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Edetate Disodium 0.1%/Gentamicin 0.25%/Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray

FDA-approved generic
Dose form
Nasal Spray
Active ingredients
Edetate Disodium
Gentamicin Sulfate
Itraconazole Hydrochloride
Mupirocin Calcium

The Edetate Disodium 0.1%/Gentamicin 0.25%/Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray is a compounded liquid formulation designed for targeted delivery to the nasal cavity. This unique combination of medications offers a multifaceted approach to treating various nasal conditions. Edetate Disodium acts as a chelating agent that may help in reducing calcification and enhancing the effects of other medications. Itraconazole, an antifungal agent, addresses fungal infections, while Mupirocin, another antibiotic, is included for its efficacy against gram-positive bacteria, including MRSA. This nasal spray is indicated for the treatment of chronic rhinosinusitis, nasal polyposis, and certain nasal infections, including those caused by bacteria and fungi. It may also be used in the management of biofilm-associated infections of the nasal cavity.

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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

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.
Edetate Disodium
Gentamicin Sulfate
Itraconazole Hydrochloride
Mupirocin Calcium
Nasal Spray
655e9a1c0d4168288eb379cd

Formula Information

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The Edetate Disodium 0.1%/Gentamicin 0.25%/Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray is a compounded medication designed for intranasal administration. This liquid formulation is delivered as a spray, allowing for direct application to the nasal mucosa. The combination of active ingredients is chosen for their synergistic effects to treat a variety of nasal and sinus conditions, potentially including chronic rhinosinusitis, nasal polyps, and certain nasal infections.

Edetate Disodium (EDTA) at 0.1% acts as a chelating agent, which may help in disrupting biofilm formation by bacteria, making them more susceptible to antibiotics. This can be particularly useful in treating chronic sinus infections where biofilms are present. Gentamicin, an aminoglycoside antibiotic at a concentration of 0.25%, provides broad-spectrum antibacterial activity, particularly against Gram-negative organisms, and is used to treat or prevent bacterial infections in the nasal passages.

Itraconazole, a triazole antifungal agent at 0.2%, is included for its efficacy against a wide range of fungal organisms. This can be particularly beneficial in cases of fungal sinusitis or in patients who are prone to fungal infections due to immunocompromised states or the use of nasal steroids.

The combination of these agents in a nasal spray allows for targeted therapy with minimal systemic absorption, which can reduce the potential for side effects and drug interactions. The formulation is designed to be used under the guidance of a healthcare provider, with dosing and duration of therapy tailored to the individual patient's needs. It is important for patients to understand the proper technique for nasal spray administration to ensure the medication is delivered effectively to the affected areas.

Patients and prescribers considering the use of this compounded nasal spray should be aware of the potential for local irritation or sensitivity reactions to any of the components. It is also essential to consider the patient's overall medication profile to avoid interactions, especially with systemic antifungals or antibiotics. As with all compounded medications, this nasal spray should be used as part of a comprehensive treatment plan that may include other medications, saline nasal rinses, or surgery, depending on the underlying condition.

If you have any questions or require further information about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing personalized care and support to both patients and prescribers to ensure the safe and appropriate use of our compounded medications.

Drug Interactions

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The formulation you have described contains a combination of four active ingredients: Edetate Disodium, Gentamicin, Itraconazole, and Mupirocin, each with its own mechanism of action and potential for drug interactions. When considering the use of this nasal spray, it is important to evaluate the patient's current medication regimen to identify possible interactions.

Edetate Disodium (EDTA) is a chelating agent that can bind to metal ions. It is important to be cautious when administering this medication concurrently with other drugs that contain metal ions or are affected by chelation, such as certain antibiotics (e.g., tetracyclines, quinolones) and supplements (e.g., iron, magnesium, calcium). Chelation may reduce the absorption and effectiveness of these agents. Additionally, EDTA can increase the risk of hypocalcemia, especially when used with drugs known to lower serum calcium levels.

Gentamicin is an aminoglycoside antibiotic that can be nephrotoxic and ototoxic, especially when used with other drugs that share these toxicities, such as loop diuretics, cisplatin, and other aminoglycosides. Monitoring renal function and hearing is advised when these drugs are used concomitantly. Additionally, the neuromuscular blocking effects of gentamicin can be potentiated by anesthetics and neuromuscular blockers, which may lead to increased risk of respiratory depression.

Itraconazole is an antifungal agent that is metabolized by the cytochrome P450 enzyme system, particularly CYP3A4. Drugs that are strong inhibitors or inducers of CYP3A4 can significantly alter the levels of itraconazole, potentially leading to either toxicity or reduced efficacy. Examples include certain antivirals, antiepileptics, and macrolide antibiotics. Itraconazole itself can increase the plasma concentrations of drugs metabolized by CYP3A4, such as certain statins, calcium channel blockers, and immunosuppressants, which may necessitate dose adjustments of these medications.

Mupirocin is an antibiotic with a unique mechanism and has minimal systemic absorption when applied topically. However, it is still important to consider the potential for local irritation or allergic reactions when used with other topical preparations. Additionally, the use of mupirocin in combination with other nasal preparations should be approached with caution to avoid altering the absorption or effects of either medication.

Given the complexity of this formulation, it is crucial to review the patient's complete medication profile for potential interactions. This nasal spray is designed to treat various conditions, such as nasal colonization with bacteria like Staphylococcus aureus, local infections, and fungal infections within the nasal cavity. The combination of these agents allows for a broad-spectrum approach to treatment. However, the systemic absorption of these drugs through the nasal mucosa can vary, and the potential for systemic effects and interactions should not be overlooked.

Patients and prescribers should be aware of the signs and symptoms of drug interactions, such as changes in renal function, hearing loss, or unexpected systemic effects like QT prolongation with itraconazole. Regular monitoring and communication with the healthcare team are essential for the safe use of this 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 personalized advice and support.

How Does it Work

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The Edetate Disodium 0.1%/Gentamicin 0.25%/Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray is a compounded medication that combines four active ingredients, each with a specific role, to treat various conditions affecting the nasal passages and sinuses. This liquid formulation is designed to be delivered as a spray, allowing for direct application to the nasal mucosa, which can provide both local and systemic therapeutic effects.

Edetate Disodium (EDTA) at 0.1% acts as a chelating agent. It binds to metal ions that may be present in the nasal environment, which can help reduce microbial biofilm formation. Biofilms are protective layers created by bacteria that make them more resistant to antibiotics. By disrupting these biofilms, EDTA can enhance the effectiveness of the other antimicrobial agents in the formulation.

Gentamicin, an aminoglycoside antibiotic, at a concentration of 0.25%, provides broad-spectrum antibacterial activity. Gentamicin works by binding to the bacterial ribosome, inhibiting protein synthesis and leading to cell death. This makes it useful for treating bacterial infections of the nasal passages and sinuses.

Itraconazole, included at 0.2%, is a triazole antifungal agent. It functions by inhibiting the enzyme lanosterol 14-alpha-demethylase, which is involved in the synthesis of ergosterol, a key component of fungal cell membranes. By disrupting the production of ergosterol, itraconazole compromises the integrity of the fungal cell membrane, leading to cell death.

Mupirocin at 0.2% is another antibiotic, but it works differently from gentamicin. Mupirocin inhibits bacterial isoleucyl-tRNA synthetase, an enzyme necessary for the synthesis of bacterial proteins. This action is specific to bacteria, making mupirocin a good choice for targeting bacterial infections without affecting human cells.

When combined, these four agents provide a broad-spectrum approach to treating infections within the nasal cavity, which can be caused by a variety of bacteria and fungi. The nasal spray formulation allows for the medication to be directly applied to the site of infection, potentially reducing the risk of systemic side effects and increasing the concentration of the medication at the site of action. This formulation may be used to treat chronic rhinosinusitis, nasal polyposis, or other conditions where biofilm-forming bacteria or fungi are a concern.

For patients and prescribers interested in using this formulation, it is important to note that it should be used under the guidance of a healthcare professional familiar with the patient's medical history and the specific condition being treated. If you have any questions or require further information about this nasal spray formulation, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the support and information you need to ensure appropriate treatment.

Other Uses

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The compound formulation consisting of Edetate Disodium 0.1%, Gentamicin 0.25%, Itraconazole 0.2%, and Mupirocin 0.2% has been primarily tailored for treating specific nasal conditions. However, this unique mixture of pharmaceutical agents may have other therapeutic applications beyond its primary indications due to the individual properties of each component. For instance, Edetate Disodium is known for its chelating abilities and may aid in the removal of metal deposits in various tissues. Though its presence in this nasal spray is typically to enhance the activity of other antibiotics by disrupting biofilms, it could theoretically be used in conditions where chelation in the nasal mucosa is deemed beneficial.

Gentamicin and Itraconazole are antimicrobial agents with broad-spectrum antibiotic and antifungal properties, respectively. While they target bacterial and fungal organisms afflicting the nasal cavity, these agents might also be considered for off-label use in cases of sinusitis, rhinitis, or other infections of the upper respiratory tract where their combined antimicrobial properties would prove advantageous. Furthermore, Mupirocin is included for its potent activity against gram-positive bacteria, particularly Staphylococcus aureus, which can sometimes be found in nasal carriage and is implicated in skin infections that could be secondary to nasal colonization.

It is important to remember that while this nasal spray formulation may lend itself to off-label uses, any such applications should be guided by a healthcare professional with due consideration to evidence-based practice, potential off-target effects, and proper risk-benefit analysis. Patients or prescribers seeking to utilize this compound formulation for alternate therapeutic purposes should engage in a collaborative discussion to assess suitability and safety for the intended use.

Additionally, this nasal spray compound may provide a delivery vehicle for medications in individuals who have trouble swallowing oral medications or in situations where a rapid absorption via the nasal mucosa into the systemic circulation is desired. Nonetheless, each component's spectrum of activity, potential for systemic absorption, and localized efficacy should be closely monitored and evaluated on a case-by-case basis.

Finally, our knowledgeable team at Bayview Pharmacy is dedicated to ensuring that our patients and prescribers have access to in-depth information about the possible uses of this formulation. Assessing individual patient needs and clinical contexts is paramount in determining the appropriateness of this compound. If you have any questions or require more personalized information regarding this nasal spray, please do not hesitate to reach out to us for assistance.

Frequently Asked Questions

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What is the purpose of this compounded nasal spray?

This compounded nasal spray is formulated to deliver a combination of medications including Edetate Disodium, Gentamicin, Itraconazole, and Mupirocin. It is designed to treat a variety of conditions affecting the nasal cavity, possibly including infections and inflammation. Each component serves a different purpose, with antimicrobial and antifungal properties.

How should I use this nasal spray?

To use the nasal spray, gently shake the bottle before use, and spray the prescribed amount into each nostril while inhaling gently. Follow your healthcare provider’s instructions for the exact dosage and frequency of application.

Can this nasal spray cause any side effects?

Like all medications, this nasal spray can cause side effects, though not everyone will experience them. Potential side effects may include nasal irritation, discomfort, or a burning sensation. If you experience any severe side effects or signs of an allergic reaction, contact your healthcare provider immediately.

Is this nasal spray suitable for children?

The suitability of this nasal spray for children depends on the specific case and should be determined by a healthcare provider. Use in children should be supervised by a healthcare professional to ensure safety and appropriate dosing.

How should this nasal spray be stored?

Store the nasal spray at room temperature, away from direct light and moisture. Make sure the cap is tightly closed when not in use to maintain the efficacy and shelf life of the medication. Always keep out of reach of children and pets.

Can I use other nasal products while using this spray?

Before using additional nasal products or medications, it is essential to consult your healthcare provider. They can advise you on possible interactions and ensure safe use of multiple treatments.

What should I do if I miss a dose?

If you miss a dose, use the nasal spray as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra spray to make up for a missed dose.

Are there any contraindications for using this nasal spray?

There may be contraindications based on individual allergies, pre-existing conditions, or current medications. Inform your healthcare provider about your complete medical history to avoid potential contraindications.

What happens if I use too much of the spray?

Using too much of the nasal spray can lead to an overdose, which may increase the risk of side effects. If you suspect an overdose, seek immediate medical attention.

Can I share this nasal spray with someone else?

No, this nasal spray is prescribed for individual use and should not be shared with others, even if they have similar symptoms. Sharing nasal sprays can spread infection and may not be appropriate for another person’s condition.

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.

Edetate Disodium 0.1%/Gentamicin 0.25%/Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray
Nasal Spray
10 mL
controlled

Inhale intranasally