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Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment

The Diltiazem HCl 2%/Lidocaine 1% 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. Diltiazem, a calcium channel blocker, and Lidocaine, a local anesthetic, work synergistically to treat anal fissures by promoting relaxation of the anal sphincter and providing pain relief. The ointment's emollient properties also aid in protecting the affected area, promoting a conducive environment for healing. This formulation is specifically used for the treatment of anal fissures and associated pain and discomfort.

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Diltiazem Hydrochloride
Lidocaine Hydrochloride
Topical Ointment
654e5eeb66914be0994095f4
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Formula Information

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Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment is a compounded medication specifically formulated to provide symptomatic relief and treatment for anal fissures and associated conditions. Diltiazem, a calcium channel blocker, works by relaxing the smooth muscles in the anal sphincter, thereby reducing resting anal pressure and improving blood flow to the area, which can facilitate the healing of fissures. Lidocaine, a local anesthetic, offers immediate relief from pain and discomfort by numbing the affected area. This dual-action formulation combines the therapeutic effects of both medications to promote healing and provide analgesia.

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 helps in the delivery of the active ingredients to the localized site but also provides a protective barrier that can prevent further irritation during bowel movements. This characteristic makes the ointment suitable for external application to the perianal skin and just inside the rectum, where it can exert its effects directly on the affected tissues.

Patients prescribed with this formulation can expect a reduction in pain and discomfort associated with anal fissures, as well as an environment conducive to healing. Prescribers opting for this compounded medication should consider it for patients who require a combination of muscle relaxation and analgesia for the treatment of anal fissures, particularly when standard therapies have not provided adequate relief or are not suitable. It is important to instruct patients on the correct method of application and to discuss the potential side effects, which may include local irritation or allergic reactions, although these are generally rare due to the localized action of the medication.

As compounding pharmacists at Bayview Pharmacy, we ensure that each batch of Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment is prepared to the highest standards, with each ingredient carefully measured and incorporated to achieve the desired therapeutic effect. We are available to answer any questions from both patients and prescribers regarding the formulation, its use, or any other concerns related to the compounded medication. Please do not hesitate to reach out to us for further information or guidance.

Drug Interactions

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The Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment is a compounded medication designed for rectal application to provide relief from anal fissures and associated pain. Diltiazem is a calcium channel blocker that helps to relax the smooth muscles in the blood vessels, improving blood flow and reducing blood pressure. In the context of anal fissures, it helps by reducing the pressure in the anal sphincter, thus promoting healing. Lidocaine is a local anesthetic that provides temporary relief from pain by blocking nerve signals in the body.

When considering the use of this compounded ointment, it is important to be aware of potential drug interactions. Diltiazem is metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme and can therefore interact with other drugs that are substrates, inhibitors, or inducers of this enzyme. Strong inhibitors of CYP3A4, such as ketoconazole, itraconazole, ritonavir, and clarithromycin, may increase the plasma concentration of diltiazem, potentially leading to enhanced effects and side effects. Conversely, inducers of CYP3A4, such as rifampin, phenytoin, carbamazepine, and St. John's Wort, may decrease the plasma concentration of diltiazem, reducing its efficacy.

Lidocaine, when applied topically, is generally considered to have a low risk of systemic absorption and thus a low risk of systemic drug interactions. However, caution should be exercised when lidocaine is used in conjunction with other local anesthetics or medications that affect cardiac conduction, as there may be an additive effect leading to increased risk of systemic toxicity or cardiac effects.

Patients should also be advised to avoid the concurrent use of other rectal products or those that may affect rectal mucosa, unless specifically directed by a healthcare provider, as this may alter the absorption or effects of the medication. Additionally, patients with pre-existing cardiac conditions, liver disease, or renal impairment should use this medication with caution and under the supervision of a healthcare provider, as these conditions may affect the metabolism and excretion of the drugs.

It is essential for patients to inform their healthcare providers of all medications, supplements, and herbal products they are currently taking before starting treatment with Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment. This will help to identify any potential interactions and allow for appropriate monitoring or adjustments to therapy. If you have any questions or require further information regarding drug interactions with this formulation, please reach out to us at Bayview Pharmacy.

How Does it Work

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The Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment is a specially compounded formulation that combines two active pharmaceutical ingredients, Diltiazem Hydrochloride and Lidocaine, in a semi-solid base suitable for rectal application. This ointment is designed to provide localized relief from specific conditions such as anal fissures, which are small tears in the lining of the anus that can cause pain and bleeding during bowel movements.

Diltiazem Hydrochloride is a calcium channel blocker that works by relaxing the smooth muscles in the walls of blood vessels, which in the case of anal fissures, helps to increase blood flow to the affected area, promoting healing and providing pain relief. The vasodilatory effect of Diltiazem also helps to reduce the resting pressure of the internal anal sphincter, which can alleviate the spasm and discomfort associated with anal fissures.

Lidocaine, on the other hand, is a local anesthetic that provides immediate relief from pain by blocking the transmission of pain signals along the nerves. When applied to the affected area, Lidocaine numbs the region, offering a soothing effect and making bowel movements less painful. This can be particularly beneficial in allowing the fissure to heal without the constant interruption of pain during defecation.

The ointment is formulated in a greasy or oily base, which not only ensures that the active ingredients are delivered directly to the site of pain and inflammation but also provides a protective layer that can prevent further irritation during bowel movements. This base also helps to maintain the hydration of the skin, which is essential for the healing process.

When using this compounded ointment, it is important to follow the directions provided by the prescriber. Typically, a small amount of the ointment is applied to the perianal area and gently massaged in, usually before and after bowel movements and at bedtime. This regimen helps to ensure that the medication is consistently delivered to the affected area, optimizing the healing environment and providing sustained pain relief.

As with any medication, there may be potential side effects, and it is important to monitor for any adverse reactions. If you experience any unusual symptoms or have concerns about the use of this ointment, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to both patients and prescribers to ensure the safe and effective use of this formulation.

Other Uses

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While Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment is specifically formulated for rectal application, primarily intended to treat conditions such as anal fissures and accompanying pain or spasms, its unique combination of ingredients allows for some additional uses. Please note that any alternative use should only be considered under the guidance and prescription of a healthcare provider.

The formulation's active components have properties that may be beneficial beyond the rectal area. Diltiazem, a calcium channel blocker, can help to relax smooth muscles and improve blood flow. Although the concentration in this ointment is tailored for rectal use, it may have potential off-label applications in other areas of the body where muscle relaxation is desired. However, such use must be approached with caution due to the systemic absorption and the risk of adverse effects.

Lidocaine, on the other hand, is a well-known local anesthetic and can also act as an antiarrhythmic agent. In this ointment, it helps alleviate pain by numbing the area of application. This analgesic effect may be beneficial in managing localized pain in other dermal or mucosal areas. Healthcare providers sometimes use lidocaine formulations for superficial skin procedures or to soothe other painful conditions, with caution to prevent systemic toxicity.

It is essential to understand that the off-label use of diltiazem and lidocaine for conditions like superficial thrombophlebitis, other smooth muscle spasms, or localized pain management outside of the rectal area is not the primary purpose of this product. The safety and efficacy of such applications have not been established for this particular formulary concentration and vehicle. Patients or prescribers considering any alternate use must discuss potential risks and benefits thoroughly, consider individual patient circumstances, and adhere to regulatory guidelines.

Given the specialized nature of this rectal ointment, patients and prescribers are encouraged to reach out to us at Bayview Pharmacy with any questions or to discuss appropriate uses. Our compounding pharmacy team is dedicated to providing accurate and comprehensive information to ensure the safe and effective use of all our formulations. We are here to support our patients' healthcare needs and collaborate with prescribers to optimize therapeutic outcomes.

Frequently Asked Questions

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What is Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment used for?

This compounded ointment is primarily used for treating pain, discomfort, and inflammation associated with anal fissures or hemorrhoids. The medication helps to relax the anal muscles and relieve pain, making bowel movements less painful.

How should this rectal ointment be applied?

Apply a small amount of ointment externally to the affected area. If internal application is instructed by a healthcare provider, use an appropriate applicator. Always cleanse the area gently but thoroughly before applying the medication, and wash your hands both before and after use.

Can Diltiazem HCl 2%/Lidocaine 1% Rectal Ointment be used with other medications?

It is important to consult your healthcare provider before combining this ointment with other medications. They will advise you if any interactions may occur with other drugs you are taking.

Are there any side effects associated with this compounded ointment?

Common side effects may include local irritation, itching, or a burning sensation at the application site. If you experience any severe reactions or systemic side effects, such as dizziness or heart palpitations, contact your healthcare provider immediately.

How often should I use the ointment?

The frequency of application will be determined by your healthcare provider based on the severity of your condition. Follow their directions carefully and do not use more often than prescribed.

Should this ointment be stored under specific conditions?

Store the ointment at room temperature, away from heat and direct light. Do not freeze it, and keep the tube tightly closed when not in use. Make sure to keep the medication out of reach of children and pets.

What should I do if I miss a dose of the rectal ointment?

If you miss a dose, apply 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 the dose to catch up.

Is this rectal ointment suitable for pregnant or breastfeeding women?

Prior to using this medication, it is crucial that pregnant or breastfeeding women consult their healthcare provider. They will assess the potential benefits and risks associated with the ointment's use.

Can I use this ointment for a condition not prescribed by my doctor?

No, you should only use this compounded formulation for the condition for which it was prescribed. Do not use it for other skin conditions without consulting your healthcare provider.

What should I do in case of an overdose?

While an overdose is unlikely with proper external application, if you suspect an overdose or experience severe side effects, seek medical attention immediately. Contact your local poison control center or head to the nearest emergency facility.

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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.