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Is Prednisolone Moxifloxacin Bromfenac Available? The Compounded Ophthalmic Option

5 min read

Over 3.8 million cataract surgeries were performed in the US in 2021, and managing complex post-operative care is a critical need for many patients. The question, is prednisolone moxifloxacin bromfenac available, arises because a single, compounded eye drop combines these three medications to simplify this regimen, a formulation that is not commercially manufactured.

Quick Summary

This article explores the availability of prednisolone moxifloxacin bromfenac, detailing its status as a prescription-only, compounded medication for treating post-surgical ocular inflammation and infection. It highlights the benefits of this triple-combination approach, its role in improving patient compliance, and how to access it through specialized pharmacies.

Key Points

  • Compounded Prescription Only: The triple combination is not available as a standard, FDA-approved commercial product but is prepared by compounding pharmacies.

  • Simplified Regimen: Combining the three medications into a single eye drop simplifies the dosing schedule, which significantly improves patient compliance, especially after eye surgery.

  • Multi-action Formula: The compounded drop combines a steroid (prednisolone), an antibiotic (moxifloxacin), and an NSAID (bromfenac) to address inflammation, infection, and pain simultaneously.

  • Cost-Effective Option: For some patients, particularly those with poor insurance coverage for multiple drugs, the single compounded formulation can be a more affordable alternative.

  • Not FDA Approved as a Combination: While the individual components are FDA-approved, the combined compounded product itself is not reviewed by the FDA for efficacy or safety.

  • Insurance May Not Cover: Because compounded medications are not standard commercial products, health insurance, including Medicare and Medicaid, may not cover the cost.

  • Requires Specific Prescription: Accessing this formulation requires a prescription from an ophthalmologist who works with compounding pharmacies.

In This Article

Understanding the Triple Combination

A combination medication featuring prednisolone, moxifloxacin, and bromfenac is an ophthalmic solution created to address both infection and inflammation simultaneously. While the individual ingredients are commercially available, and some combinations of two are, the triple-ingredient product is not sold as a mass-produced, FDA-approved drug by major pharmaceutical companies. Instead, it is available through compounding pharmacies that specialize in creating customized prescriptions based on a doctor's order. This practice allows physicians to prescribe a single, convenient medication that replaces a complex, multi-drop regimen for patients recovering from ocular procedures like cataract surgery.

The Compounded Solution

Compounded medications are prepared by a pharmacist specifically to meet a patient's unique needs, based on a valid prescription. A compounding pharmacy combines the active ingredients—in this case, prednisolone, moxifloxacin, and bromfenac—into a single, sterile eye drop formulation. The specific concentrations, such as prednisolone 1%, moxifloxacin 0.5%, and bromfenac 0.075% or 0.09%, are determined by the prescribing ophthalmologist. The resulting product, often referred to by brand names like Pred-Moxi-Brom (PMB), is designed for ease of use. This is a crucial distinction, as a non-compounded version does not exist.

Individual Components and Their Function

  • Prednisolone: This is a potent corticosteroid that effectively suppresses inflammatory responses in the eye. It works by reducing swelling, redness, and discomfort, which are common symptoms after eye surgery or due to inflammation. Prednisolone acetate, a form often used in these compounds, is particularly effective for anti-inflammatory action.
  • Moxifloxacin: A broad-spectrum fluoroquinolone antibiotic, moxifloxacin is included to prevent or treat bacterial infections. It works by inhibiting enzymes vital for bacterial DNA replication, thereby killing and stopping the growth of harmful bacteria.
  • Bromfenac: As a nonsteroidal anti-inflammatory drug (NSAID), bromfenac inhibits cyclooxygenase (COX) enzymes, reducing the production of prostaglandins that cause inflammation and pain. It provides an analgesic effect and further helps to control postoperative inflammation.

Why Compounding is Necessary

For many patients, especially the elderly or those with motor difficulties, managing a regimen of three separate eye drops can be challenging. An individual patient might be required to administer prednisolone up to four times daily, moxifloxacin up to four times daily, and bromfenac once daily, each on a different schedule and for varying durations. This complexity can lead to missed doses, incorrect application, and ultimately, poor treatment outcomes. Compounding this medication into a single drop dramatically simplifies the process, boosting patient compliance and reducing the potential for error. The single formulation also represents a cost benefit, as it can often be less expensive than purchasing three separate medications, particularly branded versions.

The Benefits of a Combined Formulation

The use of a single, compounded ophthalmic solution offers several key advantages:

  • Improved Patient Compliance: Combining multiple medications into a single drop simplifies the dosing schedule, making it significantly easier for patients to adhere to their prescribed regimen, which is particularly beneficial for elderly patients or those with multiple health issues.
  • Reduced Risk of Contamination: With only one bottle to handle, the risk of cross-contamination between different eye drop bottles is eliminated, reducing the chance of introducing foreign bacteria into the eye.
  • Cost Savings: For patients paying out-of-pocket or with limited insurance coverage for multiple prescriptions, a compounded single-drop solution can be more cost-effective than purchasing and using three separate drugs.
  • Comprehensive Therapeutic Action: The combination provides a synergistic effect, offering anti-inflammatory, antibiotic, and analgesic benefits in a single administration. This supports faster recovery and better management of symptoms following ocular surgery.

Risks and Considerations of Compounded Drugs

While highly beneficial, compounded medications do carry certain risks and considerations. Unlike mass-produced drugs, they are not typically reviewed by the FDA for safety and efficacy in the same manner. Instead, compounding pharmacies operate under federal regulations, such as those governing 503A or 503B facilities. A 503B-registered pharmacy, for example, must adhere to Current Good Manufacturing Practices (cGMP) similar to commercial pharmaceutical companies. Patients must rely on the compounding pharmacy's quality assurance processes, and it is crucial to use a reputable facility. The lack of FDA-approved status also means compounded medications are often not covered by insurance.

Comparing Options: Compounded vs. Individual Drops

Feature Compounded Pred/Moxi/Brom Drops Individual Prednisolone, Moxifloxacin, Bromfenac Drops
Availability Only via specialized compounding pharmacies and a doctor's prescription. Widely available as separate, FDA-approved commercial drugs.
Dosing Regimen Simplified to one drop multiple times daily. Complex; up to four doses per day for each drug, on varying schedules.
Patient Compliance High due to convenience and ease of use. Lower, particularly for elderly patients or those with dexterity issues.
FDA Approval No FDA review for efficacy and safety; facilities regulated under specific federal acts. Each ingredient is individually FDA-approved.
Cost Often a single, potentially lower out-of-pocket cost. Potentially higher cost, especially if paying for three separate drugs.
Insurance Coverage Rarely covered by health insurance plans. Dependent on insurance plan; may be covered but with varying co-pays.
Formulation Stability Requires high-quality standards by compounding pharmacy to ensure stability and sterility. Established by the commercial drug manufacturer.

How to Access a Prednisolone Moxifloxacin Bromfenac Combination

Patients cannot simply go to a standard pharmacy and request this combination. It requires a specific prescription from an ophthalmologist who is aware of and uses compounding pharmacies for their patients. The process typically involves:

  1. Consultation: The patient discusses their needs with their ophthalmologist, who determines if the triple-combination compounded drop is the most suitable treatment option.
  2. Prescription: The doctor writes a prescription for the specific compounded formula, including the desired concentrations of each ingredient.
  3. Compounding Pharmacy: The prescription is sent to a specialized compounding pharmacy. Facilities like ImprimisRx and OSRX Pharmaceuticals are known providers.
  4. Delivery: The compounded medication is then dispensed and delivered to the patient.

Conclusion

In summary, the specific combination of prednisolone moxifloxacin bromfenac is not commercially available as a single, off-the-shelf product. However, it is readily available as a compounded prescription eye drop from specialized pharmacies. This formulation serves a crucial role in improving treatment compliance and convenience for patients recovering from ocular surgery. While offering significant benefits, patients and doctors must consider the regulatory differences and potential insurance limitations associated with compounded medications. This innovative solution represents a tailored approach to ophthalmic care, addressing the specific needs of patients beyond what standard pharmaceutical products can provide.

Frequently Asked Questions

No, a single, commercially manufactured (FDA-approved) product combining prednisolone, moxifloxacin, and bromfenac is not available.

You can get this medication as a compounded prescription eye drop from specialized compounding pharmacies, requiring a specific order from your ophthalmologist.

Compounding addresses the need for a simplified post-operative regimen, which improves patient compliance by combining three separate medications into one convenient eye drop.

In most cases, health insurance, including Medicare and Medicaid, does not cover compounded medications, so patients often pay for them out-of-pocket.

The benefits include improved patient compliance, greater convenience, and potentially lower cost compared to managing three separate eye drop medications, along with comprehensive treatment for inflammation, infection, and pain.

While compounded drugs are not individually reviewed by the FDA, compounding pharmacies, especially 503B facilities, are regulated and must adhere to strict quality standards. It is crucial to use a reputable compounding pharmacy.

This combination is primarily used for managing post-operative inflammation and preventing infection following ocular surgery, such as cataract extraction.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.