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Terbinafine 10 mg/g Urea 200 mg/g Topical Cream

FDA-approved generic
Dose form
Topical Cream
Active ingredients
Urea
Terbinafine Hydrochloride

This Terbinafine 10 mg/g Urea 200 mg/g Topical Cream is a semisolid preparation dispensed in a pump mechanism, designed for convenient and controlled application on the skin. It is formulated to provide localized treatment and absorption of active ingredients.

This topical cream is used to treat fungal infections such as athlete's foot, jock itch, and ringworm. The combination of Terbinafine, an antifungal agent, and Urea, a keratolytic agent, helps to effectively manage and alleviate symptoms associated with these conditions by targeting the fungal cells and promoting skin hydration and exfoliation.

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For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription detailsOrder form
Controlled substance: e-prescribe (EPCS) from your EHR. Faxed and phoned prescriptions cannot be accepted for this preparation.
Send it from your EHR, or fax to (401) 284-4506. How to e-prescribe this formula
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.
To prescribe, you must be a verified prescriber.
To prescribe, you must be in a state where we hold an active out-of-state pharmacy license.
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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.

For prescribersSign in for prescription details and order forms.
Compounded preparations are prepared by Bayview pursuant to a prescription for an individual patient. They are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Urea
Terbinafine Hydrochloride
Topical Cream
66fd7b0bdc31c32733aec9f2
Service area

Can we ship this formula to your state?

Bayview fills prescriptions for patients in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, Pennsylvania and Rhode Island. New York patients are served on a limited basis while nonresident pharmacy registration is pending.

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Formula Information

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This topical cream combines Terbinafine at a concentration of 10 mg/g with Urea at 200 mg/g in a semisolid formulation. It is dispensed in a convenient pump mechanism that allows for controlled and precise application to the skin. Terbinafine is a potent antifungal agent that works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes. This leads to increased membrane permeability and ultimately the death of the fungal cells.

Urea acts as a keratolytic and humectant agent. At the concentration provided, Urea softens and hydrates the skin by breaking down the intercellular matrix of the stratum corneum. This action enhances the penetration of Terbinafine into deeper layers of the skin. Additionally, Urea helps to remove scales and dead skin cells, promoting a healthier skin environment that is less conducive to fungal growth.

The combination of Terbinafine and Urea in this cream is particularly beneficial for treating skin conditions where thickening or hyperkeratosis is present alongside a fungal infection. The enhanced absorption provided by Urea ensures that Terbinafine reaches the target site in adequate concentrations to eliminate the fungal infection effectively.

Patients are advised to apply the cream to the affected area once or twice daily, as directed by their healthcare provider. The pump mechanism ensures that the correct amount of cream is dispensed with each application, promoting consistent dosing and minimizing waste. It is important to use the medication for the full duration prescribed, even if symptoms improve, to prevent recurrence of the infection.

Before using this formulation, patients should inform their healthcare provider of any allergies, medical conditions, or other medications they are taking to avoid potential interactions. Common side effects may include mild irritation, redness, or itching at the application site. If severe reactions occur, use should be discontinued, and medical advice sought promptly.

For prescribers, this compounded formulation offers a targeted therapeutic approach for managing complex dermatological fungal infections. The synergy between Terbinafine and Urea enhances treatment efficacy and patient compliance due to its ease of application and effectiveness.

If you have any questions, please reach out to us.

Drug Interactions

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Terbinafine 10 mg/g Urea 200 mg/g Topical Cream is a compounded formulation designed for the treatment of fungal skin infections, such as athlete's foot, jock itch, and ringworm, as well as conditions characterized by dry, rough, and scaly skin. The combination of terbinafine, an antifungal agent, and urea, a keratolytic and moisturizing agent, provides a dual mechanism of action. Terbinafine works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, thereby exerting its antifungal effects. Urea helps to soften and moisturize the skin, enhancing the penetration of terbinafine and improving the overall condition of the skin.

When considering the use of this topical cream, it is important to be aware of potential drug interactions, although they are less common with topical formulations compared to systemic medications. However, certain interactions may still occur, particularly if the patient is using other topical or systemic medications concurrently. Patients should inform their healthcare provider of all medications they are currently using, including over-the-counter products, supplements, and herbal remedies, to ensure safe and appropriate use of this cream.

One potential interaction to consider is with other topical medications applied to the same area of the skin. The concurrent use of multiple topical products may alter the absorption and effectiveness of terbinafine and urea. It is advisable to apply other topical medications at different times or to different areas of the skin to minimize this risk. Additionally, systemic medications that affect liver enzymes, such as CYP2D6 inhibitors or inducers, may theoretically alter the metabolism of terbinafine if significant systemic absorption occurs, although this is unlikely with topical application.

Patients with a history of hypersensitivity to terbinafine, urea, or any other components of the cream should avoid using this formulation. If signs of an allergic reaction, such as rash, itching, or swelling, occur, the use of the cream should be discontinued immediately, and medical advice should be sought. Furthermore, patients with compromised skin integrity or open wounds should use this cream with caution, as increased absorption of the active ingredients may occur.

For prescribers, it is essential to consider the patient's overall medication regimen and skin condition when recommending this topical cream. Monitoring for any adverse reactions or changes in the effectiveness of the treatment is crucial, especially in patients with complex medication profiles or those with extensive skin conditions. Educating patients on the proper application technique and advising them to follow the prescribed treatment duration will enhance therapeutic outcomes.

If you have any questions or require further information regarding the use of Terbinafine 10 mg/g Urea 200 mg/g Topical Cream, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have.

How Does it Work

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Terbinafine 10 mg/g Urea 200 mg/g Topical Cream is a specialized formulation designed to deliver targeted treatment for fungal skin infections while simultaneously enhancing skin hydration and barrier function. This semisolid preparation is dispensed in a pump mechanism, ensuring a convenient and controlled application directly onto the affected skin areas. The formulation combines the antifungal properties of terbinafine with the keratolytic and moisturizing effects of urea, providing a comprehensive approach to managing skin conditions.

Terbinafine is an allylamine antifungal agent that works by inhibiting the enzyme squalene epoxidase, a key component in the biosynthesis of ergosterol, an essential component of fungal cell membranes. By disrupting ergosterol production, terbinafine compromises the integrity of the fungal cell membrane, leading to cell death and resolution of the infection.

Urea, present at a concentration of 200 mg/g, serves multiple roles in this formulation. As a keratolytic agent, urea helps to break down the intercellular matrix of the stratum corneum, facilitating the removal of dead skin cells and enhancing the penetration of terbinafine into deeper layers of the skin. Additionally, urea acts as a humectant, attracting and retaining moisture in the skin, which is particularly beneficial in conditions where the skin barrier is compromised. By improving skin hydration, urea helps to restore the skin's natural barrier function, reducing dryness and scaling often associated with fungal infections.

The pump mechanism of this topical cream ensures precise dosing and minimizes waste, allowing for consistent application and optimal therapeutic outcomes. Patients and prescribers can appreciate the ease of use and the ability to apply the cream directly to localized areas, ensuring that the active ingredients are delivered exactly where they are needed. This targeted approach not only enhances the efficacy of the treatment but also reduces the risk of systemic side effects.

For patients experiencing fungal skin infections, this formulation offers a dual-action treatment that addresses both the infection and the associated skin symptoms. Prescribers can confidently recommend this topical cream, knowing that it provides a synergistic effect through the combination of terbinafine and urea, promoting faster healing and improved skin health. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. We are here to assist you with any inquiries you may have.

Other Uses

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Terbinafine 10 mg/g Urea 200 mg/g Topical Cream, dispensed in a semisolid preparation with a pump mechanism, is primarily used for the treatment of fungal skin infections. However, this formulation may have other potential uses due to the properties of its active ingredients. Terbinafine is an antifungal agent that works by inhibiting the growth of fungi. Urea, on the other hand, is a keratolytic agent that helps to soften and moisturize the skin, enhancing the penetration of terbinafine and improving the overall condition of the skin.

Beyond its primary indication, this formulation may be beneficial in managing conditions characterized by hyperkeratosis or thickened skin, such as psoriasis or ichthyosis. The urea component can help to reduce scaling and improve skin texture, while terbinafine may provide additional benefits by reducing any secondary fungal colonization that can occur in these conditions. Additionally, the moisturizing properties of urea can be advantageous in treating dry, cracked skin, potentially providing relief in conditions like eczema or dermatitis, where maintaining skin hydration is crucial.

For patients with compromised skin barriers, such as those with diabetic foot ulcers or chronic wounds, the antimicrobial properties of terbinafine, combined with the hydrating effects of urea, may offer supportive care by reducing the risk of fungal infections and promoting a healthier skin environment. However, it is essential for prescribers to evaluate the suitability of this formulation on a case-by-case basis, considering the patient's specific condition and any potential interactions with other treatments.

As with any compounded medication, it is important for both patients and prescribers to be aware of the potential for allergic reactions or sensitivities to the active ingredients or excipients in the formulation. Patients should be advised to apply a small amount to a test area of skin before using it more extensively. If you have any questions or need further information about the potential uses of Terbinafine 10 mg/g Urea 200 mg/g Topical Cream, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have.

Frequently Asked Questions

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What is Terbinafine 10 mg/g Urea 200 mg/g Topical Cream used for?

This topical cream is used for the treatment of fungal skin infections. Terbinafine is an antifungal agent, while urea helps to moisturize and soften the skin, enhancing the absorption of the active ingredient.

How should I apply the Terbinafine and Urea topical cream?

Apply a thin layer of the cream to the affected area once or twice daily, as directed by your healthcare provider. Use the pump mechanism for a controlled and convenient application.

Can I use this cream on any part of my body?

This cream is intended for external use only and should be applied to the skin. Avoid contact with eyes, mouth, and other mucous membranes. Consult your healthcare provider for specific guidance on application areas.

How long should I use the Terbinafine and Urea cream?

The duration of treatment depends on the type and severity of the infection. Follow your healthcare provider's instructions, and do not stop using the cream prematurely, even if symptoms improve.

Are there any side effects associated with this topical cream?

Some users may experience mild skin irritation, redness, or itching at the application site. If you experience severe reactions or symptoms persist, discontinue use and consult your healthcare provider.

Can I use this cream if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult your healthcare provider before using this cream to ensure it is safe for you and your baby.

How should I store the Terbinafine and Urea topical cream?

Store the cream at room temperature, away from direct sunlight and moisture. Keep it out of reach of children and pets.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not apply extra cream to make up for a missed dose.

Can I use other skin products while using this cream?

Consult your healthcare provider before using other skin products in conjunction with this cream, as some products may interfere with its effectiveness or cause irritation.

What should I do if I accidentally ingest the cream?

If the cream is accidentally ingested, seek medical attention immediately or contact a poison control center. Do not induce vomiting unless instructed by a healthcare professional.

About this compounded preparation

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.

The conditions listed on this page are indications prescribers have ordered this preparation for. They are not FDA-approved indications, and listing them is not a statement that this preparation is effective for them.

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.

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.
For prescribers

How to e-prescribe this formula

Controlled substance: e-prescribe only (EPCS). Faxed, phoned, and handwritten prescriptions cannot be filled. Rhode Island law (R.I. Gen. Laws § 21-28-3.18) requires Schedule II to V prescriptions to be transmitted electronically.
1

Find Bayview in your EHR's pharmacy directory

Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.

NCPDP4106882NPI1750455143Address3844 Post Rd, Warwick, RI 02886Phone(401) 284-4505Fax(401) 284-4506
2

Enter the formula as a compound

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.

3

Copy the prescription details

RxFormula name
Dose formDose form
Quantity________
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription details

Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.

4

Send it

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.

Do not use Notes to Pharmacy for the formula. Some EHRs keep that field internal and never transmit it. A prescription that arrives without the formula is delayed while we call your office.

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.

Terbinafine 10 mg/g Urea 200 mg/g Topical Cream
Topical Cream
30 g
controlled

Apply topically to affected area(s)

Twice daily