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Dapsone 5%/Pyridoxine HCl 1% Topical Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Dapsone
Pyridoxine Hydrochloride

The Dapsone 5%/Pyridoxine HCl 1% Topical Gel is a specialized semisolid formulation designed for targeted skin application. The gel is dispensed through a pump mechanism, which ensures ease of use and precise dosing. The consistency of the gel allows for the active ingredients to be absorbed effectively into the skin. This formulation is primarily used in the treatment of dermatitis herpetiformis, a skin condition characterized by blistering and intensely itchy skin. Additionally, it may be utilized in the management of acne vulgaris, where its anti-inflammatory and antibacterial properties help reduce the occurrence of acne lesions. The inclusion of Pyridoxine HCl (Vitamin B6) is intended to mitigate potential peripheral neuropathy associated with Dapsone use.

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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.
Dapsone
Pyridoxine Hydrochloride
Topical Gel
654ec11b71d51699490b0f71

Formula Information

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The Dapsone 5%/Pyridoxine HCl 1% Topical Gel is a specialized semisolid formulation designed to deliver a combination of therapeutic agents directly to the skin. Dapsone, the primary active ingredient, is an anti-inflammatory and antibacterial agent commonly used in the treatment of dermatitis herpetiformis, acne vulgaris, and other skin conditions characterized by inflammation and/or bacterial infection. The inclusion of Pyridoxine HCl, also known as Vitamin B6, helps to mitigate potential side effects of Dapsone, such as peripheral neuropathy, by providing nutritional support and aiding in the maintenance of healthy skin. The gel's unique composition allows for a controlled release of the active ingredients, ensuring a sustained therapeutic effect.

The gel is dispensed through a pump mechanism, which offers several advantages for both patients and prescribers. This delivery system allows for precise dosing, reducing the risk of over-application and ensuring consistent treatment. The pump also minimizes contamination of the product, as it limits the exposure to external factors. The gel base is designed to be easily spreadable, enhancing the absorption of the active ingredients and providing a convenient and mess-free application process.

For patients, this formulation offers a targeted approach to treatment, with the potential for reduced systemic side effects compared to oral medications. The gel's consistency and the pump dispenser contribute to a more pleasant and user-friendly experience, which may improve adherence to the treatment regimen. Prescribers can expect a formulation that is well-suited for patients requiring localized treatment of skin conditions, with the added benefit of Vitamin B6 to support skin health and reduce the risk of Dapsone-induced neuropathy.

It is important for both patients and prescribers to be aware of the potential side effects and contraindications associated with Dapsone, including but not limited to hemolytic anemia and hypersensitivity reactions. Regular monitoring and follow-up are recommended to ensure the safe and appropriate use of this medication. If you have any questions or require further information about the Dapsone 5%/Pyridoxine HCl 1% Topical Gel, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing comprehensive support and guidance to optimize patient care.

Drug Interactions

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The Dapsone 5%/Pyridoxine HCl 1% Topical Gel is a specialized medication formulated for the treatment of certain skin conditions. Dapsone is an antibacterial and anti-inflammatory agent, commonly used for dermatitis herpetiformis, acne, and other skin conditions. Pyridoxine, also known as vitamin B6, is included to potentially reduce the risk of peripheral neuropathy, a possible side effect of dapsone when used systemically. However, it is important to consider potential drug interactions when using this topical formulation.

While the systemic absorption of dapsone and pyridoxine from a topical gel is expected to be lower than from oral administration, interactions may still occur. Dapsone can interact with a variety of drugs, including but not limited to, certain antiretroviral drugs, antimalarial agents, and warfarin. These interactions can lead to increased levels of dapsone in the blood, potentially increasing the risk of hemolytic anemia and methemoglobinemia, especially in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Patients should be advised to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and supplements.

Topical use of dapsone may also interact with benzoyl peroxide-containing acne treatments, which can cause a temporary local yellow or orange discoloration of the skin and facial hair. It is recommended to apply these products at different times of the day to avoid this interaction. Additionally, the use of other topical medications on the same area of skin should be discussed with a healthcare provider to avoid potential additive irritant effects or altered absorption.

Pyridoxine, when used in large doses, has the potential to interact with medications such as levodopa, reducing its efficacy. However, the risk of this interaction is likely low with the topical application of pyridoxine at a 1% concentration. Nevertheless, patients on medication for Parkinson's disease should consult their healthcare provider before using this formulation.

It is also important to note that while the topical route of administration reduces systemic exposure, patients with significant renal or hepatic impairment should use this product with caution, as systemic absorption, although minimal, could still occur. In such cases, monitoring for systemic side effects may be warranted.

Patients should be instructed to use this medication only on the skin areas prescribed by their healthcare provider and to avoid contact with eyes, nose, mouth, and other mucous membranes. In case of accidental contact, the area should be rinsed thoroughly with water. Patients should also be advised to report any signs of adverse reactions, such as severe rash, difficulty breathing, or unusual bruising or bleeding, to their healthcare provider immediately.

If you have any questions or require further information regarding the use of Dapsone 5%/Pyridoxine HCl 1% Topical Gel, including potential drug interactions and disease state treatments, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing you with the necessary support and guidance to ensure appropriate treatment.

How Does it Work

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The Dapsone 5%/Pyridoxine HCl 1% Topical Gel is a specialized medication formulated to deliver active ingredients directly to the skin. Dapsone is an antibacterial and anti-inflammatory agent, which works by inhibiting the synthesis of dihydrofolic acid in bacteria and suppressing the inflammatory responses in the skin. The anti-inflammatory properties of Dapsone reduce redness and swelling associated with these conditions.

Pyridoxine HCl, also known as Vitamin B6, is included in the formulation for its skin-healing properties. It plays a vital role in maintaining the health of skin, nerves, and red blood cells. Pyridoxine HCl is known to help manage certain skin conditions that may be responsive to vitamin B6 supplementation. In combination with Dapsone, it may help to reduce inflammation and promote healthy skin.

The gel is designed to be a semisolid formulation that is dispensed through a pump mechanism. This delivery system allows for easy and precise application, ensuring that the medication is applied directly to the affected area, minimizing waste and reducing the risk of spreading the medication to unaffected areas. The gel base is absorbed quickly by the skin, allowing for the active ingredients to begin working promptly after application.

For patients, it is important to use the medication as directed by a healthcare provider. The area of application should be clean and dry before applying the gel. Patients should wash their hands before and after applying the medication unless the hands are the area being treated. For prescribers, it is essential to consider the patient's medical history, current medications, and potential for drug interactions before prescribing this topical gel.

If you have any questions about the Dapsone 5%/Pyridoxine HCl 1% Topical Gel or its use in treating specific skin conditions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide you with the information and support you need to effectively use this formulation.

Other Uses

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The Dapsone 5%/Pyridoxine HCl 1% Topical Gel is primarily indicated for a range of dermatological conditions, notably for its anti-inflammatory and antibacterial properties. Dapsone, a synthetic sulfone, is commonly used in the treatment of dermatitis herpetiformis, acne vulgaris, and as part of the management of other skin conditions like leprosy, cutaneous lupus, and bullous pemphigoid. Pyridoxine, also known as vitamin B6, is integrated into this formula for its potential benefit in preventing peripheral neuropathy, which can be a rare side effect of dapsone when used systemically or even topically in sensitive individuals.

Outside of these primary indications, the anti-inflammatory action of dapsone could potentially make the gel useful in the off-label management of other inflammatory skin disorders. Similarly, the blend might provide benefits for conditions where neutrophilic infiltration is a component of the pathogenesis, such as pyoderma gangrenosum. However, clinicians and patients should exercise caution and consult with a healthcare professional before using this formulation for off-label purposes, as its safety and efficacy for these uses may not be well established. Additionally, given the antioxidant properties of pyridoxine, there is the potential for its role in skin repair and regeneration, though such use should be done under medical supervision.

It is also essential for patients and prescribers to be aware of the contraindications or potential interactions with other medications when considering alternative uses. Due to its contents, this formulation should not be used in patients who are hypersensitive to dapsone or pyridoxine, or who have certain types of anemia. The gel is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) due to the risk of hypertensive crisis. Patients already on medication that affects blood cell count or those with glucose-6-phosphate dehydrogenase (G6PD) deficiency should use this medication cautiously, and under strict medical supervision.

While off-label uses may exist for Dapsone 5%/Pyridoxine HCl 1% Topical Gel, such as for its immunomodulatory effects, these uses should be researched and approached with the guidance of medical professionals experienced in dermatology and pharmacotherapy. Should patients or prescribers have any questions regarding the use, potential off-label applications, or safety considerations of this formulation, they should not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing comprehensive information to ensure the safe and appropriate use of our compounded medications.

Frequently Asked Questions

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What is Dapsone 5%/Pyridoxine HCl 1% Topical Gel used for?

Dapsone 5%/Pyridoxine HCl 1% Topical Gel is typically used to treat skin conditions such as dermatitis herpetiformis, acne, and certain types of skin lesions caused by leprosy. The combination of Dapsone, an antibiotic, with Pyridoxine HCl, a form of vitamin B6, is meant to act against inflammation and bacterial growth while minimizing potential peripheral neuropathy associated with Dapsone use.

How do I use this topical gel?

To use the gel, clean and dry the affected skin area. Then, press the pump to dispense a small amount of gel onto your finger and apply a thin layer over the affected area as instructed by your healthcare provider. Wash your hands immediately after applying the gel unless your hands are the area being treated.

What are the advantages of the pump dispenser for this medication?

The pump dispenser provides a convenient and hygienic way to apply the gel and helps to deliver a consistent amount of medication with each use. This can enhance treatment adherence by making application easier and more precise compared to other dispensing methods.

Can I use this gel on any part of my body?

Use the gel only on the skin areas that have been diagnosed and recommended for treatment by your healthcare provider. Avoid applying the gel to areas of your skin that are unaffected, sensitive, broken, or on mucous membranes.

How often should I apply the Dapsone/Pyridoxine Topical Gel?

The frequency of application will depend on the instructions provided by your healthcare provider. It's important to follow their guidance closely for optimal results. Do not apply more often than prescribed.

Are there any side effects of using this topical gel?

As with any medication, side effects can occur. Common side effects may include mild skin irritation, redness, or dryness at the application site. If you experience severe skin reactions or other concerning symptoms, contact your healthcare provider immediately.

Should I cover the treated area with a bandage or dressing?

Do not cover the treated area with a bandage or other covering unless directed by your healthcare provider. Covering the area can increase the absorption of the medication, potentially leading to unwanted side effects.

Can I apply makeup or sunscreen over the treated area?

Wait until the medication has fully dried before applying any makeup or sunscreen over the treated area. To protect your skin, it is usually advisable to apply sunscreen when going outdoors, but consult your healthcare provider for specific recommendations regarding product use in conjunction with the gel.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. However, if it is nearly 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.

How should I store the Dapsone/Pyridoxine Topical Gel?

Store the gel at room temperature, away from direct light and heat. Do not freeze it. Keep the container tightly closed and out of reach of children and pets. Dispose of any unused medication after the expiration date or as instructed by your healthcare provider or a medication take-back program.

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

If you are pregnant, planning to become pregnant, or breastfeeding, you should discuss the potential risks and benefits with your healthcare provider before using the medication. They will be able to provide guidance based on your specific circumstances.

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.

Dapsone 5%/Pyridoxine HCl 1% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)