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Hydrocortisone 1%/Terbinafine 1% Otic Drops

FDA-approved generic
Dose form
Otic Drops
Active ingredients
Hydrocortisone
Terbinafine Hydrochloride

The Hydrocortisone 1%/Terbinafine 1% Otic Drops is a liquid formulation specifically compounded for otic administration. This dual-agent preparation combines the anti-inflammatory properties of hydrocortisone with the antifungal activity of terbinafine. The drops are designed to be easily administered into the ear canal, allowing for direct action on the affected area. This targeted approach ensures that the medication provides relief from symptoms such as itching, redness, and discomfort, while also addressing the underlying infection. The precise drop form facilitates controlled dosing, which is crucial for the treatment of delicate structures within the ear.

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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.
Hydrocortisone
Terbinafine Hydrochloride
Otic Drops
65add133492634fd34add905
Service area

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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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Our Hydrocortisone 1%/Terbinafine 1% Otic Drops is a compounded liquid formulation meticulously prepared for otic administration. This bespoke medication combines the anti-inflammatory properties of hydrocortisone with the antifungal capabilities of terbinafine, each at a concentration of 1%. The formulation is designed to be administered directly into the ear canal, providing a convenient and efficient delivery system for patients suffering from various ear-related conditions.

Hydrocortisone, a corticosteroid, works by reducing inflammation, itching, and swelling. By mitigating inflammation, hydrocortisone can alleviate discomfort and prevent further irritation from scratching or external factors.

Terbinafine, on the other hand, is an antifungal agent that targets the cell membrane of fungi, causing cell death and resolving infections. It is especially useful in treating otomycosis, a fungal infection in the ear, which can cause symptoms such as itching, redness, and sometimes a feeling of fullness or hearing loss. By combining terbinafine with hydrocortisone, our formulation addresses both the infection and the inflammatory response, leading to a more comprehensive treatment approach.

The precise drop application ensures that the medication is delivered directly to the site of infection and inflammation, allowing for targeted therapy with minimal systemic absorption.

Patients prescribed this medication should follow the dosing instructions provided by their healthcare provider to achieve optimal results. It is important to use the drops consistently and for the full duration prescribed, even if symptoms improve, to ensure the infection is fully treated and to prevent recurrence. As with any medication, potential side effects may occur, and patients should be advised to contact their healthcare provider if they experience any adverse reactions or if their symptoms persist or worsen.

Prescribers considering this formulation for their patients can expect a medication that is tailored to treat specific otic conditions with an anti-inflammatory and antifungal action. Our team at Bayview Pharmacy is committed to providing high-quality, customized medications to meet the unique needs of each patient. If you have any questions or require further information about our Hydrocortisone 1%/Terbinafine 1% Otic Drops, please do not hesitate to reach out to us. We are here to support both patients and healthcare providers with expert advice and comprehensive care.

Drug Interactions

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The combination of hydrocortisone and terbinafine in an otic drop formulation is used to treat ear conditions that may involve inflammation and fungal infections. Hydrocortisone is a corticosteroid that reduces inflammation, itching, and swelling. Terbinafine is an antifungal agent that works by inhibiting the enzyme squalene epoxidase, which is a key component in the fungal cell membrane synthesis pathway. This dual-action formulation provides both anti-inflammatory and antifungal effects, making it suitable for treating otic conditions where both inflammation and fungal infection are present or suspected.

When considering drug interactions, it is important to note that while systemic absorption of hydrocortisone and terbinafine from otic drops is generally low, there is still potential for interaction with other medications. Hydrocortisone, even at low levels, can interact with drugs that induce or inhibit CYP3A4, an enzyme that metabolizes corticosteroids. Strong CYP3A4 inducers, such as rifampin and phenytoin, may decrease the effectiveness of hydrocortisone, while CYP3A4 inhibitors like ketoconazole and ritonavir may increase hydrocortisone levels, potentially leading to increased risk of systemic corticosteroid side effects.

Terbinafine's interactions are primarily related to its potential to inhibit CYP2D6, which can affect the metabolism of other drugs metabolized by this enzyme. Drugs that are substrates of CYP2D6, such as certain antidepressants, beta-blockers, and antiarrhythmics, may have increased plasma concentrations when used concomitantly with terbinafine, potentially leading to adverse effects or toxicity. Additionally, terbinafine may decrease the effectiveness of hormonal contraceptives, so alternative or additional contraceptive measures should be considered.

Patients should be advised to inform their healthcare provider of all medications they are taking, including prescription drugs, over-the-counter medications, and herbal supplements, to assess for potential interactions. It is also important to monitor for signs of ototoxicity, such as hearing changes or balance disturbances, as the use of otic preparations can carry a risk of ear damage, especially if the tympanic membrane is perforated.

For prescribers, it is crucial to review the patient's medication profile for potential interactions before prescribing this otic drop formulation. Adjustments to therapy or additional monitoring may be necessary to ensure safe and appropriate use of the medication. If you have any questions or require further information regarding this formulation and its potential drug interactions, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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The Hydrocortisone 1%/Terbinafine 1% Otic Drops is a compounded medication that combines the anti-inflammatory properties of hydrocortisone with the antifungal capabilities of terbinafine, creating a potent treatment for various otic conditions. This liquid formulation is specifically designed for aural administration, providing a convenient and efficient way to deliver the medication directly to the site of infection or inflammation within the ear canal.

Hydrocortisone, a corticosteroid, works by reducing inflammation, itching, and swelling. When administered as otic drops, hydrocortisone targets the inflamed tissues within the ear, providing relief from discomfort and reducing the symptoms associated with otic inflammation, such as redness and pain. This can be particularly beneficial in treating otitis externa, also known as swimmer's ear, or other inflammatory ear conditions.

Terbinafine, on the other hand, is an antifungal agent that functions by inhibiting the enzyme squalene epoxidase, which is a key component in the fungal cell membrane synthesis pathway. By disrupting this pathway, terbinafine causes the fungal cell membranes to become deficient and leaky, leading to the death of the fungal cells.

The combination of these two active ingredients in a 1% concentration for each allows for a broad-spectrum approach to treating ear conditions. The hydrocortisone addresses the inflammatory response, while the terbinafine targets the underlying fungal infection. This dual-action treatment is particularly useful for patients who are experiencing an ear infection that is both inflammatory and fungal in nature.

For optimal results, the Hydrocortisone 1%/Terbinafine 1% Otic Drops should be used as directed by a healthcare provider. The precise and controlled drop application ensures that the medication is delivered in the right dosage, minimizing the risk of side effects while maximizing therapeutic efficacy. Patients should follow the prescribed dosing regimen and complete the full course of treatment to ensure the best outcome.

As with any medication, it is essential to consult with a healthcare provider before starting treatment to ensure it is appropriate for the individual's specific condition.

If you have any questions about the Hydrocortisone 1%/Terbinafine 1% Otic Drops or would like to discuss its suitability for your condition, please 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 otic health.

Other Uses

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The Hydrocortisone 1%/Terbinafine 1% Otic Drops formulation, while primarily indicated for the management of ear infections and associated inflammation, may have other potential applications based on the individual constituents’ pharmacological properties. Beyond ear infections, this formulation might be employed off-label to address certain dermatological conditions within the outer ear, like inflamed eczema or psoriasis patches, due to the anti-inflammatory action of hydrocortisone. However, it should be noted that such uses would be off-label and should only be considered when other treatments are ineffective, contraindicated, or not tolerated.

For individuals dealing with itchy or inflamed skin conditions affecting the earlobes or external auditory meatus, this otic solution may provide symptom relief. Furthermore, terbinafine, an antifungal agent, could theoretically have utility in the sterilization of fungal-contaminated objects or sites, albeit this is not a conventional use and there is limited evidence supporting such practices. These kinds of alternative applications should be pursued only under the guidance and monitoring of a healthcare professional to ensure safety and effectiveness.

Prescribers contemplating the use of Hydrocortisone 1%/Terbinafine 1% Otic Drops for conditions other than those approved should weigh the benefits against potential risks, taking into account the lack of formal studies for these unapproved therapies. Additionally, patients seeking alternative uses for this formulation are advised to discuss their options with a healthcare provider to confirm suitability and to establish appropriate dosing regimens. It's important for both patients and prescribers to recognize that while the agents in this formulation have wide-ranging therapeutic effects, their combination in this particular ratio is optimized for otic use and their effects in other contexts may not be well-characterized.

Bayview Pharmacy takes pride in compounding medications that meet the specific needs of patients and practitioners. Should you have any questions regarding the use of Hydrocortisone 1%/Terbinafine 1% Otic Drops for indications other than the treatment of ear infections and inflammation, or if you are interested in custom formulations, please reach out to us. Our team of knowledgeable compounding pharmacists is ready to provide the necessary guidance and support.

Frequently Asked Questions

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What are Hydrocortisone 1%/Terbinafine 1% Otic Drops used for?

Hydrocortisone 1%/Terbinafine 1% Otic Drops are used for treating ear infections and associated inflammation. Hydrocortisone acts as an anti-inflammatory agent, while Terbinafine is an antifungal medication used to treat fungal infections. Together, they offer targeted relief for conditions affecting the ear canal.

How do I use these otic drops?

To use these drops, tilt your head to one side and instill the prescribed number of drops into the affected ear. Keep your head tilted for a few minutes to allow the medication to penetrate the ear canal. Use the drops according to your healthcare provider's instructions.

Can these drops be used for swimmer’s ear?

Yes, these otic drops can be prescribed to treat swimmer’s ear, which is an outer ear infection. However, it is important to consult your healthcare provider for an accurate diagnosis and to confirm that this medication is appropriate for your specific condition.

Are there any side effects associated with Hydrocortisone 1%/Terbinafine 1% Otic Drops?

Possible side effects can include local irritation, itching, or a burning sensation within the ear. If you experience any severe reactions or signs of an allergic reaction, contact your healthcare provider immediately.

How often should I use these drops?

The frequency of use will be determined by your healthcare provider based on the severity of your condition. Always follow the prescribed dosage and do not use these drops more or less frequently without consulting your healthcare provider.

Can I use these drops if I have a perforated eardrum?

No, if you have a known or suspected perforated eardrum, you should not use these drops without consulting a healthcare professional. Medications administered into the ear could potentially pass through the perforation and cause complications.

Can I use these otic drops if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should consult your healthcare provider before using these otic drops. They will assess whether the benefits outweigh any potential risks to you or your child.

How should I store these otic drops?

Store the drops at room temperature, away from light and moisture. Keep the bottle tightly closed when not in use and out of reach of children.

What should I do if I miss a dose?

If you miss a dose, apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double-dose to make up for a missed one.

Can I continue using these drops after my symptoms have resolved?

It is important to complete the full course of treatment prescribed by your healthcare provider, even if symptoms improve, to ensure the infection is fully treated and to prevent recurrence. Do not stop using the medication without consulting your healthcare provider.

Are there any drugs or supplements that should not be taken while using these otic drops?

While systemic interactions are less common with otic drops, it's still important to discuss all medications and supplements you're taking with your healthcare provider to prevent potential interactions. Always disclose your full medical history to your healthcare provider before starting any new medication.

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.

Hydrocortisone 1%/Terbinafine 1% Otic Drops
Otic Drops
controlled
Twice daily