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The Misoprostol 0.0024%/Phenytoin 5% Topical Gel is a specialized semisolid formulation designed for targeted treatment of chronic wounds and ulcers, including diabetic foot ulcers, venous leg ulcers, and pressure sores. The unique combination of Misoprostol, a prostaglandin analogue, and Phenytoin, an anticonvulsant with wound healing properties, works synergistically to promote tissue repair and reduce inflammation. This gel is dispensed through a pump mechanism, ensuring easy and precise application while maintaining the consistency required for optimal absorption and effect on the skin. Its use is specifically indicated for patients requiring localized treatment of complex, non-healing wounds where traditional therapies have been insufficient.
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.
The Misoprostol 0.0024%/Phenytoin 5% Topical gel is a specialized semisolid formulation designed for targeted application on the skin. This unique preparation combines the therapeutic effects of misoprostol, a prostaglandin analogue, with the anticonvulsant and potential wound-healing properties of phenytoin. The gel is dispensed through a pump mechanism, which ensures ease of use and precise dosing, allowing for consistent application to the affected area.
Misoprostol, in this topical formulation, is used for its anti-inflammatory and vasodilatory properties. It may promote healing of various skin ulcers and wounds by improving blood flow and reducing inflammation. Phenytoin, traditionally known for its use in the management of seizures, has been found to have beneficial effects on wound healing when used topically. It may stimulate fibroblast proliferation, collagen deposition, and ultimately enhance tissue repair. The combination of misoprostol and phenytoin in a gel base allows for direct application to the skin, which can be particularly useful in treating chronic wounds, such as diabetic foot ulcers, pressure ulcers, or vascular insufficiency ulcers, where both inflammation and impaired healing are present.
Patients should be advised that the use of this topical gel should be under the guidance of a healthcare professional, and it is important to follow the prescribed dosing regimen. Prescribers considering this formulation for their patients should be aware of the potential benefits of each active ingredient and monitor for any adverse effects. The gel's consistency and the pump dispenser aid in the application process, potentially improving patient adherence to the treatment plan.
For further information or questions regarding the Misoprostol 0.0024%/Phenytoin 5% Topical gel, including its pharmacology, potential interactions, contraindications, and specific usage instructions, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing comprehensive support and guidance to both patients and healthcare providers to ensure the safe and appropriate use of this compounded medication.
The combination of Misoprostol and Phenytoin in a topical gel formulation is unique and not commonly encountered in clinical practice. Misoprostol is a synthetic prostaglandin E1 analog typically used to prevent gastric ulcers, induce labor, and as part of medical abortion regimens. Phenytoin is an anticonvulsant medication often used to control seizures. When used topically, Phenytoin has been reported to promote wound healing. The combination of these two drugs in a topical gel is likely intended for the promotion of wound healing, taking advantage of the cytoprotective effects of Misoprostol and the tissue regenerative effects of Phenytoin.
When considering drug interactions for this formulation, it is important to note that systemic absorption of both Misoprostol and Phenytoin through the skin may be minimal; however, it is not non-existent. Therefore, interactions that occur with oral or systemic use of these medications should be considered.
Misoprostol should be used with caution in patients taking antacids, especially those containing magnesium, as this may worsen Misoprostol-induced diarrhea. Additionally, since Misoprostol can cause uterine contractions, it should not be used in pregnant women due to the risk of inducing premature labor or miscarriage. Misoprostol may also interact with other prostaglandins or prostaglandin analogs, oxytocin, and nonsteroidal anti-inflammatory drugs (NSAIDs), potentially altering the effects of these medications.
Phenytoin's interactions are more extensive due to its impact on cytochrome P450 enzymes. It is an inducer of CYP450 enzymes, which means it can decrease the levels and efficacy of drugs metabolized by these enzymes, such as certain anticoagulants (e.g., warfarin), corticosteroids, and some antiretrovirals. Conversely, drugs that inhibit CYP450 enzymes can increase Phenytoin levels, potentially leading to toxicity. These include some antibiotics (e.g., isoniazid, chloramphenicol), antifungals (e.g., fluconazole), and antidepressants (e.g., fluoxetine). Phenytoin may also interact with other anticonvulsants, calcium channel blockers, and cyclosporine, among others.
It is crucial for prescribers to review the patient's current medication list for potential interactions and adjust therapy as necessary. Patients should be advised to report any new medications or changes in their medication regimen to their healthcare provider. Additionally, patients should be monitored for signs of Misoprostol side effects, such as gastrointestinal distress, and for signs of Phenytoin toxicity, which can include ataxia, nystagmus, and mental confusion.
Given the potential for systemic absorption and the serious nature of some drug interactions, it is essential that both patients and prescribers are aware of these possibilities when using this formulation. If you have any questions or require further information, please reach out to us at Bayview Pharmacy for assistance.
The Misoprostol 0.0024%/Phenytoin 5% Topical gel is a specialized medication formulated by compounding pharmacists to deliver active ingredients directly to the site of action through the skin. Misoprostol is a synthetic prostaglandin E1 (PGE1) analog that has various effects in the body, including causing cervical ripening and uterine contractions, as well as protecting the gastrointestinal mucosa. In a topical formulation, misoprostol is used for its ability to promote healing of skin wounds and ulcers by increasing blood flow and stimulating secretion of protective mucus. Phenytoin, traditionally known as an anticonvulsant, has been found to have wound healing properties when used topically. It promotes wound healing by stimulating fibroblast proliferation, collagen deposition, and by reducing enzymatic degradation of the wound healing tissue.
The combination of misoprostol and phenytoin in a topical gel form is designed to synergistically enhance wound healing, particularly in patients with chronic wounds such as diabetic foot ulcers, venous stasis ulcers, or pressure ulcers. The gel is formulated to be applied directly to the wound, providing a moist environment that can promote tissue repair and protect the area from further injury or infection. The semisolid consistency of the gel allows it to stay in place upon application, ensuring that the active ingredients are delivered to the wound site effectively.
The gel is dispensed through a pump mechanism, which offers several advantages. It allows for a hygienic application, as the product is not exposed to the environment or contaminated by touch. Additionally, the pump provides a measured dose, which helps to ensure consistent application of the medication and reduces the risk of over- or under-dosing. This is particularly important for medications like misoprostol and phenytoin, where precise dosing can significantly impact the effectiveness of the treatment.
For patients and prescribers considering the use of Misoprostol 0.0024%/Phenytoin 5% Topical gel, it is important to understand that this is a specialized medication prepared by compounding pharmacists. It should be used under the guidance of a healthcare professional who can monitor the progress of wound healing and make any necessary adjustments to the treatment regimen. As with any medication, there may be potential side effects or interactions with other drugs, so a thorough medical history and understanding of the patient's overall health condition are essential before initiating treatment.
If you have any questions about the Misoprostol 0.0024%/Phenytoin 5% Topical gel or its use in treating specific disease states, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide the information and support you need to make informed decisions about your healthcare or the care of your patients.
This compounded formulation is designed for topical application to provide targeted treatment for a specific medical condition. Misoprostol may be used for its wound-healing properties, and phenytoin for pain management and tissue regeneration. It is used as prescribed by a healthcare provider.
Clean and dry the affected area before applying. Use the pump to dispense the gel and apply a thin layer over the area as instructed by your healthcare provider. Do not cover with a bandage unless advised to do so.
The dosage will vary depending on the individual’s condition and medical advice. Always follow the prescribed amount and frequency of application provided by your healthcare provider.
As with all medications, side effects are possible. Common side effects might include local irritation, redness, or swelling. If you experience any severe reactions or signs of an allergic response, contact your healthcare provider immediately.
Before using this topical gel, inform your healthcare provider about all other medications you are using, as there may be interactions. This includes over-the-counter drugs, vitamins, and herbal supplements.
Store the gel at room temperature, away from direct sunlight and moisture. Keep the container tightly closed when not in use. Make sure to keep it out of reach of children and pets.
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not apply extra gel to make up for a missed dose.
This formulation may not be suitable for everyone, especially those with allergies to misoprostol or phenytoin, pregnant or breastfeeding women, or individuals with certain medical conditions. Consult with your healthcare provider to determine if it is safe for you.
The pump mechanism is designed to dispense a specific amount of gel with each actuation. To use, remove the cap and press down on the pump to release the product. Be sure to prime the pump before the first use, according to the manufacturer’s instructions, if necessary.
Depending on your healthcare provider’s recommendation, the gel can be used to manage symptoms related to certain chronic conditions. Follow your provider’s guidance regarding long-term use and monitoring.
If you experience any discomfort, adverse effects, or if your symptoms worsen after using the topical gel, contact your healthcare provider promptly for advice. Do not continue to use the gel until your provider assesses the situation.
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.
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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.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
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.
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.
Apply topically to affected area(s)
