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Amitriptyline HCl 4%/Baclofen 2%/Ketamine HCl 11.5% Topical Gel

This formulation is a semisolid compound of Amitriptyline HCl 4%, Baclofen 2%, and Ketamine HCl 11.5% in a topical gel form. It is dispensed through a pump mechanism, which allows for easy and precise application on the skin. The gel-like consistency ensures targeted treatment or absorption of the active ingredients.

The combination of these three active ingredients is designed to treat a variety of disease states. Amitriptyline HCl is a tricyclic antidepressant used to manage chronic pain. Baclofen is a muscle relaxer and an antispastic agent, often used in the treatment of muscle symptoms caused by multiple sclerosis. Ketamine HCl is a potent analgesic used for the management of severe, chronic pain.

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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, NY, NJ, NH, FL and ME.
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

Licensed to fill prescriptions for patients in RI, MA, CT, NY, NJ, NH, FL and ME.

Prescriber? Sign in or create an account 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.
Amitriptyline Hydrochloride
Ketamine Hydrochloride
Baclofen
Topical Gel
653089e003b830825a30ae7f

Formula Information

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This formulation is a compounded topical gel containing Amitriptyline HCl 4%, Baclofen 2%, and Ketamine HCl 11.5%. It is a semisolid formulation that is dispensed through a pump mechanism, which allows for easy and precise application on the skin. The gel-like consistency ensures that the active ingredients are absorbed effectively into the targeted area for optimal therapeutic effect.

Amitriptyline HCl is a tricyclic antidepressant that is used in this formulation for its analgesic properties. It works by increasing the levels of certain chemicals in the brain that help elevate mood and reduce the sensation of pain. Baclofen is a muscle relaxer and an antispastic agent. It is used in this formulation to relieve muscle symptoms such as spasms, pain, and stiffness. Ketamine HCl is a potent analgesic that provides pain relief by blocking certain receptors in the brain.

This unique combination of ingredients works synergistically to provide relief from various disease states. The topical application allows for targeted treatment, reducing systemic side effects often associated with oral medications. Furthermore, the inclusion of Ketamine HCl provides a potent analgesic effect, making this formulation suitable for patients with severe or chronic pain conditions.

Patients using this formulation should apply it as directed by their healthcare provider, typically to the affected area 3-4 times daily. It is important to wash hands before and after application and to avoid contact with eyes, mouth, and other mucous membranes. Side effects may include skin irritation at the application site, drowsiness, or dizziness. If these persist or worsen, contact your healthcare provider immediately.

Prescribers should consider this formulation for patients who have not responded to traditional oral medications or who cannot tolerate their side effects. It is also suitable for patients who prefer a topical treatment method. As with all compounded medications, this formulation should be prescribed as part of a comprehensive treatment plan and should be monitored regularly for efficacy and tolerability.

If you have any questions about this formulation or its use in treating specific disease states, please do not hesitate to reach out to us. Our team of knowledgeable compounding pharmacists at Bayview Pharmacy is always here to assist you.

Drug Interactions

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This compounded formulation contains Amitriptyline HCl, Baclofen, and Ketamine HCl. These active ingredients can interact with other medications, potentially altering their effects. It's crucial to inform your healthcare provider about all the medications you're currently taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements.

Amitriptyline HCl is a tricyclic antidepressant that can interact with MAO inhibitors, leading to serious, potentially fatal, side effects. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication.

Baclofen is a muscle relaxant and antispastic agent. It can interact with other central nervous system depressants, including alcohol, antihistamines, sedatives, prescription pain medications, and certain over-the-counter medications. These interactions can lead to increased drowsiness and potentially dangerous respiratory depression.

Ketamine HCl is a potent anesthetic that can interact with other anesthetics, sedatives, and certain psychiatric medications. These interactions can lead to increased sedation, respiratory depression, and potentially serious changes in heart rate and blood pressure.

This formulation is designed for topical application and is intended to provide targeted relief from pain and muscle spasms. Amitriptyline HCl can help manage neuropathic pain, Baclofen can reduce muscle spasms, and Ketamine HCl can provide potent pain relief. However, the systemic absorption of these medications through the skin can still lead to drug interactions.

It's important to use this medication as directed by your healthcare provider. Do not apply more than the recommended amount, and avoid applying this medication to broken or irritated skin, which can increase systemic absorption and the risk of side effects.

If you have any questions about this medication or potential drug interactions, please don't hesitate to reach out to us. We're here to help ensure that you can use this medication safely and effectively.

How Does it Work

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The Amitriptyline HCl 4%/Baclofen 2%/Ketamine HCl 11.5% Topical Gel is a unique formulation that combines three active ingredients, each with its own mechanism of action, to provide targeted relief from various disease states. This formulation is designed to be applied topically, directly to the skin, where it can be absorbed into the affected area.

Amitriptyline HCl is a tricyclic antidepressant that works by increasing the levels of certain chemicals in the brain that help elevate mood. In a topical formulation, it can help to numb the skin and block pain signals.

Baclofen is a muscle relaxer and an antispastic agent. It works by restoring the balance of certain natural substances (GABA) in the brain. Baclofen in this topical gel formulation is absorbed through the skin directly into the muscle tissue, providing targeted relief from muscle spasms and spasticity.

Ketamine HCl is a powerful anesthetic that works by blocking certain receptors in the brain (NMDA receptors) that are responsible for transmitting pain signals. In this topical formulation, it provides localized pain relief without the systemic side effects associated with oral or injectable administration.

Together, these three active ingredients work synergistically to provide relief from a variety of conditions, including neuropathic pain, muscle spasms, and spasticity. The gel formulation allows for targeted application and absorption, providing relief directly to the affected area. The pump mechanism allows for easy and precise dosing.

It's important to note that while this formulation can provide significant relief from these conditions, it should be used as part of a comprehensive treatment plan under the supervision of a healthcare provider. Always use this medication as directed by your healthcare provider, and reach out to us if you have any questions or concerns.

Other Uses

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The custom formulation of Amitriptyline HCl 4%/Baclofen 2%/Ketamine HCl 11.5% Topical Gel is typically used to target a variety of pain-focused conditions due to the compounding benefits of three active ingredients. However, beyond these common indications, this treatment has potential for other applications.

Its constituent, Amitriptyline, a tricyclic antidepressant, may be beneficial for its off-label use in chronic pruritus (itching) due to its sedating and antihistaminic properties. Some studies have suggested its utility in insomnia and mood disorders due to the calming effect it has on the central nervous system.

Baclofen's muscle relaxant and antispastic properties could potentially be utilized in conditions that feature muscle spasm or rigidity. For example, in patients with conditions such as multiple sclerosis, cerebral palsy or who have sustained stroke or spinal cord injury, topical application of this gel could provide localized relief from muscle stiffness or spasticity.

Ketamine, a widely acknowledged NMDA receptor antagonist, largely has applications in pain management. However, research has begun exploring its use in refractory depression, post-traumatic stress disorder, and obsessive-compulsive disorder. This off-label use has not yet been widely accepted and should be approached with caution and under the strict supervision of a healthcare professional.

While these potential uses expand the scope of the formulation, it is always crucial to note that, as with any medication, individual patient response varies greatly. Potential side effects, interactions, and contraindications should be given due consideration. Additionally, the use of this formulation for off-label purposes should always be monitored by a healthcare provider, and therapy must be individualized for optimal benefit.

If you have any further questions or concerns about the uses of Amitriptyline HCl 4%/Baclofen 2%/Ketamine HCl 11.5% Topical Gel, please do not hesitate to reach out to our expert team at Bayview Pharmacy. We are committed to ensuring you receive the most accurate and beneficial information to guide your treatment decisions.

Frequently Asked Questions

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What is Amitriptyline HCl 4%/Baclofen 2%/Ketamine HCl 11.5% Topical Gel?

This is a compounded medication that combines Amitriptyline HCl, Baclofen, and Ketamine HCl in a gel form. The combination of these ingredients is used for targeted skin treatment or absorption.

How should I use this topical gel?

The gel is dispensed through a pump mechanism, which makes it easy to apply on the skin for targeted treatment. Just use the amount recommended by your healthcare provider.

What is the consistency of this medication?

This medication comes in a gel-like consistency, which aids in proper skin absorption of the active ingredients.

What is the purpose of the pump mechanism?

The pump mechanism facilitates precise application of the gel on the skin, ensuring that you apply just the right amount needed for treatment.

Do I need a prescription for this medication?

Yes, this is a prescription medication and should only be used under the supervision of a healthcare provider.

Is this medication safe for all skin types?

While this formula is made with skin-friendly ingredients, it is always advisable to discuss your skin type and any skin conditions with your healthcare provider before beginning treatment. They can advise you on whether the medication is safe for your specific skincare needs.

Can this medication be used on all areas of the body?

Please follow the instructions of your healthcare provider when it comes to the areas of treatment. In most cases, it's used on targeted areas of the skin and not intended for whole body application.

Can I apply this gel more than once a day?

The frequency of application should be determined by your healthcare provider, who will recommend a treatment plan based on your specific needs and condition.

Does the gel have any side effects?

Like any medication, it may have side effects, though these can vary from person to person. It's advised to immediately inform your doctor if you notice anything unusual after starting the medication.

Can I use this gel alongside other medications?

You need to discuss this with your healthcare provider. They'll need to know your full medical history and all medications you are currently taking to decide whether this gel is suitable for you.

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, 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.

Amitriptyline HCl 4%/Baclofen 2%/Ketamine HCl 11.5% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)