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Ketamine HCl 15%/Lidocaine 10%/Morphine HCl 3% Transdermal Gel

Ketamine HCl 15%/Lidocaine 10%/Morphine HCl 3% Transdermal Gel is a customized, compounded treatment from Bayview Pharmacy for chronic pain, neuropathic pain, and diabetic neuropathy.
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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
Morphine Hydrochloride
Lidocaine Hydrochloride
Topical Gel
65aea42ae8b71c8f67fb2a9b

Formula Information

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The Ketamine HCl 15%/Lidocaine 10%/Morphine HCl 3% Transdermal Gel is a compounded medication designed to deliver potent analgesic effects through the skin. This semisolid formulation is dispensed through a pump mechanism, which ensures easy and precise dosing. The gel base allows for the medication to be spread smoothly over the affected area, providing targeted relief from pain.

Ketamine, an NMDA receptor antagonist, works by blocking pain signals in the central nervous system and has been shown to reduce pain sensitivity. Lidocaine, a local anesthetic, provides immediate relief by numbing the area to which it is applied, blocking the pain signals at the peripheral level. Morphine, a potent opioid analgesic, binds to opioid receptors in the brain and spinal cord, altering the perception of pain. The transdermal route of administration allows for a steady absorption of these medications, leading to sustained pain relief without the peaks and troughs often associated with oral or parenteral administration.

This formulation is particularly useful for patients who have difficulty with oral administration or those who require a localized effect to avoid systemic side effects. It is also beneficial for patients with conditions that necessitate long-term pain management strategies. The use of a transdermal gel allows for the medication to be applied directly to the site of pain, which can result in faster onset of action and reduction in pain intensity.

It is important for prescribers to consider the individual patient's pain management needs, potential interactions with other medications, and the patient's overall health profile when prescribing this compound. Patients should be instructed on the proper use of the pump mechanism to ensure accurate dosing and should be advised on the importance of applying the gel to clean, intact skin. They should also be made aware of the potential side effects of each active ingredient, including but not limited to drowsiness, dizziness, or skin irritation at the site of application.

As compounding pharmacists at Bayview Pharmacy, we are committed to providing high-quality, customized medications to meet the specific needs of our patients. We are available to answer any questions and provide guidance to both patients and prescribers regarding the use of this Ketamine/Lidocaine/Morphine transdermal gel formulation. Please reach out to us for further information or to discuss the suitability of this medication for your pain management regimen.

Drug Interactions

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The combination of Ketamine HCl, Lidocaine, and Morphine HCl in a transdermal gel formulation is designed to provide pain relief through the skin. Each of these active ingredients has its own mechanism of action and potential drug interactions that should be considered when prescribing or using this medication.

Ketamine is an NMDA receptor antagonist that can provide analgesia and has been used in various pain management protocols. It is metabolized primarily by the liver's cytochrome P450 enzymes, particularly CYP3A4. Therefore, drugs that induce or inhibit CYP3A4 may affect the metabolism of ketamine. For example, certain anticonvulsants (like phenytoin) and antibiotics (such as rifampin) can increase the metabolism of ketamine, potentially reducing its efficacy. Conversely, CYP3A4 inhibitors like ketoconazole can increase ketamine levels, raising the risk of side effects.

Lidocaine is a local anesthetic and antiarrhythmic agent that works by blocking sodium channels. It is also metabolized by the liver, and its clearance can be affected by drugs that affect liver enzymes, particularly CYP1A2 and CYP3A4. Drugs that inhibit these enzymes, such as cimetidine and fluvoxamine, may increase lidocaine levels and the risk of systemic toxicity. Additionally, combining lidocaine with other local anesthetics or medications that affect cardiac conduction can increase the risk of cardiac side effects.

Morphine is an opioid agonist that provides analgesia by acting on the central nervous system. It is metabolized by glucuronidation in the liver, and drugs that affect glucuronidation can alter morphine levels. For example, drugs that induce glucuronidation, such as rifampin, may decrease morphine's effectiveness, while inhibitors can increase the risk of morphine toxicity. Additionally, combining morphine with other central nervous system depressants, such as benzodiazepines or alcohol, can increase the risk of respiratory depression and sedation.

When using this transdermal gel, it is important to consider the cumulative effects of the three active ingredients, as they can all cause central nervous system depression. The risk of sedation, respiratory depression, and hypotension is increased when this medication is combined with other drugs that depress the CNS, including alcohol, benzodiazepines, muscle relaxants, and other opioids. Caution is advised when prescribing this medication to patients who are taking such drugs.

Additionally, because this formulation is applied transdermally, there may be interactions with topical agents that could affect the absorption or local metabolism of the active ingredients. It is important to avoid applying other topical medications or occlusive dressings over the area where the gel is applied unless specifically directed by a healthcare provider.

Patients should be monitored for signs of systemic toxicity, particularly if they have conditions that affect drug metabolism, such as liver or kidney disease. Prescribers should also be aware of the potential for abuse and dependence due to the presence of morphine, an opioid, in the formulation.

It is crucial for prescribers and patients to provide a complete list of all medications, including over-the-counter drugs and supplements, to the pharmacist to avoid potential drug interactions. If you have any questions or require further information regarding this formulation and its interactions, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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The Ketamine HCl 15%/Lidocaine 10%/Morphine HCl 3% Transdermal Gel is a specialized medication designed for transdermal delivery, meaning it is absorbed through the skin to provide localized or systemic therapeutic effects. This semisolid formulation is dispensed through a pump mechanism, which allows for easy and precise application. The gel-like consistency ensures that the medication stays in place on the skin, facilitating the absorption of the active ingredients.

Ketamine HCl, or ketamine hydrochloride, is an NMDA receptor antagonist that provides analgesic effects and has been shown to have a role in the management of chronic pain. In this transdermal formulation, ketamine is used to help reduce the sensation of pain by blocking the NMDA receptors in the central nervous system, which are involved in pain transmission. This can be particularly beneficial for patients with neuropathic pain or those who have not responded well to other pain management therapies.

Lidocaine is a local anesthetic and antiarrhythmic drug that works by blocking sodium channels, thereby preventing the generation and conduction of nerve impulses.

Morphine HCl, or morphine hydrochloride, is a potent opioid analgesic that acts on the central nervous system to relieve severe pain. It binds to opioid receptors in the brain and spinal cord, altering the perception of and response to pain. In a transdermal gel, morphine can provide continuous pain relief over an extended period, which can be particularly helpful for patients with chronic pain conditions.

The combination of these three active ingredients in a transdermal gel allows for a multimodal approach to pain management, targeting different pain pathways and providing both immediate and sustained relief. This can be especially useful for patients with complex or refractory pain syndromes. The transdermal route of administration also offers the advantage of avoiding gastrointestinal side effects and providing consistent plasma levels of the drugs without the peaks and troughs associated with oral administration.

This formulation is intended for use under the guidance of a healthcare professional experienced in the use of potent analgesics. It is important to follow the prescribed dosing regimen and to apply the gel to intact skin only. The use of this medication should be closely monitored due to the potential for systemic absorption and the risk of side effects associated with opioids and other central nervous system depressants.

If you have any questions about this formulation or its appropriate use, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide you with the information and support you need to ensure appropriate treatment for your patients.

Other Uses

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The formulation of Ketamine HCl 15%/Lidocaine 10%/Morphine HCl 3% in a transdermal gel is primarily designed for the management of chronic and acute pain that may not be adequately controlled by other analgesics. However, its combination of ingredients lends it to several off-label or other potential uses, primarily stemming from the individual properties of each active compound. For instance, ketamine is known not only for its analgesic properties but also for its potential as an antidepressant, particularly in cases where patients suffer from treatment-resistant depression. The rapid action observed with certain formulations of ketamine could imply potential benefits in the management of acute episodes of severe depression when applied in this transdermal system, although clinical data may be limited and further research is necessary.

Lidocaine, as a local anesthetic, adds to the analgesic properties of the gel but also serves to alleviate local sensations of itchiness or irritation that may be unresponsive to other treatments. Such a feature could be useful in certain dermatological conditions where pain and pruritus are significant symptoms. In addition, its inclusion could potentially moderate the sensations associated with neuropathic pain, affording patients comfort beyond conventional pain management strategies.

Morphine, which is a potent opioid analgesic, adds a strong pain-relief component to the gel that aids in the management of intense pain states. Morphine has been widely used in palliative care for its efficacy in severe pain, and as such, this transdermal formulation may be of use in palliative settings where oral administration of drugs is impracticable or undesirable, and steady absorption through the skin can provide more consistent pain relief.

It should be noted that the use of this transdermal gel for any indications other than those approved requires careful consideration by a healthcare professional due to the potential for serious side effects and the risk of abuse given the opioid content. Additionally, this gel’s application may be investigated for synergistic effects, where the combination of ketamine, lidocaine, and morphine may provide a cumulative benefit that exceeds the sum of their individual effects, particularly in complex pain syndromes that have a neuropathic component.

Prescribers considering this formulation for other uses should do so with circumspection and in accordance with the latest clinical guidelines and evidence. Patients using this gel should be closely monitored for efficacy as well as for any adverse reactions, especially considering the psychoactive and addictive potential inherent in some of the constituents. If there are any questions about this formulation or its potential other uses, please do not hesitate to reach out to us at Bayview Pharmacy for further information and guidance. We are here to support both patients and healthcare providers with expert knowledge on the safe and appropriate use of compounded medications.

Frequently Asked Questions

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What is the purpose of this compounded transdermal gel?

This transdermal gel is designed to deliver a combination of Ketamine HCl, Lidocaine, and Morphine HCl through the skin to provide localized relief from pain. It may be prescribed for patients who require medication for chronic pain conditions when other treatments have not been effective or in situations where oral administration is not desirable.

How do I use the transdermal gel?

Apply the gel as instructed by your healthcare provider. Typically, it is applied to a clean, intact area of skin free of any cuts or abrasions. Use the pump mechanism to dispense the prescribed amount of gel, and gently rub it into the skin until it is fully absorbed.

How often should I apply the gel?

The frequency of application will be determined by your healthcare provider based on your individual needs and response to the medication. Do not alter the dosing schedule without consulting your doctor.

What side effects can occur with this transdermal gel?

Possible side effects include local skin irritation, dizziness, drowsiness, nausea, and changes in blood pressure. If you experience any severe side effects or signs of an allergic reaction, contact your healthcare provider immediately.

Can I cover the area after applying the gel?

After applying the gel, wait until the area is completely dry before covering it with any clothing or bandages. Your healthcare provider may give you specific instructions depending on your unique treatment plan.

What should I do if I miss a dose?

If you miss a dose, apply the gel as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and return to your regular application schedule. Do not apply extra gel to make up for a missed dose.

Is it safe to use this gel while pregnant or breastfeeding?

The safety of this medication during pregnancy or breastfeeding has not been fully established. Please consult with your healthcare provider to discuss the potential risks and benefits before using this transdermal gel.

How should I store the transdermal gel?

Keep the gel at room temperature, away from heat and direct light, and out of reach of children and pets. Do not freeze the gel. Dispose of any unused or expired gel according to your healthcare provider's instructions or the appropriate disposal guidelines.

Can I shower or swim after applying the gel?

Avoid showering, bathing, or swimming immediately after applying the gel to ensure the medication has time to be absorbed. Your healthcare provider will give you more specific guidelines regarding wait times for water activities.

What should I avoid while using this transdermal gel?

Avoid applying heat to the treated area, as it may increase absorption and the risk of side effects. Also, avoid using other topical products on the same area without your healthcare provider's advice. It is important to avoid driving or operating heavy machinery if you experience drowsiness or dizziness after using this medication.

What happens if I apply too much gel?

If you have applied an excessive amount of gel or suspect an overdose, contact your healthcare provider or seek emergency medical attention immediately. Overdose symptoms may include extreme drowsiness, slow breathing, fainting, or seizure.

Can this gel interact with other medications?

Yes, this transdermal gel may interact with other medications, especially those affecting the central nervous system, such as sedatives, muscle relaxants, and other pain medications. Always inform your healthcare provider of all medications and supplements you are currently taking to determine any possible interactions.

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.

Ketamine HCl 15%/Lidocaine 10%/Morphine HCl 3% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)