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Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository

The Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository is a solid dosage form designed for insertion into the rectum. Upon administration, the suppository dissolves or melts, facilitating the release of hydrocortisone and mesalamine for local absorption. Hydrocortisone, a corticosteroid, helps to reduce inflammation, itching, and discomfort. Mesalamine is an anti-inflammatory agent specifically targeting the colon. This combination is commonly used in the treatment of inflammatory bowel diseases, including ulcerative colitis and proctitis. The dual action of both medications provides synergistic effects to alleviate local inflammation, reduce rectal bleeding, and promote healing of the colonic mucosa.

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Formula Information

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The Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository is a specially compounded medication designed to deliver its active ingredients directly to the site of inflammation in the rectum. This solid dosage form is intended for rectal administration, where it will dissolve or melt, allowing the active compounds to exert their therapeutic effects locally within the rectal tissue. Hydrocortisone is a corticosteroid that works by reducing inflammation, itching, and swelling. It is commonly used in the treatment of various inflammatory conditions of the rectum, including proctitis and hemorrhoids. Mesalamine, on the other hand, is an anti-inflammatory drug specifically targeted for the treatment of ulcerative colitis, a type of inflammatory bowel disease (IBD). It helps to reduce symptoms such as rectal bleeding, diarrhea, and abdominal pain by directly affecting the inflamed tissue.

The combination of hydrocortisone and mesalamine in a single rectal suppository offers the advantage of synergistic effects against inflammation. Hydrocortisone provides rapid relief from acute symptoms by suppressing the immune response, while mesalamine works more slowly to heal the lining of the colon and prevent future episodes of inflammation. This dual-action approach can be particularly beneficial for patients with conditions that have both acute and chronic components, such as IBD flare-ups. The rectal route of administration ensures that the medication is delivered directly to the affected area, which can result in fewer systemic side effects compared to oral medications and potentially lead to a quicker therapeutic response.

Patients and prescribers should be aware that this formulation is custom-made by compounding pharmacists at Bayview Pharmacy to meet the specific needs of individual patients. The use of this medication should be guided by a healthcare professional, and it is important to follow the prescribed dosing regimen to achieve the best therapeutic outcomes. As with any medication, there may be potential side effects, and patients should be counseled on what to expect and when to seek medical attention. For any questions or concerns regarding the Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository, or to discuss the suitability of this formulation for a particular patient, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide support and guidance to both patients and prescribers.

Drug Interactions

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The combination of hydrocortisone and mesalamine in a rectal suppository form is designed to exert local effects in the rectum and distal colon, primarily for the treatment of inflammatory bowel diseases such as ulcerative colitis. Hydrocortisone is a corticosteroid that reduces inflammation by suppressing the immune response, while mesalamine is an anti-inflammatory agent specifically targeting the lining of the large intestine. When considering drug interactions for this formulation, it is important to take into account both systemic and local effects, although systemic absorption is generally lower with rectal administration compared to oral forms.

Hydrocortisone, even when used rectally, can interact with other corticosteroids, potentially increasing the risk of systemic corticosteroid side effects such as adrenal suppression, osteoporosis, and immunosuppression. Caution is advised when this suppository is used concurrently with other corticosteroids, whether they are taken orally, injected, inhaled, or applied topically. Additionally, the use of hydrocortisone with drugs that induce hepatic enzymes, such as phenytoin, phenobarbital, or rifampin, may reduce the efficacy of hydrocortisone due to increased metabolism.

Mesalamine may interact with nephrotoxic agents, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and certain diuretics, which can increase the risk of renal dysfunction. Concurrent use of mesalamine with drugs that affect renal function should be monitored closely. Additionally, the use of mesalamine with anticoagulants like warfarin may increase the risk of bleeding due to mesalamine's potential to inhibit platelet aggregation. Regular monitoring of coagulation parameters is recommended when these drugs are used together.

Both hydrocortisone and mesalamine can interact with certain immunosuppressants, such as azathioprine or 6-mercaptopurine, leading to an increased risk of hematologic toxicity. Patients on these medications should be closely monitored for signs of myelosuppression. Live vaccines should be used with caution in patients receiving hydrocortisone, as the immunosuppressive effect may potentiate the risk of infection from the vaccine.

It is also important to consider the potential for local irritation or hypersensitivity reactions with the excipients used in the compounding of the suppository, which could affect drug absorption or cause local adverse effects. Patients with known hypersensitivity to any of the ingredients should not use this formulation.

Patients and prescribers should be aware that this is not an exhaustive list of all potential drug interactions. It is essential to review all medications, including over-the-counter drugs and herbal supplements, that the patient is taking to identify any possible interactions. For any questions or concerns regarding this formulation and its potential drug interactions, please reach out to us at Bayview Pharmacy for personalized advice and support.

How Does it Work

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The Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository is a solid dosage form designed to be inserted into the rectum, where it dissolves or melts at body temperature. Upon administration, the suppository base, typically composed of substances like cocoa butter or a synthetic substitute, begins to melt, allowing the active pharmaceutical ingredients, hydrocortisone and mesalamine, to be released and absorbed by the rectal mucosa.

Hydrocortisone is a corticosteroid that works by reducing inflammation, itching, and swelling. It exerts its effect by inducing the production of lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. By doing so, hydrocortisone helps to alleviate the inflammatory symptoms associated with conditions like inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, as well as other forms of proctitis and rectal inflammation.

Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is an anti-inflammatory agent specifically used in the treatment of ulcerative colitis, a type of IBD. It is believed to work topically on the colonic and rectal mucosa, inhibiting the production of inflammatory mediators such as prostaglandins, leukotrienes, and cytokines. Mesalamine's exact mechanism of action is not fully understood, but it is thought to involve the inhibition of the enzyme cyclooxygenase and the prevention of free radical formation, both of which play a role in the inflammatory process.

When combined in a rectal suppository, hydrocortisone and mesalamine provide a synergistic effect, targeting both the systemic and local aspects of rectal and colonic inflammation. This dual-action approach can be particularly beneficial for patients with IBD, as it can lead to a more comprehensive reduction in inflammation and symptom relief. The rectal route of administration ensures that the medication is delivered directly to the affected area, allowing for higher concentrations of the drugs at the site of inflammation with reduced systemic absorption and potential side effects.

This formulation is intended for use under the guidance of a healthcare professional. It is important for patients and prescribers to follow the recommended dosing schedule and to be aware of potential side effects and contraindications associated with the use of corticosteroids and mesalamine. If you have any questions or require further information about the Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to support you with the knowledge and expertise necessary to ensure safe and effective treatment.

Other Uses

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Hydrocortisone and Mesalamine Rectal Suppositories are primarily formulated to deliver medication directly to the rectal area, which can be advantageous in treating conditions characterized by inflammation or ulceration of the colon and rectum. The principal indication for this compound includes inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, where Hydrocortisone, a corticosteroid, helps to reduce inflammation while Mesalamine, an aminosalicylate, acts on the lining of the colon to decrease inflammation at the site.

Apart from these primary uses, this formulation could potentially have other applications, subject to further research and professional discretion. For instance, it might be considered for use in other inflammatory conditions of the gastrointestinal tract where local administration of these medications could prove beneficial. Additionally, in scenarios of proctitis or radiation proctitis, not directly related to the abovementioned diseases, the anti-inflammatory action may aid in symptom relief. However, it is important to note that the use of this preparation beyond approved indications should only be considered when prescribed by a healthcare professional after careful consideration of the patient's individual medical history, current condition, and the potential risks and benefits of off-label use.

In some cases, Hydrocortisone can also be beneficial in treating hemorrhoids due to its anti-inflammatory and vasoconstrictive effects, potentially reducing swelling and discomfort. Meanwhile, Mesalamine’s use beyond inflammatory bowel disease has not been well-established, but there could be a theoretical benefit in conditions where contact with the rectal mucosa can alleviate inflammation or irritation. Nevertheless, due to Mesalamine's specific mechanism of action and its primary target in inflammatory bowel conditions, its utility might be limited in other disorders without clear data to support additional indications.

It's crucial for both patients and prescribers to approach the use of a compounded Hydrocortisone/Mesalamine rectal suppository with full awareness of the patient's health status and an understanding that the off-label uses are not typically covered by manufacturers' prescribing information. Ensuring proper diagnosis, monitoring for side effects, and adjusting regimens as necessary is essential when selecting a compounded medication for an alternative indication. Additionally, since compounding pharmacies like Bayview Pharmacy customize formulations for specific needs, a thorough discussion between the prescriber, pharmacist, and patient about the potential and appropriate uses of such formulations is advised. If you have any questions or require further information regarding the potential other uses of Hydrocortisone/Mesalamine Rectal Suppositories, please do not hesitate to reach out to us. Our team at Bayview Pharmacy is committed to providing comprehensive support and guidance to ensure the safe and effective use of our compounded medications.

Frequently Asked Questions

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What is a Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository?

A Hydrocortisone 60 mg/Mesalamine 500 mg Rectal Suppository is a compounded formulation designed as a solid dosage form. The suppository is inserted into the rectum, where it dissolves or melts and releases the active compounds, hydrocortisone and mesalamine, for local treatment or systemic absorption.

How does this suppository work?

Once inserted into the rectum, the suppository's solid form responds to body temperature and melts or dissolves, releasing hydrocortisone, a corticosteroid, and mesalamine, an anti-inflammatory agent. These drugs then act locally to reduce inflammation in conditions such as ulcerative colitis, proctitis, and other inflammatory diseases of the lower intestinal tract.

How often should I use the suppository?

The frequency of use will be determined by your prescribing healthcare provider, based on your specific condition and treatment response. Always follow the dosage instructions provided by your healthcare professional.

What are the potential side effects of using this rectal suppository?

Potential side effects include local irritation, rectal discomfort, and a burning sensation. Systemic side effects may include changes in hormone levels due to hydrocortisone absorption and kidney issues related to mesalamine. If you experience any severe or persistent side effects, contact your healthcare provider immediately.

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

Consult your healthcare provider before using Hydrocortisone/Mesalamine suppositories if you are pregnant or breastfeeding. Your provider will assess the benefits versus the risks and will decide whether or not this medication is appropriate for you.

How should I store the Hydrocortisone/Mesalamine suppositories?

Store them in a cool, dry place, away from direct heat and light. Do not refrigerate or freeze them unless instructed otherwise. Keep out of reach of children and pets.

Can I use the suppository rectally and vaginally?

No, this particular suppository is designed and compounded specifically for rectal use. The medication's release and absorption profiles are tailored for application in the rectum. Vaginal use is not recommended and may not provide the intended therapeutic effects.

How should I prepare for the administration of the suppository?

Follow your healthcare provider's instructions, which typically include hygienic measures such as washing your hands before and after insertion. It's often recommended to empty your bowel prior to insertion for maximum comfort and efficacy.

What should I do if I miss a dose of the suppository?

If you miss a dose, insert the missed dose as soon as you remember. However, if it's almost time for your next dose, skip the missed dose to avoid doubling up. Do not use two doses at one time. Contact your healthcare provider if you need guidance on missed doses.

Can this suppository interact with other medications?

Yes, there is a potential for drug interactions, as hydrocortisone and mesalamine both have specific interaction profiles. Inform your healthcare provider of all medications and supplements you are currently taking to avoid any unwanted interactions.

Is it normal to see remnants of the suppository post-administration?

Yes, it is not uncommon to notice small amounts of residue from the suppository, as not all of the material may dissolve. If you notice a significant amount of undissolved material repeatedly, consult your healthcare provider.

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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.
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