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Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel

Customized at Bayview Pharmacy, our Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel may help manage chronic pain, osteoarthritis, and neuropathic pain.
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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.
Diclofenac Sodium
Ketamine Hydrochloride
Topical Gel
654eb07aeddbd7e30ecb3c92

Formula Information

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The Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel is a specialized medication designed for topical application. This semisolid formulation is dispensed through a pump mechanism, which ensures that patients can apply a consistent and precise dose of the medication directly to the affected area. The gel base provides a convenient medium for the transdermal delivery of the active ingredients, allowing for localized treatment with potential systemic benefits.

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. When applied topically, it is used to relieve pain from conditions such as osteoarthritis, especially in joints close to the skin surface, such as the knees and hands. Ketamine HCl, on the other hand, is an NMDA receptor antagonist with analgesic properties. In this formulation, it is used to provide additional pain relief, particularly for neuropathic pain, which is often resistant to other treatments.

The combination of Diclofenac Sodium and Ketamine HCl in a transdermal gel allows for the synergistic effects of both analgesic and anti-inflammatory action, which can be beneficial in treating various disease states characterized by pain and inflammation. This may include chronic conditions such as arthritis, localized musculoskeletal pain, or certain types of neuropathic pain. The transdermal route of administration offers the advantage of targeted therapy with a reduced risk of systemic side effects commonly associated with oral NSAIDs and systemic ketamine use.

Patients using this formulation should be advised on the proper application technique to maximize the therapeutic effects while minimizing potential adverse reactions. Prescribers considering this medication for their patients should evaluate the suitability based on the individual's specific condition, pain severity, and previous response to pain management strategies. It is important to note that while this formulation can provide significant relief, it should be used as part of a comprehensive pain management plan that may include physical therapy, lifestyle modifications, and other medications as necessary.

For more detailed information on the Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel, including pharmacokinetics, contraindications, potential side effects, and patient counseling points, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing in-depth knowledge and guidance to ensure the safe and appropriate use of this medication.

Drug Interactions

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The transdermal gel formulation containing Diclofenac Sodium 10% and Ketamine HCl 2.3% is designed for topical application and is intended to provide localized relief from pain and inflammation. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. Ketamine is an NMDA receptor antagonist that has been found to provide analgesic effects, particularly in neuropathic pain states. When used together in a transdermal gel, these medications may offer synergistic effects for the management of chronic pain conditions such as arthritis, neuropathic pain, and musculoskeletal pain.

When considering drug interactions, it is important to note that while the systemic absorption of diclofenac and ketamine from a transdermal gel is lower than oral or parenteral routes, interactions can still occur. Diclofenac, being an NSAID, may increase the risk of bleeding when combined with anticoagulants such as warfarin, antiplatelet agents like aspirin, or selective serotonin reuptake inhibitors (SSRIs). It may also reduce the effectiveness of antihypertensive drugs, including ACE inhibitors, angiotensin receptor blockers, beta-blockers, and diuretics. Concurrent use with other NSAIDs or corticosteroids can increase the risk of gastrointestinal ulceration or bleeding. Additionally, diclofenac may increase serum potassium levels, so caution is advised when used with potassium-sparing diuretics or supplements.

Ketamine may interact with central nervous system (CNS) depressants, including alcohol, benzodiazepines, opioids, and barbiturates, potentially leading to increased sedation, respiratory depression, and decreased CNS function. It is also important to be cautious when using ketamine with other drugs that increase blood pressure or heart rate, as ketamine itself can cause these effects. Monoamine oxidase inhibitors (MAOIs) should be avoided due to the risk of hypertensive crisis or serotonin syndrome when combined with ketamine.

Patients should be advised to inform their healthcare providers of all medications they are taking, including prescription drugs, over-the-counter medications, and herbal supplements, to avoid potential interactions. Prescribers should review the patient's medication history to assess for any possible drug interactions and adjust therapy as needed. Monitoring for signs of adverse effects, such as gastrointestinal bleeding, changes in blood pressure, or CNS depression, is recommended when using this transdermal gel formulation.

It is also important to consider that the application site of the transdermal gel should not be exposed to heat or occlusive dressings, as this may increase the systemic absorption of the active ingredients, potentially leading to increased risk of systemic side effects or interactions. Patients should be instructed on the proper use of the pump mechanism and the correct application of the gel to ensure safety and efficacy.

If you have any questions or require further information regarding the use of this transdermal gel formulation, including potential drug interactions and their management, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is available to provide the necessary support and guidance to both patients and prescribers.

How Does it Work

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The Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel is a specialized medication designed for topical application to provide pain relief directly at the site of discomfort. This semisolid formulation is dispensed through a pump mechanism, which allows for easy and precise dosing. The gel base facilitates the transdermal delivery of the active ingredients, ensuring that they are absorbed through the skin to reach the targeted tissues.

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting the cyclooxygenase (COX) enzymes, which are involved in the synthesis of prostaglandins. Prostaglandins are lipid compounds that play a key role in the inflammation process. By reducing their production, diclofenac sodium effectively decreases inflammation and pain in the affected area. This makes it particularly useful for treating localized musculoskeletal conditions, such as sprains, strains, and arthritis-related pain.

Ketamine HCl, on the other hand, is an N-methyl-D-aspartate (NMDA) receptor antagonist. By blocking these receptors, ketamine can modulate pain signaling pathways, providing analgesic effects. This action is beneficial for neuropathic pain, which is often resistant to other pain medications. The inclusion of ketamine in this formulation aims to address the complex nature of chronic pain, which may involve both inflammatory and neuropathic components.

The combination of diclofenac sodium and ketamine HCl in a transdermal gel allows for synergistic effects in pain management. The transdermal route offers the advantage of localized treatment, minimizing systemic absorption and potential side effects associated with oral administration of these drugs. The gel consistency ensures that the medication stays in place, providing a sustained release of the active ingredients over time.

Patients and prescribers should note that this formulation is intended for use under medical supervision and should be applied as directed to the affected area. It is important to follow the prescribed dosing regimen to achieve optimal therapeutic outcomes. The pump mechanism of the dispenser helps in administering a consistent dose with each application, which is crucial for maintaining the desired drug concentration at the site of action.

For any questions or further information regarding the Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing comprehensive support and guidance to both patients and healthcare providers.

Other Uses

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Beyond its primary indication for the management of pain and inflammation associated with musculoskeletal disorders, the Diclofenac Sodium 10%/Ketamine HCl 2.3% transdermal gel formulation may have other therapeutic applications. Patients and prescribers have sometimes found it useful in the treatment of localized neuropathic pain, such as that associated with certain neuropathies or complex regional pain syndrome. The anti-inflammatory properties of diclofenac combined with the NMDA receptor antagonism of ketamine could potentially provide symptomatic relief in these conditions, which are often characterized by abnormal pain perception. However, it is important to note that such use may be off-label and should be considered only after a thorough evaluation by a healthcare professional.

Furthermore, the ketamine component has been studied for its possible role in reducing the sensation of pruritus, which can be a bothersome symptom in various dermatological conditions. While not its primary purpose, relief of itch may be a secondary benefit for some patients using this formulation. Moreover, ketamine's potential mood-stabilizing and antidepressant effects are being investigated in various routes of administration, though the clinical relevance of these effects via transdermal application remains uncertain and application for mental health conditions is not established.

Prescribers are encouraged to consider this transdermal formulation as an alternative in cases where systemic side effects of oral NSAIDs or ketamine pose a concern, or when gastrointestinal intolerance limits the use of oral diclofenac. The targeted application may improve patient adherence and allow for direct delivery to the affected area which may potentially enhance therapeutic outcomes. Nevertheless, prescribers should weigh the benefits against risks such as potential skin irritation or systemic absorption, especially in patients with sensitive skin or those receiving other medications that may interact with the components of this gel. It is critical to use this medication under the guidance and prescription of a healthcare provider, and patients should report any unusual side effects or lack of improvement to their prescriber.

It is worth acknowledging that all potential applications of this transdermal gel may not be well-established through rigorous clinical trials, and its efficacy can vary among individuals. Patients interested in exploring alternative uses of the Diclofenac Sodium 10%/Ketamine HCl 2.3% transdermal gel should engage in an informed discussion with their healthcare provider. Prescribers should always consider the evidence base, clinical guidelines, and individual patient factors when recommending this formulation for conditions beyond those for which it is typically prescribed. If you have further questions about the possible uses of this transdermal gel or if it may be suitable for your circumstances, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing accurate information and quality care to our patients and can offer personalized advice and support for your medication needs.

Frequently Asked Questions

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What is Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel used for?

This medication is commonly prescribed for the relief of localized pain and inflammation. The combination of diclofenac sodium and ketamine HCl may provide synergistic effects to reduce pain in the applied area.

How should I use this transdermal gel?

To use the gel, apply it to the affected area as directed by your healthcare provider. The pump mechanism allows for easy and precise dosing. Gently rub the gel into the skin for maximum absorption.

Can this transdermal gel be used for any type of pain?

This medication should be used specifically for the conditions recommended by your healthcare provider, typically for localized pain and inflammation. It may not be suitable for all types of pain, so it is essential to follow their guidance.

How often should I apply the gel?

The frequency of application will depend on your healthcare provider's instructions. Do not apply more often than prescribed as this could increase the risk of side effects.

Are there any side effects associated with Diclofenac Sodium/Ketamine HCl Transdermal Gel?

As with any medication, side effects are possible. Common side effects may include local skin irritation, redness, or itching. If you experience any severe reactions or signs of systemic absorption, contact your healthcare provider immediately.

Can this gel be applied with other medications?

Before using this gel with other medications, especially other topical treatments, consult with your healthcare provider to avoid potential interactions.

Should I cover the area after applying the gel?

Your healthcare provider will advise whether you should cover the treated area. In some cases, leaving the area uncovered to let the gel absorb is recommended, while in other situations, you might be instructed to use a dressing.

What should I do if I miss a dose?

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

Can I use this gel for a prolonged period?

The duration of use should be as recommended by your healthcare provider. Using the gel for extended periods without medical advice is not encouraged due to the potential risk of side effects with long-term use.

Can I apply this medication to broken or irritated skin?

You should avoid applying the gel to broken skin, open wounds, or areas with active skin irritation. If you’re uncertain about whether you should apply it, consult your healthcare provider for guidance.

What should I do in case of an accidental ingestion or overdose?

In the event of accidental ingestion or if you suspect an overdose, seek immediate medical attention or contact a poison control center right away.

How should I store the gel?

Keep the gel at room temperature, away from heat and direct light, and ensure the cap of the pump is closed tightly to maintain the integrity of the medication. Keep it out of reach of children and pets.

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.

Diclofenac Sodium 10%/Ketamine HCl 2.3% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)