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The Fluconazole 3%/Itraconazole 3%/Terbinafine HCl 1%/Urea 30% Topical Nail Lacquer is a specialized liquid formulation crafted for direct application to the nails. This potent combination of antifungal agents and a keratolytic is designed to treat a variety of nail conditions, including onychomycosis (fungal nail infections), nail brittleness, and discoloration. Urea serves as a keratolytic, softening the nail plate and enhancing the penetration of the antifungal agents. This formulation is intended to promote healthy nail growth and improve the overall appearance of the nails by delivering a targeted treatment directly to the affected areas.
Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
The Fluconazole 3%/Itraconazole 3%/Terbinafine HCl 1%/Urea 30% Topical Nail Lacquer is a specialized liquid formulation created for direct application to the nails. This compounded medication is designed to address a variety of nail conditions, including fungal infections, which are often characterized by nail brittleness, discoloration, and thickening. The combination of antifungal agents in this lacquer works synergistically to treat onychomycosis, a common nail fungus, by disrupting the cell membrane of the fungi, thereby inhibiting their growth and reproduction.
Fluconazole and Itraconazole are azole antifungals that interfere with the synthesis of ergosterol, an essential component of fungal cell membranes. By weakening these membranes, the formulation helps to eradicate the fungal cells. Terbinafine HCl, an allylamine antifungal, works by inhibiting the enzyme squalene epoxidase, which is another critical component in the fungal cell membrane synthesis pathway. The inclusion of Urea at a high concentration serves a dual purpose: it has keratolytic properties that enhance the penetration of the antifungal agents into the nail plate and also softens and moisturizes the nail, improving its appearance and texture.
This topical nail lacquer is particularly beneficial for patients who may not tolerate systemic antifungal treatments due to potential side effects or interactions with other medications. By applying the medication directly to the affected area, systemic absorption is minimized, reducing the risk of systemic side effects. The lacquer is formulated to adhere to the nail surface.
For optimal results, patients should apply the lacquer as directed by their healthcare provider, typically once daily, ensuring the entire nail surface and the skin immediately surrounding the nail are covered. Before each application, the affected nails should be filed down as much as possible and cleaned to allow for better penetration of the lacquer. Consistency in application is key to the success of the treatment, as nail fungus can be quite persistent and may require several months of therapy to achieve full resolution.
Prescribers considering this formulation for their patients should be aware of the potential for drug interactions and contraindications associated with azole antifungals and terbinafine. It is important to review the patient's medication history and consider any underlying health conditions that may affect the suitability of this topical treatment. Additionally, while the risk of systemic side effects is low with topical application, patients should be monitored for any local reactions, such as redness, itching, or irritation at the site of application.
Bayview Pharmacy is committed to providing high-quality, customized medications to meet the specific needs of our patients. If you have any questions about this formulation or its appropriateness for a particular patient, please do not hesitate to reach out to us. Our team of expert compounding pharmacists is here to support healthcare providers and patients with the information and guidance necessary to ensure appropriate treatment.
The Fluconazole 3%/Itraconazole 3%/Terbinafine HCl 1%/Urea 30% Topical Nail Lacquer is a compounded medication designed to treat fungal nail infections (onychomycosis) and improve nail health. Each component of this formulation has a specific role in treating nail conditions. Fluconazole and Itraconazole are antifungal agents that inhibit the growth of a wide range of fungi by interfering with fungal cell membrane formation. Terbinafine HCl is another antifungal that works by inhibiting an enzyme essential for fungal cell membrane synthesis. Urea serves as a keratolytic agent, softening the nail plate and enhancing the penetration of the antifungal agents into the nail.
When using this topical nail lacquer, it is important to consider potential drug interactions, especially if the patient is taking systemic medications. Although systemic absorption of topical antifungals is minimal, interactions can still occur. Fluconazole and Itraconazole are both metabolized by the cytochrome P450 enzyme system, particularly CYP3A4, and can interact with other drugs metabolized by this pathway. This can lead to increased levels of concomitant medications, such as certain statins, calcium channel blockers, benzodiazepines, and others, potentially increasing the risk of adverse effects.
Additionally, Fluconazole and Itraconazole can inhibit the metabolism of warfarin, leading to an increased risk of bleeding. Patients on warfarin should have their prothrombin time or international normalized ratio (INR) monitored closely. These antifungals can also interact with sulfonylureas, increasing the risk of hypoglycemia in diabetic patients. Patients should be advised to monitor their blood glucose levels more frequently when starting treatment with this nail lacquer.
Terbinafine, although less likely to interact due to its minimal systemic absorption, can still theoretically interact with drugs metabolized by CYP2D6, such as certain antidepressants and beta-blockers. Caution is advised when using this medication concurrently with drugs metabolized by this enzyme.
Urea, being primarily a keratolytic, does not have significant drug interactions. However, its ability to enhance the penetration of other drugs could theoretically increase the systemic absorption of the antifungal agents in this formulation, although this is unlikely to be clinically significant given the topical route of administration.
It is essential for patients to inform their healthcare providers of all medications they are currently taking, including over-the-counter drugs and herbal supplements, to avoid potential drug interactions. Prescribers should review the patient's medication profile for interactions before prescribing this nail lacquer. If you have any questions or concerns regarding the use of this formulation or potential drug interactions, please reach out to us at Bayview Pharmacy for further assistance.
The Fluconazole 3%/Itraconazole 3%/Terbinafine HCl 1%/Urea 30% Topical Nail Lacquer is a specially compounded medication designed to treat a variety of nail conditions, primarily fungal infections such as onychomycosis, which is characterized by the thickening, discoloration, and splitting of the nails. This liquid formulation is applied directly to the nail, allowing for targeted therapy and minimizing systemic absorption, which can lead to unwanted side effects.
Fluconazole and Itraconazole are both azole antifungal agents that work by inhibiting the fungal cytochrome P450 enzyme lanosterol 14-alpha-demethylase. This enzyme is crucial for converting lanosterol to ergosterol, an essential component of the fungal cell membrane. By disrupting this process, these medications compromise the integrity of the fungal cell membrane, leading to cell death and the resolution of the infection.
Terbinafine hydrochloride (HCl) is an allylamine antifungal that works through a different mechanism. It inhibits the enzyme squalene epoxidase, which is also involved in the biosynthesis of ergosterol. By blocking this enzyme, Terbinafine leads to a deficiency in ergosterol and causes an accumulation of squalene within the fungal cell, which is toxic to the cell.
Urea, at a high concentration of 30%, serves a dual purpose in this formulation. Firstly, it acts as a keratolytic agent, which means it helps to soften and dissolve the keratin in the nail plate, allowing for deeper penetration of the antifungal agents into the nail bed where the fungus resides. Secondly, urea has hydrating properties that can help to improve the overall appearance and texture of the nails, making them less brittle and prone to cracking.
Together, these ingredients create a potent topical treatment that can effectively manage and treat fungal nail infections while also improving the cosmetic appearance of the nails. The lacquer is designed to form a protective layer over the nail, ensuring that the active ingredients remain in contact with the nail for an extended period and reducing the frequency of application needed.
For optimal results, patients should apply the nail lacquer as directed by their healthcare provider, usually once daily, ensuring that the nail is clean and dry before application. It is important to continue the treatment for the full duration prescribed, as nail fungus can be persistent and may require several months of therapy to fully eradicate.
If you have any questions about this formulation or how it can be used to treat specific nail conditions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to both patients and prescribers.
This compounded formulation is used to treat nail conditions, especially fungal infections, and also to improve nail health by addressing issues like brittleness or discoloration. It combines the antifungal properties of fluconazole, itraconazole, and terbinafine HCl with the keratolytic effects of urea to promote healthy nail growth and improve nail appearance.
The lacquer should be applied directly to the affected nails, usually once or twice a day as instructed by your healthcare provider. It’s recommended to use it on clean, dry nails and allow it to fully dry before putting on socks or shoes.
The active ingredients, fluconazole, itraconazole, and terbinafine HCl, are antifungals that work by inhibiting the growth of the fungi responsible for the infection. Urea serves to soften the keratin in the nails, allowing better penetration of the antifungal agents and improving the texture of the nails.
It's not recommended to use regular nail polish or other nail cosmetic products over the medicated lacquer, as they can form a barrier and prevent the medication from being absorbed properly. If you wish to use nail polish, discuss it with your healthcare provider.
As nails grow slowly, it may take several weeks or even months to see significant improvements in nail conditions. It’s important to continue using the lacquer as directed by your healthcare provider to achieve the best results.
Some people may experience local reactions at the application site, such as redness, itching, or irritation. If you experience any severe side effects or signs of an allergic reaction, contact your healthcare provider immediately.
The safety of this formulation has not been established in pregnant or breastfeeding women. It is important to consult your healthcare provider before beginning the treatment if you are pregnant or plan to become pregnant, or if you are breastfeeding.
If the lacquer accidentally gets on the skin around your nails, simply wipe it off with a tissue or a piece of cloth.
Store the nail lacquer at room temperature, away from direct sunlight and heat. Make sure the cap is tightly closed to prevent the medication from drying out. Keep it out of reach of children and pets.
If you miss a dose of the lacquer, apply it as soon as you remember. If it's almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
It’s advisable to avoid activities such as swimming or taking a bath immediately after application to allow the lacquer to dry and adhere to the nail properly. Always allow sufficient drying time before exposing the treated nails to water.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
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Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Apply topically to affected area(s)
