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The Ketoconazole 2%/Terbinafine HCl 1% Topical Cream is a specialized antifungal medication formulated for the treatment of various dermatological fungal infections. This semisolid preparation is dispensed in a pump mechanism, which allows for convenient, hygienic, and controlled application directly to the affected areas of the skin. The combination of ketoconazole and terbinafine hydrochloride in this cream is specifically designed to target a broad spectrum of fungal pathogens responsible for conditions such as athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis), and yeast infections of the skin (cutaneous candidiasis). The dual-action formula works by inhibiting the growth of fungi, thereby providing relief from the associated symptoms such as itching, burning, and scaling.
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.
Ketoconazole 2%/Terbinafine HCl 1% Topical Cream is a specially compounded medication designed to treat fungal skin infections. This cream combines the antifungal properties of two active ingredients, ketoconazole and terbinafine hydrochloride, to provide a broad-spectrum approach to managing dermatophytic infections and yeast infections of the skin. Ketoconazole is an imidazole antifungal agent that works by disrupting the fungal cell membrane, leading to the death of the fungus. Terbinafine HCl, on the other hand, is an allylamine antifungal that inhibits the enzyme squalene epoxidase, which is a key component in the fungal cell wall synthesis pathway. By inhibiting this enzyme, terbinafine HCl causes the fungal cell to become deficient in ergosterol, an essential component of fungal cell membranes, leading to fungal cell death.
The cream is formulated as a semisolid preparation, which allows for a smooth and uniform application to the affected area. The inclusion of a pump mechanism in the packaging is designed to provide patients with a convenient and controlled method of application, ensuring that the correct dose is administered each time. This is particularly beneficial for maintaining consistent treatment and improving patient adherence to the medication regimen. The cream is intended for topical use only and should be applied to clean, dry skin as directed by a healthcare provider.
This compounded formulation is particularly useful for treating localized fungal infections such as tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), and cutaneous candidiasis. It is important for patients to follow the prescribed treatment duration, even if symptoms improve before the medication is finished, to prevent recurrence of the infection.
Patients should be advised of potential side effects, which may include local irritation, redness, or itching at the application site. Serious side effects are rare when the cream is used as directed. Prescribers should consider the patient's medical history, including any known allergies to the active ingredients or excipients in the formulation, before recommending this treatment. Additionally, prescribers should monitor for signs of improvement and any adverse reactions throughout the course of treatment.
For more detailed information or if you have any questions regarding the Ketoconazole 2%/Terbinafine HCl 1% Topical Cream, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing quality care and is available to assist with any inquiries or concerns you may have about this formulation.
The combination of ketoconazole and terbinafine hydrochloride in a topical cream formulation is designed to treat fungal skin infections by leveraging the antifungal properties of both active ingredients. Ketoconazole is an imidazole derivative that works by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes, leading to increased membrane permeability and ultimately cell death. Terbinafine hydrochloride, a member of the allylamine class, primarily acts by inhibiting squalene epoxidase, another enzyme important for ergosterol synthesis. This dual-action approach enhances the antifungal efficacy against a broad spectrum of dermatophytes and yeasts.
When considering drug interactions for this topical cream, it is important to note that systemic absorption of both ketoconazole and terbinafine is minimal with proper topical application. However, certain factors such as the use of occlusive dressings, application to large surface areas, or use in patients with a compromised skin barrier could potentially increase systemic absorption. In such cases, the potential for drug interactions similar to those seen with oral administration may arise.
Ketoconazole, when absorbed systemically, is known to inhibit cytochrome P450 3A4 (CYP3A4) enzymes and can increase plasma concentrations of drugs metabolized by this pathway. This could potentially lead to increased risk of adverse effects or toxicity when used concomitantly with drugs such as certain statins, calcium channel blockers, and benzodiazepines. Additionally, ketoconazole may interact with drugs that prolong the QT interval, increasing the risk of cardiac arrhythmias.
Terbinafine, when absorbed systemically, can also affect the metabolism of other drugs. It may decrease the effectiveness of drugs metabolized by CYP2D6, such as certain antidepressants and beta-blockers. Conversely, drugs that induce or inhibit CYP2D6 may alter the metabolism of terbinafine, affecting its efficacy and safety profile.
It is also important to consider the potential for additive irritant or sensitization effects when using this combination cream with other topical agents. Patients should be advised to inform their healthcare provider of all topical products they are using to avoid potential interactions.
Patients should be instructed to apply the cream as directed and to avoid the use of occlusive dressings unless advised by a healthcare provider. They should also be aware of signs of systemic side effects, such as nausea, dizziness, or skin rash, and report these to their healthcare provider immediately. Prescribers should evaluate the patient's current medication list for potential interactions, especially if there is a concern for increased systemic absorption of the topical agents.
If you have any questions or require further information regarding the use of this formulation or potential drug interactions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing comprehensive support to ensure the safe and appropriate use of our formulations.
The Ketoconazole 2%/Terbinafine HCl 1% Topical Cream is a specially compounded medication that combines the antifungal properties of two active ingredients, ketoconazole and terbinafine hydrochloride, in a cream base. This formulation is designed to treat fungal skin infections by providing a dual mechanism of action against the fungi responsible for conditions such as athlete's foot, jock itch, ringworm, and other dermatophyte infections.
Ketoconazole is an imidazole antifungal agent that works by disrupting the fungal cell membrane. It inhibits the synthesis of ergosterol, a key component of the fungal cell membrane, leading to increased membrane permeability and ultimately cell death.
Terbinafine hydrochloride, on the other hand, is an allylamine antifungal that primarily acts by inhibiting squalene epoxidase, an enzyme involved in the biosynthesis of ergosterol in fungi. This leads to a deficiency in ergosterol and causes an accumulation of squalene within the cell, which is toxic to the fungal cell.
The combination of these two antifungal agents in a single cream enhances the spectrum of antifungal activity and may improve the overall efficacy of the treatment. The cream is formulated to be applied topically, directly to the affected area. The semisolid preparation is dispensed in a pump mechanism, which allows for convenient, controlled, and hygienic application. This delivery system helps to ensure that a consistent dose is applied each time, which is important for the effectiveness of the treatment.
When applied to the skin, the cream creates a local environment that is inhospitable to the growth and survival of the fungi. With regular application as directed by a healthcare provider, the cream can reduce the fungal load, alleviate symptoms, and promote healing of the infected skin. It is important to use the medication for the full prescribed duration, even if symptoms improve before the end of the treatment period, to prevent recurrence of the infection.
Patients and prescribers should be aware that while this compounded formulation is designed to maximize therapeutic outcomes, it is essential to follow the specific instructions for use and to monitor for any potential side effects. If there are any questions or concerns regarding the use of Ketoconazole 2%/Terbinafine HCl 1% Topical Cream, or if additional guidance is needed, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to support and provide the necessary information to ensure appropriate treatment.
Ketoconazole 2%/Terbinafine HCl 1% Topical Cream is used to treat fungal skin infections, such as athlete's foot, ringworm, jock itch, and certain kinds of dandruff.
Apply a thin layer of the cream to the affected area and a small amount of the surrounding skin once or twice daily or as directed by your healthcare provider. Wash your hands after applying the cream unless your hands are the area being treated. Do not cover the treated area with a bandage or dressing unless advised by your doctor.
The pump mechanism is designed for convenient, controlled application, ensuring you dispense the correct amount of cream each time. It also helps to prevent contamination of the product, maintaining its integrity throughout use.
You should consult with your healthcare provider before applying this cream to facial areas, as some ingredients may cause irritation, especially near the eyes or on sensitive skin.
Side effects may include itching, burning, irritation, redness, or dryness at the application site. If these persist or worsen, contact your healthcare provider. Serious side effects are rare; however, if you experience any severe reactions, seek immediate medical attention.
If you miss a dose, apply it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Wait until the cream is fully absorbed into your skin before applying makeup or sunscreen. However, to ensure effectiveness and to avoid potential interactions or reduced absorption, consult with your healthcare provider for specific instructions.
Store the cream at room temperature away from direct light and heat. Do not freeze it. Keep the bottle tightly closed when not in use and keep it out of reach of children and pets.
Before using this medication on children, it is essential to consult a pediatrician or dermatologist. The safety and effectiveness in pediatric patients may differ, and a healthcare provider can provide the appropriate advice.
Improvement in symptoms can vary depending on the type and severity of the infection. Some patients may notice improvement within a few days, while for others, it may take longer. If there is no improvement after a few weeks of use or if the condition worsens, consult your healthcare provider.
The safety of Ketoconazole 2%/Terbinafine HCl 1% Topical Cream during pregnancy or breastfeeding has not been fully established. It is essential to discuss with your healthcare provider the risks and benefits before using this medication if you are pregnant, planning to become pregnant, or are breastfeeding.
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)
