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Budesonide 0.0125%/Ketoconazole 0.3%/Vancomycin 0.4% Otic Liquid

FDA-approved generic
Dose form
Otic Solution
Active ingredients
Budesonide
Ketoconazole
Vancomycin Hydrochloride

This formulation is a combination of Budesonide 0.0125%, Ketoconazole 0.3%, and Vancomycin 0.4% in an otic liquid form. It is specifically designed for use in the ear canal, providing targeted treatment for various ear conditions. Budesonide is a corticosteroid that reduces inflammation, Ketoconazole is an antifungal medication, and Vancomycin is an antibiotic that fights bacteria. Together, they effectively treat ear infections and inflammation. The medication is administered using a specific ear dropper or applicator as directed.

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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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This medication requires a prescription from your doctor
Ships within 1 to 2 business days after pharmacist verification
HSA and FSA eligible
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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.
Budesonide
Ketoconazole
Vancomycin Hydrochloride
Otic Solution
6536f1062787e423ba688bf0
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 formulation is a compounded otic liquid containing Budesonide 0.0125%, Ketoconazole 0.3%, and Vancomycin 0.4%. It is specifically designed to treat a variety of ear conditions, including infections and inflammation. The unique combination of these three active ingredients provides a broad-spectrum approach to treatment, targeting different aspects of ear disease.

Budesonide is a corticosteroid that works by reducing inflammation in the ear. It can help to alleviate symptoms such as pain, swelling, and discomfort, which are often associated with ear conditions.

It works by disrupting the cell membrane of the fungi, causing them to die. This makes it a useful treatment for fungal ear infections, which can be difficult to treat with other medications.

It works by preventing the bacteria from forming cell walls, which are necessary for their survival. This makes it a powerful treatment for bacterial ear infections, including those caused by MRSA (methicillin-resistant Staphylococcus aureus).

The liquid formulation is designed for easy administration into the ear canal using a specific ear dropper or applicator. This allows for targeted treatment of the affected area. The dose and frequency of administration will depend on the specific condition being treated and should be determined by a healthcare provider.

As with any medication, this formulation may cause side effects, including local irritation or allergic reactions. Patients should be advised to seek medical attention if they experience any unusual or severe symptoms. It is also important to use this medication only as directed, and to complete the full course of treatment, even if symptoms improve before the medication is finished.

If you have any questions about this formulation, or if you are a prescriber interested in using it for your patients, please don't hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always here to help.

Drug Interactions

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The combination of Budesonide, Ketoconazole, and Vancomycin in an otic liquid formulation is designed to treat various ear conditions, such as infections and inflammation. Budesonide is a corticosteroid that reduces inflammation, Ketoconazole is an antifungal medication, and Vancomycin is an antibiotic that fights bacteria. However, it's important to be aware of potential drug interactions.

Budesonide, when used with certain drugs such as Ketoconazole, can increase the level of Budesonide in the body, potentially leading to increased side effects. Ketoconazole can also interact with many other drugs, including certain antibiotics, antifungals, and antivirals, potentially leading to serious side effects such as QT prolongation, a serious irregular heart rhythm condition. Therefore, it's important to inform your healthcare provider of all the medications you are currently taking, including over-the-counter drugs and herbal supplements.

Vancomycin, on the other hand, can interact with certain drugs that may affect your kidneys, such as nonsteroidal anti-inflammatory drugs (NSAIDs), certain antibiotics, and certain antiviral medications. This can potentially increase the risk of kidney damage. Therefore, it's crucial to inform your healthcare provider if you are taking any of these medications.

It's also important to note that this otic liquid formulation should not be used if you have a viral infection in the ear, such as herpes or chickenpox, as it may worsen the infection. Also, avoid contact with the eyes, and do not swallow the medication. If you accidentally swallow it, seek medical help immediately.

Always use this medication as directed by your healthcare provider. Do not use more or less of it, or use it more often than prescribed. Your condition will not improve faster, and your risk of side effects may increase. If your condition does not improve after a few days or if it worsens, contact your healthcare provider immediately.

If you have any questions about this medication or its potential interactions, please do not hesitate to reach out to us at Bayview Pharmacy. We are a team of knowledgeable compounding pharmacists who are here to help you.

How Does it Work

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The Budesonide 0.0125%/Ketoconazole 0.3%/Vancomycin 0.4% Otic Liquid is a compounded medication that combines three active ingredients to treat various ear conditions. Each ingredient plays a unique role in managing the disease states.

Budesonide is a corticosteroid that works by reducing inflammation in the body. In the context of ear conditions, it can help to reduce swelling and discomfort caused by inflammation in the ear canal. This can be particularly beneficial in cases of otitis externa (inflammation of the outer ear and ear canal) or other inflammatory ear conditions.

Ketoconazole is an antifungal medication that works by stopping the growth of fungus. It is used in this formulation to treat fungal infections in the ear, which can cause symptoms such as itching, redness, and discomfort. By stopping the growth of fungus, Ketoconazole helps to alleviate these symptoms and clear the infection.

Vancomycin is an antibiotic that works by stopping the growth of bacteria. It is used in this formulation to treat bacterial infections in the ear, which can cause symptoms such as pain, discharge, and hearing loss. By stopping the growth of bacteria, Vancomycin helps to alleviate these symptoms and clear the infection.

The liquid formulation is designed for direct application into the ear canal, allowing for targeted treatment of the affected area. The medication is typically administered using a specific ear dropper or applicator, as directed by a healthcare provider.

It's important to note that while this medication can help to manage symptoms and clear infections, it does not treat the underlying cause of ear conditions. Therefore, it's important to follow up with a healthcare provider to determine the underlying cause and appropriate long-term management strategies.

If you have any questions about this formulation or how it works, please don't hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always here to help.

Other Uses

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This particular formulation of Budesonide, Ketoconazole, and Vancomycin in an Otic Liquid has been specifically designed for immediate release in the ear canal to treat various ear conditions. Outside of its essential use, this formulation may also be handy in the management of bacterial skin infections that are susceptible to Vancomycin, when other antibiotics are not successful or fail to meet the requirements, provided it is used as per the directions of a healthcare provider. It should not be used for deep-seated skin infections or severe burns unless direction is given by a healthcare provider.

The Ketoconazole in the compound also exhibits broad-spectrum antifungal activity. However, off-label topical use should be done under supervision, as its safety and effectiveness for fungal skin infections have not been established in otic solutions. For the Budesonide component, although it primarily treats inflammatory conditions in the ear, it may also be utilized off-label for dermatological purposes, to potentially help alleviate inflammation-based skin issues.

Even though it may be used for off-label purposes, caution should be used due to the potential increased risk of systemic absorption and accompanying side effects. These could include, but are not limited to, adrenal suppression and skin atrophy, mainly when used for prolonged periods, on large surface areas, or under occlusion. While Ketoconazole and Vancomycin are less likely to be absorbed through the skin to a significant degree, localized effects such as skin irritation can still occur. Consequently, it's essential for patients and prescribers to understand that the long-term safety and effectiveness of this compounded formulation for off-label use have not been firmly established.

Ultimately, this medication should only be utilized for other applications under the close guidance and supervision of a healthcare provider. If you have any questions about this formulation and its other possible uses, feel free to reach out to our team at Bayview Pharmacy. We're here to assist you in any way we can.

Frequently Asked Questions

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What is the Budesonide 0.0125%/Ketoconazole 0.3%/Vancomycin 0.4% Otic Liquid used for?

It is a liquid medication specifically designed for use in the ear canal. It's used to provide targeted treatment for various ear conditions, such as infections or inflammation.

How should this medication be administered?

This medication should be administered using a specific ear dropper or applicator, as directed. Do not consume orally or apply to other parts of the body unless instructed by a healthcare professional.

What do the three different percentages in the compound mean?

The percentages represent the concentration of each drug in the formulation. Here, Budesonide is 0.0125%, Ketoconazole is 0.3%, and Vancomycin is 0.4%.

How often should this medication be used?

Usage often depends on the severity of the condition and the direction of a healthcare provider. Always follow their instructions for frequency and dosage.

What side effects can this compound cause?

Any medication can cause potential side effects. If you experience discomfort, rash, irritation or ototoxicity, discontinue use and consult your healthcare provider.

What if I miss a dose of the Budesonide/Ketoconazole/Vancomycin otic liquid?

If you miss a dose, apply as soon as you remember. But if it's almost time for your next application, it's advisable to wait and continue with your regular schedule. Do not double dose.

Can this medication be used by children?

As with any medication, it is recommended to consult a healthcare provider before administering to children. They should only use it if specified and monitored by a healthcare provider.

Can this medication be used during pregnancy?

If you're pregnant or breastfeeding, it is extremely important to consult your healthcare provider before using this medication. Some substances may have effects on the fetus or nursing child.

Can I drive or operate heavy machinery while using this otic liquid?

Unless you experience dizziness or other noticeable side effects after the usage of this medication, it should not affect your ability to drive or operate heavy machinery.

What should I do in case of an overdose?

If you suspect an overdose or experience severe side effects, seek immediate medical attention. Unintended overdose in the ear is unlikely to be life-threatening, but may cause discomfort and potential side effects.

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.

Budesonide 0.0125%/Ketoconazole 0.3%/Vancomycin 0.4% Otic Liquid
Otic Solution
15 mL
controlled

Place drops into affected ear(s)

Twice daily