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Formulas

Gentamicin 0.2%/Lidocaine HCl 5%/Misoprostol 0.0024%/Phenytoin 5% Topical Gel

The Gentamicin 0.2%/Lidocaine HCl 5%/Misoprostol 0.0024%/Phenytoin 5% Topical Gel is a specialized medication designed for the treatment of various skin conditions. This unique formulation combines the antibiotic properties of Gentamicin, the anesthetic effects of Lidocaine, the healing facilitation of Misoprostol, and the tissue regeneration promotion of Phenytoin. The gel is specifically compounded to address wound care, particularly for patients with diabetic foot ulcers, venous stasis ulcers, and pressure ulcers, where infection prevention and pain management are crucial. Additionally, the inclusion of Misoprostol and Phenytoin aids in the healing process and the reduction of scar tissue formation.

Presented in a semisolid state, the gel is dispensed through a pump mechanism that ensures a clean, easy, and precise application. This delivery system allows for the direct treatment of affected areas, promoting better absorption of the active ingredients. The gel-like consistency of the formulation is designed to adhere to the skin without causing excessive moisture, providing a suitable environment for optimal healing.

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Lidocaine Hydrochloride
Misoprostol
Phenytoin
Gentamicin Sulfate
Topical Gel
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Formula Information

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Our unique compounding formulation combines Gentamicin, Lidocaine HCl, Misoprostol, and Phenytoin in a topical gel designed for targeted treatment of various skin conditions. Gentamicin, an aminoglycoside antibiotic, is effective against a broad range of Gram-negative and some Gram-positive bacteria, making it suitable for treating and preventing skin infections. Lidocaine HCl, a local anesthetic, provides rapid and effective relief from pain by blocking nerve signals in the body, which can be particularly beneficial in painful skin conditions or when applying dressings to wounds.

Misoprostol, a synthetic prostaglandin E1 analog, has anti-inflammatory properties and can promote healing by increasing blood flow and promoting healthy granulation tissue, potentially useful in chronic wounds or ulcers. Phenytoin, traditionally used as an anticonvulsant, has been found to have wound healing properties by promoting fibroblast proliferation and collagen deposition, which can be advantageous in the management of various skin ulcers.

The gel is formulated at a concentration of 0.2% Gentamicin, 5% Lidocaine HCl, 0.0024% Misoprostol, and 5% Phenytoin, ensuring a potent therapeutic effect while minimizing systemic absorption and side effects. The semisolid formulation is dispensed through a pump mechanism, which allows for easy and precise application, ensuring consistent dosing and reducing the risk of contamination. The gel-like consistency provides a cooling effect upon application, which can be soothing for inflamed or irritated skin.

This formulation is particularly suited for patients with skin infections, painful lesions, inflammatory skin conditions, and non-healing wounds. It offers the convenience of multiple active ingredients in a single application, potentially improving patient compliance and treatment outcomes. As with any medication, it is essential to use this compounded gel under the guidance of a healthcare professional who can evaluate its suitability for a patient's specific condition.

For prescribers considering this formulation for their patients, it is important to note that the combination of these active ingredients in a topical gel is not commonly found in commercial products, and thus, it represents a tailored approach to patient care. The pharmacists at Bayview Pharmacy are available to discuss the potential benefits and considerations of this compounded medication, ensuring optimal patient care. If you have any questions or require further information about this formulation, please do not hesitate to reach out to us.

Drug Interactions

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The formulation you have described contains a combination of active ingredients that each have distinct pharmacological actions and potential interactions with other medications. It is important to consider these interactions to ensure the safety and efficacy of the treatment. Gentamicin is an aminoglycoside antibiotic that can be nephrotoxic and ototoxic, especially when used systemically or in patients with pre-existing kidney dysfunction or when combined with other nephrotoxic or ototoxic drugs such as loop diuretics, cisplatin, or other aminoglycosides. Although the systemic absorption of gentamicin in a topical formulation is typically low, caution is advised in patients taking medications that could potentiate these effects.

Lidocaine is a local anesthetic and antiarrhythmic agent. When applied topically, it is generally well-tolerated, but systemic absorption can occur, especially with high doses or prolonged use. Lidocaine can interact with other local anesthetics and medications that affect cardiac conduction, such as beta-blockers or antiarrhythmic drugs, potentially leading to additive cardiac effects. Caution is also advised when used with other CNS depressants, as systemic absorption can enhance CNS depression.

Misoprostol is a synthetic prostaglandin E1 analog that has gastroprotective properties and is used to prevent NSAID-induced gastric ulcers. It is absorbed through the skin to a certain extent. Misoprostol can interact with antacids and other gastric pH altering agents, potentially altering its absorption and efficacy. Additionally, misoprostol should be used with caution in women of childbearing potential as it can induce uterine contractions and cause miscarriage.

Phenytoin is an anticonvulsant that can be used topically for wound healing due to its effects on promoting fibroblast proliferation. Systemic absorption of phenytoin from a topical formulation can occur. Phenytoin has a wide range of drug interactions, including with other anticonvulsants, warfarin, certain antibiotics, and antifungal agents, due to its effects on hepatic enzyme systems. It is important to monitor for signs of systemic phenytoin toxicity and drug interactions that can alter phenytoin levels or the levels of other drugs.

This topical gel formulation is designed for targeted treatment of various conditions, such as skin infections (gentamicin), local pain relief (lidocaine), wound healing (phenytoin), and potentially for the prevention of NSAID-induced ulcers in the skin (misoprostol). However, the combination of these agents in a single formulation requires careful consideration of the potential for drug interactions and the specific disease states being treated. It is crucial for prescribers to review the patient's complete medication profile for potential interactions and to monitor for adverse effects. Patients should be advised to report any unusual symptoms or changes in their condition. If you have any questions or require further information regarding this formulation and its use, please reach out to us at Bayview Pharmacy.

How Does it Work

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The Gentamicin 0.2%/Lidocaine HCl 5%/Misoprostol 0.0024%/Phenytoin 5% Topical Gel is a compounded medication designed to deliver a combination of active ingredients directly to the skin for targeted therapy. This semisolid formulation is dispensed through a pump mechanism, which allows for easy and precise application, ensuring consistent dosing and adherence to treatment regimens. The gel-like consistency of the formulation facilitates the absorption of the active ingredients into the skin, where they exert their therapeutic effects.

Gentamicin is an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis, leading to the death of susceptible bacteria. At a concentration of 0.2%, it is used in this topical formulation to treat or prevent skin infections caused by bacteria. It is particularly useful in treating superficial skin infections and can help in wound healing by reducing the bacterial load.

Lidocaine HCl, present at 5%, is a local anesthetic that provides rapid numbing of the skin and surrounding tissues. It works by blocking sodium channels in the neuronal membrane, which prevents the initiation and conduction of nerve impulses, thereby providing pain relief. This can be particularly beneficial in painful skin conditions, wounds, or ulcers, making dressing changes less painful and improving patient comfort.

Misoprostol, included at a concentration of 0.0024%, is a synthetic prostaglandin E1 analog. It has cytoprotective properties that can help in the healing of ulcers and wounds. Misoprostol may promote ulcer healing by increasing mucosal blood flow and enhancing the production of protective mucus. Additionally, it has anti-inflammatory effects that can be beneficial in reducing inflammation associated with various skin conditions.

Phenytoin, at a 5% concentration, is an anticonvulsant that has been found to have wound healing properties when applied topically. It promotes wound healing by stimulating fibroblast proliferation, collagen deposition, and by modulating the inflammatory response. Phenytoin is particularly useful in the management of chronic wounds, such as diabetic foot ulcers, and can aid in reducing the wound size and enhancing the overall healing process.

This unique combination of ingredients in the Gentamicin/Lidocaine/Misoprostol/Phenytoin Topical Gel makes it a versatile formulation for treating a variety of skin conditions, including infections, wounds, and ulcers. The gel formulation is designed to maximize patient compliance and ensure the delivery of the active ingredients in a targeted manner. If you have any questions about this formulation or its use in specific disease states, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide guidance and support to both patients and prescribers.

Other Uses

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While the primary indication for this compounded Gentamicin 0.2%/Lidocaine HCl 5%/Misoprostol 0.0024%/Phenytoin 5% Topical Gel formulation is often tied to its individual components' usual indications, such as infection prevention or treatment (Gentamicin), local anesthesia (Lidocaine), wound healing (Misoprostol and Phenytoin), it can be used for a broader spectrum of dermatological and soft tissue conditions that benefit from the combination of these agents. Beyond the typical applications, this formulation may have utility in complex skin ulcers where infection, pain, and suboptimal healing are of significant concern. Misoprostol's properties may offer additional benefits in ulcer healing due to its ability to increase the secretion of gastric mucus and bicarbonate, which suggests a potential role in enhancing mucosal defense mechanisms. Furthermore, Phenytoin is known to promote wound healing through its stimulating effect on fibroblast proliferation.

Another potential application could be for patients undergoing certain dermatological procedures that may result in localized pain and require infection control; the combination of lidocaine for its anesthetic properties, gentamicin as an antibiotic, and the healing effects of misoprostol and phenytoin, might provide both prophylactic and post-procedural benefits. It is also conceivable that in certain cases of superficial neuropathic pain or other inflammatory skin conditions not primarily related to infection, the formulation's anti-inflammatory and anesthesia-inducing components may offer symptomatic relief.

It is important to note that the applications mentioned for this formulation should be considered off-label, and the combination therapy has not been widely studied. Therefore, it should be used with appropriate clinical judgment. Providers should monitor for potential side effects associated with each active ingredient, such as ototoxicity or nephrotoxicity (gentamicin), allergic reactions or methemoglobinemia (lidocaine), gastrointestinal disturbances (misoprostol), or local irritation and systemic toxicity (phenytoin).

Our pharmacy team at Bayview Pharmacy is committed to providing professional guidance and can address any questions regarding the potential uses, preparations, and precautions of this specialized formulation. We are here to assist in individualized patient care by offering our expertise in compounding to suit unique therapeutic needs. If there are any concerns or inquiries, we encourage both patients and prescribers to reach out to us for further clarification and information.

Frequently Asked Questions

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What is the purpose of this compounded medication?

This medication is a specially compounded formula containing Gentamicin, Lidocaine, Misoprostol, and Phenytoin. It is designed for topical use to treat various conditions as prescribed by your healthcare provider, which may include but not limited to wound care, pain management, and tissue healing.

How do I apply the Gentamicin/Lidocaine/Misoprostol/Phenytoin Topical Gel?

Apply a thin layer of the gel to the affected area of the skin as prescribed by your healthcare professional. The pump mechanism allows for easy and precise application. Ensure that the skin is clean before applying, and wash your hands thoroughly after application unless they are the area being treated.

Can this medication be used for open wounds?

It may be prescribed for open wounds to aid in healing and prevent infection. However, always follow the specific directions provided by your healthcare provider concerning the treatment of wounds.

How often should I use this topical gel?

The frequency of application will depend on your specific condition and the instructions provided by your healthcare professional. Do not exceed the prescribed amount or frequency of application.

What are the possible side effects of this medication?

Possible side effects may include skin irritation, redness, itching, or a burning sensation at the application site. Systemic side effects are less common but could occur due to absorption. If you experience any severe or persistent side effects, contact your healthcare provider immediately.

Should I cover the area after applying the gel?

Your healthcare provider may advise you on whether to cover the treated area. Some conditions may benefit from occlusion while others may require the area to remain uncovered to enhance healing.

Is this medication safe to use during pregnancy or while breastfeeding?

The safety of this medication during pregnancy or lactation has not been established. It is important to consult your healthcare provider before using this medication if you are pregnant or breastfeeding.

Can this medication be used in conjunction with other topical treatments?

It is not recommended to use this compounded formulation with other topical medications without the advice of your healthcare provider. There is a potential for interactions, which may affect the efficacy or increase the risk of side effects.

What should I do if I miss a dose?

If you miss a dose, apply the medication as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double up doses to make up for a missed one.

How should I store this medication?

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

What should I do in case of an overdose?

If you suspect an overdose or accidental ingestion of the medication, seek immediate medical attention or contact a poison control center. Avoid applying more than the prescribed amount, as using too much of the medication may lead to increased risk of side effects.

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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.