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Ketamine HCl 5% Transdermal Gel

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

The Ketamine HCl 5% Transdermal Gel is a semisolid formulation designed for targeted application on the skin. This gel is dispensed through a pump mechanism, which ensures easy and precise dosing. The gel-like consistency allows for the ketamine to be absorbed through the skin, providing localized or systemic effects. This formulation is commonly used in the management of chronic pain, including neuropathic pain, and may also be utilized in the treatment of complex regional pain syndrome (CRPS). Additionally, it has been explored for its potential benefits in addressing refractory depression, providing an alternative route of administration for patients who may not respond to traditional oral or intravenous therapies.

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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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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.

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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
Topical Gel
65ae947ab5c34cb97d33f8d2
Service area

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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 5% Transdermal Gel is a specialized medication formulated for transdermal delivery, providing an alternative route of administration for patients who may require it. This semisolid formulation is designed to be dispensed through a pump mechanism, which ensures ease of use and precise dosing. The gel-like consistency allows for targeted application on the skin, facilitating the absorption of the active ingredient, ketamine hydrochloride, directly into the systemic circulation through the skin barrier.

Ketamine, a medication traditionally used for anesthesia, has been found to have analgesic and potential antidepressant properties when used in lower, controlled doses. In a 5% concentration within a transdermal gel, ketamine can be used to manage chronic pain conditions, such as neuropathic pain, where traditional oral or systemic therapies may not be effective or cause undesirable side effects. Additionally, there is growing interest in the use of low-dose ketamine for the treatment of refractory depression, with research suggesting that it may provide rapid relief of depressive symptoms in some patients.

The transdermal route offers several advantages, including steady absorption, reduced hepatic first-pass metabolism, and the potential for fewer systemic side effects compared to oral administration. This can be particularly beneficial for patients with gastrointestinal issues or those who have difficulty swallowing pills. Moreover, the localized application may result in higher local concentrations of the drug with lower systemic exposure, which can be advantageous in managing localized pain.

It is important for both patients and prescribers to understand that the use of Ketamine HCl 5% Transdermal Gel should be guided by a healthcare professional with experience in compounding medications and managing the conditions for which ketamine is indicated. Monitoring for efficacy and safety is essential, as is adherence to the prescribed dosing regimen. As with any medication, there may be potential side effects, and patients should be counseled on what to expect and when to seek medical attention.

Bayview Pharmacy is committed to providing high-quality compounded medications tailored to the specific needs of patients. Our team of knowledgeable compounding pharmacists is available to answer any questions and provide support to both patients and prescribers considering the use of Ketamine HCl 5% Transdermal Gel. For further information or to discuss individual patient needs, please do not hesitate to reach out to us.

Drug Interactions

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Ketamine HCl 5% Transdermal Gel is a unique formulation designed for topical application and may offer an alternative route of administration for certain conditions. However, it is important to consider potential drug interactions when using this medication. Ketamine, even when used topically, can interact with a variety of substances, including central nervous system (CNS) depressants, such as benzodiazepines, opioids, and alcohol. Concurrent use of these substances with ketamine can enhance sedation, respiratory depression, and increase the risk of CNS depression. Caution is advised when using this formulation alongside CNS depressants.

Additionally, ketamine is a CYP3A4 substrate, and thus, its metabolism can be affected by CYP3A4 inhibitors or inducers. Strong inhibitors of CYP3A4, such as clarithromycin, itraconazole, or grapefruit juice, may increase plasma concentrations of ketamine, potentially leading to enhanced or prolonged effects. Conversely, CYP3A4 inducers like rifampin or St. John's Wort may reduce the effectiveness of ketamine by increasing its metabolism. It is crucial to monitor for changes in the therapeutic and adverse effects of ketamine if a CYP3A4 inhibitor or inducer is initiated or discontinued.

Furthermore, ketamine has been reported to have anticholinergic properties, so it should be used with caution in combination with other anticholinergic medications, as this may increase the risk of anticholinergic side effects such as dry mouth, urinary retention, and constipation. Additionally, ketamine may interact with monoamine oxidase inhibitors (MAOIs), potentially leading to hypertensive or hyperthermic crises. A washout period is typically recommended when transitioning between MAOIs and ketamine.

Patients with a history of substance abuse may be at increased risk of misuse or abuse of ketamine. Therefore, careful consideration should be given when prescribing this medication to this patient population. It is also important to consider that the transdermal route bypasses first-pass metabolism, which may result in different pharmacokinetic properties compared to other routes of administration.

Given the potential for drug interactions and the serious nature of these interactions, it is imperative that prescribers and patients communicate openly about all medications, supplements, and substances being used concurrently with Ketamine HCl 5% Transdermal Gel. Adjustments to therapy may be necessary, and close monitoring for adverse effects is recommended. If you have any questions or require further clarification on the use of this formulation and its interactions with other drugs, please reach out to us at Bayview Pharmacy for professional advice and guidance.

How Does it Work

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Ketamine HCl 5% Transdermal Gel is a specialized medication formulated for transdermal delivery, meaning it is designed to be absorbed through the skin. The active ingredient, Ketamine HCl, is a compound that has traditionally been used as an anesthetic but has found a role in pain management and the treatment of certain mood disorders when used in lower, controlled doses. The 5% concentration indicates that the gel contains 5 grams of Ketamine HCl per 100 grams of gel.

The gel is compounded in a semisolid base that allows it to be dispensed through a pump mechanism. This design ensures that patients can apply a consistent and precise dose of medication with each use. The gel base is specifically chosen for its ability to facilitate the penetration of Ketamine HCl through the skin and into the systemic circulation or to target local areas for a more localized effect.

Upon application, the Ketamine HCl begins to permeate the skin barrier. The rate and extent of absorption can be influenced by several factors, including the condition of the skin, the area of application, and the presence of penetration enhancers in the formulation. Once absorbed, Ketamine works by interacting with N-methyl-D-aspartate (NMDA) receptors in the nervous system. This interaction can help modulate pain signals and has been shown to provide analgesic effects. Additionally, Ketamine has been observed to have antidepressant effects, which are thought to be mediated through its action on various neurotransmitter systems, including glutamate signaling.

In the context of pain management, Ketamine HCl 5% Transdermal Gel may be used to treat chronic pain conditions, such as neuropathic pain, where traditional pain medications have not been effective. For mood disorders, such as treatment-resistant depression, the transdermal delivery of Ketamine can provide a steady absorption that may lead to a more stable mood state with fewer peaks and troughs compared to other routes of administration.

It is important for both patients and prescribers to understand that while transdermal delivery offers convenience and consistent dosing, the onset of action may be slower compared to other routes of administration, and individual responses to the medication can vary. Monitoring and adjusting the dose may be necessary to achieve the desired therapeutic effect while minimizing potential side effects.

For any questions regarding the use of Ketamine HCl 5% Transdermal Gel, its formulation, or its suitability for specific disease states, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the necessary information and support to ensure appropriate treatment for our patients.

Other Uses

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Ketamine HCl 5% Transdermal Gel is traditionally known for its primary indication in the management of chronic pain, particularly when conventional therapies have failed to provide adequate relief. However, this innovative transdermal delivery system expands its potential therapeutic utility well beyond pain management. Recent studies have suggested that transdermal ketamine may have benefits in the treatment of complex regional pain syndrome (CRPS), certain neuropathic pain conditions, and even in alleviating some symptoms of depression due to ketamine's rapid-acting antidepressant effects. In the realm of psychiatry, its use is being explored as a novel approach for mood and anxiety disorders, though such applications should always be approached with caution and under strict medical supervision given ketamine’s psychoactive properties.

In addition to these indications, ketamine's potential neuroprotective and anti-inflammatory properties are being investigated, which could open the door to other non-pain-related uses. There is preliminary evidence suggesting that the anti-inflammatory effects may benefit patients with conditions characterized by inflammation, such as certain autoimmune disorders or inflammatory skin conditions. Moreover, the neuroprotective aspects of ketamine are being studied in the context of neurodegenerative diseases and cognitive impairments, although such uses are currently experimental and not widely accepted in clinical practice.

It is important to acknowledge that the use of Ketamine HCl 5% Transdermal Gel for conditions other than chronic pain is still a matter of clinical research and not yet established in medical guidelines. As such, prescribers should exercise professional discretion and consider current evidence when contemplating off-label uses. Likewise, patients are encouraged to discuss the full range of potential benefits and risks with their healthcare provider. At Bayview Pharmacy, we are dedicated to ensuring both patients and providers are well-informed about the potential applications of our compounded formulations. As compounding pharmacists, we are here to answer any further questions and provide detailed information regarding the safe and appropriate use of Ketamine HCl 5% Transdermal Gel. Please feel free to reach out to us for any clarification or additional insights.

Frequently Asked Questions

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What is Ketamine HCl 5% Transdermal Gel used for?

Ketamine HCl 5% Transdermal Gel is used for the management of pain, especially for conditions that may benefit from its analgesic effects when delivered through the skin. Its primary use is for localized relief of neuropathic pain, although it may also be prescribed for other types of chronic pain as determined by a healthcare provider.

How is the Ketamine HCl 5% Transdermal Gel applied?

The gel is applied topically to clean, intact skin. It is typically applied to the most painful areas using the pump mechanism to deliver a measured dose of medication. The number of pumps required depends on the dosage prescribed by a healthcare provider. After dispensing, the gel should be spread gently and evenly over the affected area.

How often should the Ketamine HCl 5% Transdermal Gel be used?

The frequency of application will vary depending on the individual's specific medical condition and the instructions provided by their healthcare provider. It is crucial to follow the prescribed dosage regimen and not to use the gel more often than recommended.

Are there any special storage instructions for the Ketamine HCl 5% Transdermal Gel?

Yes, the gel should be stored at room temperature away from heat and direct sunlight. The container should be kept tightly closed when not in use. Make sure to keep the medication out of reach of children and pets.

Can Ketamine HCl 5% Transdermal Gel cause any side effects?

As with any medication, the Ketamine HCl 5% Transdermal Gel may cause side effects. These can include local skin reactions like redness, itching, or rash. More systemic side effects are uncommon due to its topical application but may occur in some individuals. Contact your healthcare provider if you notice any severe or persistent side effects.

What should I do if I miss a dose of Ketamine HCl 5% Transdermal Gel?

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

Can Ketamine HCl 5% Transdermal Gel be used with other medications?

Ketamine HCl 5% Transdermal Gel may interact with other medications. It is important to inform your healthcare provider of all the medications you are currently taking, including over-the-counter drugs and herbal supplements, to prevent potential drug interactions.

Is Ketamine HCl 5% Transdermal Gel suitable for everyone?

No, this medication may not be suitable for everyone. Patients with certain medical conditions or those who are pregnant or breastfeeding should consult with their healthcare provider to determine if this medication is safe for them.

How do I know if the Ketamine HCl 5% Transdermal Gel is working?

You may notice a reduction in pain or discomfort in the area where the gel is applied. It is important to discuss with your healthcare provider how to monitor your treatment's effectiveness and any follow-up assessments that may be required.

What should I avoid while using Ketamine HCl 5% Transdermal Gel?

Avoid contact with eyes, mouth, and mucous membranes. Do not apply the gel to broken or irritated skin. It is also advised to avoid using a heating pad or other heat sources on the area where the gel was applied as it may increase absorption of the medication leading to increased side effects.

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, 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 5% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Three times daily