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Ketamine 5%/Gabapentin 4%/Amitriptyline 4% Topical Gel

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

The Ketamine 5%/Gabapentin 4%/Amitriptyline 4% Topical Gel is a specialized medication compounded to manage neuropathic pain and chronic pain syndromes. This semisolid formulation is designed for transdermal delivery of active pharmaceutical ingredients and is dispensed through a pump mechanism, which ensures easy and precise dosing. The gel-like consistency allows for targeted application to the skin, optimizing the absorption of ketamine, gabapentin, and amitriptyline directly at the site of pain. This unique combination of medications works synergistically to provide analgesic effects, potentially reducing the need for systemic pain medications and their associated side effects.

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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
Ships within 1 to 2 business days after pharmacist verification
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.
Gabapentin
Amitriptyline Hydrochloride
Ketamine Hydrochloride
Topical Gel
65aee4c0a44ff774268e6b5f
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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The Ketamine 5%/Gabapentin 4%/Amitriptyline 4% Topical Gel is a compounded medication designed for targeted topical application. This semisolid formulation is dispensed through a pump mechanism, which ensures ease of use and precise dosing. The gel base allows for the active ingredients to be applied directly to the skin, where they are absorbed into the affected area to exert their therapeutic effects.

Ketamine, a medication primarily known for its anesthetic properties, is used in this formulation for its analgesic effects. At a 5% concentration, ketamine works by blocking NMDA receptors, which play a role in pain transmission and modulation. This can help reduce the sensation of pain in localized areas. Gabapentin, at a 4% concentration, is included for its ability to modulate the release of excitatory neurotransmitters, also contributing to pain relief.

This combination gel is particularly useful in the management of neuropathic pain, which can be a result of conditions such as diabetic neuropathy, postherpetic neuralgia, and complex regional pain syndrome. The synergistic effects of ketamine, gabapentin, and amitriptyline in this topical formulation can provide significant pain relief without the systemic side effects often associated with oral administration of these medications. Additionally, the topical route of administration allows for a lower systemic absorption, which can be beneficial for patients who are sensitive to the systemic effects of these drugs or who are taking other medications that may interact with them.

Patients and prescribers should be aware that this is a specialized medication prepared in a compounding pharmacy, and it should be used under the guidance of a healthcare professional familiar with the patient's medical history and concomitant medications. As with any medication, there may be potential side effects, and it is important to monitor the treatment area for any signs of adverse reactions. If you have any questions or require further information about this formulation and its suitability for specific disease states, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to support and provide guidance to ensure the safe and appropriate use of this compounded medication.

Drug Interactions

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The combination of ketamine, gabapentin, and amitriptyline in a topical gel formulation is designed to provide localized pain relief with reduced systemic side effects. However, it is important to consider potential drug interactions when using this formulation, especially if the patient is taking other medications systemically.

Ketamine is an NMDA receptor antagonist and may interact with other central nervous system depressants, such as benzodiazepines, opioids, and alcohol, potentially leading to increased sedation and respiratory depression. Caution is advised if the patient is concurrently using any of these substances. Additionally, ketamine may interact with serotonergic drugs, such as SSRIs or MAOIs, increasing the risk of serotonin syndrome, which is a potentially life-threatening condition.

Gabapentin, an anticonvulsant and analgesic, primarily affects the GABAergic system but does not significantly interact with other GABAergic medications. However, it may have additive effects with other CNS depressants, enhancing sedation and dizziness. It is also important to note that antacids containing aluminum or magnesium may reduce the absorption of gabapentin if taken at the same time.

Amitriptyline is a tricyclic antidepressant and has a wide range of potential drug interactions. It should be used with caution in combination with other serotonergic drugs due to the risk of serotonin syndrome. Additionally, amitriptyline may interact with MAOIs, leading to hypertensive crisis or severe CNS effects. It can also potentiate the effects of CNS depressants and anticholinergic drugs, and may affect the metabolism of other medications by inhibiting certain cytochrome P450 enzymes.

While the systemic absorption of these medications in a topical formulation is generally lower than their oral counterparts, the possibility of systemic effects and drug interactions still exists, especially in patients with compromised skin integrity or when applied over a large surface area. It is crucial for prescribers to review the patient's current medication regimen for potential interactions and adjust therapy accordingly.

Patients should be advised to inform their healthcare providers of all medications they are taking, including over-the-counter drugs and herbal supplements. They should also be instructed to report any unusual side effects or symptoms to their healthcare provider immediately. If you have any questions or require further information regarding drug interactions with this topical gel formulation, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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The Ketamine 5%/Gabapentin 4%/Amitriptyline 4% Topical Gel is a compounded medication designed to deliver active pharmaceutical ingredients directly to the site of pain or discomfort through the skin. 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 where it is applied and facilitates the absorption of the active ingredients into the skin.

Ketamine, a medication primarily used for starting and maintaining anesthesia, has been found to have analgesic properties when used in lower, sub-anesthetic doses. In this topical formulation, ketamine works by blocking N-methyl-D-aspartate (NMDA) receptors in the nervous system, which are involved in the transmission of pain signals. By inhibiting these receptors, ketamine can help reduce the sensation of pain.

Gabapentin, originally developed to treat epilepsy, is also used to relieve neuropathic pain. It is believed to work by altering the release of certain neurotransmitters, which helps to calm down nerve activity and reduce pain signals. When applied topically, gabapentin can target specific areas of the body, potentially reducing systemic side effects compared to oral administration.

Amitriptyline is a tricyclic antidepressant that has been repurposed for the treatment of chronic pain conditions, including neuropathic pain. It is thought to work by inhibiting the reuptake of serotonin and norepinephrine, two neurotransmitters that modulate pain perception. In a topical gel, amitriptyline can provide localized pain relief with a lower risk of systemic side effects.

This combination of ketamine, gabapentin, and amitriptyline in a topical gel form is particularly useful for treating localized neuropathic pain conditions, such as postherpetic neuralgia, diabetic neuropathy, and complex regional pain syndrome. By applying the medication directly to the affected area, patients may experience pain relief without the systemic side effects often associated with oral medications. Additionally, the use of a pump dispenser ensures consistent dosing and ease of use for patients with limited mobility or dexterity.

It is important for both patients and prescribers to understand the potential benefits and limitations of this compounded formulation. While it offers targeted relief with a potentially lower side effect profile, it is essential to use the medication as directed and to monitor for any adverse reactions or interactions with other medications. If you have any questions or concerns about this formulation, please reach out to us at Bayview Pharmacy for further information and guidance.

Other Uses

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The Ketamine 5%/Gabapentin 4%/Amitriptyline 4% Topical Gel formulated here at Bayview Pharmacy has been primarily compounded for the management of neuropathic pain and related conditions. However, beyond its primary indication, this topical gel formulation may present alternative uses due to the pharmacological properties of the active ingredients in synergy. For instance, patients suffering from complex regional pain syndrome (CRPS) may experience relief upon application, as this condition involves neuropathic components to which the gel's active agents are correspondingly responsive.

Additional potential applications may include use for fibromyalgia sufferers, where centralized pain amplification and nerve sensitization are characteristic. Off-label uses have also been postulated for the treatment of topical pain in localized areas, including but not limited to post-herpetic neuralgia, diabetic neuropathy, and osteoarthritis of the hands or knees. Due to the complexities of chronic pain syndromes, some patients with migraines and certain dermatological conditions involving nerve pain, such as post-surgical neuralgia, might also benefit from the tailored pharmacological effects of this gel.

It is worth noting that while the evidence for these alternative uses may stem from the individual effects of either ketamine, gabapentin, or amitriptyline, the compounded combination has yet to be thoroughly vetted through extensive clinical trials for these specific applications. Therefore, off-label use should be approached with caution and under strict guidance by a healthcare professional. Always consult with a prescriber to evaluate the suitability of this compounded medication for any conditions beyond its primary indication.

Patient safety is paramount, and the potential for systemic absorption, as well as local and systemic side effects, should be considered regardless of the condition being treated. Close communication with the patient regarding efficacy and any adverse effects is crucial for ongoing management when using this compounded formulation. If you have any questions regarding this topical gel, its additional uses, or would like further information about compound medications and their appropriate application, please do not hesitate to reach out to us at Bayview Pharmacy.

Frequently Asked Questions

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What is the purpose of this compounded topical gel?

The compounded topical gel is designed to deliver a combination of medications, specifically Ketamine, Gabapentin, and Amitriptyline, through the skin to provide targeted treatment for conditions such as neuropathic pain or other specific medical indications that have been prescribed by your healthcare provider.

How should this topical gel be applied?

The gel should be applied to the affected area as directed by your healthcare provider. Make sure the skin is clean and dry before application. Use the pump to dispense the gel, then gently spread it over the area with a thin, even layer. Avoid wrapping or bandaging the treated area unless instructed by a doctor.

What are the advantages of using a pump mechanism for this gel?

A pump mechanism allows for more controlled and consistent dosing of the medication with each application. It also ensures minimal contamination of the product, as it prevents direct contact with the fingers or other surfaces.

Can this topical gel be applied more than once a day?

The frequency of application will depend on the instructions provided by your healthcare provider. Do not apply more often than recommended, and follow the dosing directions precisely to avoid possible side effects.

What should I do if I miss a dose?

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

Are there any possible side effects of using this topical gel?

Side effects from topical application may include skin irritation, redness, itching, or rash at the site of application. Systemic side effects are less common due to the localized nature of the treatment but can occur, especially if used over large areas or for prolonged periods. Contact your healthcare provider if you experience any concerning or persistent side effects.

Can this gel be used with other medications?

You should inform your healthcare provider of all the medications you're currently using, including this topical gel. While the risk of systemic interaction is lower with topical applications, interactions can still occur, especially with other compounds that affect similar pathways in the body.

How should this gel be stored?

Store the gel at room temperature, away from light and heat. Keep the container tightly closed, and make sure it is out of reach of children and pets. Do not freeze the medication unless instructed by the pharmacist or product labeling.

What precautions should be taken when using this gel?

Wash your hands thoroughly after applying the gel unless the hands are the treated area. Avoid contact with eyes, mouth, and mucous membranes. If accidental contact occurs, rinse thoroughly with water. Do not apply to broken or irritated skin unless directed by a healthcare provider.

Is this compound suitable for all ages?

The suitability of this compounded formulation for different ages depends on a case-by-case basis and should be determined by a healthcare provider. Children, the elderly, or those with certain medical conditions may require special consideration or dosing adjustments.

How long should I use this compounded topical gel?

The duration of use for this compounded topical formulation will vary based on your condition and the response to treatment. Follow your healthcare provider’s guidance and do not use it for longer than prescribed. Regularly review the effectiveness and any side effects with your provider.

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 5%/Gabapentin 4%/Amitriptyline 4% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Three times daily