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Diclofenac Sodium 10%/Ketoprofen 10%/Lidocaine HCl 5% Topical Gel

This Diclofenac Sodium 10%/Ketoprofen 10%/Lidocaine HCl 5% Topical Gel is a specialized semisolid preparation intended for topical application. The formulation is compounded to combine the anti-inflammatory and analgesic properties of Diclofenac Sodium and Ketoprofen with the local anesthetic effects of Lidocaine HCl. The gel is dispensed in a pump mechanism, which allows for convenient, controlled, and targeted application to the affected area of the skin.

The gel is specifically designed to treat localized musculoskeletal pain, inflammation, and arthritis-related discomfort. It may also be used to alleviate pain associated with strains, sprains, and sports injuries. The combination of active ingredients works synergistically to provide relief from pain and reduce inflammation directly at the site of application, minimizing systemic exposure and potential side effects.

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Topical Cream
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Formula Information

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The Diclofenac Sodium 10%/Ketoprofen 10%/Lidocaine HCl 5% Topical Gel is a specially compounded medication designed to deliver potent anti-inflammatory and analgesic effects directly to the site of pain and inflammation. This unique formulation combines the powerful nonsteroidal anti-inflammatory drugs (NSAIDs) Diclofenac Sodium and Ketoprofen, both at a concentration of 10%, with the local anesthetic Lidocaine HCl at a concentration of 5%. The gel is prepared as a semisolid dosage form, which allows for a localized effect with minimal systemic absorption, thereby reducing the potential for systemic side effects commonly associated with oral NSAIDs.

Diclofenac Sodium and Ketoprofen are both NSAIDs that work by inhibiting the cyclooxygenase (COX) enzymes, which are involved in the synthesis of prostaglandins, substances that mediate pain, inflammation, and fever. By reducing the production of prostaglandins, these agents effectively alleviate pain and reduce inflammation in conditions such as osteoarthritis, rheumatoid arthritis, and other musculoskeletal disorders. Lidocaine HCl is a local anesthetic that provides immediate relief from pain by blocking the transmission of pain signals along the nerves. The inclusion of Lidocaine in the formulation offers rapid symptomatic pain relief, which can be particularly beneficial for patients awaiting the anti-inflammatory effects of the NSAIDs to take full effect.

The gel is dispensed in a pump mechanism, which ensures a consistent and controlled dose with each application. This delivery system is not only convenient for patients but also helps to minimize the risk of contamination and maintains the stability of the active ingredients. The topical route of administration is advantageous for patients who may have contraindications to oral NSAIDs, such as gastrointestinal issues or those at risk for cardiovascular events. Additionally, the localized application minimizes systemic exposure and potential drug interactions.

This compounded gel is indicated for the treatment of localized pain and inflammation and can be particularly useful for patients with joint pain, soft tissue injuries, or chronic conditions requiring long-term pain management. It is important for both patients and prescribers to understand that while this formulation provides targeted relief, it should be used with caution in patients with known hypersensitivity to any of the components, and it is not intended for use on open wounds or damaged skin. As with any medication, the potential for side effects exists, and patients should be monitored for any adverse reactions.

For more detailed information on the use of this compounded topical gel, or if you have any questions regarding its suitability for specific patients or conditions, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is committed to providing high-quality, customized medications to meet the unique needs of each patient.

Drug Interactions

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The combination of Diclofenac Sodium, Ketoprofen, and Lidocaine HCl in a topical gel formulation is designed to provide localized relief from pain and inflammation. Diclofenac Sodium and Ketoprofen are both nonsteroidal anti-inflammatory drugs (NSAIDs) that work by inhibiting the enzymes (COX-1 and COX-2) involved in the synthesis of prostaglandins, which are mediators of inflammation and pain. Lidocaine HCl is a local anesthetic that provides temporary relief of pain by blocking the transmission of pain signals along nerves.

When using this topical gel, it is important to consider potential drug interactions, especially if the patient is taking other medications systemically. Although the systemic absorption of Diclofenac Sodium, Ketoprofen, and Lidocaine HCl from a topical formulation is lower than from oral forms, interactions can still occur. Patients should be advised to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and herbal supplements.

Concomitant use of other NSAIDs, either topically or systemically, should be avoided to reduce the risk of additive side effects, such as increased risk of gastrointestinal bleeding or renal impairment. Caution is also advised when this gel is used in patients taking anticoagulants (such as warfarin) or antiplatelet agents (such as aspirin), as there may be an increased risk of bleeding. The use of corticosteroids with this formulation may also increase the risk of gastrointestinal side effects.

Patients on selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) may have an increased risk of bleeding when using topical NSAIDs. Additionally, the use of this gel in patients taking methotrexate or cyclosporine may increase the toxicity of these drugs due to potential NSAID-induced renal function impairment.

Topical Lidocaine may interact with other local anesthetics or medications that affect cardiac conduction. Caution is advised when using this gel in patients taking class I antiarrhythmic drugs (such as tocainide and mexiletine) or other drugs that have a potential to cause methemoglobinemia, as the risk may be increased.

It is important to apply the gel as directed, avoiding application on open wounds, mucous membranes, or near the eyes. The gel should not be used with occlusive dressings unless directed by a healthcare provider, as this may increase systemic absorption of the active ingredients.

This topical gel formulation is intended for the treatment of localized musculoskeletal pain, such as that associated with osteoarthritis, strains, sprains, and sports injuries. It is not intended for the treatment of widespread pain conditions or for use on large areas of the body. Patients should be advised to use the minimum effective amount for the shortest duration necessary to control symptoms.

If you have any questions or require further information regarding the use of this topical gel formulation or potential drug interactions, 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 ensure the safe and effective use of this medication.

How Does it Work

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The Diclofenac Sodium 10%/Ketoprofen 10%/Lidocaine HCl 5% Topical Gel is a compounded medication that combines the therapeutic effects of an anti-inflammatory and an analgesic for localized treatment of pain and inflammation. This formulation is designed to be applied directly to the skin where it can exert its effects on the affected area with minimal systemic absorption.

Diclofenac Sodium and Ketoprofen are both nonsteroidal anti-inflammatory drugs (NSAIDs). They work 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. By reducing the production of these prostaglandins, Diclofenac Sodium and Ketoprofen decrease inflammation, swelling, and pain in the localized area where the gel is applied. The 10% concentration of each NSAID in the gel ensures a potent anti-inflammatory effect, which can be particularly beneficial for conditions such as arthritis, sprains, strains, and other musculoskeletal injuries.

Lidocaine HCl is a local anesthetic that works by blocking sodium channels in the neuronal cell membrane. This action inhibits the initiation and conduction of nerve impulses, thereby providing a numbing effect and temporary relief from pain. At a 5% concentration, Lidocaine HCl in the gel formulation helps to alleviate discomfort quickly, making it easier for patients to manage their pain while the anti-inflammatory effects of Diclofenac Sodium and Ketoprofen develop.

The gel is formulated as a semisolid preparation, which allows for a smooth and consistent application over the skin. The inclusion of a pump mechanism in the packaging is designed to provide a convenient and controlled dosing method. This ensures that patients can apply the correct amount of medication to the affected area with each use, minimizing waste and maximizing therapeutic effect. The gel base also facilitates absorption of the active ingredients through the skin, targeting the site of pain and inflammation directly.

This compounded formulation is particularly suited for patients who require localized relief from pain and inflammation associated with conditions such as osteoarthritis, rheumatoid arthritis, tendinitis, bursitis, and other similar ailments. It is also beneficial for those who may experience gastrointestinal side effects from oral NSAIDs, as the topical route of administration bypasses the gastrointestinal tract, potentially reducing systemic side effects.

It is important for patients and prescribers to understand that while this topical gel can provide significant relief from pain and inflammation, it should be used as directed and is intended for localized treatment rather than systemic conditions. As with any medication, there may be potential side effects, and it is essential to consult with a healthcare provider before starting any new treatment. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with your medication needs.

Other Uses

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The combination of Diclofenac Sodium, Ketoprofen, and Lidocaine HCl in a 10%/10%/5% topical gel provides a potent formulation intended primarily for the management of pain and inflammation associated with musculoskeletal conditions such as arthritis, sprains, strains, and sports injuries. However, the therapeutic uses of this formulation may extend beyond these commonly recognized indications.

Patients and prescribers may find this tri-compound gel beneficial for the symptomatic relief of other inflammatory conditions of the skin and soft tissues not necessarily classed as musculoskeletal disorders. For instance, the anti-inflammatory properties of both Diclofenac Sodium and Ketoprofen may be useful in conditions like tendonitis, bursitis, or localized inflammatory dermatoses, where reducing inflammation is a key aspect of the treatment. Additionally, the presence of Lidocaine, a local anesthetic, may provide symptomatic relief from the pain of minor burns, insect bites, or other localized painful skin conditions, although it's not the primary indication for this product. It's important to note, though, that the formulation should only be applied to intact skin and not to open wounds or mucous membranes, as the ingredients could cause irritation or could be absorbed systemically in greater amounts than desired.

Moreover, in the realm of palliative care, the gel may serve as a beneficial agent in the management of localized pain due to its anesthetic virtue, potentially aiding to improve the quality of life for patients with cutaneous involvement of chronic conditions. While the formulation is not indicated for the treatment of neuropathic pain, the combination of ingredients might offer some level of symptomatic relief due to the multifactorial nature of complex pain syndromes in this patient population.

The benefits of this gel in a semisolid preparation with a pump mechanism are multifold: it provides a user-friendly, non-invasive method of application that allows for clean, consistent dosing and minimizes the likelihood of systemic side effects associated with oral formulations. Additionally, the formulation facilitates localized action of the drugs, potentially enhancing their efficacy and safety profile. This means the gel could be considered an alternative or adjunct to systemic treatments, or for patients who are unable to tolerate oral medications due to gastrointestinal side effects or other contraindications.

It must be emphasized that while there could be various potential applications of this topical gel formulation, the use of this compound should be guided by clinical judgment and a thorough patient evaluation. Off-label uses should only be explored when evidence supports the safety and effectiveness of the gel for the condition being treated, and should follow a discussion between the prescriber and patient about the risks and benefits of such use. As with any medication, close monitoring for any adverse effects or allergic reactions is crucial.

If you have any questions about this formulation or its potential uses, please feel free to reach out to us at Bayview Pharmacy. We are always here to support our patients and prescribers with expert advice and quality care.

Frequently Asked Questions

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What is Diclofenac Sodium 10%/Ketoprofen 10%/Lidocaine HCl 5% Topical Gel used for?

This topical gel is used for relieving pain, reducing inflammation, and alleviating discomfort in localized areas. It combines the anti-inflammatory effects of Diclofenac Sodium and Ketoprofen with the anesthetic properties of Lidocaine to address various kinds of pain, including muscular and joint pain.

How should I apply the Diclofenac Sodium/Ketoprofen/Lidocaine Topical Gel?

Apply a thin layer of the gel to the affected area using the pump mechanism, which is designed for controlled dispensing. Rub the gel gently into the skin until it is absorbed. Follow the dosage instructions prescribed by your healthcare provider, and don't use it more often than recommended.

Is this topical gel suitable for children?

Before using this gel for children, consult a pediatrician or healthcare provider. The safety and efficacy of this combination medication in children have not been established.

Can I use Diclofenac Sodium/Ketoprofen/Lidocaine Topical Gel with other medications?

Using this gel in combination with other medications may increase the risk of adverse effects or alter the effectiveness of the drugs. Discuss with your healthcare provider any medications you are currently taking to ensure they are safe to use with this gel.

Are there any known side effects of using this compounded gel?

Common side effects might include skin irritation, redness, or itching at the site of application. If you experience more severe reactions or systemic effects, such as difficulty breathing or gastrointestinal issues, discontinue use and seek medical attention.

What should I do if I miss a dose?

If you miss an application of the gel, apply it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue with your regular application schedule. Do not apply extra gel to make up for the missed dose.

How should I store the Diclofenac Sodium/Ketoprofen/Lidocaine Topical Gel?

Store the gel at room temperature, away from direct sunlight and heat. Keep the pump container tightly closed when not in use. Do not freeze the gel, and keep it out of reach of children and pets.

Can I use Diclofenac Sodium/Ketoprofen/Lidocaine Topical Gel while pregnant or breastfeeding?

Consult your healthcare provider before using this gel if you are pregnant, planning to become pregnant, or breastfeeding. There may be potential risks that need to be carefully weighed against the benefits.

What should I avoid while using this topical gel?

Avoid contact with eyes, mucous membranes, and open wounds. Do not cover the treated area with occlusive dressings unless advised by a healthcare provider. Avoid exposure to sunlight or tanning beds on the treated areas due to the potential for increased sensitivity.

Can I apply cosmetics or sunscreen over the area where I have used the gel?

Wait until the gel has completely dried before applying cosmetics, sunscreen, or any other topical product over the same area. Additionally, consult with your healthcare provider regarding the wait time between applying the gel and other substances.

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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.