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Formulas

Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream

The Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream is a semisolid preparation that is specifically formulated for the management of chronic pain and pruritus (itching) associated with various dermatological conditions. This cream is dispensed in a pump mechanism, which allows for convenient and controlled application directly to the affected areas of the skin. The inclusion of Doxepin HCl, a tricyclic antidepressant with antipruritic and analgesic properties, helps to alleviate itching and reduce pain sensations. Naloxone HCl, an opioid antagonist, is added to potentially mitigate the risk of systemic opioid side effects when applied topically. This combination aims to provide localized relief from discomfort while minimizing systemic exposure and side effects.

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Topical Cream
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Formula Information

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The Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream is a specialized medication compounded by the team at Bayview Pharmacy to address specific dermatological and pain-related conditions. Doxepin, a tricyclic antidepressant, has been found to have significant antipruritic and analgesic properties when applied topically. At a concentration of 5.65%, it is used to alleviate itching associated with eczema, lichen simplex chronicus, and other skin conditions. Additionally, it may provide a degree of pain relief for localized neuropathic pain syndromes due to its ability to inhibit the reuptake of serotonin and norepinephrine in the skin, which can modulate pain signaling pathways.

Naloxone HCl, commonly known for its role in reversing opioid overdoses, is included in this formulation at a 1% concentration for its potential to reduce inflammation and pruritus. When applied topically, naloxone may act on local opioid receptors in the skin, which can be involved in the itch and inflammatory responses. This dual-action cream is designed to be applied directly to the affected area, providing targeted relief with the potential for fewer systemic side effects compared to oral medications.

The cream is compounded into a semisolid preparation and dispensed in a pump mechanism container. This delivery system is intended to ensure a consistent dose with each application and to minimize contamination and degradation of the product. The pump mechanism also allows for convenient and controlled application, which is particularly beneficial for patients with limited dexterity or for application to hard-to-reach areas.

Patients and prescribers should be aware that this formulation is intended for localized treatment and should not be used on large areas of the body or for systemic conditions. It is also important to consider the potential for sedative effects due to the doxepin component, although these are less likely with topical administration compared to oral forms. As with any compounded medication, this cream should be used under the guidance of a healthcare professional, and it is essential to follow the prescribed dosing instructions to minimize the risk of side effects and to ensure the effectiveness of the treatment.

For more detailed information on the Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream, or if you have any questions regarding its use, potential side effects, or suitability for specific patients, 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 prescribers to ensure the safe and effective use of our compounded medications.

Drug Interactions

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The combination of Doxepin HCl and Naloxone HCl in a topical cream formulation is unique and may not have extensive documented interactions in the same way systemic medications do. However, it is important to consider the pharmacological profiles of both active ingredients when discussing potential drug interactions. Doxepin is a tricyclic antidepressant (TCA) that has antihistaminic and anti-inflammatory properties when used topically. Naloxone is an opioid antagonist that, when used topically, is thought to counteract the local effects of opioids, which may be beneficial in conditions like pruritus or certain types of pain.

When considering drug interactions for this topical formulation, it is important to note that systemic absorption of both doxepin and naloxone can occur, although it is typically minimal with proper topical use. However, if systemic absorption does occur, the potential for interactions increases. Patients should be advised to inform their healthcare providers of all medications they are taking, including over-the-counter drugs and herbal supplements, as well as any pre-existing medical conditions that may affect drug metabolism, such as liver or kidney impairment.

For doxepin, concurrent use with other central nervous system (CNS) depressants, such as benzodiazepines, opioids, antihistamines, or alcohol, may increase sedation and the risk of respiratory depression if systemic absorption occurs. Additionally, because doxepin is metabolized by the liver enzyme CYP2D6, drugs that inhibit or induce this enzyme could potentially affect the levels of doxepin. For example, MAO inhibitors, SSRIs, and certain antifungals and antibiotics may increase doxepin levels, leading to potential toxicity. Conversely, medications that induce CYP2D6, such as some anticonvulsants and smoking, may decrease doxepin levels and reduce its efficacy.

Naloxone, when absorbed systemically, can precipitate withdrawal symptoms in patients who are dependent on opioids. Therefore, caution should be exercised when this topical cream is used in opioid-dependent individuals. Additionally, because naloxone is also metabolized by the liver, drugs that affect hepatic enzyme activity may alter the metabolism of naloxone.

It is also important to consider the potential for local skin interactions. The use of other topical medications on the same area of skin where the doxepin/naloxone cream is applied may alter the absorption or effectiveness of either medication. Patients should be advised to discuss the use of other topical products with their healthcare provider.

This topical cream is designed for localized treatment and is not intended for systemic therapy. It may be used for conditions such as chronic pain, neuropathic pain, or inflammatory skin conditions where the combination of an antihistamine and opioid antagonist may provide relief. The specific mechanism by which this cream treats these disease states is not fully understood but is thought to involve local modulation of pain and inflammatory signals.

Patients should be instructed on the proper use of the pump mechanism to ensure they are applying the correct dose. They should also be advised to wash their hands after applying the cream unless the hands are the area being treated. If you have any questions or require further information regarding this formulation and its potential interactions, please reach out to us at Bayview Pharmacy for personalized advice and support.

How Does it Work

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The Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream is a specialized medication formulated by compounding pharmacists to address certain medical conditions through topical application. Doxepin is a tricyclic antidepressant that, in this topical form, is used primarily for its analgesic and anti-itch properties. When applied to the skin, Doxepin can help to relieve itching associated with various dermatological conditions and neuropathic pain. It works by blocking histamine receptors and stabilizing neuronal membranes, which in turn reduces the sensation of itch and pain.

Naloxone HCl, on the other hand, is an opioid antagonist traditionally used to reverse the effects of opioid overdose when administered systemically. However, in this topical formulation, Naloxone is used for its potential to reduce local inflammation and counteract pruritus (itching) that does not respond to traditional treatments. It is believed that Naloxone works by blocking the action of certain substances in the body that can cause itching and inflammation.

The combination of Doxepin and Naloxone in a cream base allows for the synergistic effects of both medications to be utilized in treating localized conditions. The cream is designed to be applied directly to the affected area, providing targeted relief with minimal systemic absorption. This can be particularly beneficial for patients who require localized treatment or those who may be sensitive to the systemic effects of these medications.

The semisolid preparation is dispensed in a pump mechanism, which offers several advantages. The pump allows for a consistent and measured dose with each application, ensuring that patients receive the correct amount of medication every time. This dosage form also minimizes the risk of contamination, as the medication is not exposed to the environment during dispensing. Additionally, the pump mechanism is user-friendly and can be particularly helpful for patients with limited dexterity.

This topical cream is indicated for the treatment of conditions such as lichen simplex chronicus, atopic dermatitis, or other forms of dermatoses where inflammation and itching are prominent symptoms. It may also be used for localized neuropathic pain where the use of systemic medications is not desired or is contraindicated. The specific concentration of Doxepin and Naloxone in this formulation has been chosen to maximize therapeutic effects while minimizing potential side effects.

It is important for both patients and prescribers to understand the proper use of this medication, including application techniques and frequency of use, to ensure optimal results. As with any medication, there may be potential side effects, and it is essential to monitor the treatment area for any signs of adverse reactions. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist you with your medication needs.

Other Uses

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While the primary indication of Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream is geared towards providing relief from certain skin conditions associated with pruritus or chronic pain, there may be exploratory or off-label uses for this unique formulation due to the properties of its active ingredients. Doxepin, being a tricyclic antidepressant with histamine-blocking capabilities, not only assists in reducing the itchiness from dermatological conditions but has also been observed to provide a degree of analgesia and alleviate neuropathic pain when applied topically. This might suggest potential utility in managing localized painful neuropathies or in conditions with dysesthesia, particularly with instances where systemic therapies are contraindicated or unwanted.

Naloxone, traditionally used to reverse opioid overdose, has been formulated here at a lower topical concentration. In such a formulation, naloxone may serve to mitigate some of the local side effects of opioids if used concurrently for pain management, or theoretically could be explored for its anti-inflammatory properties. There is emerging research suggesting that topically applied naloxone may have a beneficial effect on inflammatory skin diseases, such as atopic dermatitis or psoriasis, potentially attributed to the modulation of immune response and attenuation of inflammation when applied directly to the affected skin areas.

Beyond these considerations, the synergistic effects of doxepin and naloxone in this cream compounding form could entail a broader application for various chronic skin conditions that have not yet been fully explored. However, the use of this formulation for indications other than those approved requires careful consideration and should be guided by a healthcare professional with an understanding of the patient's overall medical condition and other therapies in use. Due to the nature of compounding pharmacy, we are able to tailor treatments like this to the specific needs of patients when conventional treatments are not suitable or effective.

Patient safety is paramount, and thus any alternate use of this product must be based on sound clinical evidence and under the supervision of a healthcare provider. If prescribers or patients are considering this compounded formulation of Doxepin HCl/Naloxone HCl Topical Cream for indications outside those currently targeted, we encourage reaching out to us at Bayview Pharmacy for further guidance and counseling. Proper use, potential benefits, risks, and the scope of use should be thoroughly discussed to ensure the most favorable outcomes while minimizing any risks associated with off-label usage of medications.

Frequently Asked Questions

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What is Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream used for?

Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream is a medication compounded for the treatment of certain chronic pain conditions and inflammatory skin disorders. The combination of Doxepin HCl and Naloxone HCl is designed to alleviate pain and reduce symptoms like itching or inflammation in the localized area of application.

How should I apply Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream?

This cream should be applied as directed by your healthcare provider. Generally, you can press the pump to dispense a small amount of the cream, then gently massage it into the affected area of the skin. Make sure to wash your hands after application unless the hands are the treated area.

How often should I use this compounded cream?

The frequency of application will be determined by your healthcare provider based on your condition and response to treatment. It’s important to follow their instructions and not alter the dosage without consultation.

Does Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream have any side effects?

Like all medications, Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream may cause side effects, although not everybody gets them. Common side effects include local skin irritation, redness, or itching at the site of application. If you experience severe or persistent side effects, contact your healthcare provider immediately.

Should I cover the treated area after applying Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream?

Unless instructed by your healthcare provider, it is not usually necessary to cover the treated area. If you've been told to cover it, use a breathable, non-medicated bandage or gauze.

Can I use this cream if I am pregnant or breastfeeding?

The safety of Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream during pregnancy or breastfeeding hasn't been firmly established. You should use this medication only if clearly needed and prescribed by your healthcare provider, who will assess the benefits and risks.

What should I do if I miss a dose?

If you miss a dose, apply the cream as soon as you remember. However, if it’s almost time for your next dose, skip the missed one and continue with your regular dosing schedule. Do not apply extra cream to make up for a missed dose.

Can I use other skin products on the area where I apply this cream?

Before using any other skin products on the treated area, consult your healthcare provider as other products may interfere with the absorption or effectiveness of the Doxepin/Naloxone cream.

How should I store Doxepin HCl 5.65%/Naloxone HCl 1% Topical Cream?

Store the cream at room temperature away from direct sunlight and heat. Do not freeze it. Keep the medication out of sight and reach of children and pets. The pump mechanism should remain attached to the container to avoid contamination.

What should I do in the case of an accidental ingestion or overdose?

If there has been an accidental ingestion or you suspect an overdose, seek emergency medical attention or call Poison Control immediately for guidance. It's important to keep this and all medications away from children, who might accidentally ingest them.

Can I use this medication if I have a known allergy to Doxepin or Naloxone?

If you have a known allergy to Doxepin, Naloxone, or any other components of the cream, you should not use it. Contact your healthcare provider to discuss alternative treatments that are safe for you.

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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.