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Amitriptyline 4%/Clonidine 0.2%/Ketoprofen 10%/Lidocaine 10% Transdermal Gel

This formulation is a transdermal gel containing Amitriptyline 4%, Clonidine 0.2%, Ketoprofen 10%, and Lidocaine 10%. 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.

The combination of these active ingredients is designed to treat a variety of disease states. Amitriptyline, a tricyclic antidepressant, is used for its analgesic properties, particularly in treating neuropathic pain. Clonidine, an alpha-2 adrenergic agonist, is used for its ability to manage withdrawal symptoms, hypertension, and pain. Ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID), is used for its anti-inflammatory and analgesic properties, particularly in treating arthritis and acute pain. Lidocaine, a local anesthetic, is used for its ability to provide temporary relief of pain and itching from minor burns, sunburn, minor cuts, and scrapes.

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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
Clonidine Hydrochloride
Ketoprofen
Lidocaine Hydrochloride
Topical Gel
65300c90e3a73bd0b059e53e

Formula Information

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This formulation is a compounded transdermal gel containing Amitriptyline 4%, Clonidine 0.2%, Ketoprofen 10%, and Lidocaine 10%. It is a semisolid formulation that 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 is a tricyclic antidepressant that is used in this formulation for its analgesic properties. Clonidine is an alpha-2 adrenergic agonist that can help reduce certain types of pain, particularly neuropathic pain, by inhibiting pain signal transmission. Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain by inhibiting prostaglandin synthesis. Lidocaine is a local anesthetic that provides immediate relief from pain by blocking sodium channels and thus inhibiting the conduction of nerve impulses.

These include conditions like neuropathic pain, fibromyalgia, arthritis, and other musculoskeletal disorders. The transdermal route allows for targeted therapy, reducing systemic side effects and providing direct relief at the site of pain.

For patients, it is important to apply the gel as directed by your healthcare provider, usually to the affected area 3-4 times daily. Avoid contact with eyes, mouth, and other mucous membranes. Wash your hands thoroughly after application. If you experience any adverse reactions such as skin irritation, rash, or unusual symptoms, discontinue use and contact your healthcare provider immediately.

For prescribers, please consider the patient's overall health status, other medications, and potential for drug interactions before prescribing this formulation. Monitor the patient's response to therapy and adjust the treatment plan as necessary. This formulation is a part of personalized medicine and can be adjusted based on the patient's specific needs and response to therapy.

If you have any questions or need further information about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always ready to assist you.

Drug Interactions

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This formulation combines four active ingredients: Amitriptyline, Clonidine, Ketoprofen, and Lidocaine, each with its own therapeutic properties. Amitriptyline is a tricyclic antidepressant that can help manage chronic pain. Clonidine is an alpha-2 adrenergic agonist that can provide relief from neuropathic pain. Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that can reduce pain and inflammation. Lidocaine is a local anesthetic that can provide immediate relief from pain by numbing the skin.

While this formulation is designed to minimize systemic absorption and focus treatment on the area where it's applied, it's important to be aware of potential drug interactions. If you're taking other medications, particularly those that affect the central nervous system, please inform your healthcare provider. This includes other antidepressants, sedatives, tranquilizers, sleeping pills, and medications for anxiety or seizures.

Amitriptyline can interact with MAO inhibitors, leading to serious side effects. If you're taking an MAO inhibitor, you should stop its use at least two weeks before starting this formulation. Clonidine can interact with beta-blockers, leading to a rapid rise in blood pressure. If you're taking a beta-blocker, your healthcare provider may need to adjust your dose or monitor you more closely.

Ketoprofen can interact with blood thinners, increasing the risk of bleeding. If you're taking a blood thinner, your healthcare provider may need to monitor your blood clotting time more closely. Lidocaine can interact with certain heart medications, potentially affecting heart rhythm. If you're taking a heart medication, your healthcare provider may need to monitor your heart rhythm more closely.

It's also important to avoid alcohol while using this formulation, as it can increase the risk of side effects, particularly drowsiness and dizziness. If you're pregnant, planning to become pregnant, or breastfeeding, please inform your healthcare provider, as this formulation may not be suitable for you.

This formulation is designed to provide targeted treatment for a variety of pain-related conditions, including neuropathic pain, musculoskeletal pain, and inflammation. By combining multiple active ingredients, it can provide immediate relief from pain (Lidocaine), reduce inflammation (Ketoprofen), and manage chronic or neuropathic pain (Amitriptyline and Clonidine).

If you have any questions about this formulation or its potential interactions with other medications or substances, please don't hesitate to reach out to us.

How Does it Work

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This formulation is a combination of four active ingredients: Amitriptyline, Clonidine, Ketoprofen, and Lidocaine, each playing a unique role in managing various disease states. The formulation is designed to be applied topically, directly to the skin, where it is absorbed into the body to provide targeted treatment.

Amitriptyline is a tricyclic antidepressant that works by increasing the levels of certain chemicals in the brain that help improve mood, relieve pain, and promote sleep. In this formulation, it is used for its analgesic properties to help manage chronic pain conditions such as neuropathic pain.

Clonidine is an alpha-2 adrenergic agonist that works by stimulating receptors in the brain that reduce nerve signal transmission. This results in a decrease in nerve pain signals sent to the brain, providing relief from neuropathic pain and other related conditions.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain in the body. It is used in this formulation to help reduce inflammation and provide relief from pain.

Lidocaine is a local anesthetic that works by blocking nerve signals in your body. It is used in this formulation to provide immediate, temporary relief from pain or discomfort.

The transdermal gel formulation allows for the active ingredients to be absorbed directly through the skin, providing targeted relief. The gel is dispensed through a pump mechanism, which allows for easy and precise application. This formulation is particularly beneficial for patients who have difficulty swallowing pills or who prefer a non-invasive method of medication administration.

This formulation can be used to treat a variety of disease states, including chronic pain conditions, neuropathic pain, inflammation, and related conditions. It provides a multi-pronged approach to pain management, addressing both the symptoms and the underlying causes of pain.

If you have any questions about this formulation, how it works, or how it can be used to treat specific disease states, please don't hesitate to reach out to us. We are here to provide you with the information and support you need to make informed decisions about your health.

Other Uses

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Amitriptyline 4%/Clonidine 0.2%/Ketoprofen 10%/Lidocaine 10% transdermal gel formulation is uniquely designed to combine the analgesic, anti-inflammatory, and neurologic benefits of its key ingredients. While it is primarily used to manage chronic neuropathic pain conditions, such as postherpetic neuralgia, complex regional pain syndrome, peripheral neuropathy, or trigeminal neuralgia, it has several other potential uses as well.

Due to its properties, this complex transdermal gel may be beneficial for patients suffering from various musculoskeletal conditions, including osteoarthritis or soft tissue inflammation. The presence of ketoprofen, a strong nonsteroidal anti-inflammatory drug (NSAID), could potentially reduce inflammation and thereby alleviate associated pain. As such, individuals suffering from acute sports injuries or those with chronic inflammatory conditions might find this formulation beneficial in improving mobility and reducing discomfort.

The combination of amitriptyline and clonidine can synergistically act to alleviate some forms of anxiety and depression, particularly when these are associated with chronic pain conditions. Amitriptyline is known for its efficacy in treating various forms of depression, while clonidine's neurologic action as an alpha-2 adrenergic agonist can potentially reduce symptoms of anxiety. While this use is off-label and less common, it might provide an alternative therapy route for patients with treatment-resistant depression or anxiety disorders that are directly linked to chronic pain.

The inclusion of lidocaine, a potent local anesthetic, might also make this gel a useful tool in managing localized pain or discomfort from minor burns, abrasions, and insect bites. However, this type of application should always be discussed with a healthcare professional due to the complex nature of this compounded medication.

As always, it is vital that healthcare professionals thoroughly discuss all potential uses, benefits and risks with the patient based on their unique medical history and current condition. Dosage and application frequency should be adjusted as per individual patient’s response and tolerance to the medication. If you have any further questions or require additional information on use and application of Amitriptyline 4%/Clonidine 0.2%/Ketoprofen 10%/Lidocaine 10% transdermal gel, please do not hesitate to reach out to us at Bayview Pharmacy.

Frequently Asked Questions

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What is the Amitriptyline 4%/Clonidine 0.2%/Ketoprofen 10%/Lidocaine 10% Transdermal Gel?

This is a compounded medication that combines four active ingredients: Amitriptyline, Clonidine, Ketoprofen, and Lidocaine, in a semisolid gel-like formulation for targeted treatment over the skin.

How does the pump mechanism work?

The pump mechanism dispenses the formulation in a controlled manner, making it easy to apply the precise amount of medication required for treatment.

How is this medication applied?

This medication is applied topically on the skin. Make sure the skin is clean and free from any other substances before application. The pump will dispense a specific amount of the gel that you can directly apply to the affected area.

Can this medication be taken orally?

No, this medication is a transdermal gel and is designed only for external use on the skin. It should not be ingested orally.

Why are there four active ingredients in this gel?

Each active ingredient serves different therapeutic function. Amitriptyline is used for its analgesic properties, Clonidine is known to alleviate nerve pain, Ketoprofen is a non-steroidal anti-inflammatory drug and Lidocaine is a local anesthetic.

What is the consistency of this medication?

This medication is a semisolid formulation with a gel-like consistency. It is designed to spread well and absorb into your skin.

What should I do in case of an overdose?

If you believe that you have used more than the recommended dosages, seek immediate medical attention. Symptoms of overdose may include dizziness, seizures, slow heart rate, and severe drowsiness.

Are there any side effects of this medication?

As with any medication, this gel can potentially cause side effects. These can include redness or irritation at the site of application, dizziness, drowsiness, or dry mouth. If these persist or worsen, consult your doctor promptly.

Can I use this medication while pregnant or breastfeeding?

If you are pregnant or breastfeeding, inform your doctor before using this medication. The active ingredients can be absorbed through the skin and may have effects on the baby.

Can this gel be used in conjunction with other medications?

Before starting any new medication, you should always inform your doctor of all the medications you are currently taking to avoid any 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 4%/Clonidine 0.2%/Ketoprofen 10%/Lidocaine 10% Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)