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Baclofen 2%/Cyclobenzaprine HCl 2%/Diclofenac Sodium 3%/Tetracaine HCl 2% Topical Gel

This formulation is a semisolid compound consisting of Baclofen 2%, Cyclobenzaprine HCl 2%, Diclofenac Sodium 3%, and Tetracaine HCl 2%. It is dispensed through a pump mechanism, which allows for easy and precise application on the skin. The gel-like consistency of the formulation ensures targeted treatment or absorption of the active ingredients.

The formulation is designed to treat a variety of disease states. Baclofen is a muscle relaxant and antispastic agent used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness. Cyclobenzaprine HCl is a muscle relaxant that works by blocking nerve impulses (or pain sensations) that are sent to your brain. Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. Tetracaine HCl is a local anesthetic used to numb different parts of the body to reduce pain and discomfort caused by surgical or other invasive medical procedures.

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Topical Gel
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Formula Information

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This formulation is a compounded topical gel containing Baclofen 2%, Cyclobenzaprine HCl 2%, Diclofenac Sodium 3%, and Tetracaine HCl 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 aids in the targeted treatment or absorption of the active ingredients.

Baclofen is a muscle relaxant and antispastic agent that works by restoring the normal transmission of nerve signals in certain parts of the brain. It is used to relieve the symptoms of muscle spasms, particularly in conditions like multiple sclerosis and spinal cord diseases. Cyclobenzaprine HCl is another muscle relaxant that works by blocking nerve impulses (or pain sensations) that are sent to your brain, providing relief from discomfort associated with acute, painful musculoskeletal conditions.

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. It is used to treat mild to moderate pain, or signs and symptoms of osteoarthritis or rheumatoid arthritis. Tetracaine HCl is a local anesthetic that works by blocking nerve signals in your body and is used to numb different parts of the body before medical procedures or to relieve pain and itching caused by certain skin conditions.

Together, these four active ingredients work synergistically to provide relief from various painful conditions, including muscle spasms, inflammation, and localized pain. The topical application allows for targeted treatment, reducing systemic side effects often associated with oral medications. It is important to use this medication as directed by your healthcare provider and to not use it on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

If you have any questions about this formulation, its uses, or how to apply it, please don't hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist you.

Drug Interactions

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This topical gel formulation contains four active ingredients: Baclofen, Cyclobenzaprine HCl, Diclofenac Sodium, and Tetracaine HCl. Each of these ingredients has its own potential for drug interactions, which can be increased when used in combination. It's important to note that the risk of systemic interactions is generally lower with topical formulations compared to oral medications, but it is still present, especially in patients with impaired skin barrier or when applied over large skin areas.

Baclofen is a muscle relaxant and antispastic agent. It may interact with other central nervous system depressants like alcohol, benzodiazepines, opioids, and antihistamines, potentially leading to increased sedation and respiratory depression. Patients should be advised to avoid alcohol while using this medication.

Cyclobenzaprine HCl is another muscle relaxant. It can interact with monoamine oxidase inhibitors (MAOIs), causing a potentially life-threatening condition called serotonin syndrome. It can also interact with other central nervous system depressants, leading to increased sedation. Patients should be advised to avoid alcohol and to inform their healthcare provider if they are taking any MAOIs or other medications that affect the central nervous system.

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID). It may interact with other NSAIDs, increasing the risk of gastrointestinal bleeding. It can also interact with blood thinners, potentially increasing the risk of bleeding. Patients should be advised to inform their healthcare provider if they are taking any other NSAIDs or blood thinners.

Tetracaine HCl is a local anesthetic. It can interact with other local anesthetics and with medications that are known to cause methemoglobinemia, a serious condition that reduces the amount of oxygen that can be carried in the blood. Patients should be advised to inform their healthcare provider if they are taking any other local anesthetics or medications that can cause methemoglobinemia.

This formulation is intended for topical use only and should not be ingested or applied to the eyes or mucous membranes. It should be used with caution in patients with impaired skin barrier or when applied over large skin areas, as this can increase the risk of systemic absorption and potential drug interactions.

This formulation is used to treat various disease states, including muscle spasms, pain, and inflammation associated with conditions like fibromyalgia, arthritis, and neuropathic pain. The combination of active ingredients works to provide both local anesthetic effects (Tetracaine HCl) and anti-inflammatory effects (Diclofenac Sodium), while the muscle relaxants (Baclofen and Cyclobenzaprine HCl) help to reduce muscle spasms and tension.

If you have any questions about this formulation or its potential interactions with other medications, please don't hesitate to reach out to us. We are here to help ensure that your treatment is both safe and effective.

How Does it Work

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This formulation is a combination of four active ingredients: Baclofen, Cyclobenzaprine HCl, Diclofenac Sodium, and Tetracaine HCl. Each of these ingredients plays a unique role in the treatment of various disease states.

Baclofen is a muscle relaxant and antispasmodic agent. It works by inhibiting the transmission of reflexes at the spinal level, which can help to alleviate muscle spasms, pain, and stiffness. This makes it particularly useful in conditions such as multiple sclerosis and spinal cord injuries.

Cyclobenzaprine HCl is another muscle relaxant. It acts centrally and reduces motor activity of the tonic somatic origins influencing both alpha and gamma motor neurons. It is used to relieve muscle spasms associated with acute, painful musculoskeletal conditions.

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause pain and inflammation. This makes it effective in treating conditions such as osteoarthritis and rheumatoid arthritis.

Tetracaine HCl is a local anesthetic. It works by blocking nerve signals in your body, which helps to numb the area and reduce pain or discomfort. It is often used in minor surgical or diagnostic procedures, and in the relief of pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, and minor cuts and scratches.

The gel formulation allows for easy and precise application of these active ingredients directly to the affected area. This can help to provide targeted relief from symptoms, while also reducing the risk of systemic side effects that can occur with oral medications. The pump mechanism ensures that the correct dose is dispensed each time, and the gel-like consistency helps to ensure that the medication stays in place on the skin for optimal absorption.

If you have any questions about this formulation, or if you would like more information on how it can be used to treat specific conditions, please don't hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is always here to help.

Other Uses

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This formulation contains four active ingredients: Baclofen, Cyclobenzaprine HCl, Diclofenac Sodium, and Tetracaine HCl. Each of these provides a unique therapeutic effect, hence they can potentially be effective for several off-label uses beyond those for which they are typically prescribed.

Baclofen is a muscle relaxant and antispasmodic agent that can be used off-label for treating conditions such as hiccups or muscle rigidities related to conditions like Multiple sclerosis. However, it is important to note that its use in these capacities is an off-label use and not approved by regulatory authorities.

Cyclobenzaprine is another muscle relaxant. Its off-label applications could include the treatment of non-specific muscle pain and as a prophylactic measure for migraines. However, the evidence supporting these uses is limited and their effectiveness may vary from patient to patient.

Diclofenac Sodium is a non-steroidal anti-inflammatory drug (NSAID). In addition to being used for pain relief, it has off-label use as an antimigraine agent and may alleviate certain menstrual symptoms. Its anti-inflammatory action also makes it potentially useful for soft tissue injuries and inflammation.

Tetracaine HCl is a local anesthetic. While its primary use is for topical anesthesia or numbing the skin, it may theoretically prove beneficial to alleviate itching or irritation associated with certain dermatological conditions, however, more robust data is needed to substantiate these potential off-label uses.

It must be highlighted that the stated off-label uses are potential, and the effectiveness of this formulation for these off-label uses will vary widely among individuals. It's also important to note that off-label use often lacks the rigorous testing and safety data required for formal approval, so possible side effects or contraindications may not be fully understood or identified.

It is crucial that all patients and medical professionals consider the potential risks and benefits and discuss them thoroughly before starting any new medication, including this compound. Feel free to reach out to us if you have any concerns or need more information about this formulation.

Frequently Asked Questions

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What is this compounded formulation made out of?

This compounded formulation consists of Baclofen 2%, Cyclobenzaprine HCl 2%, Diclofenac Sodium 3%, and Tetracaine HCl 2% in a gel-like consistency.

How is this product administered?

This product is a semisolid formulation that is dispensed through a pump mechanism, allowing for easy and precise application directly onto the skin.

What does the pump mechanism do?

The pump mechanism facilitates a convenient and accurate dosage of the formulation. It helps to dispense the right amount of product for targeted treatment.

What is the product used for?

This product is used for targeted treatment or absorption of active ingredients in the body through the skin. It's often used to treat a variety of conditions as prescribed by healthcare professionals.

What's the consistency of this drug?

This product has a gel-like consistency, which facilitates its easy application and absorption into the skin.

Can this gel be used on all body parts?

Generally, yes, unless specified otherwise by your healthcare provider. Do avoid sensitive areas such as eyes and open wounds, and only use the formulation as prescribed.

How often should this product be used?

Usage depends on your specific condition and the advice of your medical professional. Always follow the proper dosage instructions given by your healthcare provider.

How should this product be stored?

Store this product at room temperature, away from heat and light. Also, ensure it is kept out of reach of children and pets.

What should I do if I experience side effects?

If you experience any adverse effects or allergic reactions from using this formulation, discontinue its use immediately and seek medical attention.

Do I need a prescription to use this product?

Yes, this is a prescription medication. It should only be used under the supervision of a healthcare professional and as directed by them.

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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.