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Amitriptyline HCl 0.5% to 2%/Baclofen 0.5% to 2% Transdermal Gel

This formulation is a semisolid transdermal gel containing Amitriptyline HCl and Baclofen in concentrations ranging from 0.5% to 2%. It is dispensed through a pump mechanism, allowing 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 mental/mood disorders. Baclofen is a muscle relaxer and an antispastic agent. Together, they work to treat conditions such as neuropathic pain, fibromyalgia, and muscle spasms. The transdermal delivery allows for direct application to the affected area, providing relief from symptoms associated with these disease states.

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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.

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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.
Amitriptyline Hydrochloride
Baclofen
Topical Gel
653149b67faf617ee3b85a7a

Formula Information

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This formulation combines Amitriptyline HCl and Baclofen in a transdermal gel, which is a semisolid formulation dispensed through a pump mechanism. This allows for easy and precise application on the skin, ensuring targeted treatment or absorption of the active ingredients. The gel-like consistency of the formulation ensures that it adheres well to the skin, providing a sustained release of the medication for optimal therapeutic effect.

Amitriptyline HCl is a tricyclic antidepressant that is used off-label for the management of chronic pain. It works by increasing the levels of certain chemicals in the brain that help elevate mood and reduce the sensation of pain. Baclofen, on the other hand, is a muscle relaxant and antispastic agent. It works by inhibiting the transmission of nerve signals, thereby reducing muscle spasms, tightness, and pain.

These include conditions like fibromyalgia, neuropathic pain, and certain types of chronic back pain. The transdermal route of administration allows for direct application to the affected area, providing targeted relief while minimizing systemic side effects.

It's important for patients to use this medication as directed by their healthcare provider. The gel should be applied to clean, dry skin and rubbed in gently until it is fully absorbed. Patients should avoid applying the gel to broken or irritated skin, and should wash their hands immediately after application. It's also important to avoid heat, sunlight, or bandaging of the treated area unless directed by a healthcare provider.

Prescribers should consider the patient's overall health status, other medications, and the severity of their symptoms when determining the appropriate concentration of Amitriptyline HCl and Baclofen in the transdermal gel. Regular follow-up is necessary to monitor the patient's response to treatment and adjust the dosage if necessary.

If you have any questions about this formulation, please don't hesitate to reach out to us. Our team of compounding pharmacists at Bayview Pharmacy is always here to provide the information and support you need.

Drug Interactions

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Amitriptyline HCl and Baclofen are both central nervous system depressants. When used together, they can increase each other's effects, leading to potentially serious side effects such as respiratory depression, hypotension, profound sedation, and even coma. Therefore, it is crucial to monitor patients closely, especially during initiation of therapy, and upon any changes in dosage or addition of other CNS depressants.

Patients should be advised to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them. They should also avoid alcohol or other substances that can further increase the risk of side effects. It is important to inform patients about the signs of respiratory depression such as shortness of breath, long pauses between breaths, or difficulty waking up, and they should seek immediate medical attention if these occur.

Furthermore, Amitriptyline HCl can interact with many other medications, including other antidepressants, antipsychotics, certain antihistamines, and certain antihypertensives. These interactions can increase the risk of side effects or reduce the effectiveness of the medications. Therefore, it is important for prescribers to review all medications that a patient is taking before prescribing this formulation.

Baclofen can also interact with other medications, including other muscle relaxants, certain pain medications, and certain medications for seizures. These interactions can increase the risk of side effects or reduce the effectiveness of the medications. Therefore, it is important for prescribers to review all medications that a patient is taking before prescribing this formulation.

This formulation is used to treat various conditions such as neuropathic pain, muscle spasticity, and certain types of chronic pain. Amitriptyline HCl is a tricyclic antidepressant that works by increasing the levels of certain chemicals in the brain that help elevate mood and reduce pain sensation. Baclofen is a muscle relaxant and antispastic agent that works by restoring the normal balance of electrical activity in the brain and spinal cord, thereby reducing muscle spasms and pain.

It is important to note that this formulation is not suitable for everyone. Patients with certain medical conditions such as glaucoma, urinary retention, or certain types of heart disease may not be able to use this formulation. Therefore, it is important for prescribers to review a patient's medical history before prescribing this formulation.

If you have any questions about this formulation or its potential interactions, please do not hesitate to reach out to us.

How Does it Work

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The Amitriptyline HCl/Baclofen Transdermal Gel is a unique formulation that combines two potent active ingredients, Amitriptyline HCl and Baclofen, in a semisolid gel base. This formulation is designed to be applied topically, directly to the skin, where it is absorbed into the body to exert its therapeutic effects.

Amitriptyline HCl is a tricyclic antidepressant that works by increasing the levels of certain chemicals in the brain that help improve mood, reduce pain, and promote sleep. In this formulation, Amitriptyline HCl is used for its analgesic properties, helping to alleviate pain in various conditions.

Baclofen, on the other hand, is a muscle relaxer and an antispastic agent. It works by restoring the balance of certain natural substances (gamma-aminobutyric acid, GABA) in the brain. Baclofen is used to treat muscle symptoms such as spasm, pain, and stiffness.

When combined in a transdermal gel, these two active ingredients work synergistically to provide relief from various disease states. The gel formulation allows for targeted application, ensuring that the medication is delivered directly to the affected area. This not only enhances the effectiveness of the treatment but also minimizes systemic side effects that are often associated with oral administration of these medications.

The transdermal gel is dispensed through a pump mechanism, which allows for easy and precise application. The gel-like consistency ensures that the medication stays on the skin, facilitating better absorption of the active ingredients. This formulation is particularly beneficial for patients who have difficulty swallowing pills or those who prefer a non-invasive method of medication administration.

This formulation can be used to treat a variety of conditions, including neuropathic pain, fibromyalgia, and certain types of chronic pain. It can also be used in the management of muscle spasticity associated with conditions like multiple sclerosis and spinal cord injury. As with any medication, it is important to use this formulation under the guidance of a healthcare provider, and any side effects or concerns should be reported immediately.

If you have any questions about the Amitriptyline HCl/Baclofen Transdermal Gel, or if you would like more information about how it works, please don't 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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In addition to the primary indication of use, the combination of Amitriptyline HCl 0.5% to 2% and Baclofen 0.5% to 2% in a transdermal gel provides additional potential uses.

Recognizing that each individual patient's case requires careful consideration, these uses could extend towards treating neuropathic pain beyond the typical chronic nerve-related conditions. Certain painful neurological disorders, such as trigeminal neuralgia and post-herpetic neuralgia, could potentially benefit from the combination therapy provided by this gel.

Amitriptyline's properties could also assist in managing symptoms of fibromyalgia, a chronic condition characterized by widespread pain and tenderness, often associated with fatigue and sleep disturbances. Similarly, Baclofen's muscle relaxant characteristics might provide additional relief in conditions involving muscle spasticity or involuntary muscle contractions, including multiple sclerosis or cerebral palsy.

Moreover, the topical nature of this gel can provide localized relief with reduced systemic side effects, which is beneficial in managing localized pain due to musculoskeletal conditions like arthritis or sports-related injuries. It should be noted, however, that uses outside of the primary indication should only be pursued under the careful supervision and prescription of a qualified healthcare provider, as both Amitriptyline and Baclofen have their own unique side effects and interactions.

If you have any further queries or require more detailed information regarding the use of this medication, please do not hesitate to get in contact with us at Bayview Pharmacy. As professional compounding pharmacists, we are here to assist with your medication needs.

Frequently Asked Questions

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What is Amitriptyline HCl 0.5% to 2%/Baclofen 0.5% to 2% Transdermal Gel?

This is a compounded medication that combines Amitriptyline HCl and Baclofen in a transdermal gel formulation. It is a semisolid formulation that is dispensed through a pump mechanism for easy and precise application on the skin. This allows for targeted treatment and optimal absorption of the active ingredients.

What is the purpose of the gel formulation of Amitriptyline HCl and Baclofen?

The gel formulation allows the active ingredients to be absorbed directly through the skin and into the body. This method can potentially provide localized relief while minimizing systemic side effects generally associated with oral medications.

How do I use this Amitriptyline HCl and Baclofen Transdermal Gel?

Apply the transdermal gel to the affected area of your skin as directed by your healthcare provider. The pump mechanism allows for easy and precise delivery of the medication.

What conditions does this gel treat?

The specific conditions treated will depend on your healthcare provider's evaluation, but the gel might be used to manage various chronic pain disorders, nerve pain, or muscle spasms among other conditions.

What are possible side effects of this gel?

Most people experience minimal side effects directly attributable to the gel formulation. However, some people may experience skin irritation or other localized skin reactions. If you experience any unusual symptoms, you should consult your healthcare provider.

Should I use the gel if I’m pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult with your healthcare provider before using this gel, due to the nature of the active ingredients involved.

What should I do if I forget to apply the gel?

If you forget a dose, apply it as soon as you remember. If it's already time for the next dose, skip the missed dose and maintain your regular medication schedule. Avoid doubling the dose to make up for a missed one.

Can I cover the applied area with a bandage?

Unless your healthcare provider instructs you otherwise, it's generally best to apply the gel and let the area breathe without a bandage or other covering.

What precautions should I consider when using this gel?

Avoid applying the gel on open wounds, burns, or to irritated and infected skin areas. Also, avoid contact with eyes and mouth. Always wash your hands thoroughly after application, unless the treated area is on the hands.

Can this gel be used with other medications?

Before starting this medication, inform your doctor about any other medications, over-the-counter products, or dietary supplements you might be using to avoid potential drug interactions.

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, 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 0.5% to 2%/Baclofen 0.5% to 2% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)