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Fluconazole 1%/Urea 20% Topical Liquid

The Fluconazole 1%/Urea 20% Topical Liquid is a specially compounded medication intended for external use on the skin or mucosal surfaces. This formulation combines the antifungal properties of Fluconazole with the keratolytic and hydrating effects of Urea. Fluconazole is effective in treating a variety of fungal infections, including those caused by Candida species, which can lead to conditions such as athlete's foot, ringworm, and yeast infections. Urea acts to soften and moisturize the skin, aiding in the penetration of Fluconazole and providing symptomatic relief from scaling and itching associated with these infections. The liquid form ensures ease of application and allows for the medication to be spread over affected areas, delivering targeted treatment while minimizing systemic absorption and side effects.

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Topical Liquid
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Formula Information

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Fluconazole 1%/Urea 20% Topical Liquid is a custom-compounded medication that combines the antifungal properties of fluconazole with the keratolytic and hydrating effects of urea. This topical formulation is specifically designed for direct application to affected skin or mucosal surfaces, providing a localized treatment that minimizes systemic absorption and potential side effects. Fluconazole, as an azole antifungal, works by inhibiting the fungal cytochrome P450 enzyme 14α-demethylase, thereby preventing the conversion of lanosterol to ergosterol, an essential component of the fungal cell membrane. This disruption leads to increased cell membrane permeability and ultimately the death of the fungal cell.

Urea, on the other hand, serves as a potent moisturizer and keratolytic agent. It enhances the penetration of fluconazole by altering the skin's barrier function and helps to soften and remove scales and crusts. The high concentration of urea in this formulation (20%) is particularly effective in breaking down hard, thickened skin, making it useful in the treatment of hyperkeratotic conditions. By combining these two agents, the Fluconazole 1%/Urea 20% Topical Liquid is particularly suited for treating a variety of dermatological conditions, including fungal infections complicated by excessive keratinization or scaling, such as tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm).

Patients and prescribers should note that this formulation is intended for external use only and should be applied as directed by a healthcare professional. The frequency and duration of application will depend on the severity and type of infection. It is important to use this medication for the full prescribed length of time, even if symptoms improve before the infection is completely cleared. Avoid contact with the eyes, nose, mouth, and other mucous membranes. Patients should be advised to report any signs of local adverse reactions, especially in sensitive areas.

For prescribers, it is essential to consider the patient's medical history, including any known hypersensitivities or contraindications to fluconazole or urea. Additionally, the potential for drug interactions should be evaluated, particularly with other topical treatments or systemic medications that the patient may be using. As with all compounded medications, this formulation should be prescribed within the scope of a valid patient-prescriber relationship and in accordance with state and federal regulations.

If you have any questions or require further information about the Fluconazole 1%/Urea 20% Topical Liquid, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing the highest quality of care and is available to support both patients and healthcare providers with their medication needs.

Drug Interactions

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Fluconazole is an antifungal agent that works by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. It is effective against a variety of fungal infections, particularly those caused by Candida species. Urea is a keratolytic agent that helps to hydrate and soften the skin, promoting the shedding of dead skin cells. When combined in a topical liquid formulation, fluconazole and urea can be particularly useful for treating skin conditions where fungal infection and excessive keratinization occur simultaneously, such as certain types of dermatophytosis or onychomycosis.

When considering drug interactions for this topical formulation, it is important to note that systemic absorption of fluconazole and urea through the skin is generally minimal. However, interactions can still occur, particularly if the formulation is used over large surface areas of the skin or in instances where the skin barrier is compromised. Patients should be advised to inform their healthcare provider of all medications they are currently taking, including over-the-counter drugs, herbal supplements, and topical treatments.

Fluconazole, even when used topically, could potentially interact with systemic medications that are metabolized by the cytochrome P450 enzyme system, particularly the CYP2C9, CYP2C19, and CYP3A4 isoenzymes. Drugs such as warfarin, certain antiepileptics (like phenytoin), benzodiazepines, and some statins may have increased effects or toxicity if fluconazole inhibits their metabolism. Additionally, fluconazole can enhance the effects of sulfonylureas (used in diabetes), leading to hypoglycemia. Patients on these medications should be monitored closely for adverse effects.

Topical urea is unlikely to interact with systemic medications due to its limited absorption. However, because urea can alter the skin barrier, it may affect the absorption of other topical medications applied concurrently. It is advisable to separate the application of different topical agents to avoid potential interactions and ensure the efficacy of each medication.

Patients should also be aware that alcohol consumption may increase the risk of liver toxicity when using formulations containing fluconazole, even though the risk is lower with topical application compared to systemic administration. It is generally recommended to avoid alcohol during treatment with fluconazole-containing products.

It is important for patients to follow the prescribed directions for use and to not apply the formulation more frequently than directed, as this could increase the risk of systemic absorption and potential drug interactions. If there are any concerns or questions regarding the use of this formulation or potential interactions with other medications, patients are encouraged to reach out to us at Bayview Pharmacy for personalized advice and support.

How Does it Work

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The Fluconazole 1%/Urea 20% Topical Liquid is a specially crafted medication that combines the antifungal properties of fluconazole with the keratolytic effects of urea to treat a variety of skin conditions. Fluconazole is a well-established antifungal agent that works by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes. By disrupting the cell membrane, fluconazole effectively halts the growth and replication of a wide range of fungi, making it particularly useful in the treatment of fungal infections such as tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm). It can also be used to treat yeast infections of the skin, such as those caused by Candida species.

Urea, on the other hand, serves as a potent moisturizer and keratolytic agent. At a concentration of 20%, urea helps to hydrate the skin by increasing its water-binding capacity, which is beneficial in dry, scaly skin conditions. Additionally, urea's keratolytic action aids in the softening and exfoliation of the stratum corneum, the outermost layer of the skin. This helps to remove dead skin cells and promotes the penetration of fluconazole into the deeper layers of the skin, enhancing its antifungal efficacy. Urea can also improve the appearance of the skin by promoting the shedding of the outer layer, leading to a smoother skin texture.

This topical liquid formulation is designed for ease of application and rapid absorption. When applied to the affected area, the liquid vehicle allows for a uniform distribution of the active ingredients, ensuring that they are delivered directly to the site of infection or irritation. This localized approach minimizes systemic absorption and reduces the risk of systemic side effects, making it a suitable option for patients who may be sensitive to oral antifungal medications or those who prefer a targeted treatment.

For patients and prescribers considering the use of Fluconazole 1%/Urea 20% Topical Liquid, it is important to understand that this medication is intended for external use only and should be applied as directed by a healthcare professional. The duration of treatment and frequency of application will depend on the type and severity of the condition being treated. It is also essential to maintain good hygiene and follow any additional recommendations provided by the prescriber to achieve the best therapeutic outcomes.

If you have any questions about the Fluconazole 1%/Urea 20% Topical Liquid or its use in treating specific skin conditions, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide you with the information and support you need to make informed decisions about your healthcare.

Other Uses

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The combination of fluconazole and urea in a 1%/20% topical liquid preparation is primarily indicated for the treatment of certain skin conditions, such as fungal infections where the yeast or dermatophyte may be susceptible to fluconazole. This includes conditions such as athlete's foot, ringworm, and yeast infections of the skin. The urea acts as a keratolytic agent, softening the stratum corneum, the outer layer of skin, which may enhance the antifungal activity of fluconazole by promoting deeper penetration into the affected tissues. This synergistic effect is particularly beneficial when treating infections with a hyperkeratotic component.

Aside from its principal use, this formulation could also serve various 'off-label' or ancillary purposes, exploiting urea's moisturizing and exfoliative properties. It may be helpful in managing conditions such as ichthyosis, where excessive skin scaling occurs, or in psoriasis, where urea can aid in the removal of scales and improve the appearance and feel of affected skin. Also, urea's hydrating effect can be effective in treating onychomycosis (fungal infection of the nails) when the compound is used under occlusion to enhance penetration into the nail plate. However, the efficacy of fluconazole in treating onychomycosis is less established compared to other antifungals, and this use should be considered with caution, and under proper medical guidance.

Another potential use of the fluconazole/urea liquid could be in the management of seborrheic dermatitis, where fungal overgrowth can contribute to skin flaking and inflammation. Moreover, even though fluconazole is mainly antifungal, its role in reducing inflammation can be beneficial in lesions that have secondary yeast colonization, such as in intertrigo. The urea component can additionally act as a humectant, offering symptomatic relief by moisturizing dry or inflamed skin in various conditions. For optimal results, the consistency of the liquid formulation allows for easy application on hairy areas or intertriginous zones, which could be problematic for cream or ointment formulations.

However, it is essential for patients and prescribers to note that while this fluconazole/urea topical liquid could be used in these various capacities, its employment should be based on a careful assessment of the individual's conditions, and alternate or additional treatments might be necessary. The formulation's effectiveness in these 'other uses' has not been as thoroughly researched or validated as its primary indication for fungal infections. Therefore, off-label application should be approached with caution and under the direct guidance of a healthcare professional. If there are any questions about the suitability of this medication for an individual's specific condition or its potential off-label uses, please reach out to us at Bayview Pharmacy for more personalized information and advice.

Frequently Asked Questions

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What is Fluconazole 1%/Urea 20% Topical Liquid used for?

Fluconazole 1%/Urea 20% Topical Liquid is a medicated formulation used to treat fungal skin infections and soften the skin. The fluconazole component treats the infection by inhibiting the growth of fungi, while the urea acts as a keratolytic, hydrating and softening thickened or hardened skin.

How should I apply Fluconazole 1%/Urea 20% Topical Liquid?

This liquid should be applied directly to the affected area of the skin or mucosal surfaces as per your healthcare provider's instructions. Typically, it is applied once or twice daily after gently cleaning and drying the affected area.

Can Fluconazole 1%/Urea 20% Topical Liquid be used on all areas of the body?

It is generally safe for use on most parts of the body, but avoid contact with the eyes, inside the mouth or other mucous membranes, unless directed by your healthcare provider. Special care should be taken when applying near sensitive areas.

Are there any side effects associated with Fluconazole 1%/Urea 20% Topical Liquid?

Common side effects include mild skin irritation, redness, or a burning sensation at the application site. If you experience severe itching, hives, blistering, or symptoms of an allergic reaction, discontinue use and seek medical attention immediately.

What should I do if 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 resume your regular dosing schedule. Do not apply extra liquid to make up for the missed dose.

How long does it take for Fluconazole 1%/Urea 20% Topical Liquid to work?

The time it takes to see an improvement varies depending on the type and severity of the fungal infection. While some may see improvements within a few days, it may take several weeks for the full therapeutic benefits to be noticeable.

Can Fluconazole 1%/Urea 20% Topical Liquid be used during pregnancy or breastfeeding?

Consult your healthcare provider before using this medication if you are pregnant or breastfeeding. Your provider will assess the potential benefits and risks to determine whether it's suitable for you.

Should I cover the treated area after applying the medication?

Unless directed by your healthcare provider, it is usually not necessary to cover the treated area. However, your provider may recommend covering the area with a breathable bandage if it helps with the absorption or protects the site of application.

Can I apply cosmetics or other skin products over the treated area?

It’s best to avoid applying other cosmetics or skin products on the treated area without consulting your healthcare provider, as they may interfere with the absorption or action of the medication.

How should I store Fluconazole 1%/Urea 20% Topical Liquid?

Store the medication at room temperature, away from direct sunlight and heat. Keep the bottle tightly closed when not in use. Make sure to keep it out of reach of children and pets.

Is Fluconazole 1%/Urea 20% Topical Liquid safe for children?

The safety and efficacy in children have not been fully established. Use in children should be under the direct supervision of a healthcare provider who can determine the appropriate use and dose for pediatric patients.

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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.
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