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Amitriptyline HCl 3%/Clonidine HCl 0.2316%/Lidocaine 5% Topical Gel

Custom-compounded at Bayview Pharmacy, this topical gel combines Amitriptyline, Clonidine, and Lidocaine to help manage neuropathic pain, fibromyalgia, and chronic back pain.
For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
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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.
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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
Lidocaine Hydrochloride
Topical Gel
6531371d464b763ab2cccb29

Formula Information

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This formulation combines Amitriptyline HCl 3%, Clonidine HCl 0.2316%, and Lidocaine 5% in a topical gel. It works by increasing the levels of certain chemicals in the brain that help improve mood, sleep, and the body's response to pain. Clonidine is an alpha-2 adrenergic agonist that is primarily used to treat high blood pressure, but it also has pain-relieving properties. It works by relaxing blood vessels and decreasing heart rate, which can help to reduce pain. Lidocaine is a local anesthetic that works by blocking nerve signals in your body, providing temporary relief from pain and discomfort.

The gel is dispensed through a pump mechanism, which allows for easy and precise application on the skin. This targeted treatment ensures that the active ingredients are absorbed directly into the area where they are needed. The gel-like consistency also makes the formulation easy to spread and absorb, and it is less likely to cause skin irritation compared to other types of topical treatments.

This formulation can be used to treat a variety of disease states that involve chronic pain, including neuropathic pain, fibromyalgia, and certain types of arthritis. It can also be used to manage pain associated with certain skin conditions, such as shingles. As with any medication, it is important to use this formulation as directed by your healthcare provider. Side effects may include skin irritation, dizziness, dry mouth, and constipation. If you experience any severe or persistent side effects, contact your healthcare provider immediately.

For prescribers, it is important to note that this formulation should be used with caution in patients with certain medical conditions, such as heart disease, liver disease, and kidney disease. It may also interact with other medications, so it is important to review the patient's medication list before prescribing this formulation. Regular monitoring may be required to ensure the safety and effectiveness of the treatment.

If you have any questions about this formulation, please do not hesitate to reach out to us. Our team of knowledgeable compounding pharmacists at Bayview Pharmacy is always here to help.

Drug Interactions

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This formulation contains Amitriptyline HCl, Clonidine HCl, and Lidocaine, all of which can interact with other medications. It's important to inform your healthcare provider about all the medications you're currently taking, including prescription and over-the-counter drugs, vitamins, and herbal supplements.

Amitriptyline HCl, a tricyclic antidepressant, can interact with MAO inhibitors, SSRIs, anticholinergic drugs, and certain antihypertensive medications. Combining these drugs can lead to serious side effects such as serotonin syndrome, increased heart rate, and elevated blood pressure. It's also important to avoid alcohol while using this medication as it can increase drowsiness and dizziness.

Clonidine HCl, an alpha-2 adrenergic agonist, can interact with beta-blockers, calcium channel blockers, and digitalis. These interactions can lead to a significant decrease in blood pressure, slow heart rate, or heart block. Clonidine should not be discontinued abruptly as it can cause a rapid rise in blood pressure.

Lidocaine, a local anesthetic, can interact with antiarrhythmic drugs like mexiletine and phenytoin, leading to additive systemic toxicity. It's also important to avoid applying this medication to broken or inflamed skin, as it can lead to increased absorption and potential toxicity.

This formulation is used topically for the management of neuropathic pain conditions. Amitriptyline HCl and Clonidine HCl work by blocking the transmission of pain signals to the brain, while Lidocaine numbs the specific area of the body to block pain signals. This combination provides a targeted approach to pain management, reducing the need for systemic pain medications.

Remember, this is not a complete list of drug interactions. Always consult with your healthcare provider or pharmacist to understand the potential interactions of your medications. If you have any questions or concerns, don't hesitate to reach out to us at Bayview Pharmacy. We're here to help!

How Does it Work

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The formulation of Amitriptyline HCl 3%/Clonidine HCl 0.2316%/Lidocaine 5% Topical Gel works by combining the therapeutic effects of three active ingredients: Amitriptyline, Clonidine, and Lidocaine. Each of these ingredients plays a crucial role in managing various disease states, primarily those related to pain and inflammation.

It works by increasing the levels of certain chemicals in the brain that help improve mood, sleep, appetite, and energy level. It also decreases anxiety and pain levels. The 3% concentration in this formulation provides a targeted, localized effect, reducing systemic exposure and potential side effects.

Clonidine HCl, on the other hand, is an alpha-2 adrenergic agonist. It works by relaxing and widening blood vessels, which in turn helps to reduce pain and inflammation. The 0.2316% concentration in this formulation ensures a potent, localized effect.

Lidocaine is a local anesthetic that works by blocking nerve signals in your body. It is commonly used to relieve pain and discomfort from a wide range of conditions, including post-herpetic neuralgia, minor burns, abrasions, and insect bites. The 5% concentration in this formulation provides a strong, immediate numbing effect on the application area, providing rapid relief from pain and discomfort.

The semisolid formulation dispensed through a pump mechanism allows for easy and precise application on the skin. This ensures that the active ingredients are delivered directly to the area of pain or inflammation, providing targeted treatment and reducing the risk of systemic side effects. The gel-like consistency also helps to keep the skin moisturized and promotes better absorption of the active ingredients.

This formulation is typically used to treat conditions such as neuropathic pain, post-herpetic neuralgia, minor burns, abrasions, and insect bites. However, it may also be used for other conditions as determined by your healthcare provider.

As compounding pharmacists, we are committed to providing high-quality, personalized medications to meet the unique needs of each patient. If you have any questions about this formulation or how it may benefit you, please don't hesitate to reach out to us at Bayview Pharmacy. We are here to help.

Other Uses

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The topical gel formulation of Amitriptyline HCl 3%, Clonidine HCl 0.2316%, and Lidocaine 5% is primarily intended to provide localized relief from painful conditions like post-herpetic neuralgia or other types of neuropathic pain ongoing. However, this mixture has several other potential uses due to the individual properties of each active ingredient.

For instance, Amitriptyline in low doses can help with sleep-related problems, chronic headaches, or conditions involving persistent pain, like fibromyalgia, despite it originally being a drug intended for depression. Clonidine is known to possess features contributing to the management of withdrawal symptoms arising due to opioid cessation, and in some instances, it could be utilized to manage attention-deficit hyperactivity disorder (ADHD). Moreover, Lidocaine, reputed as a local anesthetic, could be used to soothe itching, burning, and pain from skin inflammations when applied topically.

Though there's potential, prescribing this formulation for applications other than treating pain should only be done after careful consideration due to the risk of side effects. Absorption rates can differ when the medication is applied to the skin instead of ingested, which can lead to unexpected results. It's fundamental that any off-label use of this compound is guided by a healthcare professional's expert judgement, considering the patient's entire health picture, including any other medications they may be taking, their overall physical condition, and the potential risks and benefits.

If you need further information on the varied uses of this formulation, including situations where it might be appropriate as part of a multimodal approach to managing certain health conditions, please reach out to us at Bayview Pharmacy. We are highly experienced in the field of compounding pharmacy, keeping up with the latest research and advancements to provide our patients with up-to-date, thorough consultations and advice.

Frequently Asked Questions

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What is Amitriptyline HCl 3%/Clonidine HCl 0.2316%/Lidocaine 5% Topical Gel?

This is a compounded formulation that combines Amitriptyline HCl, Clonidine HCl and Lidocaine in specific concentrations into a semisolid gel form. It is dispensed through a pump mechanism to be applied directly on the skin for precise treatment.

What is the dose form of this compounded formulation?

This medication is packaged as a semisolid gel that is dispensed through a pump. It’s easy to apply and provides localized treatment or absorption of active ingredients.

How to apply Amitriptyline HCl 3%/Clonidine HCl 0.2316%/Lidocaine 5% Topical Gel?

This topical gel is meant to be applied directly to the skin. Please follow your healthcare provider's instructions regarding the amount to apply and the area of application.

Is this a cream or a gel?

This medication is a gel-like consistency, which allows for easy and accurate application.

What are the active ingredients in this topical gel?

The active ingredients in this formulation are Amitriptyline HCl, Clonidine HCl, and Lidocaine in the percentage amounts stated.

Why is it dispensed through a pump mechanism?

The pump is designed to facilitate the easy and precise application of the gel. It helps in controlling the amount of gel dispensed, reducing the chance of wastage or over-application.

Is this topical gel for internal or external use?

This gel is for external use only. It should be applied topically to the skin as instructed by your healthcare provider.

How does this topical gel work?

When applied to the skin, the active ingredients are absorbed where they work to treat the specific condition as directed by your healthcare provider. Please consult your healthcare provider for more specific information.

Who should use Amitriptyline HCl 3%/Clonidine HCl 0.2316%/Lidocaine 5% Topical Gel?

This medication is used under the directions of a healthcare provider. Do not use this medication without consulting your healthcare provider, since they will need to determine if it is appropriate for you.

What to do in case of an allergic reaction to this topical gel?

If you experience signs of an allergic reaction such as hives, difficulty breathing, or swelling of your face, lips, tongue or throat, stop the use of the medication and seek immediate medical attention.

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 3%/Clonidine HCl 0.2316%/Lidocaine 5% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)