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Gentamicin Sulfate 2 mg/mL/Misoprostol 0.024 mg/mL/Phenytoin 50 mg/mL Topical Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Gentamicin Sulfate
Misoprostol
Phenytoin

This topical gel formulation combines Gentamicin Sulfate, Misoprostol, and Phenytoin to provide a targeted treatment for skin infections, inflammation, and wound healing. Gentamicin Sulfate acts as an antibiotic to combat bacterial infections, Misoprostol aids in reducing inflammation, and Phenytoin promotes wound healing and tissue repair.

Designed as a semisolid formulation, it is dispensed through a pump mechanism, ensuring easy and precise application on the skin. The gel-like consistency allows for effective absorption of the active ingredients, making it suitable for treating conditions such as infected wounds, ulcers, and inflammatory skin disorders.

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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.

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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.
Gentamicin Sulfate
Misoprostol
Phenytoin
Topical Gel
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 topical gel formulation combines Gentamicin Sulfate 2 mg/mL, Misoprostol 0.024 mg/mL, and Phenytoin 50 mg/mL to create a synergistic treatment option for skin conditions requiring antibacterial action, promotion of wound healing, and reduction of inflammation.

When applied topically, it helps prevent or treat bacterial infections in wounds or skin lesions, reducing the risk of complications arising from bacterial colonization.

Misoprostol, a synthetic prostaglandin E1 analog, is included for its cytoprotective properties. It enhances mucosal blood flow and stimulates the production of protective mucus, which can aid in the healing process of ulcers and wounds. Its presence in the gel supports tissue regeneration and repair.

Phenytoin, traditionally used as an anticonvulsant, has been found to have wound-healing properties when applied topically. It promotes granulation tissue formation and reduces the healing time of ulcers and wounds. Phenytoin's role in the gel is to accelerate tissue repair and improve the overall healing outcome.

The gel is dispensed through a pump mechanism, allowing for precise and hygienic application directly to the affected area. The semisolid, gel-like consistency ensures that the active ingredients remain in contact with the skin, maximizing absorption and efficacy. This formulation is particularly useful for treating chronic wounds, pressure ulcers, diabetic foot ulcers, and other skin conditions where enhanced healing and infection control are desired.

It is important to use the gel as directed by a healthcare professional, applying the prescribed amount to the clean, affected area.

Prescribers may find this formulation beneficial for patients with wounds that are resistant to standard treatments or in cases where infection and delayed healing are of concern. The combined action of antibiotic, cytoprotective, and wound-healing agents provides a comprehensive approach to wound management.

If you have any questions, please reach out to us.

Drug Interactions

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When using the Gentamicin Sulfate 2 mg/mL, Misoprostol 0.024 mg/mL, and Phenytoin 50 mg/mL topical gel, it is crucial to consider potential drug interactions that may affect the efficacy and safety of the treatment. This formulation is designed for topical application, which generally reduces the risk of systemic drug interactions compared to oral or intravenous administration. However, interactions can still occur, particularly if the patient is using other medications that may be absorbed systemically or affect skin integrity.

Gentamicin is an aminoglycoside antibiotic that can interact with other nephrotoxic or ototoxic drugs, potentially increasing the risk of kidney damage or hearing loss. Although systemic absorption from topical application is minimal, caution is advised if the patient is concurrently using other aminoglycosides, loop diuretics, or medications known to affect renal function. Patients with pre-existing renal impairment should be monitored closely.

Misoprostol, a prostaglandin analog, is primarily used for its protective effects on the gastric mucosa and its ability to induce labor. While systemic absorption from topical application is limited, patients should be aware of potential interactions with NSAIDs, as misoprostol can enhance their effects on the gastrointestinal tract. Additionally, women of childbearing potential should be informed about the potential for misoprostol to induce uterine contractions, and appropriate contraceptive measures should be discussed.

Phenytoin is an anticonvulsant that can interact with a wide range of medications due to its effects on hepatic enzyme induction. Although topical application reduces systemic exposure, patients should be monitored for potential interactions with other medications metabolized by the liver, such as warfarin, oral contraceptives, and certain antiretrovirals. Phenytoin can also affect folic acid metabolism, so patients should be advised to maintain adequate folic acid intake.

For both patients and prescribers, it is important to review the patient's complete medication list, including over-the-counter drugs and supplements, to identify any potential interactions. Patients should be advised to report any unusual symptoms or side effects promptly. If you have any questions or need further information, please reach out to us at Bayview Pharmacy. We are here to assist you in ensuring safe and appropriate use of this formulation.

How Does it Work

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The Gentamicin Sulfate 2 mg/mL/Misoprostol 0.024 mg/mL/Phenytoin 50 mg/mL Topical Gel is a carefully compounded formulation designed to deliver a synergistic combination of active ingredients directly to the skin. This semisolid gel is dispensed through a pump mechanism, ensuring easy and precise application, which is crucial for targeted treatment and optimal absorption of the active ingredients. The gel-like consistency allows for smooth application and rapid absorption, enhancing the therapeutic effects of the formulation.

Gentamicin Sulfate is an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis, leading to the elimination of susceptible bacteria. By targeting the bacteria directly at the site of infection, Gentamicin Sulfate helps reduce inflammation and promotes healing of the affected area.

Misoprostol, a prostaglandin E1 analog, is included in the formulation for its ability to enhance mucosal defense and promote healing. It works by increasing the production of protective mucus and bicarbonate, as well as improving blood flow to the affected area. This action helps in reducing inflammation and promoting the repair of damaged tissues. Misoprostol's role in the formulation is particularly beneficial in conditions where tissue repair and protection are needed, such as in ulcerative skin conditions or wounds.

Phenytoin, traditionally used as an anticonvulsant, has been found to have beneficial effects in wound healing when applied topically. It promotes fibroblast proliferation, enhances collagen deposition, and accelerates the formation of granulation tissue, all of which are critical steps in the wound healing process. Phenytoin's inclusion in this topical gel formulation aids in the rapid closure of wounds and the restoration of skin integrity, making it a valuable component in the treatment of chronic wounds and ulcers.

The combination of these three active ingredients in a topical gel formulation allows for a multifaceted approach to treatment. The antibiotic action of Gentamicin Sulfate helps control and eliminate infection, while Misoprostol and Phenytoin work synergistically to promote tissue repair and healing.

For both patients and prescribers, it is important to understand that the precise application facilitated by the pump mechanism ensures that the correct dose is delivered to the affected area, minimizing systemic absorption and potential side effects. This targeted approach not only enhances the efficacy of the treatment but also improves patient compliance and outcomes.

If you have any questions about this formulation or its use in specific disease states, 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 treatment options.

Other Uses

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The Gentamicin Sulfate 2 mg/mL/Misoprostol 0.024 mg/mL/Phenytoin 50 mg/mL Topical Gel is a versatile formulation that may have potential applications beyond its primary indications. This semisolid gel, dispensed through a convenient pump mechanism, allows for precise application on the skin, ensuring targeted treatment and optimal absorption of its active ingredients. While primarily used for specific dermatological conditions, the unique combination of gentamicin, misoprostol, and phenytoin in a topical gel form may offer additional therapeutic benefits in other contexts.

Its inclusion in this formulation suggests potential use in managing localized bacterial skin infections, particularly those resistant to other topical antibiotics. Misoprostol, a prostaglandin E1 analog, is known for its anti-inflammatory and cytoprotective properties, which could be beneficial in treating inflammatory skin conditions or promoting wound healing. Phenytoin, traditionally used as an anticonvulsant, has been shown to enhance wound healing and tissue regeneration, making this formulation potentially useful in managing chronic wounds, ulcers, or other skin injuries where enhanced healing is desired.

For patients and prescribers considering this formulation for off-label uses, it is important to weigh the potential benefits against any risks or side effects. The combination of these active ingredients may offer synergistic effects, providing a multifaceted approach to skin care and treatment. However, as with any compounded medication, individual patient response can vary, and careful monitoring is advised. Patients should be informed about the proper application technique to maximize efficacy and minimize any potential adverse effects. Prescribers should consider the patient's overall health status, existing conditions, and concurrent medications when recommending this formulation for alternative uses.

As always, if you have any questions or need further information about this formulation and its potential uses, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have.

Frequently Asked Questions

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What is the purpose of this compounded formulation?

This compounded formulation is designed for targeted treatment or absorption of active ingredients through the skin, utilizing a gel-like consistency for easy application.

How should I apply the Gentamicin Sulfate/Misoprostol/Phenytoin Topical Gel?

Apply the gel directly to the affected area using the pump mechanism, which ensures precise and controlled dispensing. Follow your healthcare provider's instructions regarding the amount and frequency of application.

What are the active ingredients in this topical gel?

The active ingredients in this topical gel are Gentamicin Sulfate at 2 mg/mL, Misoprostol at 0.024 mg/mL, and Phenytoin at 50 mg/mL.

What conditions can this topical gel be used to treat?

This formulation may be used to treat various skin conditions as prescribed by a healthcare provider, leveraging the antibacterial, anti-inflammatory, and wound-healing properties of its active ingredients.

Are there any side effects associated with this topical gel?

Possible side effects may include skin irritation, redness, or allergic reactions. If you experience any severe or persistent side effects, contact your healthcare provider immediately.

Can I use this gel on broken or damaged skin?

Consult your healthcare provider before applying the gel to broken or damaged skin to ensure it is safe and appropriate for your specific condition.

How should I store the Gentamicin Sulfate/Misoprostol/Phenytoin Topical Gel?

Store the gel at room temperature, away from direct sunlight and moisture. Keep it out of reach of children and pets.

Is this topical gel suitable for all skin types?

While the gel is generally suitable for various skin types, it is important to consult your healthcare provider to ensure it is appropriate for your specific skin condition and type.

Can I use this gel in conjunction with other topical medications?

Before using this gel with other topical medications, consult your healthcare provider to avoid potential interactions or adverse effects.

How long does it take to see results with this topical gel?

The time it takes to see results can vary depending on the condition being treated and individual response to the medication. Follow your healthcare provider's guidance and report any concerns regarding treatment progress.

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.

Gentamicin Sulfate 2 mg/mL/Misoprostol 0.024 mg/mL/Phenytoin 50 mg/mL Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Twice daily