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Formulas

Lidocaine HCl 1%/Nifedipine 0.2% Rectal OIntment

The Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment is a semi-solid formulation designed for rectal application. This ointment is dispensed in a tube and provides a greasy or oily base that facilitates the localized delivery of the active ingredients. Lidocaine HCl, a local anesthetic, offers symptomatic relief from pain by numbing the affected area. Nifedipine, a calcium channel blocker, helps by promoting blood flow and reducing muscle spasms. This combination is commonly used in the treatment of anal fissures and associated pain. The ointment's emollient properties also support the healing process in the rectal tissue.

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Lidocaine Hydrochloride
Nifedipine Hydrochloride
Topical Ointment
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Formula Information

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Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment is a compounded medication specifically formulated to provide symptomatic relief and treatment for anal fissures and associated conditions. Lidocaine, a local anesthetic, works by blocking nerve signals in the body, which helps to reduce pain at the site of application. This can be particularly beneficial for patients experiencing sharp pain due to anal fissures or other anorectal disorders. The inclusion of 1% Lidocaine ensures that the medication has a rapid onset of action, providing quick relief from discomfort.

Nifedipine, a calcium channel blocker, is included in the formulation at a concentration of 0.2%. It functions by relaxing the smooth muscles in the blood vessels, which in the context of anorectal disorders, helps to increase blood flow to the affected area, promoting healing and reducing the spasm of the sphincter muscle. This can alleviate pain and facilitate the healing process of anal fissures. The combination of Lidocaine and Nifedipine in this ointment targets both pain relief and healing, making it a comprehensive treatment option for patients suffering from these conditions.

The ointment is prepared as a semi-solid formulation, which is dispensed in a tube for ease of application. The base of the ointment is designed to be greasy or oily, which not only aids in the delivery of the active ingredients to the affected area but also provides a protective barrier that can help to soothe irritated tissues. This type of base is particularly suitable for rectal application, as it adheres well to the mucosal surfaces and can resist being washed away by bodily secretions.

Patients are advised to apply the ointment as directed by their healthcare provider, typically in small amounts to the affected area. It is important to follow the specific instructions provided by the prescriber to ensure optimal treatment outcomes. Prescribers should consider the patient's medical history, including any known allergies or contraindications to the active ingredients, before recommending this formulation.

For any questions or additional information regarding the Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment, or to discuss its suitability for a particular patient, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing the highest level of care and is available to support both patients and healthcare providers with their medication needs.

Drug Interactions

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Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment is a compounded medication designed for rectal application to provide localized relief from pain and to promote healing in conditions such as anal fissures. Lidocaine is a local anesthetic that works by blocking nerve signals in the body, thereby reducing pain sensation in the area of application. Nifedipine is a calcium channel blocker that, when applied topically, can help to relax smooth muscles and improve blood flow, aiding in the healing of anal fissures.

When using this compounded formulation, it is important to consider potential drug interactions. Lidocaine, being metabolized primarily by the liver's cytochrome P450 3A4 (CYP3A4) enzymes, may interact with drugs that induce or inhibit this enzyme system. Strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and ritonavir, may increase lidocaine levels, potentially leading to systemic toxicity. Conversely, CYP3A4 inducers like rifampin and phenytoin may decrease lidocaine levels, reducing its efficacy.

Nifedipine, also metabolized by CYP3A4, can have its levels affected by the same inducers and inhibitors as lidocaine. Additionally, nifedipine may interact with other blood pressure medications, potentially leading to an additive hypotensive effect. Patients taking beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs) should be monitored for blood pressure changes. Concurrent use with digoxin may increase the risk of digoxin toxicity due to increased serum concentrations. Grapefruit juice can also increase nifedipine levels and should be avoided.

Given the potential for systemic absorption, patients should be advised to inform their healthcare provider of all medications they are taking, including prescription drugs, over-the-counter medications, and herbal supplements. This is to ensure that any potential interactions can be assessed and managed appropriately. It is also important to note that while systemic absorption of lidocaine and nifedipine from this rectal ointment is expected to be minimal, the risk of systemic side effects and interactions still exists, especially in patients with compromised liver function or those applying the ointment over large surface areas or for prolonged periods.

Patients should be instructed to use this medication as directed by their healthcare provider and to report any unusual symptoms or side effects. Prescribers should review the patient's medication profile for potential interactions and adjust therapy as needed. If you have any questions or require further information regarding the use of Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment is a specially compounded medication designed to provide relief from certain anorectal disorders. This semi-solid formulation is dispensed in a tube and is intended for rectal application. The ointment base is greasy or oily, which not only facilitates the application of the medication but also serves as a protective layer on the skin, potentially enhancing the healing process.

Lidocaine, the first active ingredient in this formulation, is a local anesthetic. It works by blocking the sodium channels in the neuronal cell membranes, which are essential for the initiation and conduction of nerve impulses. When applied to the affected area, lidocaine causes a temporary loss of sensation in the surrounding tissue. This numbing effect provides relief from pain and discomfort that can be associated with conditions such as hemorrhoids, anal fissures, and other sources of anorectal pain.

Nifedipine, the second active ingredient, is a calcium channel blocker. Although primarily used for the treatment of hypertension and angina, in this topical formulation, nifedipine serves a different purpose. It helps to relax the smooth muscles in the blood vessels, promoting increased blood flow to the affected area. This vasodilatory effect can aid in reducing the internal anal sphincter pressure, which is beneficial in the healing of anal fissures. The improved blood flow can also facilitate the healing process by allowing more oxygen and nutrients to reach the damaged tissue.

The combination of lidocaine and nifedipine in this rectal ointment provides both immediate pain relief and a mechanism to aid in the healing of anorectal disorders. The lidocaine offers prompt analgesic effects, while the nifedipine works over time to assist in the healing process by improving blood flow. This dual-action approach can be particularly effective for patients suffering from painful conditions that also require healing of the affected tissue.

It is important for patients and prescribers to understand that this formulation should be used as directed, and it is intended for rectal use only. The specific concentration of the active ingredients has been carefully chosen to maximize therapeutic effects while minimizing potential side effects. Patients should follow the application instructions provided by their healthcare provider or pharmacist to ensure safe and effective use of the medication.

If you have any questions about this formulation or its use in treating anorectal disorders, 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 ensure optimal treatment outcomes.

Other Uses

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While the primary indication for Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment is the treatment of anal fissures, which benefits from lidocaine's local anesthetic properties and nifedipine's ability to promote vasodilation and thereby reduce anal sphincter spasms, this unique formulation has potential utility in other clinical scenarios. The lidocaine component provides symptomatic relief by numbing the affected area, making this ointment potentially useful in managing other conditions that cause localized pain, such as pruritus ani (anal itching) or superficial skin pain due to other etiologies. The addition of nifedipine furthers its utility in conditions that could benefit from its vasodilatory effect, potentially improving blood flow to ischemic tissues in the rectal area or promoting healing in other localized circulatory insufficiencies.

Moreover, while not its primary use, the combination of these two agents in a rectal ointment may have off-label uses in certain dermatological conditions where both analgesia and vasodilation could play a role in management. For instance, patients with painful cutaneous vasospasm disorders, like Raynaud's phenomenon that occasionally can affect the perianal skin, may experience symptomatic relief from the nifedipine component. However, it should be used with caution and under a healthcare professional's guidance because systemic absorption of these drugs could have unintended effects.

It is also conceivable that this ointment could be applied to manage localized discomfort from procedures or trauma to the perianal area, again benefiting from the lidocaine's analgesic effect. Healthcare providers might consider this formulation for uses beyond the conditions mentioned, drawing on the properties of its active components and the general palliative care of skin irritation and inflammation where appropriate.

Patients and prescribers must consult with a compounding pharmacist or other healthcare provider before using this ointment for indications other than those for which it was primarily prescribed. Dosing, application frequency, and duration of use for off-label conditions should be carefully considered to optimize therapeutic outcomes and minimize risk. As compounding pharmacists at Bayview Pharmacy, we are equipped to provide further information and guidance on the potential uses of this compounded rectal ointment. Do not hesitate to reach out to us with your questions and for more personalized advice regarding the formulation. We are here to ensure safe and effective use of all compounded medications.

Frequently Asked Questions

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What is Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment used for?

This compounded ointment is typically prescribed for the treatment of conditions such as anal fissures, which may include symptoms like pain and muscle spasm. The lidocaine provides local anesthesia to relieve pain, while nifedipine helps to relax the blood vessels and improve blood flow to expedite healing.

How should I apply Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment?

It should be applied externally to the affected area around the anus as per your physician's instructions. Clean and dry the area before application, and wash your hands thoroughly before and after using the ointment.

What are the side effects of using this rectal ointment?

Some common side effects may include mild localized reactions like itching or redness at the application site. If you notice severe reactions, such as difficulty breathing, swelling, or intense pain, contact your healthcare provider immediately.

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

Consult your healthcare provider before using this ointment if you are pregnant or breastfeeding. Your doctor will determine if it is safe for you to use based on your specific circumstances.

How often should I apply the ointment?

Follow your healthcare provider's dosing instructions closely. Typically, it may be applied 2 to 3 times daily, but the exact frequency will be determined by your physician based on the severity of your condition.

Can I cover the treated area after application of the ointment?

After applying the ointment, it is generally not necessary to apply a bandage unless instructed by your healthcare provider. If a bandage is recommended, use a breathable, non-stick gauze to allow for proper air circulation and promote healing.

Is it safe to use other medications or products in the treated area?

Before applying other medications or products, it's important to consult with your healthcare provider to avoid potential interactions or adverse effects.

What should I do if I accidentally ingest the ointment?

If the ointment is accidentally ingested, seek medical attention or contact a poison control center immediately. Do not attempt to induce vomiting unless specifically instructed to do so by medical personnel.

How should I store the Lidocaine HCl 1%/Nifedipine 0.2% Rectal Ointment?

Store the ointment at room temperature, away from light and moisture. Make sure the cap is tightly closed and keep the tube out of reach of children and pets.

What should I do if I miss a dose?

If you miss a dose, apply the ointment as soon as you remember unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not apply extra ointment to make up for a missed dose.

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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.