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Dextromethorphan HBr 3%/Diclofenac Na 4%/Guaifenesin 10% Topical Gel

Description: This unique topical gel formulation combines Dextromethorphan HBr at 3%, Diclofenac Na at 4%, and Guaifenesin at 10% to provide targeted relief for patients suffering from localized musculoskeletal pain and chest congestion. Dextromethorphan, commonly used as a cough suppressant, may offer a novel approach to pain management when applied topically. Diclofenac Na, a nonsteroidal anti-inflammatory drug (NSAID), is included for its potent anti-inflammatory and analgesic properties. Guaifenesin serves as an expectorant, potentially aiding in the management of respiratory symptoms by loosening and thinning mucus in the airways. The semisolid gel is dispensed through a pump mechanism, ensuring easy and precise application to the affected area, allowing for the absorption of the active ingredients directly through the skin.

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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, NY, NJ, NH, FL and ME.
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, NY, NJ, NH, FL and ME.

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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.
Dextromethorphan Hydrobromide
Diclofenac Sodium
Guaifenesin
Topical Gel
654e88c266e2f5d1b9902566

Formula Information

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Our unique compounding formulation combines Dextromethorphan HBr at 3%, Diclofenac Na at 4%, and Guaifenesin at 10% in a topical gel base. This semisolid preparation is designed for ease of use, with a pump mechanism that ensures consistent and precise dosing. The gel's consistency allows for smooth application and targeted delivery of the active ingredients directly to the affected area on the skin.

Dextromethorphan HBr, commonly known for its use as a cough suppressant, is included in this formulation for its potential to provide neuropathic pain relief when applied topically. This could be particularly beneficial for patients experiencing localized pain with a neuropathic component. Diclofenac Na, a nonsteroidal anti-inflammatory drug (NSAID), contributes its well-established anti-inflammatory and analgesic properties.

Guaifenesin is traditionally used as an expectorant to facilitate mucus clearance from the airways. However, in this topical formulation, it may enhance the penetration of the other active ingredients through the skin, potentially improving their efficacy. The combination of these three agents in a topical gel allows for a multimodal approach to pain and inflammation management, with the added benefit of minimizing systemic exposure and side effects commonly associated with oral administration of these medications.

This formulation is intended for patients seeking localized relief from pain and inflammation, possibly with a neuropathic component, without the systemic side effects of oral medications. It may be particularly useful for those who have contraindications to systemic NSAIDs or who prefer a targeted approach to pain management. As with any compounded medication, it is essential that this formulation is prescribed by a healthcare provider familiar with the patient's medical history and current medications to avoid potential interactions and ensure optimal treatment outcomes.

If you have any questions regarding this formulation or its appropriateness for your patients, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide guidance and support to ensure the safe and appropriate use of this customized medication.

Drug Interactions

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The combination of Dextromethorphan HBr, Diclofenac Na, and Guaifenesin in a topical gel formulation is unique and primarily designed for symptomatic relief in various conditions. Dextromethorphan is a cough suppressant that affects the signals in the brain that trigger cough reflex. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain in the body. Guaifenesin is an expectorant that helps loosen congestion in the chest and throat, making it easier to cough out through the mouth.

When considering drug interactions, it is important to note that while the systemic absorption of these medications in a topical formulation is lower than their oral counterparts, interactions can still occur. Dextromethorphan should be used with caution in patients taking monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), or serotonin-norepinephrine reuptake inhibitors (SNRIs), as there is a potential risk for serotonin syndrome, a rare but serious condition. Additionally, the use of dextromethorphan with other central nervous system depressants, such as alcohol, antihistamines, or sedatives, may increase drowsiness and dizziness.

Diclofenac, being an NSAID, can interact with anticoagulants like warfarin, increasing the risk of bleeding. It may also reduce the effectiveness of antihypertensive drugs and can potentially lead to kidney damage when used with other nephrotoxic drugs. Concurrent use with other NSAIDs, including over-the-counter aspirin, ibuprofen, or naproxen, should be avoided to reduce the risk of additive side effects, such as gastrointestinal irritation or ulceration.

Guaifenesin has fewer known significant drug interactions; however, it may interact with medications that reduce gastric acidity, such as proton pump inhibitors or H2 antagonists, potentially altering its dissolution and absorption. It is also important to consider that the increased fluid content in the lungs, as a result of guaifenesin's expectorant action, may affect the absorption of other inhaled medications.

Patients should be advised to inform their healthcare provider of all medications they are taking, including prescription, over-the-counter drugs, and herbal supplements. Prescribers should review the patient's medication profile for potential interactions before recommending this topical gel. It is also important to consider any underlying health conditions that may be affected by the active ingredients, such as asthma, cardiovascular disease, or liver and kidney impairment.

For any questions or concerns regarding this formulation or its potential drug interactions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is available to provide detailed information and guidance to ensure safe and appropriate use of this medication.

How Does it Work

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The Dextromethorphan HBr 3%/Diclofenac Na 4%/Guaifenesin 10% Topical Gel is a unique compounding formulation designed to deliver active pharmaceutical ingredients directly to the site of discomfort or inflammation through the skin. This semisolid dosage form is dispensed through a pump mechanism, which ensures that a precise and consistent amount of medication is applied with each use. The gel base facilitates the penetration of the active ingredients into the skin, providing localized relief and treatment.

Dextromethorphan HBr, commonly known for its use as a cough suppressant, is included in this formulation for its potential role in reducing pain and inflammation when applied topically. It is believed to work by blocking NMDA receptors and other pain pathways in the peripheral nervous system. Diclofenac Na, a nonsteroidal anti-inflammatory drug (NSAID), works by inhibiting the cyclooxygenase (COX) enzymes, which are involved in the synthesis of prostaglandins, substances that mediate inflammation and pain. By reducing the production of these prostaglandins, diclofenac Na can provide targeted relief from inflammation and pain at the site of application.

Guaifenesin is traditionally used as an expectorant to help loosen and expel mucus from the airways. However, in this topical formulation, guaifenesin is included for its potential muscle relaxant properties and its ability to enhance the penetration of the other active ingredients through the skin. By increasing the permeability of the skin, guaifenesin may improve the delivery of dextromethorphan and diclofenac to the underlying tissues where they can exert their therapeutic effects.

This combination of active ingredients in a gel base is particularly suited for the treatment of localized musculoskeletal conditions, such as strains, sprains, and arthritis-related pain. The gel formulation allows for the active ingredients to be absorbed directly into the affected area, providing relief from pain and inflammation without the systemic side effects that can occur with oral administration of these medications. The pump dispenser also minimizes the risk of contamination and allows for easy self-administration by the patient.

For patients and prescribers considering the use of this compounded formulation, it is important to understand the mechanism of action of each component and how they work synergistically to provide relief. The pharmacists at Bayview Pharmacy are available to answer any questions regarding the formulation, its proper use, and its potential benefits and contraindications. We are committed to ensuring that each patient receives personalized care and the most appropriate treatment for their specific condition.

Other Uses

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The primary use of this compounded topical gel formulation containing Dextromethorphan HBr 3%, Diclofenac Na 4%, and Guaifenesin 10% is for symptomatic relief of cough (due to dextromethorphan's antitussive properties) and for the management of musculoskeletal pain and inflammation (due to diclofenac's anti-inflammatory and analgesic effects). Furthermore, guaifenesin's presence as an expectorant might have been intended to aid in loosening mucus or phlegm on the surface of the skin in the context of chest physical therapy for respiratory conditions, although this is an unconventional use for guaifenesin, which is typically employed systemically.

However, beyond these typical indications, this unique combination in a topical gel could potentially offer other benefits. For example, while not traditionally used for this purpose, some patients with localized neuropathic pain or certain types of localized spastic pain could potentially find relief from the application of this gel. The inclusion of dextromethorphan, which has NMDA receptor antagonist properties similar to those of certain medications used to manage neuropathic pain, suggests that it could provide an adjunct or alternative therapy for controlling localized neuropathic symptoms.

Additionally, the anti-inflammatory properties of diclofenac make this gel potentially useful in various dermatologic conditions where inflammation is a component, such as in some forms of dermatitis or mild localized skin reactions where an anti-inflammatory effect is desired. Diclofenac's contribution could also be beneficial for treating soft tissue injuries, such as sprains or strains, as well as certain types of arthritis that affect just one or a few joints, such as osteoarthritis. It is essential, however, to ensure that the skin integrity is maintained before application since the formulation is designed for topical use and should not be applied to open wounds or damaged skin.

It is important to note that the use of this compounded gel for conditions outside its main indications should be done under the guidance of a healthcare provider, as the scientific evidence supporting these additional uses may be limited or unconventional. Patients or prescribers with particular interest in the potential 'off-label' applications of this formulation should engage in a thorough discussion regarding the risks, benefits, and existing evidence before considering use. If you have any questions or require further information or guidance on the potential uses, application methods, or any other aspect of this compounded topical gel formulation, please reach out to us at Bayview Pharmacy for personalized support.

Frequently Asked Questions

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What is the purpose of this topical gel?

This compounded gel is designed to provide relief from certain types of pain and congestion. Dextromethorphan HBr serves as a cough suppressant, Diclofenac Na is a non-steroidal anti-inflammatory drug (NSAID) for alleviating inflammation and pain, and Guaifenesin is an expectorant that helps in loosening and thinning mucus.

How do I use this topical gel?

Apply a thin layer of the gel to the affected area using the pump mechanism. Gently rub the gel into the skin until it is absorbed. Use the medication as directed by your healthcare provider, typically not more than 3-4 times a day.

What are the advantages of the pump mechanism?

The pump mechanism is designed for easy and precise dosage, which assists in applying a consistent amount of medication each time. It also helps in maintaining the hygiene of the product by minimizing direct contact with the contents.

Can this topical gel be used for children?

Consult your healthcare provider before using this topical gel for children. The dose and safety have not been established for pediatric use without professional guidance.

Are there any side effects of using this compounded formulation?

Like all medications, this compounded gel may have side effects. Some common side effects could include skin irritation, redness, or itching at the site of application. If you notice any severe reactions or signs of an allergic reaction, seek medical attention immediately.

Is it safe to use this topical gel with other medications?

As with any medication, interactions may occur. Inform your healthcare provider about all the medications and topical products you are currently using to determine if the compounded gel can be safely used in conjunction.

Can I apply this gel over other topical lotions or creams?

It is best to avoid using this gel with other topical lotions or creams on the same area without consulting your healthcare provider, as it may alter the absorption and effectiveness of the ingredients.

Should I cover the area after applying the gel?

It is not typically necessary to cover the area after application. However, your healthcare provider may give you specific instructions based on your treatment plan. If not instructed otherwise, allow the gel to absorb completely before covering or dressing.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

How should I store this compounded topical gel?

Store the gel at room temperature away from light and moisture, and keep it out of reach of children and pets. Do not freeze the gel, and discard any medication after the expiration date or if advised by your healthcare provider.

What should I do in case of an overdose?

An overdose with topical application is uncommon. Nonetheless, if you or someone else has used too much gel or ingested it, seek immediate emergency medical attention or call your local poison control center.

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, NY, NJ, NH, FL, and ME. 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 3%/Diclofenac Na 4%/Guaifenesin 10% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)