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Budesonide 5 mg/Cromolyn Na 100 mg/Mesalamine 2670 mg/60 mL Rectal Enema Liquid

This formulation, Budesonide 5 mg/Cromolyn Na 100 mg/Mesalamine 2670 mg/60 mL Rectal Enema Liquid, is a ready-to-use liquid solution contained in pre-filled enema bottles. It is specifically designed for rectal administration, providing a convenient and hygienic method for targeted treatment of various disease states. The formulation offers a measured dose of the solution for easy and controlled application without the need for additional preparation.

The active ingredients in this formulation, Budesonide, Cromolyn Sodium, and Mesalamine, are used to treat a range of conditions. Budesonide is a corticosteroid that reduces inflammation, Cromolyn Sodium is used to prevent allergic reactions, and Mesalamine is an anti-inflammatory drug used to treat ulcerative colitis. This combination of medications makes the formulation effective in treating conditions such as inflammatory bowel disease, Crohn's disease, and ulcerative colitis.

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Enema
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Formula Information

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This formulation is a combination of Budesonide, Cromolyn Sodium, and Mesalamine, all of which are active ingredients with distinct therapeutic properties. Budesonide is a corticosteroid that reduces inflammation, Cromolyn Sodium is a mast cell stabilizer that prevents allergic reactions, and Mesalamine is an anti-inflammatory drug used to treat symptoms of inflammatory bowel disease (IBD) such as ulcerative colitis and Crohn's disease.

The formulation is presented as a 60 mL rectal enema liquid, which is a ready-to-use solution contained in pre-filled enema bottles. This method of administration is designed for rectal use, providing a convenient and hygienic method for targeted treatment. It is particularly useful for patients suffering from constipation, requiring bowel cleansing, or needing medication delivery directly to the rectal area. The measured dose of the solution allows for easy and controlled application without the need for additional preparation.

Budesonide in the formulation works by decreasing the body's natural defensive response (inflammation) and reducing swelling and irritation. Cromolyn Sodium works by preventing the release of substances in the body that cause inflammation. Mesalamine works inside the bowels to reduce inflammation and other symptoms of the disease. Together, these three active ingredients provide a comprehensive approach to managing and treating symptoms associated with IBD.

It's important for patients and prescribers to understand that while this formulation can help manage and alleviate symptoms, it is not a cure for IBD. Regular use as directed by a healthcare provider is necessary to maintain symptom control and prevent flare-ups. Side effects may include nausea, vomiting, stomach pain, and diarrhea. If these persist or worsen, or if you experience any severe side effects such as chest pain or difficulty breathing, seek medical attention immediately.

As compounding pharmacists, we are here to answer any questions or concerns you may have about this formulation. Please do not hesitate to reach out to us for further information or clarification. We are committed to providing you with the most accurate and up-to-date information to ensure the safe and effective use of this medication.

Drug Interactions

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The combination of Budesonide, Cromolyn Sodium, and Mesalamine in a rectal enema liquid formulation is designed to treat various conditions related to the gastrointestinal tract. Budesonide is a corticosteroid that reduces inflammation, Cromolyn Sodium is a mast cell stabilizer that prevents allergic reactions, and Mesalamine is an anti-inflammatory drug used to treat ulcerative colitis. However, it's important to be aware of potential drug interactions.

Budesonide may interact with drugs like ketoconazole, indinavir, ritonavir, and other drugs that inhibit the CYP3A4 enzyme, leading to increased systemic corticosteroid effects. Concurrent use of Budesonide with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of peptic ulceration or GI bleeding. Patients should inform their healthcare provider if they are taking these medications.

Cromolyn Sodium has minimal systemic absorption and is unlikely to interact with other medications. However, it's always important to inform your healthcare provider about all the medications you are currently taking, including over-the-counter drugs and dietary supplements.

Mesalamine may interact with drugs like azathioprine or 6-mercaptopurine, increasing the risk for blood disorders. Concurrent use with NSAIDs, corticosteroids, or other nephrotoxic agents may increase the risk of renal adverse reactions. It's crucial to inform your healthcare provider if you are taking these medications.

It's also important to note that this formulation should not be used by patients with a known hypersensitivity to Budesonide, Cromolyn Sodium, or Mesalamine. Patients with active or latent tuberculosis, untreated systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may need to avoid using this formulation.

Patients should always inform their healthcare provider about all their current medications, including prescription drugs, over-the-counter drugs, dietary supplements, and herbal products, before starting treatment with this formulation. This will help the healthcare provider to manage potential drug interactions and ensure safe and effective treatment.

If you have any questions about this formulation or its potential interactions, please don't hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always here to help.

How Does it Work

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The Budesonide 5 mg/Cromolyn Na 100 mg/Mesalamine 2670 mg/60 mL Rectal Enema Liquid is a unique formulation that combines three active ingredients to provide targeted treatment for various gastrointestinal conditions. Each of these ingredients works in a different way to alleviate symptoms and treat the underlying disease.

Budesonide is a corticosteroid that works by reducing inflammation in the body. It is often used to treat conditions such as Crohn's disease, ulcerative colitis, and other inflammatory bowel diseases. When administered rectally, budesonide directly targets the inflamed areas of the colon and rectum, providing relief from symptoms such as pain, diarrhea, and bleeding.

Cromolyn Sodium is a mast cell stabilizer that works by preventing the release of substances in the body that cause inflammation. It is often used to treat conditions such as allergic reactions and asthma. In this formulation, Cromolyn Sodium helps to reduce inflammation in the gastrointestinal tract, further aiding in the relief of symptoms.

Mesalamine is an anti-inflammatory drug that works by reducing inflammation in the lining of the colon. It is used to treat and prevent flare-ups of ulcerative colitis. Mesalamine works topically on the site of inflammation in the colon and rectum, reducing symptoms and promoting healing of the intestinal lining.

This formulation is delivered as a rectal enema, which allows for direct application to the affected areas. This method of administration provides a number of benefits. Firstly, it allows for a higher concentration of the medication to reach the site of inflammation, providing more effective treatment. Secondly, it reduces the systemic absorption of the medication, minimizing potential side effects. Lastly, the pre-filled enema bottles provide a convenient and hygienic method of administration, with a measured dose of the solution for easy and controlled application.

It's important to note that while this formulation can provide relief from symptoms, it is not a cure for inflammatory bowel diseases. It should be used as part of a comprehensive treatment plan, under the supervision of a healthcare provider. As with any medication, it's important to use this formulation as directed, and to communicate any side effects or concerns to your healthcare provider.

If you have any questions about this formulation, or if you would like more information on how it can be used to treat your condition, please don't hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to help.

Other Uses

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This particular formulation, which features Budesonide, Cromolyn Sodium, and Mesalamine delivered via rectal enema, is designed primarily for the treatment of conditions such as ulcerative colitis, Crohn's disease, and other forms of inflammatory bowel disease (IBD). The inherent anti-inflammatory properties help to reduce inflammation in the gut, aid in achieving and maintaining disease remission, and improve the patient's overall quality of life. It also facilitates bowel cleansing, medication delivery, and potentially relieving constipation.

The multi-component nature of this formulation allows it to potentially find use in conditions apart from IBD. For instance, Budesonide, a corticosteroid, can be useful in the management of certain allergic reactions as well as asthma due to its ability to reduce inflammation and swelling. Consequently, this medication could be prescribed for off-label uses related to these conditions, following necessary clinical considerations.

Cromolyn Sodium, on the other hand, is often used to prevent the symptoms of asthma. It works by stopping the release of substances in the body that lead to inflammation. As such, this formulation could potentially be used off-label for the management of other conditions characterized by inflammation, following consideration by the healthcare provider.

Mesalamine, being an anti-inflammatory drug, also has potential for use in managing conditions characterized by inflammation, such as rheumatoid arthritis or psoriatic arthritis. However, using this formulation for off-label uses should only be considered under the direction of a licensed healthcare provider, as the delivery method via enema might not be suitable for all off-label considerations.

Please note, the uses listed are primarily speculative and assume a theoretical appropriateness for the listed conditions. Each case must be treated individually, and decisions on medication use should always be made in consultation with a healthcare provider. If you have any questions or need further information, don't hesitate to reach out to us at Bayview Pharmacy. We remain at your service to provide the most comprehensive pharmaceutical care possible.

Frequently Asked Questions

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What is the Budesonide 5 mg/Cromolyn Na 100 mg/Mesalamine 2670 mg/60 mL Rectal Enema Liquid?

This is a liquid formulation that is ready-to-use and contained in pre-filled enema bottles. It is designed for rectal administration, providing a method for the treatment of constipation, bowel cleansing, or medication delivery. It provides an exact, measured dose without requiring preparation.

How is this medication administered?

This medication is administered rectally. The liquid formulation is delivered via a pre-filled enema bottle. The medication is ready to use directly from the bottle, facilitating an easy and controlled application.

Why is this delivered in enema form?

An enema delivery provides a straightforward and hygienic method for medication administration. This method ensures that the treatment targets the rectum and lower part of the gut directly, making it suitable for treating conditions affecting these areas.

Can this medication treat constipation?

Yes, this compound formulation can be used for the treatment of constipation. It can serve as a bowel-cleansing agent as well.

How often should this medication be used?

The frequency and duration of treatment should be determined by your healthcare professional. They will take into consideration your particular condition and health status when providing instructions.

Does this medication require any additional preparation before use?

No, this medication does not require any additional preparation. It's designed to be ready-to-use, providing you with a measured dose straight from the pre-filled enema bottle.

What is the volume of the solution in one dose?

Each dose of this medication, contained within a prefilled enema bottle, holds 60 mL of the solution.

What should I do if I miss a dose?

If you miss a dose, administer it as soon as you remember. However, if it is near the time of your next dose, omit the missed one and continue with your regular medication schedule. Do not double the dose to compensate for the missed one.

Does this medication have any potential side effects?

Like all medications, this compound formulation may cause potential side effects. If you experience any unexpected or adverse reactions, consult your healthcare provider immediately.

Is this a one-time use procedure or a repetitive treatment?

Whether it's a one-time use procedure or a repetitive treatment would depend on your health condition and your healthcare provider's recommendations. Follow the professional instructions received for optimal efficacy.

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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.