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Formulas

Amitriptyline HCl 4%/Baclofen 2%/Bupivacaine HCl 2%/Clonidine HCl 0.2316%/Gabapentin 6%/Ketamine HCl 11.5% Topical Gel

This formulation is a compounded topical gel containing Amitriptyline HCl 4%, Baclofen 2%, Bupivacaine HCl 2%, Clonidine HCl 0.2316%, Gabapentin 6%, and Ketamine HCl 11.5%. It is a semisolid formulation dispensed through a pump mechanism, which allows for easy and precise application on the skin. The gel-like consistency aids in the targeted treatment or absorption of the active ingredients.

The combination of these active ingredients is designed to manage various disease states. Amitriptyline HCl is a tricyclic antidepressant used for its analgesic properties, Baclofen is a muscle relaxant and antispasmodic agent, Bupivacaine HCl is a local anesthetic, Clonidine HCl is an alpha-2 adrenergic agonist used for its analgesic and sedative properties, Gabapentin is an anticonvulsant used for neuropathic pain, and Ketamine HCl is an NMDA receptor antagonist used for its analgesic and anesthetic properties.

Together, these ingredients work synergistically to provide relief from symptoms associated with various disease states, including neuropathic pain, muscle spasms, and certain types of chronic pain. The topical application allows for targeted treatment, reducing systemic side effects often associated with oral administration of these medications.

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Amitriptyline Hydrochloride
Bupivacaine Hydrochloride
Clonidine Hydrochloride
Gabapentin
Ketamine Hydrochloride
Baclofen
Topical Gel
6530764b421ae0940c200de2
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Formula Information

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Drug Interactions

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This compounded formulation contains several active ingredients, each with its own potential for drug interactions. It's important to note that while these interactions are possible, they may not always occur. The risk can depend on individual factors such as the patient's overall health, other medications they are taking, and their specific response to medication. Always consult with a healthcare provider for personalized advice.

Amitriptyline HCl can interact with MAO inhibitors, causing an increase in the effects of both drugs. It can also interact with anticholinergic drugs, leading to increased side effects. Additionally, it can interact with thyroid medications, potentially altering their effectiveness.

Baclofen can interact with other central nervous system depressants, including alcohol, antihistamines, and opioids, potentially increasing drowsiness and respiratory depression. It can also interact with antihypertensive drugs, potentially causing an excessive drop in blood pressure.

Bupivacaine HCl can interact with other local anesthetics or sedative medications, potentially causing an increase in side effects such as drowsiness, dizziness, and slow breathing. It can also interact with certain heart medications, potentially affecting heart rhythm.

Clonidine HCl can interact with beta-blockers, potentially causing a rebound hypertension if either drug is discontinued abruptly. It can also interact with CNS depressants, potentially increasing the risk of side effects such as drowsiness and slow breathing.

Gabapentin can interact with antacids, potentially reducing the absorption of gabapentin. It can also interact with opioid pain medications, potentially increasing the risk of side effects such as drowsiness and slow breathing.

Ketamine HCl can interact with CNS depressants, potentially increasing the risk of side effects such as drowsiness, dizziness, and slow breathing. It can also interact with certain medications for Parkinson's disease, potentially causing an increase in side effects.

This formulation is designed to be applied topically, which can reduce the risk of systemic drug interactions. However, some absorption into the bloodstream can still occur, especially if the medication is applied over large areas of skin, on broken or irritated skin, or under occlusive dressings. Always use this medication as directed by your healthcare provider, and inform them of all other medications you are taking, including prescription, over-the-counter, and herbal products.

This formulation is used to manage various disease states, including neuropathic pain, muscle spasms, and certain types of chronic pain. The combination of active ingredients works to block pain signals, relax muscles, and reduce inflammation, providing targeted relief right where it's needed.

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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This topical gel formulation combines several active ingredients, each with its own unique mechanism of action, to provide a comprehensive approach to pain management. The formulation is designed to be applied directly to the skin, allowing for targeted treatment and absorption of the active ingredients.

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. In a topical formulation, it can provide localized pain relief without the systemic side effects associated with oral administration.

Baclofen is a muscle relaxer and an antispastic agent. It works by restoring the normal transmission of nerve signals in certain parts of the spinal cord, thereby reducing muscle spasms and pain.

Bupivacaine HCl is a local anesthetic that works by blocking nerve impulses in the body, thereby numbing the area to pain. It provides immediate, short-term relief from acute pain.

Clonidine HCl is an alpha-2 adrenergic agonist that works by stimulating receptors in the brain that reduce pain signals from the nerves. It also has a sedative effect which can help to reduce discomfort and anxiety associated with chronic pain.

Gabapentin is an anticonvulsant and nerve pain medication. It works by affecting the chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. In a topical formulation, it can provide localized relief from neuropathic pain.

Ketamine HCl is a powerful anesthetic that works by blocking the NMDA receptors in the brain, which play a key role in pain signaling. It provides potent, rapid relief from severe or chronic pain.

Together, these ingredients work synergistically to provide comprehensive pain relief. The gel formulation allows for easy and precise application, and the active ingredients are absorbed directly through the skin for targeted treatment. This can be particularly beneficial for patients with localized pain who may not respond well to or cannot tolerate oral pain medications.

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. Our team of knowledgeable compounding pharmacists is always here to help.

Other Uses

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This multi-ingredient gel formulation containing Amitriptyline HCl, Baclofen, Bupivacaine HCl, Clonidine HCl, Gabapentin, and Ketamine HCl is primarily compounded for managing neuropathic pain – including diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia. However, due to the unique combination of components, it may also lend itself to other therapeutic applications.

For instance, the formulation might be used off-label for treating complex regional pain syndrome (CRPS), a chronic pain condition that often affects an arm or a leg and typically develops after an injury. The combo of potent analgesics and muscle relaxants like baclofen potentially provide substantial pain relief and improve functionality in patients with CRPS.

Additionally, this compounded gel may be beneficial in treating conditions such as central post-stroke pain and migraine-related allodynia, due to the inclusivity of multiple pharmacological components that target different pathways involved in the pain process.

The topical delivery allows this compounded medication to be applied specifically where the pain is located, a feature that might also make the formulation useful for treating localized muscle or joint pain, such as osteoarthritis, tendonitis, or strains. Agent like Amitriptyline could block pain signals at the skin level, while baclofen and bupivacaine might help alleviate muscle spasms and block nerve pain, respectively.

In cases like these, it is very important to consult with your healthcare provider to discuss the potential benefits and risks as the use of this formulation in these additional applications might be off-label, and therefore, not officially approved by regulatory bodies, like the FDA. More research is needed to fully understand the efficacy of these uses.

Please reach out to us if you have more questions or need additional information about this compounded formulation or its potential applications. Logistics like how often the gel should be applied, how much to use, and side-effects would vary based on the specific condition being treated and should be discussed with your healthcare provider.

Frequently Asked Questions

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What is Amitriptyline HCl 4%/Baclofen 2%/Bupivacaine HCl 2%/Clonidine HCl 0.2316%/Gabapentin 6%/Ketamine HCl 11.5% Topical Gel?

It is a compounded formulation made of multiple active ingredients intended for topical application on the skin. This formulation is helpful for targeted treatment and is dispensed using a pump mechanism for easy and precise application.

How is this topical gel applied?

This gel is designed to be applied directly to the skin. The pump mechanism facilitates easy and precise application, simply dispense the desired amount onto the skin and rub it in until absorbed.

What are the key active ingredients in this formulation?

This formulation has several active ingredients, including Amitriptyline HCl 4%, Baclofen 2%, Bupivacaine HCl 2%, Clonidine HCl 0.2316%, Gabapentin 6%, and Ketamine HCl 11.5%.

What does the percentage value of each ingredient signify?

The percentage value indicates the weight of an active ingredient in the total weight of the formulation. Higher percentages indicate a higher concentration of that particular ingredient.

What texture does this topical gel have?

The texture of this gel is semisolid, which makes it easy to apply on the skin and allows it to be absorbed effectively.

What is the purpose of this particular combination of ingredients?

Each of the ingredients has a specific therapeutic effect and when combined, they work together to provide a targeted treatment for various medical conditions as prescribed by a healthcare professional.

How should this gel be stored?

For optimal effectiveness and longevity, it’s best to store the gel at room temperature, away from direct sunlight. Always refer to the product's label for specific storage instructions.

Can this gel be used with other medications?

Before starting any new medication, it is advisable to consult your healthcare provider to avoid potential drug interactions.

Is this topical gel safe for use on all skin types?

Generally, it is well-tolerated on most skin types. However, if you experience any adverse reactions such as redness, itching, or rash, stop using it and seek medical advice immediately.

Does the formulation have any potential side effects?

Like any medication, this topical gel may have potential side effects. It is important to read the product label and consult with your healthcare provider for potential side effects and precautions related to this specific formulation.

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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.