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Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Dextromethorphan Hydrobromide
Guaifenesin
Urea

This Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel is a semisolid formulation designed for easy and precise application on the skin through a convenient pump mechanism. The gel-like consistency ensures targeted treatment and effective absorption of active ingredients.

This formulation is used to treat neuropathic pain, muscle spasms, and dry, rough skin conditions. Dextromethorphan HBr provides relief from neuropathic pain, while Guaifenesin helps alleviate muscle spasms. Urea acts as a moisturizer, improving skin hydration and texture.

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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.
Dextromethorphan Hydrobromide
Guaifenesin
Urea
Topical Gel

Formula Information

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The Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel is a specialized formulation designed to deliver a synergistic combination of active ingredients directly to the skin. This semisolid gel is dispensed through a convenient pump mechanism, allowing for precise and targeted application. The gel-like consistency ensures smooth application and optimal absorption of the active compounds into the affected area.

Dextromethorphan HBr is commonly known for its antitussive (cough suppressant) properties in oral formulations. However, when applied topically, dextromethorphan acts as an N-methyl-D-aspartate (NMDA) receptor antagonist. By blocking NMDA receptors in peripheral nerves, it may help in reducing pain signals associated with certain neuropathic conditions. This property makes it a potential agent for managing localized pain or discomfort when administered through the skin.

Guaifenesin, traditionally used as an expectorant in cough medications, has muscle relaxant properties that can be beneficial when applied topically. It may help alleviate muscle tension or spasms by promoting relaxation of skeletal muscles. Incorporating guaifenesin into a topical gel allows it to act directly at the site of discomfort, potentially enhancing relief from muscle stiffness or tightness.

Urea at 8% concentration serves as a keratolytic and humectant agent in this formulation. It helps to exfoliate dead skin cells and hydrate the skin by increasing water retention in the stratum corneum. This leads to improved skin barrier function and facilitates deeper penetration of the active ingredients. Urea's moisturizing effect also helps to soothe dry or rough skin areas, contributing to overall skin health.

The combination of dextromethorphan HBr, guaifenesin, and urea in a topical gel provides a multifaceted approach to managing discomfort associated with certain conditions. By delivering analgesic, muscle relaxant, and moisturizing effects directly to the affected area, this formulation may enhance patient comfort and aid in the recovery process. The pump mechanism ensures that patients can apply the gel easily and accurately, minimizing waste and maximizing efficacy.

For patients and prescribers considering this formulation, it's important to apply the gel as directed, typically to clean, dry skin over the affected area. Patients should monitor for any signs of skin irritation or allergic reactions, and consult their healthcare provider if such symptoms occur. Prescribers should assess the suitability of this compounded formulation based on the individual patient's needs and consider any potential interactions with other medications.

If you have any questions or need further information about this topical gel formulation, please reach out to us.

Drug Interactions

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The topical gel formulation containing Dextromethorphan HBr 10%, Guaifenesin 10%, and Urea 8% is designed for targeted application on the skin, allowing for localized treatment and absorption of the active ingredients. While this formulation is primarily intended for topical use, it is important to consider potential drug interactions, especially if the patient is using other medications concurrently. Dextromethorphan, an antitussive agent, and Guaifenesin, an expectorant, are typically used in oral formulations for the treatment of cough and congestion. However, when used topically, their systemic absorption is minimal, reducing the likelihood of systemic drug interactions. Nonetheless, caution should be exercised.

Patients using monoamine oxidase inhibitors (MAOIs) or those who have used them in the past two weeks should avoid using this formulation, as Dextromethorphan can interact with MAOIs, potentially leading to serotonin syndrome, a serious condition characterized by symptoms such as confusion, agitation, rapid heart rate, and increased blood pressure. Although the risk is lower with topical application, it is still advisable to avoid concurrent use.

Additionally, patients taking selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) should use this formulation with caution. Dextromethorphan can increase serotonin levels, and when combined with these medications, there is a potential risk of serotonin syndrome. Patients should be monitored for symptoms such as restlessness, hallucinations, loss of coordination, or rapid heart rate.

Guaifenesin, when used topically, is unlikely to interact with other medications due to its minimal systemic absorption. However, patients should inform their healthcare provider of all medications they are taking, including over-the-counter drugs and supplements, to ensure there are no unforeseen interactions.

Urea, a keratolytic agent, is generally well-tolerated and does not have significant drug interactions. However, it can enhance the absorption of other topical medications applied concurrently, potentially increasing their effects. Patients should be advised to apply other topical medications at different times to avoid this interaction.

For prescribers, it is crucial to review the patient's complete medication profile before recommending this topical gel to ensure safety and efficacy. 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 both patients and healthcare providers in ensuring safe and appropriate use of compounded medications.

How Does it Work

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The Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel is a specialized formulation designed to deliver active ingredients directly to the skin, providing targeted relief and treatment. This semisolid gel is dispensed through a convenient pump mechanism, ensuring precise application and dosage control. The gel-like consistency allows for easy spreading and absorption.

Dextromethorphan HBr, commonly known for its use as a cough suppressant, is included in this formulation for its potential neuromodulatory effects. When applied topically, dextromethorphan may help modulate pain signals and provide relief from certain types of neuropathic pain. Its mechanism involves the inhibition of NMDA receptors, which play a role in pain transmission and perception. By blocking these receptors, dextromethorphan can help reduce the sensation of pain in the affected area.

Guaifenesin, traditionally used as an expectorant in oral formulations, is incorporated into this topical gel for its muscle relaxant properties. When applied to the skin, guaifenesin may help alleviate muscle tension and discomfort. It is believed to work by reducing the viscosity of secretions and promoting the clearance of mucus, but in a topical form, it may also aid in relaxing muscle tissues and improving local circulation, which can be beneficial in conditions involving muscle stiffness or spasms.

Urea, a well-known keratolytic agent, is included at an 8% concentration to enhance the skin's moisture retention and promote exfoliation of dead skin cells. Urea works by breaking down the intercellular matrix, which holds the outer layer of skin cells together, thus facilitating the shedding of rough and scaly skin. This action not only improves skin texture but also enhances the penetration and efficacy of the other active ingredients in the formulation. Additionally, urea's hydrating properties help maintain skin integrity and barrier function, which is crucial for overall skin health.

This topical gel formulation is particularly useful for patients experiencing localized pain, muscle tension, or skin conditions that benefit from enhanced hydration and exfoliation. The combination of dextromethorphan, guaifenesin, and urea provides a multifaceted approach to treatment, addressing pain modulation, muscle relaxation, and skin health simultaneously. The pump mechanism ensures that patients and prescribers can apply the gel with precision, minimizing waste and maximizing therapeutic outcomes.

For prescribers, this formulation offers a unique option for patients who may not tolerate oral medications or who require targeted therapy. The topical route of administration can reduce systemic side effects and provide direct relief to the affected area. Patients can benefit from the ease of use and the ability to self-administer the gel as needed, following the guidance of their healthcare provider.

If you have any questions about this formulation or its use, 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.

Other Uses

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The Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel is primarily formulated for its potential benefits in managing certain dermatological conditions, but it may also have other uses that could be of interest to both patients and prescribers. This semisolid formulation, dispensed through a convenient pump mechanism, allows for easy and precise application on the skin, ensuring targeted treatment and optimal absorption of the active ingredients. While the primary indications for this formulation are not specified here, the individual components suggest a range of potential applications beyond traditional uses.

Dextromethorphan HBr, commonly known for its antitussive properties, may offer benefits in topical formulations due to its NMDA receptor antagonist activity, which could potentially aid in neuropathic pain management when applied to the skin. This could be particularly useful for patients experiencing localized pain or discomfort, providing a non-invasive option for relief. Guaifenesin, typically used as an expectorant, may contribute to the formulation by enhancing skin hydration and improving the penetration of other active ingredients, potentially making it beneficial for conditions characterized by dry or rough skin. Urea, a well-known keratolytic agent, helps to soften and moisturize the skin, making it useful in treating hyperkeratotic conditions such as psoriasis or eczema, where the skin may become thickened and scaly.

In addition to these potential uses, the combination of these ingredients in a topical gel form may offer synergistic effects that could be explored for other dermatological applications. For instance, the formulation might be considered for use in managing symptoms of certain chronic skin conditions where inflammation, dryness, and discomfort are prevalent. The gel's ability to deliver active ingredients directly to the affected area can provide targeted relief, potentially reducing the need for systemic medications and minimizing associated side effects. Furthermore, the ease of application and controlled dosing through the pump mechanism make it a practical option for patients who require regular and consistent treatment.

As with any compounded formulation, it is essential for prescribers to consider the individual needs of their patients and the specific characteristics of the formulation when determining its suitability for off-label uses. Patients should be advised to follow their healthcare provider's instructions carefully and report any adverse reactions or concerns. If you have any questions or require further information about this formulation and its potential uses, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist you with any inquiries you may have.

Frequently Asked Questions

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What is Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel used for?

This topical gel is used for targeted treatment or absorption of active ingredients through the skin. It combines Dextromethorphan HBr, Guaifenesin, and Urea to provide relief and support for various skin conditions.

How do I apply the Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel?

The gel is dispensed through a pump mechanism, allowing for easy and precise application. Apply a small amount to the affected area and gently rub it into the skin until fully absorbed.

Can I use this gel on broken or irritated skin?

It is recommended to avoid applying the gel on broken or severely irritated skin. Consult with a healthcare professional if you have concerns about specific skin conditions.

How often should I use the topical gel?

Usage frequency can vary based on individual needs and the specific condition being treated. Follow the instructions provided by your healthcare provider or the product packaging.

Are there any side effects associated with this topical gel?

Some users may experience mild skin irritation or allergic reactions. If you notice any adverse effects, discontinue use and consult a healthcare professional.

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

Before using this gel with other topical medications, consult with a healthcare professional to ensure there are no interactions or contraindications.

Is this topical gel safe for children?

Consult with a healthcare professional before using this gel on children to ensure safety and appropriate usage.

How should I store the Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel?

Store the gel in a cool, dry place away from direct sunlight and out of reach of children. Ensure the cap is tightly closed after each use.

Can I use this gel during pregnancy or while breastfeeding?

If you are pregnant or breastfeeding, consult with a healthcare professional before using this gel to ensure it is safe for you and your baby.

What should I do if I accidentally ingest the gel?

If the gel is accidentally ingested, seek medical attention immediately or contact a poison control center for guidance.

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.

Dextromethorphan HBr 10%/Guaifenesin 10%/Urea 8% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)