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Ketamine HCl 10%/Lidocaine HCl 4% Transdermal Gel

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

The Ketamine HCl 10%/Lidocaine HCl 4% Transdermal Gel is a specialized medication designed for the management of neuropathic pain and chronic pain conditions. This semisolid formulation is dispensed through a pump mechanism, which allows for easy and precise application directly to the skin. The gel-like consistency ensures that the active ingredients, ketamine and lidocaine, are absorbed at the site of pain for targeted relief. Ketamine, an NMDA receptor antagonist, and lidocaine, a local anesthetic, work synergistically to reduce pain signaling and provide analgesic effects. This transdermal gel is particularly useful for patients who require localized pain management without the systemic side effects associated with oral medications.

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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
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HSA and FSA eligible
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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.
Ketamine Hydrochloride
Lidocaine Hydrochloride
Topical Gel
65ae8f5ec516b6f45f6bb9f8
Service area

Can we ship this formula to your state?

Bayview fills prescriptions for patients in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, Pennsylvania and Rhode Island. New York patients are served on a limited basis while nonresident pharmacy registration is pending.

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Formula Information

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Ketamine HCl 10%/Lidocaine HCl 4% Transdermal Gel is a compounded medication designed for topical application. 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, ketamine and lidocaine, directly to the site of pain or discomfort. Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist, has been shown to provide analgesic effects, particularly in neuropathic pain conditions. Lidocaine, a local anesthetic, works by blocking sodium channels, thereby reducing pain signaling at the peripheral level. The combination of these two agents in a transdermal gel form offers a synergistic approach to pain management, potentially reducing the need for systemic analgesics.

This formulation is particularly useful in the management of chronic pain syndromes, including neuropathic pain, complex regional pain syndrome (CRPS), and fibromyalgia. It may also be beneficial for patients experiencing localized pain from conditions such as postherpetic neuralgia or musculoskeletal disorders. The transdermal route of administration provides a targeted therapy with a lower risk of systemic side effects compared to oral medications. Additionally, the gel formulation is designed to minimize skin irritation and is suitable for patients who may have difficulties with oral dosing or those who require localized pain relief.

Patients and prescribers should be aware that this is a customized medication prepared in a compounding pharmacy, and its use should be based on a thorough evaluation of the patient's medical history and current medications to avoid potential drug interactions. The efficacy and safety profile of this compounded formulation are based on the known pharmacological actions of the individual ingredients, and its use should be monitored by a healthcare professional. For any questions or concerns regarding this formulation, or to discuss its appropriateness for specific patients, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is available to provide additional information and support to ensure optimal treatment outcomes.

Drug Interactions

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The combination of Ketamine HCl 10% and Lidocaine HCl 4% in a transdermal gel is designed to provide analgesic effects when applied topically. Ketamine is an NMDA receptor antagonist that can help manage pain by reducing central sensitization, while Lidocaine is a local anesthetic that blocks sodium channels, leading to a decrease in pain signaling. This formulation is often used for the management of neuropathic pain, localized chronic pain, and in some cases, for the symptomatic relief of certain types of dermatological pain syndromes.

When considering the use of this transdermal gel, it is important to be aware of potential drug interactions. Ketamine is metabolized primarily by the cytochrome P450 enzyme CYP3A4. Therefore, concomitant use with strong inhibitors of CYP3A4 (such as clarithromycin, ketoconazole, or ritonavir) may increase plasma concentrations of ketamine, potentially leading to enhanced effects and side effects. Conversely, strong inducers of CYP3A4 (such as rifampin, carbamazepine, or phenytoin) may decrease ketamine levels, reducing its efficacy.

Lidocaine is also metabolized by cytochrome P450 enzymes, including CYP1A2 and CYP3A4. Similar interactions as those described for ketamine may occur with lidocaine. Additionally, caution should be exercised when lidocaine is used with other local anesthetics or antiarrhythmic drugs due to the additive systemic effects on cardiac conduction and potential toxicity.

Both ketamine and lidocaine may have CNS depressant effects, which can be potentiated when used with other CNS depressants such as opioids, benzodiazepines, or alcohol. This can increase the risk of sedation, respiratory depression, and other CNS-related side effects. Patients should be advised to avoid or limit the use of alcohol and other CNS depressants while using this medication.

It is also important to consider the potential for additive or synergistic effects on blood pressure when ketamine is used with antihypertensive medications or substances that can alter blood pressure. Blood pressure should be monitored, and dosage adjustments may be necessary.

Given the complexity of drug interactions, prescribers should review the patient's current medication regimen in detail to identify any potential interactions before prescribing this transdermal gel. Patients should be instructed to inform their healthcare provider of all medications they are taking, including over-the-counter drugs, herbal supplements, and vitamins, to ensure safe use of this formulation.

For any questions or concerns regarding this formulation or its potential drug interactions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is available to provide guidance and support to ensure the safe and appropriate use of this medication.

How Does it Work

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The Ketamine HCl 10%/Lidocaine HCl 4% Transdermal Gel is a specialized medication designed for topical application to provide localized relief from pain. This formulation combines two potent anesthetics: ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist, and lidocaine, a sodium channel blocker. When applied to the skin, this gel works by penetrating the dermal layers to reach the underlying tissues where pain receptors are located.

Ketamine, as part of this compound, works by blocking the NMDA receptors in the central nervous system. This action inhibits the transmission of pain signals to the brain, thereby reducing the sensation of pain. Ketamine's role in this formulation is particularly beneficial for neuropathic pain, which is often resistant to other types of pain medication. By targeting the NMDA receptors, ketamine can help alleviate the complex mechanisms involved in neuropathic pain syndromes.

This blockade prevents the initiation and conduction of nerve impulses, leading to a temporary loss of sensation in the applied area.

The combination of ketamine and lidocaine in a transdermal gel allows for a synergistic effect, enhancing the analgesic properties of each drug while minimizing systemic absorption and potential side effects. This makes the formulation an excellent choice for patients experiencing localized pain, such as that associated with conditions like neuropathies, post-herpetic neuralgia, or complex regional pain syndrome (CRPS).

The semisolid formulation of this gel is designed to be dispensed through a pump mechanism, which ensures a consistent and measured dose with each application. This delivery system allows patients to apply the medication directly to the affected area, providing targeted relief. The gel-like consistency facilitates absorption through the skin, ensuring that the active ingredients reach the site of pain without the need for systemic distribution that could lead to unwanted side effects.

For prescribers considering this formulation for their patients, it is important to note that the transdermal route of administration offers a convenient and non-invasive option for pain management. It is suitable for patients who may have difficulty with oral medications or those who require localized pain control without the risks associated with systemic analgesics.

If you have any questions about the Ketamine HCl 10%/Lidocaine HCl 4% Transdermal Gel or its suitability for treating specific disease states, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the information and support you need to make informed decisions about pain management options for your patients.

Frequently Asked Questions

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What is Ketamine HCl 10%/Lidocaine HCl 4% Transdermal Gel?

This is a prescription medication that combines two active pharmaceutical ingredients: Ketamine Hydrochloride at a concentration of 10% and Lidocaine Hydrochloride at a concentration of 4%. It is designed for transdermal (through the skin) delivery, providing targeted relief at the site of application.

How do I use the transdermal gel?

To use the transdermal gel, apply a thin layer to the affected area as directed by your healthcare provider. The semisolid formulation is dispensed through a pump mechanism, which allows for precise dosing and easy application directly to the skin.

Who should use this transdermal gel?

This gel is intended for patients who have been prescribed this specific medication by their healthcare provider for the management of pain or as part of a pain management regimen. It should only be used under the supervision of a healthcare professional.

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

While the gel may provide relief for various types of pain, it should only be used for conditions for which it has been prescribed. The combination of Ketamine and Lidocaine is often used for neuropathic pain or certain chronic pain conditions but should not be used without professional medical advice.

How often should I apply the Ketamine/Lidocaine transdermal gel?

The frequency of application will depend on the instructions provided by your healthcare provider. It is important to follow their recommendations and not to exceed the prescribed dose.

What are the possible side effects of using this transdermal gel?

Possible side effects may include local skin irritation, redness, itching, or a rash at the site of application. Systemic side effects may also occur but are less common. If you experience any concerning symptoms or reaction, contact your healthcare provider immediately.

How should this medication be stored?

The medication should be stored at room temperature, away from direct sunlight and heat. Keep the bottle securely closed when not in use, and keep out of reach of children and pets.

Can I cover the area with a bandage after applying the gel?

Do not cover the treated area with a bandage or dressing unless directed by your healthcare provider, as this might change the absorption of the medication.

What should I do if I miss a dose?

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

Is it safe to use this Ketamine/Lidocaine gel with other medications?

As with any medication, there may be potential interactions with other drugs. Inform your healthcare provider about all other medications, supplements, and remedies you are using to ensure appropriate treatment.

What should I avoid while using this medication?

Avoid exposure to heat, such as using a heating pad, on the area where the gel has been applied, as this might increase absorption. Additionally, avoid getting the medication in your eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.

Can I use this gel while pregnant or breastfeeding?

The safety of this medication has not been fully established during pregnancy or breastfeeding. It is crucial to discuss the risks and benefits with your healthcare provider before starting treatment if you are pregnant or planning to become pregnant, or if you are breastfeeding.

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.

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.

Ketamine HCl 10%/Lidocaine HCl 4% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Three times daily