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Baclofen 5%/Diclofenac 10%/Ketamine HCl 11.5% Transdermal Gel

This formulation is a semisolid transdermal gel containing Baclofen 5%, Diclofenac 10%, and Ketamine HCl 11.5%. 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 Baclofen component is a muscle relaxant and antispastic agent, used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that reduces substances in the body that cause pain and inflammation. It is commonly used to treat mild to moderate pain, or signs and symptoms of osteoarthritis or rheumatoid arthritis. Ketamine HCl is a potent analgesic used for the management of severe, chronic pain.

Together, these active ingredients work synergistically to provide relief from various disease states, including muscle spasms, pain, stiffness, osteoarthritis, rheumatoid arthritis, and other conditions associated with severe, chronic pain.

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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, NY, NJ, NH, FL and ME.
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, NY, NJ, NH, FL and ME.

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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.
Ketamine Hydrochloride
Baclofen
Diclofenac Sodium
Topical Gel
65357023cab6fb121b18cdf3

Formula Information

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This formulation is a combination of Baclofen 5%, Diclofenac 10%, and Ketamine HCl 11.5% in a transdermal gel. It is a semisolid formulation that 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 for targeted treatment.

Baclofen is a muscle relaxant and antispastic agent. It works by reducing the frequency and severity of muscle spasms caused by certain medical conditions. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. Ketamine HCl is a potent analgesic that provides relief from severe pain by blocking certain receptors in the brain.

It can be used to manage severe chronic pain, especially in conditions like fibromyalgia, neuropathic pain, and musculoskeletal pain. It can also be used to treat spasticity and muscle spasms in conditions like multiple sclerosis and spinal cord injury. The transdermal application allows for targeted treatment, reducing systemic side effects and improving patient compliance.

Patients using this formulation should apply it as directed by their healthcare provider, usually to the affected area 3-4 times daily. It's important to wash hands after applying unless hands are the area being treated. Avoid contact with eyes, nose, mouth, and other sensitive areas. If irritation or adverse effects occur, discontinue use and consult your healthcare provider.

Prescribers should consider the patient's overall health status, other medications, and potential drug interactions when prescribing this formulation. Regular monitoring may be necessary to assess the patient's response to treatment and adjust the dosage if necessary. As with all medications, the benefits of treatment should be weighed against the potential risks.

If you have any questions about this formulation or its use in treating specific disease states, please don't hesitate to reach out to us. Our team of knowledgeable compounding pharmacists at Bayview Pharmacy is always here to help.

Drug Interactions

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This compounded formulation contains three active ingredients: Baclofen, Diclofenac, and Ketamine HCl. Each of these medications can interact with other drugs, potentially altering their effects or increasing the risk of adverse reactions. It's important to inform your healthcare provider of all medications you are currently taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements.

Baclofen, a muscle relaxant and antispastic agent, may interact with other central nervous system (CNS) depressants such as opioids, benzodiazepines, and alcohol, potentially leading to increased sedation or respiratory depression. Concurrent use with antihypertensive drugs may result in additive hypotensive effects.

Diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), may interact with anticoagulants, antiplatelet drugs, and other NSAIDs, increasing the risk of bleeding. It may also reduce the effectiveness of certain antihypertensive drugs and diuretics. Concurrent use with lithium or methotrexate can increase the levels of these drugs, potentially leading to toxicity. Diclofenac should be used with caution in patients taking cyclosporine or other hepatotoxic drugs, as it may increase the risk of liver damage.

Ketamine HCl, an NMDA receptor antagonist, may interact with other CNS depressants, potentially leading to increased sedation or respiratory depression. It may also interact with monoamine oxidase inhibitors (MAOIs), potentially leading to a hypertensive crisis. Concurrent use with amphetamines may increase the risk of cardiovascular side effects.

This transdermal gel formulation is designed for targeted treatment or absorption of active ingredients, potentially reducing systemic exposure and the risk of drug interactions. However, systemic absorption can still occur, especially if the gel is applied over large skin areas or used for prolonged periods. Therefore, it's important to use this medication as directed by your healthcare provider.

This formulation is commonly used to manage pain and inflammation associated with various conditions, such as arthritis, muscle spasms, and neuropathic pain. Baclofen helps to relax muscles and reduce spasms, Diclofenac helps to reduce inflammation and pain, and Ketamine HCl helps to block pain signals in the nervous system. The combined effects of these medications can provide significant relief for patients suffering from these conditions.

If you have any questions about this formulation or its potential interactions with other drugs, please don't hesitate to reach out to us.

How Does it Work

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The Baclofen 5%/Diclofenac 10%/Ketamine HCl 11.5% Transdermal Gel is a unique formulation that combines three active ingredients, each with its own mechanism of action, to provide targeted relief from pain and inflammation. This formulation is designed to be applied topically, directly to the skin, where it is absorbed into the body to exert its therapeutic effects.

Baclofen is a muscle relaxant and antispastic agent. It works by inhibiting the transmission of nerve signals, thereby reducing muscle spasms, tightness, and pain. In this formulation, baclofen is used to help alleviate muscle pain and stiffness associated with conditions such as multiple sclerosis and spinal cord injuries.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. It is commonly used to treat mild to moderate pain, or signs and symptoms of osteoarthritis or rheumatoid arthritis. In this formulation, diclofenac is used to reduce inflammation and pain in the area where the gel is applied.

Ketamine HCl is a powerful anesthetic that works by blocking the NMDA receptor, a type of glutamate receptor in the brain and spinal cord. This action inhibits the transmission of pain signals to the brain, providing potent analgesic effects. In this formulation, ketamine HCl is used to provide deep, long-lasting pain relief.

The transdermal gel formulation allows for targeted application and absorption of these active ingredients. The gel is dispensed through a pump mechanism, which facilitates easy and precise application. The gel-like consistency ensures that the medication stays in place, allowing for optimal absorption through the skin and into the affected area.

This formulation is particularly useful in treating disease states that involve pain and inflammation, such as arthritis, neuropathic pain, and muscle spasms. By combining three active ingredients with different mechanisms of action, this formulation provides comprehensive pain relief, reducing both the sensation of pain and the underlying inflammation that often contributes to it.

If you have any questions about this formulation, how it works, or how it can be used to treat specific disease states, please don't hesitate to reach out to us. Our team of knowledgeable compounding pharmacists at Bayview Pharmacy is always here to help.

Other Uses

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This unique formulation of Baclofen 5%/Diclofenac 10%/Ketamine HCl 11.5% Transdermal Gel isn't limited to just one type of therapeutic application. Although it is most commonly recommended for patients with neuropathic pain and inflammation, it has potential for use in other areas of medical treatment as well.

Baclofen is traditionally used to relax muscles and relieve pain caused by spasms, particularly in cases of multiple sclerosis or certain types of spinal injuries. Consequently, the inclusion of Baclofen in the gel can make it a compelling topical therapy for muscle-related discomforts, such as those associated with fibromyalgia, strains or sprains.

Consequently, this formulation can be applied for arthritis, migraines, and even postoperative pain relief. Its topical application means less systemic exposure and potential side effects, making it safer for patients with certain comorbidities.

Ketamine HCl is a powerful anesthetic and analgesic and its incorporation within this gel formulation allows for targeted numbing and pain relief-- potentially advantageous for instances like postherpetic neuralgia (PHN), complex regional pain syndrome (CRPS), or other forms of localized chronic or acute pain.

It's also important to note that the gel form facilitation of this medication opens up applications where an oral route may not be suitable, for individuals experiencing nausea, vomiting, or having trouble swallowing.

In summary, while this formulation is primarily used for neuropathic pain and inflammation, it has a wide range of potential uses, including but not limited to fibromyalgia, arthritis, migraines, postoperative pain relief, PHN, CRPS, and other forms of localized chronic or acute pain. As always, individual patient needs and circumstances would dictate suitability, and a patient's healthcare provider should be consulted before the initiation of any new medication regimen. If you have any questions regarding this formulation, don't hesitate to reach out to our team at Bayview Pharmacy.

Frequently Asked Questions

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What is the Baclofen 5%/Diclofenac 10%/Ketamine HCl 11.5% Transdermal Gel?

This is a compounded formulation combining Baclofen, Diclofenac and Ketamine HCl in a semisolid form. It is purposefully delivered through a pump mechanism that ensures easy and precise application on the skin.

What does the compounded formulation do?

This formulation is designed for topical application facilitating the absorption of active ingredients directly through the skin to provide targeted treatment.

How should this transdermal gel be applied?

Use the pump mechanism attached to the bottle to dispense the gel onto your skin. Apply it directly over the affected area for targeted treatment.

Does the gel have a specific consistency?

Yes, the gel is semisolid and has a gel-like consistency which makes it easy to apply and maximizes contact with the skin to promote absorption.

How does the pump mechanism assist in application?

The pump facilitates easy dispensing of the gel. It also helps in maintaining hygiene and reduces wastage by dispensing a precise volume of gel.

Can this gel be used for all skin types?

Generally, it's safe for all skin types. However, if you have sensitive skin or any specific skin condition, consult your doctor before using it.

What are the active ingredients in the gel?

The active ingredients in this transdermal gel are Baclofen, Diclofenac, and Ketamine HCl.

What is the purpose of each active ingredient?

Baclofen is a muscle relaxer and anti-spasmodic agent, Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) for reducing pain and inflammation, and Ketamine HCl is used for inducing anesthesia, as it can produce an analgesic effect.

Are there any side effects of using this gel?

Like any medication, this gel may have side effects, which can range from mild to severe and include skin rash or irritation. For any unexpected effects, consult your healthcare professional immediately.

How should this transdermal gel be stored?

The gel should be stored away from direct sunlight and heat, and ideally in a cool, dry place. Also, the gel should be kept out of reach from children.

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, 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.

Baclofen 5%/Diclofenac 10%/Ketamine HCl 11.5% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)