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Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel

The Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel is a semisolid formulation designed for targeted application on the skin. This gel is dispensed through a pump mechanism, which allows for easy and precise dosing. The combination of ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID), and cyclobenzaprine, a muscle relaxant, makes this gel particularly effective in treating localized musculoskeletal conditions. It is commonly used to alleviate symptoms associated with acute muscle spasms, soft tissue injuries, arthritis-related pain, and inflammation. The gel's consistency ensures that the active ingredients are absorbed directly at the site of discomfort, providing relief from pain and muscle tightness.

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Ketoprofen
Cyclobenzaprine Hydrochloride
Topical Gel
65aed24b08ec7a962be08fb0
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Formula Information

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The Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel is a specialized semisolid formulation designed for targeted application to the skin. This gel is dispensed through a pump mechanism, which ensures ease of use and precise dosing for the patient. The gel base provides a suitable medium for the percutaneous absorption of the active ingredients, ketoprofen and cyclobenzaprine HCl, directly at the site of discomfort.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its therapeutic effects by inhibiting the cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the synthesis of prostaglandins. By reducing the production of these inflammatory mediators, ketoprofen effectively alleviates inflammation, pain, and swelling associated with various musculoskeletal conditions. Cyclobenzaprine HCl is a muscle relaxant that works at the level of the central nervous system to reduce muscle spasms without directly affecting the muscle fibers. When combined in this topical formulation, these two agents provide synergistic effects for the relief of musculoskeletal pain, particularly in conditions such as sprains, strains, and other soft tissue injuries.

The gel formulation is particularly beneficial for patients who may experience gastrointestinal side effects from oral NSAIDs or who require localized relief from muscle spasms without the sedative effects that can accompany systemic administration of muscle relaxants. The topical route of administration allows for a lower systemic absorption of the active ingredients, potentially reducing the risk of systemic side effects. This makes the Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel an attractive option for patients and prescribers looking for targeted therapy with a favorable safety profile.

It is important for patients to apply the gel as directed by their healthcare provider, typically to the affected area two to four times daily, depending on the severity of the condition and the response to treatment. The pump dispenser should be primed before the first use, and patients should be instructed on how to apply the gel evenly and in the correct quantity. Patients should be advised to wash their hands after application and to avoid contact with the eyes, mucous membranes, and open wounds.

Prescribers considering this formulation should assess the patient's medical history, concomitant medications, and potential drug interactions. As with all medications, the benefits and risks of this topical gel should be weighed on an individual basis. For further information, guidance on prescribing, or to address any specific questions regarding the Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing comprehensive support to ensure the safe and effective use of this formulation.

Drug Interactions

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The Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel is a compounded medication designed for localized treatment of musculoskeletal conditions such as muscle strains, sprains, and arthritis-related pain. Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain and inflammation. Cyclobenzaprine is a muscle relaxant that acts on the central nervous system to produce muscle relaxation. When combined in a topical gel, these two active ingredients can provide synergistic effects for pain relief and muscle relaxation.

When using this topical gel, it is important to consider potential drug interactions. Ketoprofen, being an NSAID, can interact with other NSAIDs (including aspirin), increasing the risk of gastrointestinal bleeding or ulcers. Patients should avoid using additional NSAIDs while using this formulation. Additionally, ketoprofen may interact with anticoagulants such as warfarin, antiplatelet drugs like clopidogrel, and selective serotonin reuptake inhibitors (SSRIs), potentially increasing the risk of bleeding. It is also important to monitor blood pressure as NSAIDs can reduce the effectiveness of certain antihypertensive medications, such as ACE inhibitors, beta-blockers, and diuretics.

Cyclobenzaprine may interact with central nervous system depressants, including alcohol, benzodiazepines, opioids, and other muscle relaxants, which can exacerbate drowsiness, dizziness, and impair cognitive function. Caution is advised when using this medication concurrently with monoamine oxidase inhibitors (MAOIs), as this can lead to serious, life-threatening side effects. Additionally, cyclobenzaprine should be used with caution in combination with other medications that affect serotonin levels, such as SSRIs, due to the risk of serotonin syndrome.

It is also important to note that the absorption of topical medications can be influenced by the use of other topical products. Patients should avoid applying other topical agents to the same area without consulting a healthcare provider, as this may alter the absorption or increase the risk of adverse effects.

Patients should inform their healthcare providers of all medications they are currently taking, including prescription drugs, over-the-counter medications, supplements, and herbal products, to ensure that the Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel is safe for them to use. Additionally, patients with a history of allergic reactions to NSAIDs or cyclobenzaprine should not use this formulation.

For any questions or concerns regarding the use of this compounded medication or potential drug interactions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is available to provide guidance and support to ensure the safe and effective use of this formulation.

How Does it Work

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The Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel is a specially compounded medication designed to deliver active ingredients directly to the site of pain and inflammation. This formulation combines the anti-inflammatory and analgesic properties of ketoprofen with the muscle relaxant effects of cyclobenzaprine hydrochloride, offering a dual-action approach to managing symptoms associated with various musculoskeletal conditions.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting the cyclooxygenase (COX) enzymes, which are involved in the synthesis of prostaglandins. Prostaglandins are lipid compounds that play a key role in the inflammation process, including pain and swelling. By reducing the production of these inflammatory mediators, ketoprofen effectively alleviates localized pain and inflammation. When applied topically, ketoprofen bypasses the gastrointestinal tract, minimizing systemic side effects and concentrating its action at the site of application.

Cyclobenzaprine HCl is a centrally acting muscle relaxant that reduces muscle spasms through its action on the central nervous system. Although the exact mechanism of action is not fully understood, it is believed to reduce tonic somatic motor activity, influencing both gamma and alpha motor systems. This results in a reduction of muscle spasm and associated pain and discomfort. When formulated for topical application, cyclobenzaprine HCl can provide localized relief without the sedative effects that often accompany oral administration.

The semisolid gel formulation is designed for ease of use and precise dosing. The gel base allows for quick absorption through the skin and direct delivery to the affected area, providing targeted relief. The pump mechanism ensures that each dose is consistent, reducing the risk of over- or under-dosing. This is particularly beneficial for patients who require a controlled amount of medication to manage their symptoms effectively.

This compounded gel is indicated for the treatment of conditions such as sprains, strains, and other musculoskeletal injuries where inflammation and muscle spasms are present. It may also be used for the symptomatic relief of conditions like osteoarthritis, rheumatoid arthritis, and other similar ailments. By combining ketoprofen and cyclobenzaprine HCl in a topical formulation, patients can achieve localized relief from pain and muscle spasms without significant systemic absorption, thereby reducing the potential for systemic side effects.

For optimal results, the gel should be applied to the affected area as prescribed by a healthcare provider. It is important to follow the specific dosing instructions provided and to not exceed the recommended amount. Patients should wash their hands immediately after application unless the hands are the treated area. It is also crucial to avoid contact with eyes, mucous membranes, and other sensitive areas.

If you have any questions or require further information about the Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to both patients and prescribers considering this formulation for treatment.

Other Uses

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The combination of ketoprofen and cyclobenzaprine in a 10%/3% topical gel formulation is primarily indicated for the relief of musculoskeletal pain, specifically localized areas of acute muscle spasms and the associated pain. However, this formulation may also be utilized for other therapeutic purposes.

Aside from its primary indications, the anti-inflammatory properties of ketoprofen may make this gel suitable for off-label use in the management of other soft tissue injuries, such as sprains, minor sports injuries, and tendinitis. By inhibiting prostaglandin synthesis, ketoprofen aids in reducing the inflammation and pain associated with these conditions. The inclusion of cyclobenzaprine, a muscle relaxant, can further enhance the effectiveness of the gel by relieving muscle tightness contributing to discomfort.

Patients with diseases like osteoarthritis might also experience symptomatic relief with topical application of this gel, as it can help decrease local pain and inflammation in affected joints. Although not a cure for arthritis, this topical therapy can serve as an adjunctive treatment to systemic therapy for localized and flare-up situations. Moreover, people suffering from certain neuropathic pain disorders may find some benefit from using the formulation since localized peripheral anti-inflammatory actions can at times lessen neuropathic pain.

Additionally, in certain cases, the compounds might be used for their secondary effects. For instance, cyclobenzaprine has been known to cause a mild sedative effect, which might augment relaxation and indirectly contribute to the overall treatment of localized pain, improving a patient's rest and sleep quality.

While these additional uses are supported by the pharmacological activities of the individual ingredients, prescribers should exercise caution and consider individual patient factors when using this topical gel for off-label purposes. The efficacy of the medication for these other uses would depend on various factors including the specific condition, the severity of symptoms, and the patient's overall health profile.

Patients and prescribers must also remain vigilant for potential side effects related to the active ingredients, including skin reactions at the site of application, which may include erythema, rash, itching, or irritation. Systemic absorption is minimal with topical formulations, but patients should be advised to limit application to affected areas and follow dosage recommendations to minimize the risk of systemic exposure and side effects.

If you have any questions regarding this formulation, including its potential other uses or more information about the suitability of this medication for a particular patient or condition, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing personalized medication solutions and professional guidance to enhance patient care and treatment outcomes.

Frequently Asked Questions

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What is Ketoprofen 10%/Cyclobenzaprine HCl 3% Topical Gel used for?

This compounded medication is typically used for its analgesic and muscle relaxant properties to provide relief from localized pain and muscle spasms. It can be used to treat conditions such as sprains, strains, or other musculoskeletal issues.

How do I apply the Ketoprofen/Cyclobenzaprine Topical Gel?

Clean and dry the affected area before application. Press the pump to dispense the gel, and gently apply a thin layer over the affected area as prescribed by your healthcare provider. Wash your hands after applying the gel unless your hands are the area being treated.

How often should I use this topical gel?

The frequency of application will be determined by your physician, but it is commonly used two to four times a day, depending on the severity of your condition.

Can this gel be used with other medications?

It is important to consult with your physician or pharmacist before combining this gel with other medications. There may be interactions with other topical or systemic drugs.

Are there any side effects of using this topical gel?

Side effects may include skin irritation, redness, or a burning sensation at the application site. If you experience any severe reactions or systemic side effects like gastrointestinal issues or unusual fatigue, contact your healthcare provider immediately.

How should this Ketoprofen/Cyclobenzaprine gel be stored?

Store the gel at room temperature, away from direct sunlight and heat. Do not freeze. Keep the container tightly closed when not in use.

What should I do if I miss a dose?

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

Can I cover the area with a bandage after applying the gel?

Do not cover the treated area with a bandage or occlusive dressing unless instructed by your healthcare provider, as this may increase the absorption of the medication.

Is this topical gel suitable for everyone?

While many people can use this gel, it may not be suitable for individuals with certain medical conditions or allergies. Always consult with your healthcare provider to determine if this medication is safe for you.

How does the pump mechanism work for applying this gel?

The pump mechanism is designed for ease of use and to dispense a consistent amount of gel with each pump. To use, simply unlock the pump if necessary, press down on the pump head, and release the gel onto your fingertip or directly onto the affected area.

What should I do in case of an overdose?

If you suspect you have applied too much gel or have accidental oral ingestion, contact your local poison control center or seek emergency medical attention immediately. Symptoms of overdose may include severe skin irritation, increase in pain, or any unusual symptoms.

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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.