitriptyline is a tricyclic antidepressant that is used in this formulation for its analgesic properties, particularly in neuropathic pain. Baclofen is a muscle relaxant and antispastic agent that helps to relieve muscle spasms, tightness, and pain. Clonidine is an alpha-2 adrenergic agonist that can help with pain relief and has sedative properties. Ibuprofen and Ketoprofen are nonsteroidal anti-inflammatory drugs (NSAIDs) that reduce inflammation and pain in the body. Ketamine is a NMDA receptor antagonist that provides analgesic effects, particularly for neuropathic pain. Lidocaine is a local anesthetic that provides immediate relief from pain and discomfort by numbing the affected area.

This formulation is used to treat a variety of disease states. It can be used for the management of neuropathic pain conditions such as post-herpetic neuralgia, diabetic neuropathy, and complex regional pain syndrome. It can also be used for musculoskeletal pain conditions such as osteoarthritis, rheumatoid arthritis, and fibromyalgia. Additionally, it can be used for conditions that involve muscle spasms and tightness.

It is important to note that this is a compounded medication, meaning it is made specifically for you based on a prescription from your doctor. It is not a commercially available product and should only be used under the supervision of a healthcare provider. As with any medication, it may have potential side effects and interactions, so it is important to discuss these with your healthcare provider.

If you have any questions about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to help you understand your medication and how it can help you manage your health conditions.

Drug Interactions

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This formulation is a complex mixture of several active ingredients, each with its own potential for drug interactions. It is important to note that the risk of interactions may be lower with transdermal application compared to oral administration, as the drugs are not typically absorbed systemically in large amounts. However, interactions can still occur, particularly in patients with impaired skin barrier function or those using other medications that can affect the metabolism or action of these drugs.

Amitriptyline, a tricyclic antidepressant, can interact with a variety of medications. It can increase the effects of central nervous system depressants such as alcohol, benzodiazepines, and opioids, potentially leading to increased sedation and respiratory depression. It can also interact with other antidepressants, leading to an increased risk of serotonin syndrome. Additionally, amitriptyline can increase the heart rate effects of thyroid medications and decrease the effectiveness of blood pressure medications.

Baclofen, a muscle relaxant, can also increase the effects of central nervous system depressants. It can interact with antihypertensive drugs, potentially leading to an additive effect on lowering blood pressure. Additionally, it can interact with other muscle relaxants, potentially leading to increased muscle weakness.

Clonidine, an antihypertensive, can interact with beta-blockers, potentially leading to an additive effect on lowering blood pressure. It can also interact with central nervous system depressants, potentially leading to increased sedation. Additionally, abrupt discontinuation of clonidine while taking beta-blockers can lead to rebound hypertension.

Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), can interact with anticoagulants, potentially increasing the risk of bleeding. It can also interact with other NSAIDs, potentially leading to an increased risk of gastrointestinal bleeding. Additionally, it can decrease the effectiveness of antihypertensive drugs.

Ketamine, an NMDA receptor antagonist, can increase the effects of central nervous system depressants. It can also interact with other NMDA receptor antagonists, potentially leading to increased neurotoxicity.

Ketoprofen, another NSAID, has similar interactions to ibuprofen. It can increase the risk of bleeding when used with anticoagulants and can decrease the effectiveness of antihypertensive drugs.

Lidocaine, a local anesthetic, can interact with other local anesthetics, potentially leading to increased systemic absorption and toxicity. It can also interact with antiarrhythmic drugs, potentially leading to additive effects on the heart.

This formulation is used to treat a variety of disease states, including neuropathic pain, musculoskeletal pain, and inflammation. The combination of these drugs works to target different aspects of pain and inflammation, providing a comprehensive approach to treatment. However, due to the potential for drug interactions, it is important for patients and prescribers to be aware of all medications the patient is taking, including over-the-counter drugs and supplements. If you have any questions about this formulation or its potential interactions, please reach out to us at Bayview Pharmacy.

How Does it Work

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This formulation is a combination of seven active ingredients: Amitriptyline, Baclofen, Clonidine, Ibuprofen, Ketamine, Ketoprofen, and Lidocaine. Each of these ingredients plays a unique role in managing pain and inflammation, and their combined effect can provide significant relief for a variety of disease states.

Amitriptyline is a tricyclic antidepressant that works by increasing the levels of certain chemicals in the brain that help improve mood, pain threshold, and sleep. Baclofen is a muscle relaxer and an antispastic agent. It works by helping to relax the muscles. Clonidine is an alpha-2 adrenergic agonist that decreases pain signals sent to the brain.

Ibuprofen and Ketoprofen are nonsteroidal anti-inflammatory drugs (NSAIDs) that work by reducing hormones that cause inflammation and pain in the body. Ketamine is a NMDA receptor antagonist that provides pain relief by blocking the signals of pain from the nerves to the brain. Lidocaine is a local anesthetic that works by causing temporary numbness/loss of feeling in the skin and mucous membranes.

When applied topically in a gel form, these medications are absorbed through the skin directly to the area of pain. This targeted approach allows for a high concentration of medication to be delivered to the affected area, while minimizing systemic absorption and potential side effects. The gel is dispensed through a pump mechanism, which allows for easy and precise application.

This formulation can be used to treat a variety of disease states that involve pain and inflammation. These include, but are not limited to, neuropathic pain, fibromyalgia, musculoskeletal pain, and certain types of chronic pain. It can also be used to manage pain associated with conditions like multiple sclerosis and shingles.

It's important to note that while this formulation can provide significant relief, it's only one part of a comprehensive treatment plan. It should be used in conjunction with other therapies as recommended by a healthcare provider.

If you have any questions about this formulation, how it works, or how it can be used to treat specific conditions, please don't hesitate to reach out to us. We're here to help.

Other Uses

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Apart from the traditional use in pain management, this compounded formulation has potential efficacy in other medical scenarios as well. Specifically, it may be used as an adjunct therapy for neuropathic pain conditions such as phantom limb syndrome, post-herpetic neuralgia, and diabetic neuropathy. The presence of Amitriptyline, Baclofen, and Clonidine in the formulation suggests potential use in controlling muscle spasticity associated with spinal cord injuries or multiple sclerosis. Furthermore, the inclusion of Ibuprofen, Ketoprofen, and Ketamine suggests an application in reducing inflammation and providing analgesia in instances of acute or chronic musculoskeletal pain.

Additionally, this formulation may be used in difficult-to-treat pain scenarios where oral medications have failed or are not tolerated, like in cases of fibromyalgia or other chronic pain syndromes. Thanks to the transdermal application, patients who have difficulty swallowing or those who suffer from gastrointestinal intolerance may find this route particularly beneficial. Similarly, patients requiring long-term use of analgesics such as those with osteoarthritis could benefit from this formulation due to its non-systemic nature, which is likely to have a lower risk of side effects as compared to systemic treatments.

Furthermore, this gel can potentially be used to manage the pain of peripheral vascular disease and Raynaud's phenomenon, due to the vasodilatory effects of the active ingredients. Lastly, an emerging area of interest is in the management of specific dermatological issues, where it can be employed as a patient-friendly alternative to traditional medication regimens. For instance, the topical delivery of drugs may prove beneficial in conditions like erythromelalgia or burning mouth syndrome, due to the analgesic and anti-inflammatory properties of the formulation.

It is, however, crucial for physicians to remember that this compounded formulation is patient specific. Therefore, it should only be prescribed after careful consideration of the patient’s medical history, allergies, other medications and overall health status. For further questions or inquiries, feel free to reach out to us at Bayview Pharmacy. Our team of experts are always ready to assist.

Frequently Asked Questions

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What is Amitriptyline 2%/Baclofen 2%/Clonidine 0.23%/Ibuprofen 5%/Ketamine 5.75%/Ketoprofen 5%/Lidocaine 5% Transdermal Gel?

It is a compounded medication formulated as a semi-solid gel containing various active ingredients. The gel is dispensed through a pump mechanism and applied to the skin for targeted treatment or absorption of these ingredients.

What is the purpose of this compounded formulation?

Each component of this formulation is used to alleviate different types of pain and discomfort.

How is it applied?

The formulation is applied via a pump mechanism that allows easy and precise application. The gel should be spread gently onto the skin in the targeted area.

Is it safe to use with other medications?

As with all medications, it is important to discuss with your healthcare provider about other medications you are currently taking.

What are the expected side effects?

Side effects may vary depending on your body's response to the medication. Some common side effects may include skin irritation at the application site, itching, or redness. In case of any unusual symptoms or persistent side effects, seeking immediate medical attention is advised.

Can it be used on broken or irritated skin?

It is generally recommended to avoid using this medication on broken or irritated skin unless directed otherwise by a healthcare professional. Applying the formulation to damaged skin may lead to increased absorption of the medications, potentially enhancing the risk of side effects.

Can I stop using the medication abruptly?

No, discontinuation of the medication should be under the direction of your healthcare provider. Abrupt stoppage may lead to withdrawal symptoms or a return of symptoms. Consult a healthcare professional for a suitable tapering schedule if required.

Can this formulation be used during pregnancy?

Due to the combinations of medications in this formulation, it is crucial to seek advice from a healthcare provider if you are pregnant or planning to conceive. They can balance the risks and benefits to ensure the safest approach.

What should I do if I forget to apply the gel?

If you forget a dose, apply it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply a double dose to make up for the missed one.

How should I store this medication?

The medication should be stored in a cool, dry place away from direct sunlight. It should be kept out of reach of children and pets. Also, ensure the pump mechanism is clean and properly sealed after each use to protect the integrity of the gel.

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.

Related Formulas

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, NY, NJ, NH, FL, and ME. 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%/Baclofen 2%/Clonidine 0.23%/Ibuprofen 5%/Ketamine 5.75%/Ketoprofen 5%/Lidocaine 5% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)