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Hydrocortisone 14 mg/Lidocaine 70 mg/Nifedipine 2.8 mg Rectal Suppository

The Hydrocortisone 14 mg/Lidocaine 70 mg/Nifedipine 2.8 mg Rectal Suppository is a solid dosage form designed for insertion into the rectum. Upon administration, it dissolves or melts, releasing its active ingredients for local absorption. Hydrocortisone is a corticosteroid that reduces inflammation and swelling. Lidocaine is a local anesthetic that provides temporary relief from pain and discomfort. Nifedipine is a calcium channel blocker that helps to relax muscle fibers and improve blood flow. This combination of medications is commonly used to treat conditions such as anal fissures and hemorrhoids, providing anti-inflammatory, analgesic, and vasodilatory effects to alleviate symptoms associated with these disease states.

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Hydrocortisone
Nifedipine Hydrochloride
Lidocaine Hydrochloride
Suppository
65ad9d7bd5cfc599f07929aa
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Formula Information

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The Hydrocortisone 14 mg/Lidocaine 70 mg/Nifedipine 2.8 mg Rectal Suppository is a compounded medication designed for rectal administration to treat specific anorectal conditions. This solid dosage form is inserted into the rectum, where it dissolves or melts, allowing the active ingredients to exert their therapeutic effects locally, with some potential for systemic absorption. Each of the active components in this formulation plays a crucial role in managing symptoms and the underlying causes of anorectal disorders.

Hydrocortisone, a corticosteroid, is included at a concentration of 14 mg per suppository. It works by reducing inflammation, itching, and swelling in the affected area, providing relief from discomfort. This makes it particularly useful in treating inflammatory conditions such as hemorrhoids and proctitis. Lidocaine, a local anesthetic, is present at a dose of 70 mg per suppository. It provides rapid pain relief by numbing the local area, which can be beneficial for patients experiencing pain during bowel movements or from fissures.

Nifedipine, a calcium channel blocker, is incorporated at a dose of 2.8 mg per suppository. It helps by relaxing the smooth muscles of the anus, which can reduce anal sphincter spasm and improve blood flow to the area. This can promote healing of anal fissures and contribute to the reduction of hemorrhoidal symptoms. The combination of these three agents in a single rectal suppository allows for a multi-faceted approach to treatment, targeting pain, inflammation, and muscle spasm, which are common features of anorectal diseases.

This formulation is typically prescribed for patients who have not responded adequately to conventional therapies or who require a more targeted approach to manage their symptoms. It is important for both patients and prescribers to understand that this is a specialized medication prepared by compounding pharmacists at Bayview Pharmacy, and it should be used under the guidance of a healthcare professional familiar with the patient's medical history and the specifics of their condition.

Patients should be instructed on the proper method of suppository insertion and advised on the potential side effects, which may include local irritation, burning sensation, or systemic effects due to the absorption of the active ingredients. Prescribers should monitor patient progress and adjust treatment as necessary. If you have any questions or require further information about this compounded medication, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to support you with the information and guidance needed to effectively use this formulation.

Drug Interactions

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The formulation in question combines hydrocortisone, lidocaine, and nifedipine into a rectal suppository designed for local delivery of these medications. Hydrocortisone is a corticosteroid that reduces inflammation and swelling. Lidocaine is a local anesthetic that provides pain relief by numbing the tissue to which it is applied. Nifedipine is a calcium channel blocker that can relax smooth muscle and is used in this context to improve blood flow and reduce anal sphincter spasm. This combination may be used to treat conditions such as anal fissures, hemorrhoids, and other anorectal disorders.

When considering drug interactions, it is important to note that systemic absorption of these medications from a rectal suppository can be variable but is generally lower than oral administration. However, interactions can still occur, especially in individuals with compromised metabolism or those taking multiple medications.

Hydrocortisone, being a steroid, can interact with drugs that induce or inhibit CYP3A4, an enzyme responsible for its metabolism. Strong CYP3A4 inducers, such as rifampin and phenytoin, may decrease hydrocortisone levels, potentially reducing its efficacy. Conversely, CYP3A4 inhibitors like ketoconazole and ritonavir may increase hydrocortisone levels, raising the risk of systemic corticosteroid side effects such as adrenal suppression or Cushing's syndrome.

Lidocaine is metabolized by CYP1A2 and CYP3A4 enzymes. Drugs that affect these enzymes can alter lidocaine levels. For example, CYP1A2 inhibitors like fluvoxamine may increase the risk of lidocaine toxicity, which can manifest as nervousness, dizziness, or even seizures in severe cases. Additionally, lidocaine has the potential to interact with antiarrhythmic drugs, beta-blockers, and other local anesthetics, which may enhance cardiac effects or increase the risk of systemic toxicity.

Nifedipine is also metabolized by CYP3A4. Drugs that inhibit this enzyme can lead to increased levels of nifedipine, potentially causing hypotension, edema, or other related side effects. Grapefruit juice is a well-known CYP3A4 inhibitor and should be avoided. Conversely, CYP3A4 inducers can reduce the effectiveness of nifedipine. Additionally, nifedipine may interact with other antihypertensive agents, leading to an additive effect on blood pressure, or with digoxin, leading to increased digoxin levels.

It is crucial for patients and prescribers to be aware of these potential interactions and to monitor for any adverse effects. Patients should be advised to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and herbal supplements. If you have any questions or require further information regarding this formulation and its potential drug interactions, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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The Hydrocortisone 14 mg/Lidocaine 70 mg/Nifedipine 2.8 mg Rectal Suppository is a specially compounded medication designed to deliver its active ingredients directly to the affected area via the rectal route. This solid dosage form is inserted into the rectum, where it dissolves or melts at body temperature, releasing the medication for local absorption into the surrounding tissues and, to a lesser extent, into the systemic circulation.

Hydrocortisone is a corticosteroid that works by reducing inflammation, itching, and swelling. When used in a rectal suppository, hydrocortisone acts locally to alleviate inflammatory conditions of the anorectal area, such as hemorrhoids or other inflammatory diseases of the rectum and anus. It helps to relieve the associated symptoms by suppressing the immune response that causes inflammation.

Lidocaine is a local anesthetic that provides rapid pain relief by blocking the transmission of pain signals along the nerves. In this formulation, lidocaine is used to numb the rectal area, providing relief from pain, itching, and discomfort that can accompany conditions like hemorrhoids, anal fissures, or other sources of anorectal pain.

Nifedipine is a calcium channel blocker that, in this context, is used for its ability to relax smooth muscle tissue. When included in a rectal suppository, nifedipine can help to reduce the pressure within the anal sphincter, thereby improving blood flow to the area and facilitating the healing of anal fissures. Its vasodilatory effect also contributes to reducing pain and discomfort.

Together, these three active ingredients provide a multi-faceted approach to treating anorectal disorders. The hydrocortisone reduces inflammation, the lidocaine provides pain relief, and the nifedipine aids in muscle relaxation and healing. This combination can be particularly effective for patients suffering from painful conditions like chronic anal fissures, where inflammation, pain, and muscle spasm contribute to the disease state.

It is important for both patients and prescribers to understand that while this medication provides targeted relief, it should be used as directed by a healthcare professional. Factors such as the patient's medical history, the severity of the condition, and potential interactions with other medications must be considered. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to support you with the knowledge and expertise to ensure safe and effective treatment.

Other Uses

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The Hydrocortisone 14 mg/Lidocaine 70 mg/Nifedipine 2.8 mg rectal suppository is primarily formulated to offer symptomatic relief from conditions such as anal fissures, hemorrhoids, and other related anorectal disorders. Hydrocortisone acts as a corticosteroid, reducing the inflammation and swelling associated with these conditions. Lidocaine serves as a local anesthetic, helping to numb the local area to provide pain relief. Nifedipine, a calcium channel blocker, promotes vasodilation which helps to relax the smooth muscles and can alleviate spasms, further contributing to pain relief and healing.

Beyond its primary indications, the components of this rectal suppository have properties that may be beneficial in other related contexts. For example, the anti-inflammatory effects of hydrocortisone might provide symptomatic relief for other inflammatory conditions of the anorectal area not specifically listed, provided they are not contraindicated. Lidocaine’s anesthetic properties could be useful for other sources of localized pain or discomfort in the rectal area. Additionally, the vasodilatory effect of nifedipine might assist in conditions where increased blood flow could facilitate healing or ease discomfort.

While the formulation presents potential for off-label applications, it's imperative to consult with a healthcare professional before using this suppository for any purpose other than its intended use. The use of compounded medications for conditions other than those for which they have been specifically prescribed should always be done under the guidance of a physician. Additionally, patients with known hypersensitivity to any of the components, or those with specific health conditions that contraindicate the use of steroids, anesthetics, or calcium channel blockers, should not use this product.

For healthcare providers considering this formulation for other uses, a thorough evaluation of the patient's condition and medical history is crucial. The potential benefits should be weighed against the risks associated with the components of the suppository, particularly for long-term use or for conditions not listed in the primary use case. It is always recommended to start with the lowest effective dose that yields the desired therapeutic response, and closely monitor the patient for any adverse reactions.

If you have any questions about this formulation, whether it's about additional uses, dosing, possible side effects, or contraindications, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide you with the information you need to ensure safe and effective use of this medication.

Frequently Asked Questions

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What is the purpose of this compounded formulation?

This compounded formulation of Hydrocortisone, Lidocaine, and Nifedipine is designed to be used as a rectal suppository to treat various conditions such as hemorrhoids, anal fissures, and other anal or rectal conditions. Hydrocortisone reduces inflammation, Lidocaine acts as a local anesthetic, and Nifedipine works to relax smooth muscles and improve blood flow.

How should this rectal suppository be stored?

The suppository should be stored in a cool, dry place, away from light and moisture. It should also be kept out of reach of children and pets. Refer to specific storage instructions that may accompany the medication or consult your pharmacist for optimal storage conditions.

How is this rectal suppository used?

To use the suppository, wash your hands thoroughly before and after application. Remove the suppository from its packaging and gently insert it into the rectum, pointed end first, while lying on your side with your lower leg straightened out and your upper leg bent. Remain still for a few minutes to allow the suppository to dissolve and absorb.

What are the potential side effects of using this formulation?

Common side effects may include local irritation, itching, or a burning sensation. More serious side effects can include allergic reactions, systemic effects like changes in blood pressure, or signs of infection. If you experience any severe or concerning symptoms, contact your healthcare provider immediately.

How often should I use this suppository?

The frequency of use will depend on your specific condition and the instructions provided by your healthcare provider. Do not use more often than prescribed. It is important to follow their directions to achieve the best results and avoid potential side effects.

Can I use this suppository during pregnancy?

Consult with your healthcare provider before using this suppository if you are pregnant. They will determine if the benefits outweigh the potential risks to you and your unborn child.

What should I do if I miss a dose?

If you miss a dose, use the suppository as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use two doses at one time to make up for a missed dose.

Are there any interactions with other medications or foods?

This formulation may interact with other medications, particularly those that affect blood pressure or bleeding risk. It is essential to inform your healthcare provider about all the medications, supplements, and herbs you are currently taking to prevent potential interactions.

Is it safe to drive or operate machinery after using this suppository?

If you experience dizziness, drowsiness, or blurred vision after using the suppository, you should not drive or operate heavy machinery until these effects have passed.

Can this suppository be used for other conditions not mentioned here?

It is important to use this medication only for the condition for which it was prescribed. If you have another condition that you think may benefit from this treatment, consult with your healthcare provider to determine the appropriate medication and treatment plan.

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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.