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Amitriptyline HCl 2%/Baclofen 2% Topical Gel

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

This formulation is a combination of Amitriptyline HCl 2% and Baclofen 2% in a topical gel. It is a semisolid formulation 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. Amitriptyline HCl is a tricyclic antidepressant that is used to treat various forms of depression, while Baclofen is a muscle relaxer and an antispastic agent.

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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

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.
Amitriptyline Hydrochloride
Baclofen
Topical Gel
653010776976a763a325d767

Formula Information

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This formulation combines Amitriptyline HCl 2% and Baclofen 2% in a topical gel format. It works by increasing the levels of certain chemicals in the brain that help improve mood, sleep, and the body's response to pain. Baclofen, on the other hand, is a muscle relaxer and an antispastic agent. It is used to treat muscle symptoms such as spasm, pain, and stiffness.

The combination of these two active ingredients in a topical gel format allows for targeted treatment. The gel is applied directly to the area of the skin where relief is needed, allowing for the active ingredients to be absorbed directly into the affected area. This can provide more immediate relief and reduce the potential for systemic side effects that can occur with oral medications.

This formulation is dispensed through a pump mechanism, which allows for easy and precise application. This can be particularly beneficial for patients who may have difficulty with manual dexterity or who need to apply the medication to hard-to-reach areas. The gel-like consistency also makes the medication easy to spread and absorb into the skin.

This Amitriptyline HCl 2%/Baclofen 2% Topical Gel can be used to treat a variety of disease states. It may also be used in the management of muscle spasms and stiffness associated with conditions such as multiple sclerosis or spinal cord injury.

As with any medication, it's important for patients and prescribers to understand the potential side effects and interactions. Common side effects may include skin irritation at the application site. More serious side effects may include drowsiness, dizziness, or confusion. It's important to discuss these potential risks with your healthcare provider before starting treatment.

If you have any questions about this formulation or how it may be beneficial in treating your specific condition, please don't hesitate to reach out to us. Our team of knowledgeable compounding pharmacists at Bayview Pharmacy is here to help.

Drug Interactions

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Amitriptyline HCl and Baclofen are both central nervous system depressants. They work by blocking nerve signals in your body, which helps to relieve pain. This topical gel formulation is designed to be applied directly to the skin, allowing for targeted treatment of specific areas. It is commonly used to manage neuropathic pain conditions, such as post-herpetic neuralgia and peripheral neuropathy.

While this formulation is generally well-tolerated, it's important to be aware of potential drug interactions. Amitriptyline HCl can interact with other medications that affect serotonin levels in the brain, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (MAOIs). Combining these medications can increase the risk of a rare but serious condition called serotonin syndrome. Symptoms can include agitation, hallucinations, rapid heartbeat, fever, muscle stiffness or twitching, and loss of coordination.

Baclofen can interact with other central nervous system depressants, including alcohol, antihistamines, sedatives, prescription pain medications, and certain over-the-counter sleep aids. Combining these substances can increase the risk of drowsiness, dizziness, and other side effects.

It's also important to note that both Amitriptyline HCl and Baclofen can interact with certain medical conditions. For example, they should be used with caution in patients with a history of heart disease, liver disease, or kidney disease. They can also increase the risk of suicidal thoughts or behavior, particularly in children, teenagers, and young adults.

Before starting treatment with this formulation, it's important to discuss your complete medical history and all medications (including over-the-counter drugs and dietary supplements) with your healthcare provider.

If you have any questions about this formulation or its potential interactions, please don't hesitate to reach out to us. We're here to help.

How Does it Work

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Amitriptyline HCl 2%/Baclofen 2% Topical Gel is a unique formulation that combines two active ingredients, Amitriptyline HCl and Baclofen, in a gel base for topical application. This formulation is designed to be 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 skin for targeted treatment.

Amitriptyline HCl is a tricyclic antidepressant that works by increasing the levels of certain chemicals in the brain that help improve mood, relieve anxiety, and treat certain types of chronic pain. When applied topically, Amitriptyline HCl can help to numb the skin and block pain signals to the brain, providing relief from localized pain.

Baclofen is a muscle relaxer and an antispastic agent. It works by helping to relax the muscles and reduce muscle spasm, stiffness, and pain. When used in a topical formulation, Baclofen can provide targeted relief from muscle pain and spasm without the systemic side effects associated with oral administration.

This combination of Amitriptyline HCl and Baclofen in a topical gel formulation can be used to treat a variety of disease states. It may also be used to manage musculoskeletal pain conditions, such as back pain, neck pain, and arthritis.

It's important to note that the effectiveness of this formulation can vary among individuals, and it may take some time to see the full benefits of the treatment. Always use this medication as directed by your healthcare provider, and do not apply more than the recommended dose. If you have any questions or concerns about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always here to help.

Other Uses

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Amitriptyline HCl 2%/Baclofen 2% Topical Gel is mainly used for managing neuropathic pain, inflammation, muscle spasms, and certain forms of nerve irritations. However, it also has other potential uses in an off-label capacity. For instance, it's occasionally prescribed by healthcare professionals for the treatment of fibromyalgia to help alleviate chronic muscle pain and tenderness. Moreover, it could be utilized as part of a multimodal treatment plan for complex regional pain syndrome (CRPS), a persistent condition characterized by severe discomfort, swelling, and changes in the skin color and texture. This is because of its ability to mediate factors of central sensitization, an underpinning feature of CRPS.

Similarly, conditions like trigeminal neuralgia, which cause facial pain, may benefit from this formulation due to its nerve-calming properties. This gel may also be employed as a therapy for migraines or tension headaches, due to its potential to numb nerves that trigger pain and relax muscles that contribute to tension. It's worth noting that while these applications are outside the medication's primary purpose, they are supported by limited clinical evidence and anecdotal reviews; hence, they should always be applied under the close supervision of a healthcare provider.

It is important for patients to understand that this gel is intended for topical use only and should be applied as directed by a healthcare professionals. Potential side effects with this medication can include skin reactions such as itching or redness at the application site. If any unusual side effects occur, or if the current condition does not improve or worsens, it's critical to seek medical attention promptly.

This is a general summary and does not contain all possible information or potential uses for this medication. It should not be used as the sole source of information, and it's always important to discuss health concerns, potential uses, and possible interactions with other medications with a healthcare professional. If you have any questions about Amitriptyline HCl 2%/Baclofen 2% Topical Gel or any other medications, please reach out to us at Bayview Pharmacy. We are here to help.

Frequently Asked Questions

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What is Amitriptyline HCl 2%/Baclofen 2% Topical Gel?

Amitriptyline HCl 2%/Baclofen 2% Topical Gel is a semisolid compound formulated for topical application. It is dispensed using a pump mechanism for easy and precise application on the skin.

How should I apply Amitriptyline HCl 2%/Baclofen 2% Topical Gel?

Amitriptyline HCl 2%/Baclofen 2% Topical Gel should be applied directly to the affected area using the built-in pump. This system allows for precise application of the medication.

What is the consistency of Amitriptyline HCl 2%/ Baclofen 2% Topical Gel?

This compounded formulation is a semisolid gel prescription medication. It is designed with a pump mechanism that delivers the gel in a consistent and controlled manner.

Is this product absorbed through the skin?

Yes, the active ingredients in Amitriptyline HCl 2%/ Baclofen 2% Topical Gel are designed to be absorbed through the skin to deliver targeted treatment.

Why does this product come in a pump?

The pump mechanism is designed to facilitate easy, precise application of the gel, ensuring that the right amount of the medication is dispensed each time.

Can this gel be used for conditions other than neurological pain?

The primary purpose of Amitriptyline HCl 2%/Baclofen 2% Topical Gel is to treat neurological pain. Any other use should be discussed with your healthcare provider.

Is it normal for the gel to feel cold upon application?

Yes, it is normal for the gel to feel cool upon application, but it does not typically cause any discomfort.

How often should I apply Amitriptyline HCl 2%/Baclofen 2% Topical Gel?

The frequency of application varies depending on the patient's condition and doctor's instructions. Always follow your healthcare provider's advice regarding dosage and frequency.

Can I apply the gel to broken skin or open wounds?

It is not typically recommended to apply the gel to broken skin or open wounds. Consult your healthcare provider for your specific condition.

What should I do if I experience any adverse effects after using the gel?

If you experience any adverse effects such as skin irritation, rashes, or any unusual symptoms, discontinue use and contact your healthcare provider immediately.

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.

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.

Amitriptyline HCl 2%/Baclofen 2% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)