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Diltiazem HCl 27 mg/Lidocaine 67.5 mg/Pramoxine HCl 27 mg Rectal Suppository

The Diltiazem HCl 27 mg/Lidocaine 67.5 mg/Pramoxine HCl 27 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 three active pharmaceutical ingredients for local absorption. Diltiazem, a calcium channel blocker, is employed for its vasodilatory properties, which can help in treating anal fissures by reducing sphincter pressure and improving blood flow to promote healing. Lidocaine, a local anesthetic, provides rapid relief from pain and discomfort by numbing the affected area. Pramoxine HCl, another local anesthetic, further aids in alleviating itching, pain, and discomfort associated with hemorrhoids and other anorectal disorders. This combination of medications offers a multimodal approach to managing symptoms associated with anal fissures and hemorrhoids, providing both therapeutic and symptomatic relief.

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Diltiazem Hydrochloride
Pramoxine Hydrochloride
Lidocaine Hydrochloride
Suppository
654e95e4280578d6adc28c67
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Formula Information

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The Diltiazem HCl 27 mg/Lidocaine 67.5 mg/Pramoxine HCl 27 mg Rectal Suppository is a specially compounded medication designed to provide relief from various anorectal conditions. This solid dosage form is intended for rectal administration, where it dissolves or melts to release its active ingredients for local action or systemic absorption. Each of the active components plays a crucial role in managing symptoms associated with these conditions.

Diltiazem HCl is a calcium channel blocker that works by relaxing the smooth muscles in the blood vessels and the anus, which can help reduce anal fissure pain and facilitate healing by improving blood flow to the affected area. Lidocaine is a local anesthetic that provides rapid pain relief by numbing the local area where it is applied, thus offering immediate comfort from pain and discomfort. Pramoxine HCl is another local anesthetic that works by blocking nerve signals in the body, further contributing to pain relief and reducing itching associated with hemorrhoids or other anorectal disorders.

This combination of active ingredients makes the suppository particularly effective for treating pain, discomfort, and itching caused by conditions such as anal fissures, hemorrhoids, and other anorectal disorders. The formulation is designed to act locally with minimal systemic absorption, providing targeted relief with a reduced risk of systemic side effects. However, as with any medication, there may be potential interactions and contraindications, so it is important for prescribers to consider the patient's full medical history before recommending this treatment.

Patients are advised to follow the specific instructions provided by their healthcare provider regarding the use of this medication. Proper administration is key to the effectiveness of the treatment, and patients should be counseled on how to insert the suppository correctly to ensure optimal absorption and therapeutic effect. It is also important for patients to understand that while this medication can provide symptomatic relief, it may not address the underlying cause of the anorectal condition, and additional treatment or lifestyle changes may be necessary.

If you have any questions or require further information about the Diltiazem HCl/Lidocaine/Pramoxine HCl Rectal Suppository, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide guidance and support to both patients and prescribers to ensure safe and effective use of this compounded medication.

Drug Interactions

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The formulation in question combines Diltiazem HCl, Lidocaine, and Pramoxine HCl into a rectal suppository. Diltiazem is a calcium channel blocker that is used to treat hypertension and certain types of angina. It works by relaxing the muscles of your heart and blood vessels. Lidocaine is a local anesthetic that provides temporary relief of pain and discomfort. Pramoxine is an anesthetic that decreases the sensation of pain by blocking the transmission of pain signals to the brain.

When considering drug interactions for this formulation, it is important to note that Diltiazem is metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme system in the liver. Therefore, it can interact with other drugs that are substrates, inhibitors, or inducers of this enzyme system. For example, concurrent use of Diltiazem with strong CYP3A4 inhibitors like ketoconazole or clarithromycin can increase the levels of Diltiazem, potentially leading to toxicity. Conversely, CYP3A4 inducers such as rifampin can decrease the effectiveness of Diltiazem.

Lidocaine, when used systemically, can also interact with various medications. However, when used in a local formulation such as a rectal suppository, systemic absorption is usually minimal. Nevertheless, caution should be exercised when it is used in patients taking class I antiarrhythmic drugs (such as tocainide and mexiletine) as the toxic effects are additive and potentially synergistic.

Pramoxine is generally considered to have minimal systemic absorption and a low risk of systemic drug interactions. However, it is still important to consider the potential for local irritation or allergic reaction when combined with other topical agents.

Patients should be advised to inform their healthcare providers of all medications they are taking, including prescription drugs, over-the-counter medications, and herbal supplements. This is particularly important for patients taking heart medications, blood pressure medications, or any drugs that might affect the liver enzyme systems. Additionally, patients with liver or kidney impairment may require special consideration, as these conditions can alter drug metabolism and excretion.

It is also important to note that while the primary action of this suppository is local, systemic absorption can occur, especially with damaged or inflamed mucosa. Therefore, the potential for systemic effects and interactions must be considered. Patients should be monitored for signs of systemic side effects, and prescribers should adjust dosages accordingly.

For any questions or concerns regarding this formulation and its potential drug interactions, please reach out to us at Bayview Pharmacy. We are here to ensure the safe and effective use of this medication for the treatment of your patients' conditions.

How Does it Work

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The Diltiazem HCl 27 mg/Lidocaine 67.5 mg/Pramoxine HCl 27 mg Rectal Suppository is a compounded medication designed to deliver its active ingredients directly to the rectal area. This solid dosage form is inserted into the rectum, where it dissolves or melts at body temperature, releasing the medication for local absorption. The unique combination of active ingredients in this formulation works synergistically to provide relief from various symptoms associated with anal fissures, hemorrhoids, and other anorectal disorders.

Diltiazem HCl is a calcium channel blocker that, when applied topically, can relax the smooth muscle surrounding blood vessels. In the context of anorectal disorders, diltiazem reduces the sphincter muscle tone and improves blood flow to the affected area, promoting healing and providing pain relief. Its inclusion in the suppository aims to alleviate the spasm and discomfort associated with anal fissures and hemorrhoids.

Lidocaine is a local anesthetic that provides rapid pain relief by blocking the sodium channels responsible for conducting pain signals in the nerves. When applied to the mucosal membranes of the rectum, lidocaine numbs the area, offering immediate relief from pain, itching, and discomfort. This can be particularly beneficial for patients experiencing acute episodes of pain associated with anorectal conditions.

Pramoxine HCl is another local anesthetic that works by numbing the skin and mucous membranes. It is less potent than lidocaine but provides a longer duration of action. Pramoxine HCl helps to reduce the sensation of pain and itching, making it easier for patients to manage their symptoms throughout the day.

The combination of these three active ingredients in a rectal suppository form allows for targeted therapy with minimal systemic absorption, reducing the likelihood of systemic side effects. The suppository base is formulated to ensure that the active ingredients are released consistently and effectively as the suppository dissolves within the rectal cavity.

This compounded medication is typically prescribed for patients who have not found adequate relief from over-the-counter treatments or who require a more potent or targeted therapeutic approach. It is important for patients and prescribers to understand that this is a specially compounded medication and should be used under the guidance of a healthcare professional. If you have any questions about this formulation or its appropriateness for your condition, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide the information and support you need to make an informed decision about your treatment options.

Other Uses

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While the primary indication for a suppository containing Diltiazem HCl, Lidocaine, and Pramoxine HCl is typically for the management of pain, discomfort, or spasms associated with anorectal disorders such as hemorrhoids or fissures, there may be other uses for this formulation in medical practice. The synergistic combination of these three agents may provide comprehensive relief by targeting different aspects of pain and irritation. The Diltiazem acts as a calcium channel blocker, reducing smooth muscle spasm and promoting increased blood flow to the area, which can aid in healing. Lidocaine serves as a local anesthetic, providing immediate relief from pain by numbing the affected area. Pramoxine HCl is another local anesthetic that works by inhibiting nerve signals, adding further pain relief.

Aside from their conventional role in rectal conditions, this suppository formulation may potentially be applied off-label for related conditions involving local pain and spasm where the use of systemic medications is not desired or contraindicated. However, it is crucial to note that such off-label uses should be guided by clinical judgment and based on individual patient needs. Medical professionals considering this formulation for alternate applications must weigh potential benefits against risks, taking into account the individual components' pharmacodynamics and pharmacokinetic profiles. A thorough understanding of the patient's medical history and concurrent medications is also essential to minimize drug interactions and side effects.

Patients and prescribers should be aware that while the potential exists for off-label uses of this formulation, these have not been approved by regulatory agencies and may not be supported by extensive clinical trials. Therefore, when considering this formulation for conditions outside the usual indications, it is important to engage in a shared decision-making process. Prescribers must monitor treatment outcomes closely and maintain open communication with patients regarding efficacy and side effects. Additionally, both clinicians and patients should report any adverse reactions or unique applications to the appropriate channels to contribute to the broader understanding of the potential uses of this medication.

Prior to using this suppository for any condition, the safety profile of each medication included in the formulation should be reviewed. Diltiazem may interact with other medications metabolized through the same pathways in the liver, and care should be taken in patients with known cardiac conditions. Lidocaine and Pramoxine, although less systemic in their effects, can still cause local reactions or systemic toxicity if used improperly.

If you have any questions about the potential additional uses of this rectal suppository formulation, or if you would like to discuss the appropriateness of this medication for a particular patient or condition, please reach out to us at Bayview Pharmacy. As compounding pharmacists, we are here to provide in-depth information and support to both patients and healthcare providers to ensure safe and effective medication use.

Frequently Asked Questions

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What is the purpose of this compounded suppository?

This compounded suppository is designed to provide a combination of Diltiazem HCl, Lidocaine, and Pramoxine HCl to the rectal area. It's typically used to treat conditions like anal fissures, hemorrhoids, or other anorectal disorders, providing pain relief and reducing muscle spasm.

How do I properly insert the rectal suppository?

To insert the suppository, first wash your hands thoroughly. Lie on your side with your lower leg straightened out and your upper leg bent forward toward your stomach. Lift upper buttock to expose the rectal area. Gently insert the suppository, pointed end first, into the rectum with your finger. Hold it in place for a few seconds to ensure it stays in place. Then wash your hands again.

How often should I use this medication?

The frequency of use for this medication will be determined by your healthcare provider based on the condition being treated and your response to therapy. Follow your healthcare provider's instructions exactly regarding dosage and frequency.

Can I use this suppository for vaginal administration?

No, this formulation is designed specifically for rectal use and should only be inserted into the rectum unless your healthcare provider has instructed otherwise.

What should I do if I miss a dose?

If you miss a dose, insert it as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double doses to catch up.

Will this suppository treat my condition completely?

This suppository is intended to manage symptoms and may not be a cure for your condition. It can help alleviate discomfort and promote healing, but you should follow up with your healthcare provider for comprehensive treatment and monitoring.

Can this medication be used by anyone?

No, this medication should only be used under the guidance of a healthcare provider. It's not suitable for everyone and may not be appropriate for individuals with certain medical conditions or for those who are taking specific medications that could interact.

What are the potential side effects of this compounded suppository?

Side effects may include local irritation, burning sensation, itching, and rectal discomfort. If you experience any severe side effects or signs of an allergic reaction, seek medical attention immediately.

Should I avoid any activities while using this suppository?

There are typically no restrictions on activities. However, you may want to avoid activities that may exert pressure on the rectal area shortly after administration to allow proper absorption of the medication.

How should I store the suppository?

Store the suppository in a cool, dry place away from direct heat and light. Keep them stored in their original packaging, and make sure they are out of reach of children and pets. Do not freeze the suppositories unless advised by your pharmacist or 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.

No compounded medications are reviewed by the FDA for safety or efficacy.