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Formulas

Amitriptyline HCL 2%/Clonidine HCL 0.1%/Gabapentin 3%/Ketoprofen 5%/Tetracaine 2% Transdermal Gel

This formulation is a combination of Amitriptyline HCL 2%, Clonidine HCL 0.1%, Gabapentin 3%, Ketoprofen 5%, and Tetracaine 2% in a transdermal 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.

The formulation is designed to treat a variety of disease states. Amitriptyline HCL is used for its antidepressant and analgesic properties, often prescribed for neuropathic pain. Clonidine HCL is an antihypertensive that can also be used for pain relief. Gabapentin is an anticonvulsant and nerve pain medication, commonly used for conditions like epilepsy and neuropathic pain. Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief, particularly in conditions like arthritis. Lastly, Tetracaine is a local anesthetic used to numb specific areas of the body.

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Amitriptyline Hydrochloride
Clonidine Hydrochloride
Gabapentin
Ketoprofen
Tetracaine Hydrochloride
Topical Gel
652f25f87f5b6896020e2c95
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Formula Information

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This formulation is a compounded transdermal gel containing Amitriptyline HCL 2%, Clonidine HCL 0.1%, Gabapentin 3%, Ketoprofen 5%, and Tetracaine 2%. 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 that the active ingredients are absorbed directly into the targeted area, providing localized treatment.

Amitriptyline HCL is a tricyclic antidepressant that is used in this formulation for its analgesic properties, particularly in neuropathic pain. Clonidine HCL is an alpha-2 adrenergic agonist that can help reduce certain symptoms of withdrawal, as well as aid in pain management. Gabapentin is an anticonvulsant that is often used to treat nerve pain, and can also help to reduce the intensity of pain signals reaching the brain. Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain in the body. Tetracaine is a local anesthetic that numbs specific areas of the body, providing further pain relief.

This formulation is particularly useful in treating various disease states that involve chronic pain, such as fibromyalgia, neuropathic pain, and certain types of arthritis. By delivering the medication directly to the site of pain, it can provide targeted relief with potentially fewer systemic side effects than oral medications. However, as with any medication, it is important to use this formulation under the guidance of a healthcare provider, as it may not be suitable for everyone and can cause side effects.

Patients using this formulation should apply it as directed by their healthcare provider, typically to the area of skin where pain is experienced. It is important to wash hands before and after application, and to avoid contact with eyes, mouth, and other sensitive areas. If any side effects occur, such as skin irritation or unusual symptoms, contact your healthcare provider immediately.

Prescribers considering this formulation for their patients should be aware of the individual components and their potential interactions with other medications. Regular monitoring may be necessary to ensure the medication is working effectively and to adjust the dosage if necessary. As a compounding pharmacy, we can customize this formulation to meet the specific needs of individual patients, including adjusting the concentrations of the active ingredients or changing the base if needed.

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

Drug Interactions

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This compounded formulation contains several active ingredients, each with its own potential for drug interactions. It is important to consider these interactions when prescribing or using this medication.

Amitriptyline HCL, a tricyclic antidepressant, can interact with other medications that affect serotonin levels, such as selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), and certain migraine medications. Combining these medications can increase the risk of serotonin syndrome, a potentially life-threatening condition. Amitriptyline can also interact with anticholinergic drugs, increasing the risk of side effects such as dry mouth, constipation, and confusion.

Clonidine HCL, an alpha-2 adrenergic agonist, can interact with beta-blockers, causing a decrease in heart rate and blood pressure. It can also interact with CNS depressants, potentially enhancing their sedative effects. Abrupt discontinuation of clonidine while taking beta-blockers can cause a rebound hypertension.

Gabapentin, an anticonvulsant, can interact with antacids, reducing the absorption of gabapentin. It is recommended to take gabapentin at least 2 hours after taking an antacid. Gabapentin can also increase the effects of CNS depressants, such as opioids, antihistamines, and alcohol.

Ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID), can interact with blood thinners, increasing the risk of bleeding. It can also interact with other NSAIDs, corticosteroids, and alcohol, increasing the risk of stomach ulcers. Ketoprofen can reduce the effectiveness of certain blood pressure medications and can increase the levels of lithium and methotrexate in the body.

Tetracaine, a local anesthetic, has minimal systemic absorption and therefore has a low potential for drug interactions. However, it can interact with other local anesthetics, potentially increasing the risk of systemic toxicity.

This formulation is designed to treat a variety of conditions, including neuropathic pain, inflammation, and localized pain. Amitriptyline and gabapentin can help manage neuropathic pain, clonidine can provide analgesic and anti-inflammatory effects, ketoprofen can reduce inflammation and pain, and tetracaine can provide local anesthesia.

It is important to inform your healthcare provider of all medications you are currently taking, including prescription drugs, over-the-counter medications, and dietary supplements, to avoid potential drug interactions. If you have any questions about this formulation or its potential interactions, please reach out to us.

How Does it Work

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This transdermal gel formulation combines five active ingredients: Amitriptyline HCL, Clonidine HCL, Gabapentin, Ketoprofen, and Tetracaine. Each of these ingredients plays a unique role in managing various disease states, primarily related to pain and inflammation.

Amitriptyline HCL 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, particularly in managing neuropathic pain.

Clonidine HCL is an alpha-2 adrenergic agonist that works by stimulating receptors in the brain that reduce the transmission of pain signals through the nervous system. It is commonly used to manage pain and hypertension, but in this formulation, it is used for its analgesic properties.

Gabapentin is an anticonvulsant that works by reducing the abnormal electrical activity in the brain. It is used in this formulation for its ability to manage neuropathic pain, particularly in conditions like postherpetic neuralgia and diabetic neuropathy.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing the production of prostaglandins, chemicals that cause inflammation, pain, and fever in the body. It is used in this formulation for its anti-inflammatory and analgesic properties, making it effective in managing conditions like arthritis and other musculoskeletal disorders.

Tetracaine is a local anesthetic that works by blocking the nerve signals in your body, causing numbness or loss of feeling in the treated area. It is used in this formulation for its ability to provide temporary relief from pain and discomfort.

The transdermal gel formulation allows for targeted application and absorption of these active ingredients. The gel is dispensed through a pump mechanism, which facilitates easy and precise application on the skin. The active ingredients are then absorbed through the skin and into the bloodstream, providing localized relief from pain and inflammation.

This formulation is particularly beneficial for patients who have difficulty swallowing pills, those who need targeted pain relief, and those who prefer a non-invasive method of medication administration. It is also beneficial for prescribers as it provides an alternative method of treatment that can be tailored to the individual needs of the patient.

If you have any questions about this formulation, 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 formulation is primarily intended for managing pain and inflammation, as it combines the analgesic and anti-inflammatory properties of Amitriptyline, Clonidine, Gabapentin, Ketoprofen, and Tetracaine. However, it may also find use in other applications, owing to the combined properties of its active ingredients.

In addition to pain management, Amitriptyline has been found to be effective in treating depression and certain types of neuropathy. It is also used off-label for prevention of migraines, chronic cough, and irritable bowel syndrome. Clonidine, apart from being an analgesic adjunct, can be used as a part of treatment for hypertension and attention deficit hyperactivity disorder. It also finds application for managing withdrawal symptoms in opioid detoxification.

Gabapentin is proven effective not just for neuropathic pain, but it can also be prescribed to control seizures in epilepsy patients. Additionally, it is used for treating restless legs syndrome. The ingredient, Ketoprofen, possesses robust anti-inflammatory properties and hence might find use in a wide range of conditions characterized by inflammation, such as rheumatoid arthritis and osteoarthritis. Tetracaine is an effective local anesthetic that can numb specific areas, making it potentially useful for procedures such as skin biopsies or minor surgeries.

However, it is crucial to remember that even though these are potential uses of the individual active ingredients, the combination product may not necessarily have the same uses. In-depth clinical studies are required to confirm the safety and efficacy of these indications. Moreover, the product should only be used as prescribed by a licensed healthcare professional. If there are any questions about this formulation, potential alternative uses or queries regarding any adverse reactions, please reach out to us for more information.

Frequently Asked Questions

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What is the use of this compounded transdermal gel?

This compounded transdermal gel is commonly used to manage chronic pain caused by conditions such as nerve injuries, fibromyalgia, shingles, and diabetic neuropathy. The combination of medications works together to provide analgesic and anti-inflammatory effects directly at the site of application.

How should this compounded transdermal gel be applied?

The gel should be applied to the affected area as prescribed by your physician. It should be administered in a thin layer and rubbed gently into the skin until it is absorbed. It is important to wash your hands thoroughly after application unless the medication is being used to treat hand pain.

How does the pump mechanism work?

The pump mechanism facilitates a convenient and exact dose of the medication. To use the pump, place your hand under the dispenser and press down until the precise amount of gel is dispensed.

Can I use the gel on open wounds or broken skin?

No, this formulation should not be applied to any open wounds or broken skin. It might result in faster absorption of the active ingredients, which could lead to increased risk of systemic side effects.

Are there any side effects associated with this gel?

Just like any medication, side effects may occur. These can include skin irritation or burning at the application site. If these side effects persist or become severe, please consult your healthcare professional immediately.

Can I stop using the gel when I feel better?

Do not discontinue the use of the gel without consulting your healthcare provider. The medication may need to be gradually reduced to prevent withdrawal symptoms.

Can I use other topical creams or gels alongside this formulation?

You should consult your healthcare provider or pharmacist before using any other topical products in combination with this formulation. This is to prevent any potential adverse interactions or alteration in the effectiveness of the medications.

How should this compounded gel be stored?

The compounded gel should be stored at room temperature, and away from heat, moisture, and direct light. It should also be kept out of reach and sight of children.

Can I use the gel if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, it's essential to talk to your healthcare provider before using the gel since it contains active ingredients which may affect the fetus or infant.

What should I do if I miss a dose?

If you miss a dose of this medication, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed one and apply the next at the scheduled time. Do not apply extra gel to make up for the missed dose.

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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.