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Metronidazole 2%/Misoprostol 0.0024%/Phenytoin 5% Topical gel

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

The Metronidazole 2%/Misoprostol 0.0024%/Phenytoin 5% Topical Gel is a specialized semisolid formulation designed for targeted treatment of specific skin conditions. This unique combination of active ingredients is delivered in a gel-like consistency that is easily dispensed through a pump mechanism, ensuring precise application to the affected areas. Metronidazole, an antibiotic, helps to combat bacterial infections and is commonly used in the treatment of skin ulcers and wounds. Misoprostol, a prostaglandin analogue, promotes healing and is beneficial in wound care, particularly for its ability to prevent and treat ulcers. Phenytoin, traditionally used as an anticonvulsant, has been found to aid in the management of wound healing.

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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.
Metronidazole
Misoprostol
Phenytoin
Topical Gel
65bbe1f41df1d3ce0741a434
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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Our Metronidazole 2%/Misoprostol 0.0024%/Phenytoin 5% Topical gel is a specialized compound designed to deliver a combination of active ingredients directly to the affected skin area. Metronidazole, an antibiotic, works by targeting and inhibiting the growth of bacteria and protozoa. Misoprostol, a prostaglandin analogue, has properties that can promote healing and is used off-label for wound care, potentially aiding in the treatment of chronic wounds by regulating inflammation and promoting tissue repair. Phenytoin, traditionally used as an anticonvulsant, has been found to have wound healing properties when applied topically, likely due to its effects on fibroblast proliferation.

This gel is formulated to be dispensed through a pump mechanism, which allows for clean, controlled, and precise application. The semisolid consistency ensures that the medication stays where it is applied, optimizing the localized effect of the active ingredients. This formulation is particularly useful for patients requiring targeted treatment of skin conditions, such as diabetic foot ulcers, venous stasis ulcers, pressure ulcers, or other non-healing wounds where infection or inflammation is a concern.

For prescribers, it is important to note that this compound should be used as part of a comprehensive treatment plan, which may include debridement, infection control, and other supportive measures. The unique combination of metronidazole, misoprostol, and phenytoin in a topical gel form offers a synergistic approach to wound care, potentially reducing healing time and improving patient outcomes. As with any compounded medication, it is essential to consider individual patient needs and any potential contraindications or interactions with other medications.

Patients should be instructed on the proper use of the gel, including the amount to apply and the frequency of application as determined by their healthcare provider. They should also be advised to monitor the treatment area for any signs of adverse reactions or worsening of the condition and to report these to their healthcare provider immediately. It is also important for patients to understand that while this topical gel can aid in healing, maintaining good wound care practices and following their healthcare provider's instructions are crucial to the success of their treatment.

If you have any questions about this formulation or its appropriateness for a specific patient or condition, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing the highest quality of care and is available to support both patients and prescribers with expert advice and information.

Drug Interactions

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The combination of metronidazole, misoprostol, and phenytoin in a topical gel formulation is unique and may be used for the treatment of various skin conditions, such as wound healing or specific dermatological disorders. However, it is important to consider potential drug interactions when using this compound.

Metronidazole is an antibiotic and antiprotozoal medication. When applied topically, systemic absorption is usually minimal, but it can still interact with alcohol, leading to a disulfiram-like reaction, which can cause nausea, vomiting, flushing, and headache. Patients should be advised to avoid alcohol-containing products, including certain mouthwashes and over-the-counter cough and cold remedies. Additionally, metronidazole may potentiate the effects of anticoagulants like warfarin, increasing the risk of bleeding. Patients on anticoagulant therapy should be monitored closely for changes in prothrombin time or INR.

Misoprostol is a prostaglandin analogue commonly used to prevent gastric ulcers and for its off-label use in obstetrics and gynecology. In a topical formulation, systemic absorption is expected to be low; however, if absorbed, it could theoretically interact with other prostaglandin or prostaglandin-inhibiting drugs, altering their effects. Misoprostol should be used with caution in women of childbearing potential as it can induce uterine contractions and cause miscarriage. It is contraindicated in pregnancy unless used for medical termination.

Phenytoin is an anticonvulsant that can be used topically for its potential wound healing properties. Systemic absorption from topical application is generally low, but if it occurs, it can interact with a wide range of drugs. Phenytoin is a known enzyme inducer and can decrease the levels of drugs metabolized by CYP450 enzymes, such as certain antiretrovirals, anticoagulants, and other anticonvulsants. Conversely, drugs that inhibit these enzymes can increase phenytoin levels, potentially leading to toxicity. Patients should be monitored for signs of phenytoin toxicity, such as ataxia, nystagmus, or mental confusion, especially if they are taking other medications that could interact.

Given the complexity of this formulation, it is crucial for prescribers to thoroughly review the patient's medication history for potential interactions. Patients should be instructed to report any new medications or changes in their therapy to their healthcare provider. Additionally, patients should be educated on the signs and symptoms of potential drug interactions and advised to seek medical attention if they experience any adverse effects. If you have any questions or require further information regarding this formulation and its potential interactions, please reach out to us at Bayview Pharmacy.

How Does it Work

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The Metronidazole 2%/Misoprostol 0.0024%/Phenytoin 5% Topical gel is a specialized medication formulated to deliver active ingredients directly to the site of skin conditions requiring treatment. This semisolid formulation is designed to be dispensed through a pump mechanism, which allows for easy and precise application. The gel consistency ensures that the medication adheres to the skin, providing a localized effect while minimizing systemic absorption.

When applied topically, Metronidazole can target skin infections, such as those found in wounds or ulcers, and help reduce inflammation and promote healing. Its inclusion in this formulation is primarily for its antimicrobial properties, which can prevent or treat infections in the affected skin areas.

Misoprostol, a synthetic prostaglandin E1 analog, has cytoprotective properties that can help in the healing of ulcers. In this topical formulation, Misoprostol may aid in the healing process of skin ulcers by promoting healthy tissue regeneration and reducing inflammation. Although Misoprostol is more commonly known for its gastrointestinal protective effects when taken orally, its inclusion in this topical formulation is intended to leverage its healing properties at the site of skin damage.

Phenytoin, traditionally used as an anticonvulsant, has been found to have wound-healing properties when applied topically. It can promote the proliferation of fibroblasts, which are essential for tissue repair, and increase collagen formation, leading to improved wound healing. Phenytoin's inclusion in this gel is to enhance the healing of skin wounds, ulcers, and other lesions by stimulating tissue repair mechanisms.

This combination of Metronidazole, Misoprostol, and Phenytoin in a topical gel form is particularly useful for treating and managing skin conditions such as pressure sores, diabetic foot ulcers, and venous leg ulcers, where infection, inflammation, and delayed healing are significant concerns. By applying the gel directly to the affected area, patients can benefit from the synergistic effects of these three active ingredients, which work together to reduce infection, promote tissue repair, and accelerate the healing process.

For patients and prescribers considering the use of this formulation, it is important to understand the specific actions of each component and how they contribute to the overall treatment of the skin condition. If you have any questions or require further information about this topical gel formulation, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to ensure the safe and appropriate use of this medication.

Frequently Asked Questions

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What is the purpose of this compounded topical gel?

This compounded topical gel is designed to deliver a combination of Metronidazole, Misoprostol, and Phenytoin directly to the skin for targeted treatment. Metronidazole acts as an antimicrobial agent, Misoprostol helps in healing, and Phenytoin promotes tissue regeneration. This formulation is commonly used for various dermatological conditions where these effects are beneficial.

How do I use the compounded topical gel?

To use the topical gel, depress the pump of the container to dispense a small amount of the gel onto the skin or your fingertip. Then, apply a thin layer of the gel over the affected area with a gentle circular motion until it is evenly distributed. Always follow the specific instructions provided by your healthcare professional regarding application frequency and dosage.

Can this topical gel be used on any part of the body?

While this topical gel can be used on various parts of the body, it should only be applied to the areas recommended by your healthcare provider. Avoid contact with mucous membranes, eyes, and other sensitive areas. If you are uncertain, consult with your healthcare provider for guidance.

What are the storage conditions for the compounded topical gel?

Store this compounded topical gel at room temperature, away from direct sunlight and heat. Avoid freezing the gel. Keep the container sealed when not in use to maintain the preparation's integrity and prevent contamination.

Can I cover the treated area with a bandage?

You may cover the treated area with a breathable bandage as advised by your healthcare provider. However, occlusive dressings should generally be avoided unless specifically recommended, as they can alter the absorption of the active ingredients.

Are there any side effects associated with this topical gel?

As with all medications, this topical gel may cause side effects. These can include local skin irritation, redness, itching, or rash. If you experience any severe or persistent side effects, contact your healthcare provider immediately.

What should I do if I miss a dose?

If you miss a dose of the topical gel, apply it 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 apply extra gel to make up for a missed dose.

Can I wear makeup over the treated area?

It's typically recommended to allow the gel to absorb fully and to let the treated area breathe. If you need to apply makeup, wait until the gel has fully dried. However, consult with your healthcare provider for specific advice about makeup use over the treated area, as it can vary depending on your condition and treatment goals.

Is the compounded topical gel safe for children?

The safety and effectiveness of this compounded topical gel in children have not been established. Use in pediatric populations should only occur under the direct supervision of a healthcare provider.

How long should I use the compounded topical gel?

The duration of treatment with the compounded topical gel will depend on the condition being treated and your response to the medication. Follow the directions given by your healthcare provider and do not use the gel for longer than prescribed.

What should I do in case of an overdose?

If you suspect an overdose or apply significantly more gel than prescribed, contact your healthcare provider or seek emergency medical attention immediately. While an overdose is less likely with topical application than with oral medications, it is still important to use the gel as directed.

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.

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.

Metronidazole 2%/Misoprostol 0.0024%/Phenytoin 5% Topical gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Twice daily