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Baclofen 2%/Cyclobenzaprine HCl 2%/Ketoprofen 20%/Tetracaine 2% Topical Gel

This formulation is a semisolid gel composed of Baclofen 2%, Cyclobenzaprine HCl 2%, Ketoprofen 20%, and Tetracaine 2%. It is dispensed through a pump mechanism, which allows for easy and precise application on the skin. The active ingredients in this formulation are designed to be absorbed through the skin, providing targeted treatment.

The combination of these active ingredients is intended to treat a variety of disease states. Baclofen and Cyclobenzaprine HCl are muscle relaxants used to alleviate symptoms of muscle spasms and pain. Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, swelling, and inflammation. Tetracaine is a local anesthetic that numbs the skin and decreases pain sensation.

This topical gel formulation is particularly beneficial for patients suffering from conditions such as muscle sprains, strains, arthritis, and other inflammatory conditions. It provides targeted relief right at the site of pain, reducing the need for systemic medication and minimizing potential side effects.

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Topical Gel
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Formula Information

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This formulation is a combination of Baclofen, Cyclobenzaprine HCl, Ketoprofen, and Tetracaine, all of which are active ingredients with distinct therapeutic properties. The formulation is designed to be applied topically, directly to the skin, and is dispensed through a pump mechanism for easy and precise application. The gel-like consistency allows for targeted treatment and efficient 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 body. It is commonly used to treat muscle symptoms such as spasm, pain, and stiffness. Cyclobenzaprine HCl is another muscle relaxant that works by blocking nerve impulses (or pain sensations) that are sent to your brain. It is used to relieve muscle spasms and associated pain in acute musculoskeletal 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 to treat mild to moderate pain, or inflammation caused by arthritis. Tetracaine is a local anesthetic that works by blocking nerve signals in your body and is used to numb the skin or surfaces of the eyes, nose, or throat for certain medical procedures or to lessen pain from certain conditions.

Together, these ingredients provide a comprehensive approach to pain management, targeting both the symptoms and the underlying causes of pain. The topical application allows for targeted treatment, reducing the risk of systemic side effects often associated with oral medications. This makes it an excellent choice for patients who require long-term pain management or who are unable to tolerate oral medications.

As with any medication, it is important to use this formulation as directed by your healthcare provider. Side effects may include skin irritation at the application site, dizziness, drowsiness, or dry mouth. If these effects persist or worsen, or if you experience any serious side effects such as mood changes, trouble sleeping, or increased muscle spasms, seek medical attention immediately.

For prescribers, it is important to note that this formulation may interact with other medications, and its use should be carefully considered in patients with certain medical conditions. Always review the patient's medical history and current medication list before prescribing this formulation.

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 compounded formulation contains Baclofen, Cyclobenzaprine HCl, Ketoprofen, and Tetracaine, all of which have their own unique pharmacological properties and potential for drug interactions. It is important to consider these interactions when prescribing or using this medication.

Baclofen is a muscle relaxant and antispastic agent. It may interact with other central nervous system depressants, including alcohol, antihistamines, opioids, sedative/hypnotics, and other muscle relaxants, potentially leading to increased sedation and respiratory depression. Concurrent use with monoamine oxidase inhibitors (MAOIs) may result in increased blood pressure.

Cyclobenzaprine HCl is also a muscle relaxant. It may interact with monoamine oxidase inhibitors (MAOIs), leading to serious, potentially life-threatening side effects such as hypertensive crisis. It may also interact with other central nervous system depressants, tricyclic antidepressants, and serotonergic drugs, potentially leading to increased sedation, serotonin syndrome, or increased risk of seizures.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). It may interact with anticoagulants, antiplatelet drugs, corticosteroids, and other NSAIDs, potentially increasing the risk of gastrointestinal bleeding. It may also interact with angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or diuretics, potentially reducing their effectiveness or increasing the risk of kidney damage. Concurrent use with lithium or methotrexate may increase their levels in the body.

Tetracaine is a local anesthetic. It may interact with other local anesthetics or antiarrhythmic drugs, potentially leading to additive systemic toxicity. It may also interact with cholinesterase inhibitors, potentially prolonging or enhancing its effects.

This formulation is intended for topical use, which may reduce the risk of systemic drug interactions. However, systemic absorption can still occur, especially if the medication is applied over large areas of skin, on broken or inflamed skin, or under occlusive dressings. Therefore, it is still important to consider potential drug interactions.

This formulation is used to treat various conditions, including muscle spasms, pain, and inflammation. Baclofen and Cyclobenzaprine HCl relax muscles to reduce spasms, Ketoprofen reduces pain and inflammation, and Tetracaine provides local anesthesia.

Patients should inform their healthcare provider of all medications they are currently taking, including prescription drugs, over-the-counter medications, and dietary supplements, to ensure the safe use of this medication. If you have any questions about this formulation or its potential interactions, please reach out to us at Bayview Pharmacy.

How Does it Work

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This formulation is a combination of four active ingredients: Baclofen, Cyclobenzaprine HCl, Ketoprofen, and Tetracaine, each playing a unique role in providing relief from various disease states.

Baclofen is a muscle relaxant and antispastic agent. It works by acting on the central nervous system to help reduce muscle spasm, stiffness, and pain. It is often used in conditions such as multiple sclerosis and spinal cord injuries.

Cyclobenzaprine HCl is another muscle relaxant that works by blocking nerve impulses (or pain sensations) that are sent to your brain. It is primarily used to treat muscle spasms and to relieve pain and discomfort caused by strains, sprains, and other muscle injuries.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. It is used to treat pain or inflammation caused by arthritis and also used for the treatment of mild to moderate pain, and relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.

Tetracaine is a local anesthetic. It works by blocking nerve signals in your body and is used to numb the skin or surfaces of the eyes, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

When combined in a topical gel, these four ingredients work together to provide comprehensive pain relief and muscle relaxation. The gel is designed to be applied directly to the area of discomfort, allowing for targeted treatment. The semisolid formulation is dispensed through a pump mechanism, facilitating easy and precise application on the skin. The gel-like consistency allows for the active ingredients to be absorbed through the skin, directly to the area that needs treatment.

This formulation is particularly useful in treating conditions that involve muscle spasms, inflammation, and pain. It provides a localized effect, reducing the potential for systemic side effects that can occur with oral medications.

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

Other Uses

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This compounded topical gel medication consists of Baclofen 2%, Cyclobenzaprine HCl 2%, Ketoprofen 20%, and Tetracaine 2%. Typically, it is used for treating localized pain, muscle spasm, inflammation, and providing a local anaesthetic effect thanks to the pharmacologic action of the included ingredients. However, it is important to note that there could be some additional, off-label uses that are not fully recognized yet but could provide significant benefits for patients.

For instance, due to its anti-inflammatory properties from Ketoprofen, the gel may also be used to relieve conditions where inflammation is a primary symptom, such as tendonitis, bursitis, and osteoarthritis. The soothing effect of the gel could potentially be used for relieving discomfort from minor injuries or sprains. The muscle relaxant properties of Baclofen and Cyclobenzaprine could be useful in managing symptoms associated with fibromyalgia and other conditions causing chronic muscle pain. Tetracaine, a local anaesthetic, could provide temporary relief from minor skin irritations, burns or insect bites.

In dermatology, sometimes, it is used to provide symptomatic relief in patients with neuropathic pain syndromes or dermatitis where the exact cause of the pain or itch is unknown. This topical medication is also sometimes used in some physical therapy or rehabilitation programs to desensitize trigger points and provide short term relief of acute pain that could improve the effectiveness of the treatment regime.

However, it is essential for these other uses to be supported by appropriate clinical evidence, so patients and prescribers should not solely rely on anecdotal instances of successful use. Moreover, potential side effects and drug interactions should always be evaluated in any new therapeutic use. Consultation with a healthcare provider with knowledge in compounding medications is recommended to individualize the therapy according to the patient’s specific requirements.

If you have any queries regarding the other potential uses of this formulation or how it may be beneficial for your patients, do not hesitate to contact us at Bayview Pharmacy. As a team of knowledgeable compounding pharmacists, we are always ready to provide accurate, comprehensive information to achieve the best patient outcomes.

Frequently Asked Questions

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What is the purpose of this compounded formulation of Baclofen 2%/Cyclobenzaprine HCl 2%/Ketoprofen 20%/Tetracaine 2% Topical Gel?

This compounded formulation is designed to provide targeted treatment for various conditions such as muscle spasms, inflammation and pain right at the site of application, potentially reducing systemic side effects. It is dispensed through a pump mechanism, making it easy and precise to apply.

How should I apply this formulation?

Apply a thin layer of the gel to the affected area as directed by your healthcare provider. Gently rub in until the gel is fully absorbed. Do not apply more frequently than instructed.

Can I apply this formulation to broken or damaged skin?

No, avoid applying this formulation on areas with open wounds, cuts or damaged skin as it might lead to excessive absorption of the medication, potentially resulting in serious side effects. Always apply to intact, clean, dry skin.

What is the consistency of this topical gel like?

The topical gel has a semi-solid, gel-like consistency, making it easy to apply and absorb into the skin.

Can this gel cause any side effects?

Every medication may cause side effects. While most people will not experience side effects when using this compounded gel, some possible side effects can include skin irritation at the site of application, or allergic reactions. If you notice any unusual symptoms, contact your healthcare provider immediately.

How does the pump dispenser work?

The pump dispenser facilitates easy application of the gel. Simply press down on the pump to dispense a pre-measured amount of gel that you can directly apply to the target area.

Should I store this formulation in a particular way?

Store this formulation at room temperature, away from heat and direct light. Do not freeze. Keep out of reach of children and pets.

What should I do in case I miss a dose?

If you miss a dose, apply it as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.

Can this formulation interact with other medications?

Yes, this formulation can potentially interact with other medications. To avoid any harmful interactions, inform your healthcare provider about all the products you use, including prescription drugs, non-prescription drugs, and herbal products prior to starting treatment.

Can I use this formulation if I am pregnant or breastfeeding?

Before using this product, tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. The components of this compounded formulation can be absorbed through the skin and may potentially affect an unborn or nursing baby.

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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.