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Mesalamine 50 mg/ml Rectal Gel

The Mesalamine 50 mg/ml Rectal Gel is a semisolid formulation designed for rectal administration. It is dispensed through a pump mechanism that ensures easy and precise application. The gel-like consistency of this medication allows for targeted treatment of the rectal area, facilitating the absorption of the active ingredient, mesalamine. This formulation is specifically used in the treatment of ulcerative colitis, a chronic inflammatory bowel disease characterized by inflammation and ulceration of the colon and rectum. The mesalamine works locally in the colon to reduce inflammation and can help to induce and maintain remission in patients with this condition.

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Mesalamine
Topical Gel
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Formula Information

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Mesalamine, also known as 5-aminosalicylic acid, is an anti-inflammatory drug primarily used in the treatment of inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The Mesalamine 50 mg/ml Rectal Gel is a semisolid formulation designed to deliver the active medication directly to the site of inflammation in the rectum. This localized application can lead to a reduction in systemic side effects typically associated with oral administration. The gel is dispensed through a pump mechanism, which allows for easy and precise dosing, ensuring that the correct amount of medication is administered each time.

The rectal gel formulation provides several advantages. The gel base facilitates adherence to the mucosal lining of the rectum, prolonging contact time and potentially increasing the local therapeutic effect. This can be particularly beneficial for patients with proctitis or distal colitis, where the inflammation is localized to the rectum and the lower part of the colon. By delivering the drug directly to the affected area, the gel may offer faster relief of symptoms such as pain, bleeding, and urgency.

For prescribers, it is important to note that the Mesalamine Rectal Gel should be used as part of a comprehensive treatment plan for IBD. It may be used alone in cases of mild to moderate inflammation or in combination with other medications for more severe cases. The gel's formulation is designed to minimize systemic absorption, which can be particularly advantageous for patients who are sensitive to the systemic effects of mesalamine or who may be taking other medications that could interact with it.

Patients should be instructed on the proper administration technique to ensure the effectiveness of the treatment. This includes rectal administration while lying on one side and remaining in position for a period after application to allow for optimal absorption of the medication. It is also important for patients to understand that while the gel may provide symptomatic relief, it is not a cure for IBD and regular use as directed by a healthcare provider is necessary to manage the condition effectively.

Bayview Pharmacy is committed to providing high-quality compounded medications tailored to the needs of individual patients. Our team of compounding pharmacists is available to answer any questions and provide additional information regarding the Mesalamine 50 mg/ml Rectal Gel or any other compounded formulations. We encourage both patients and prescribers to reach out to us for guidance on the use of this medication and to discuss any specific concerns or requirements related to the treatment of inflammatory bowel disease.

Drug Interactions

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Mesalamine, also known as 5-aminosalicylic acid, is an anti-inflammatory drug primarily used in the treatment of ulcerative colitis and other inflammatory bowel diseases. When formulated as a 50 mg/ml rectal gel, mesalamine acts locally in the rectum to reduce inflammation and promote healing of the mucosa. The rectal gel formulation is designed to ensure that the active ingredient is delivered directly to the affected area, minimizing systemic absorption and potential side effects.

Despite its local action, it is important to consider potential drug interactions when using mesalamine rectal gel. Mesalamine has been known to interact with certain medications, which could either reduce its effectiveness or increase the risk of adverse effects. For instance, concurrent use of nephrotoxic agents, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and certain diuretics, may increase the risk of renal impairment. Caution is advised when mesalamine is used alongside these medications, and renal function should be monitored.

Additionally, mesalamine may interact with anticoagulants like warfarin. The anti-inflammatory action of mesalamine could potentially enhance the effects of anticoagulants, increasing the risk of bleeding. Patients on anticoagulant therapy should be closely monitored for changes in coagulation parameters and bleeding signs when initiating or adjusting the dose of mesalamine rectal gel.

There is also a potential interaction with thiopurine medications, such as azathioprine or 6-mercaptopurine, which are often used in the management of inflammatory bowel diseases. Mesalamine has been reported to inhibit the thiopurine methyltransferase (TPMT) enzyme, which could lead to increased levels of thiopurines and a higher risk of myelosuppression. Patients taking these medications concurrently with mesalamine should have their blood counts regularly checked.

It is important to note that while the rectal gel formulation of mesalamine is designed for localized action, systemic absorption can still occur. Therefore, interactions that are relevant for oral forms of mesalamine should also be considered for the rectal gel. Patients should be advised to inform their healthcare provider of all medications they are taking, including over-the-counter drugs, supplements, and herbal products, to ensure safe and effective use of mesalamine rectal gel.

For any questions or concerns regarding the use of mesalamine rectal gel and potential drug interactions, please 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 optimal treatment outcomes.

How Does it Work

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Mesalamine, also known as 5-aminosalicylic acid, is an anti-inflammatory drug primarily used to treat inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. The mechanism by which mesalamine works is not fully understood, but it is thought to involve the inhibition of the production of inflammatory mediators in the colon, such as prostaglandins and leukotrienes. By reducing inflammation in the colon, mesalamine helps to alleviate symptoms such as abdominal pain, diarrhea, and rectal bleeding associated with these conditions.

The 50 mg/ml Mesalamine Rectal Gel is a semisolid formulation designed for rectal administration. This route of administration is particularly beneficial for diseases affecting the distal colon and rectum, as it allows for direct application of the medication to the inflamed tissue, potentially leading to quicker and more targeted relief. The gel formulation is designed to spread evenly and maintain contact with the mucosal surface, which may enhance the local therapeutic effects while minimizing systemic absorption and potential side effects.

The gel is dispensed through a pump mechanism, which provides a convenient and hygienic method of administration. This pump allows for precise dosing, ensuring that patients receive the correct amount of medication with each use. The consistency of the gel helps to ensure that the active ingredient, mesalamine, remains in contact with the affected area for an extended period, which may improve the efficacy of the treatment.

For patients, it is important to follow the dosing instructions provided by your healthcare provider and to use the medication as directed. For prescribers, it is essential to consider the patient's specific condition and the extent of the disease when determining the appropriate dosing regimen. The Mesalamine Rectal Gel formulation may be particularly useful for patients with distal ulcerative colitis or proctitis, where local delivery of the medication can directly target the site of inflammation.

If you have any questions about the Mesalamine 50 mg/ml Rectal Gel or its use in treating inflammatory bowel diseases, 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 manage these conditions.

Other Uses

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Mesalamine, also known as 5-aminosalicylic acid, is primarily indicated for the treatment of inflammatory bowel diseases including ulcerative colitis and Crohn’s disease, acting locally on the colonic epithelium to reduce inflammation. The preparation of Mesalamine 50 mg/ml Rectal Gel extends its utility due to its ease of administration via a pump mechanism and the possibility for precise dosing in a gel formulation that can be applied to the skin.

Beyond its principal use in bowel inflammation, this Mesalamine rectal gel may also offer benefits for certain dermatological conditions where inflammation is a key component. Some reports suggest that mesalamine could be used off-label for conditions such as pyoderma gangrenosum, which is associated with inflammatory bowel diseases but has a distinctive cutaneous manifestation. The anti-inflammatory action of Mesalamine could help in reducing the local inflammation and promoting healing when applied topically to such skin lesions.

Additionally, as the gel preparation is designed for rectal administration, it may provide a novel avenue for local therapy of proctitis or radiation-induced rectal inflammation, where systemic treatments or suppositories are either not effective or not well-tolerated. The gel could also be considered for use in patients presenting with hemorrhoids, where inflammation is a major cause of symptoms and where its local application might help alleviate pain and swelling.

It is also conceivable that Mesalamine gel could be researched for other inflammatory conditions of the anorectal area or adjacent skin. However, such uses would be off-label, and more evidence is needed to establish the efficacy and safety of Mesalamine in these conditions. Moreover, the pH and osmolarity of the formulation would need to be suitable for the skin or mucosa at the site of application to minimize irritation or other adverse effects.

Patients or prescribers considering this Mesalamine 50 mg/ml Rectal Gel for the aforementioned off-label uses should do so with caution, understanding that the evidence supporting these other uses may be limited. It is important to discuss any off-label treatment with a healthcare professional, taking into consideration individual patient needs, existing medical conditions, and concurrent medications. If you have any questions about the potential other uses of this Mesalamine gel formulation or wish to explore its suitability for a specific condition, please reach out to us at Bayview Pharmacy for further information and a personalized consultation.

Frequently Asked Questions

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What is Mesalamine 50 mg/ml Rectal Gel?

Mesalamine 50 mg/ml Rectal Gel is a semisolid formulation designed for rectal administration to treat inflammatory bowel diseases such as ulcerative colitis. The active ingredient, mesalamine, helps to reduce inflammation and promote healing in the colon and rectum.

How is this Mesalamine gel used?

The gel is applied rectally using a pump mechanism that allows for easy and precise dosing. This ensures that the medication is delivered directly to the affected area for targeted treatment.

How often should I use the Mesalamine gel?

The frequency of use for Mesalamine gel will be determined by your healthcare provider based on your medical condition and response to treatment. It's important to follow their instructions closely.

Can the gel be used externally on the skin?

No, Mesalamine 50 mg/ml Rectal Gel is specifically designed for rectal use and should not be used on the skin. It is meant to treat conditions within the rectum and colon.

Is there a specific way to store the Mesalamine gel?

Yes, you should store Mesalamine gel at room temperature away from light and moisture. Always ensure the cap is securely fastened after use to maintain the integrity of the medication.

What should I do if I miss a dose?

If you miss a dose of the Mesalamine gel, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Are there any potential side effects of Mesalamine gel?

As with any medication, there may be side effects. Common side effects of Mesalamine gel include rectal pain, diarrhea, and gas. If you experience severe or persistent side effects, contact your healthcare provider immediately.

Is Mesalamine gel safe to use during pregnancy or while breastfeeding?

Consult your healthcare provider before using Mesalamine gel if you are pregnant or breastfeeding. They will be able to determine if this medication is safe for you based on your particular situation.

Can I use other medications while using Mesalamine gel?

Inform your healthcare provider about all the medications you are currently taking, as there may be interactions. Some drugs can affect how Mesalamine works or increase your risk for side effects.

What should I do in case of an overdose with Mesalamine gel?

If you suspect an overdose of Mesalamine gel, seek emergency medical attention immediately. Overdose symptoms may include severe abdominal pain, vomiting, and diarrhea.

How do I know Mesalamine gel is working for me?

Improvements in symptoms such as reduced rectal inflammation, less frequent bowel movements, and decreased bloody diarrhea can indicate that the Mesalamine gel is effective. Discuss with your healthcare provider about monitoring your condition to assess the effectiveness of the treatment.

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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.