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Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Cyclobenzaprine Hydrochloride
Naproxen

This Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel is a semisolid formulation designed for the targeted treatment of musculoskeletal pain and inflammation. It is dispensed through a pump mechanism, allowing for easy and precise application on 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, 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.

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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.
Cyclobenzaprine Hydrochloride
Naproxen
Topical Gel

Formula Information

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The Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel is a compounded medication designed to provide targeted relief from musculoskeletal pain and inflammation. This unique formulation combines the muscle relaxant properties of Cyclobenzaprine Hydrochloride with the anti-inflammatory effects of Naproxen, resulting in a synergistic approach to managing conditions such as muscle spasms, strains, sprains, and localized joint pain.

Cyclobenzaprine HCl is a centrally acting skeletal muscle relaxant that helps reduce muscle spasms without interfering with muscle function. By blocking nerve impulses sent to the brain, it alleviates muscle stiffness and improves mobility. When applied topically, Cyclobenzaprine works directly at the site of discomfort, minimizing systemic absorption and reducing the likelihood of side effects commonly associated with oral administration.

Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), inhibits the enzymes responsible for inflammation and pain in the body. In this topical gel, Naproxen effectively reduces local inflammation and provides analgesic effects directly at the affected area. The 10% concentration ensures adequate penetration through the skin to exert its therapeutic action without the risks associated with systemic NSAID use.

This semisolid formulation is dispensed through a pump mechanism, facilitating easy and precise application on the skin. The pump ensures consistent dosing and minimizes waste, enhancing patient compliance. The gel-like consistency allows for rapid absorption and does not leave a greasy residue, making it convenient for use throughout the day without interfering with daily activities.

For patients, this combination therapy offers relief from pain and muscle spasms with minimal side effects. It is particularly beneficial for those who prefer topical treatments or who may have contraindications to oral medications. Applying the medication directly to the affected area provides prompt relief and allows for localized treatment.

Prescribers may find this formulation advantageous for patients requiring targeted therapy for musculoskeletal conditions. The topical application reduces systemic exposure, which is especially important for patients at risk of gastrointestinal, cardiovascular, or renal side effects from systemic NSAIDs. Additionally, the inclusion of Cyclobenzaprine addresses muscle spasms effectively without the sedation that may occur with oral muscle relaxants.

It is important for both patients and healthcare providers to be aware of potential side effects

Drug Interactions

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Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel is a compounded formulation designed for topical application, providing targeted relief for conditions such as musculoskeletal pain, inflammation, and muscle spasms. This formulation combines the muscle relaxant properties of cyclobenzaprine with the anti-inflammatory effects of naproxen, offering a dual-action approach to managing pain and discomfort associated with various musculoskeletal disorders.

When considering the use of Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel, it is important to be aware of potential drug interactions that may affect the safety and efficacy of the treatment. Although the topical application generally reduces systemic absorption and the likelihood of interactions compared to oral administration, some interactions may still occur, particularly if the patient is using other medications concurrently.

Cyclobenzaprine, a muscle relaxant, may interact with central nervous system (CNS) depressants such as benzodiazepines, opioids, and alcohol, potentially enhancing their sedative effects. Patients should be advised to avoid or limit the use of these substances while using the topical gel to prevent excessive drowsiness or CNS depression. Additionally, cyclobenzaprine may interact with monoamine oxidase inhibitors (MAOIs), leading to an increased risk of serotonin syndrome, a potentially life-threatening condition. Patients should inform their healthcare provider if they are taking MAOIs or have taken them within the last 14 days.

Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), may interact with other NSAIDs or aspirin, increasing the risk of gastrointestinal bleeding and ulceration. Patients should be cautioned against using multiple NSAID-containing products simultaneously. Furthermore, naproxen may reduce the antihypertensive effects of certain blood pressure medications, such as ACE inhibitors, angiotensin II receptor blockers (ARBs), and beta-blockers. Patients with hypertension should monitor their blood pressure regularly and consult their healthcare provider if they notice any changes.

Patients with renal impairment should use this formulation with caution, as NSAIDs like naproxen can potentially worsen renal function. It is advisable for prescribers to assess renal function before initiating treatment and periodically during therapy. Additionally, patients with a history of cardiovascular disease should be aware that NSAIDs may increase the risk of cardiovascular events, such as heart attack or stroke, especially with long-term use.

For both patients and prescribers, it is crucial to consider the patient's complete medication profile, including over-the-counter drugs and supplements, to identify any potential interactions. Patients should be encouraged to communicate openly with their healthcare providers about all medications they are taking to ensure safe and appropriate use of Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel. If you have any questions or concerns regarding this formulation or its interactions, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel is a compounded formulation designed to deliver targeted relief for musculoskeletal pain and inflammation directly at the site of discomfort. This semisolid gel is dispensed through a convenient pump mechanism, allowing for easy and precise application on the skin. The gel-like consistency ensures that the active ingredients are absorbed efficiently, providing localized treatment while minimizing systemic exposure and potential side effects associated with oral administration.

Cyclobenzaprine HCl is a muscle relaxant that works by blocking nerve impulses, or pain sensations, that are sent to the brain. By applying Cyclobenzaprine HCl topically, the formulation targets the affected area directly, offering rapid relief from muscle tension and pain.

Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), is included in the formulation at a concentration of 10%. It works by inhibiting the production of prostaglandins, substances in the body that mediate inflammation and pain. By reducing inflammation, Naproxen helps alleviate pain and swelling associated with conditions such as arthritis, tendonitis, and other inflammatory disorders. The topical application of Naproxen allows for concentrated delivery to the affected area, enhancing its anti-inflammatory effects while reducing the risk of systemic side effects commonly associated with oral NSAIDs.

The combination of Cyclobenzaprine HCl and Naproxen in a topical gel provides a synergistic effect, addressing both muscle spasms and inflammation simultaneously. This dual-action approach is particularly beneficial for patients experiencing both muscle and joint pain, offering comprehensive relief and improving overall mobility and function. The pump mechanism ensures that patients can apply the gel with precision, controlling the amount used and ensuring consistent dosing with each application.

For prescribers, this formulation offers a customizable treatment option that can be tailored to the specific needs of each patient. The topical delivery system minimizes systemic absorption, making it a safer alternative for patients who may be at risk for adverse effects from oral medications. Additionally, the ability to adjust the concentration of active ingredients allows for personalized treatment plans that can be optimized for efficacy and tolerability.

If you have any questions about this formulation or how it may benefit your treatment plan, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide expert guidance and support for both patients and healthcare providers.

Other Uses

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The Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel, dispensed through a convenient pump mechanism, is primarily used for the management of musculoskeletal pain and inflammation. However, this formulation may have other potential applications that could benefit patients and prescribers seeking alternative therapeutic options. The combination of cyclobenzaprine, a muscle relaxant, and naproxen, a nonsteroidal anti-inflammatory drug (NSAID), in a topical gel form allows for localized treatment, minimizing systemic exposure and potential side effects associated with oral administration.

Beyond its primary indications, this topical gel may be considered for off-label use in conditions where muscle spasms and localized inflammation coexist, such as in certain types of arthritis, fibromyalgia, or post-surgical recovery. The gel's ability to deliver active ingredients directly to the site of discomfort can be particularly advantageous in managing chronic pain conditions where systemic medications may not be well-tolerated or where patients are seeking to reduce their overall medication burden. Additionally, the topical application may be beneficial for patients with gastrointestinal sensitivities or those at risk for cardiovascular complications, as it potentially reduces the systemic absorption of naproxen.

For prescribers, the use of this formulation could be explored in patients who have contraindications to oral NSAIDs or muscle relaxants, or in those who have experienced adverse effects from systemic treatments. The gel's targeted delivery system allows for precise dosing and application, which can be tailored to the patient's specific needs and the severity of their symptoms. Furthermore, the pump mechanism ensures consistent dosing, enhancing patient compliance and ease of use.

Patients may find this formulation appealing due to its non-invasive nature and the ability to apply it directly to the affected area, providing rapid relief without the need for oral medication. This can be particularly useful for individuals who have difficulty swallowing pills or who prefer to avoid systemic medications. The gel's formulation is designed to be absorbed efficiently through the skin.

If you have any questions or need further information about the potential uses of Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or to discuss how this formulation might fit into your treatment plan.

Frequently Asked Questions

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What is Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel used for?

This topical gel is used for targeted treatment of muscle pain and inflammation. Cyclobenzaprine is a muscle relaxant, while Naproxen is a nonsteroidal anti-inflammatory drug (NSAID), and together they help alleviate discomfort and swelling.

How do I apply Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel?

Dispense the gel through the pump mechanism and apply it directly to the affected area. Gently rub it into the skin until fully absorbed. Follow your healthcare provider's instructions regarding the amount and frequency of application.

Can I use this gel on broken or irritated skin?

No, you should not apply this gel to broken, irritated, or infected skin. Doing so may increase the risk of adverse reactions or further irritation.

How does the pump mechanism work?

The pump mechanism is designed to dispense a precise amount of gel with each use, ensuring easy and accurate application. Simply press the pump to release the gel onto your hand or directly onto the skin.

Are there any side effects associated with this topical gel?

Some users may experience mild skin irritation, redness, or itching at the application site. If you experience severe side effects or an allergic reaction, discontinue use and consult your healthcare provider immediately.

Can I use this gel with other medications?

Before using this gel with other medications, consult your healthcare provider to avoid potential interactions. This is especially important if you are using other topical treatments or taking oral medications for pain or inflammation.

How should I store Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel?

Store the gel at room temperature, away from direct sunlight and moisture. Keep it out of reach of children and pets to prevent accidental ingestion or misuse.

Is this gel suitable for all age groups?

This gel is typically intended for adult use. Consult your healthcare provider before using it on children or adolescents to ensure safety and appropriate dosing.

How long does it take for the gel to work?

The onset of relief can vary depending on the individual and the severity of symptoms. Some users may experience relief within a few hours, while others may require several applications over a few days to notice significant improvement.

Can I use this gel during pregnancy or while breastfeeding?

If you are pregnant or breastfeeding, consult your healthcare provider before using this gel. They can help assess the potential risks and benefits based on your specific situation.

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.

Cyclobenzaprine HCl 0.5%/Naproxen 10% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)