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Formulas

Diltiazem HCl 2 % Rectal Ointment

Description: Diltiazem HCl 2% Rectal Ointment is a semi-solid pharmaceutical preparation intended for rectal application. The ointment is compounded in a greasy or oily base to ensure ease of application and optimal delivery of the active ingredient, Diltiazem HCl, directly to the affected area. This formulation is specifically designed to treat anal fissures and associated conditions. The ointment works by promoting blood flow and relaxing the anal sphincter, which helps to alleviate pain and facilitate the healing process of the fissures. Packaged in a tube, this rectal ointment provides a localized treatment that is both convenient and effective for patients suffering from these distressing conditions.

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Topical Ointment
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Formula Information

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Diltiazem HCl 2% Rectal Ointment is a specially compounded semi-solid formulation designed for rectal application. This ointment is dispensed in a tube and is intended for direct application to the rectal area. The base of the ointment is greasy or oily, which not only facilitates the delivery of the active pharmaceutical ingredient, diltiazem hydrochloride, but also provides a soothing effect on the application site. Diltiazem is a calcium channel blocker that, when applied rectally, helps to relax the smooth muscles in the anal region. This relaxation can reduce the pain, discomfort, and spasms associated with anal fissures, a common and painful condition characterized by a small tear in the lining of the anus.

The 2% concentration of Diltiazem HCl in the ointment ensures a localized effect with minimal systemic absorption, providing targeted relief without significant side effects. The ointment is typically applied topically to the affected area, and the frequency of application will depend on the specific needs of the patient as determined by the prescriber. Patients should be instructed on proper application techniques to maximize the therapeutic benefits while minimizing potential irritation or adverse effects.

For prescribers, it is important to note that this formulation of Diltiazem HCl is specifically compounded for rectal use and is not interchangeable with other diltiazem products intended for oral or intravenous administration. The use of this ointment should be part of a comprehensive treatment plan that may include other modalities such as increased dietary fiber, sitz baths, and adequate hydration. Prescribers should monitor patient progress and adjust treatment as necessary, considering any contraindications or potential interactions with other medications the patient may be taking.

Patients should be advised that while Diltiazem HCl 2% Rectal Ointment can provide significant relief from the symptoms associated with anal fissures, it is not a cure for the underlying condition. Consistent use as directed by a healthcare professional, along with lifestyle modifications, can aid in the healing process and reduce the likelihood of recurrence. Any questions or concerns regarding the use of this compounded medication should be directed to the compounding pharmacists at Bayview Pharmacy, who are available to provide additional information and support to both patients and prescribers.

If you have any questions or require further clarification on the use, benefits, or potential side effects of Diltiazem HCl 2% Rectal Ointment, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is committed to ensuring the safe and effective use of this medication and is ready to assist with any inquiries you may have.

Drug Interactions

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Diltiazem HCl is a calcium channel blocker that is commonly used to treat hypertension, angina, and certain heart rhythm disorders when taken orally or intravenously. However, as a 2% rectal ointment, it is typically used for anal fissures to reduce sphincter spasm and improve blood flow to the area, promoting healing. It is important to consider potential drug interactions when using diltiazem in any form, as it can affect the absorption, metabolism, or excretion of other drugs.

Patients should be advised that diltiazem can interact with other medications that affect heart rate and rhythm, such as beta-blockers (e.g., metoprolol, atenolol) and digoxin. Combining these medications with diltiazem may lead to an additive effect on the heart, potentially resulting in bradycardia or other cardiac conduction abnormalities. Close monitoring by a healthcare provider is recommended when these drugs are used concurrently.

Diltiazem is metabolized by the liver enzyme CYP3A4. Drugs that inhibit this enzyme, such as certain antifungals (ketoconazole, itraconazole), macrolide antibiotics (erythromycin, clarithromycin), and protease inhibitors (used in HIV therapy), can increase the levels of diltiazem in the body, potentially leading to toxicity. Conversely, medications that induce CYP3A4, such as rifampin, phenytoin, carbamazepine, and St. John's Wort, may decrease the effectiveness of diltiazem.

Additionally, diltiazem can increase the levels of statins (e.g., simvastatin, atorvastatin) in the body by inhibiting their metabolism. This can raise the risk of muscle-related side effects, including rhabdomyolysis. Patients using statins concurrently with diltiazem should be monitored for signs of muscle pain, tenderness, or weakness, particularly during the initial stages of therapy or during dose adjustments.

Patients on antihypertensive therapy or medications that lower blood pressure should also be cautious, as diltiazem may potentiate the effects of these drugs, leading to an increased risk of hypotension. Blood pressure should be monitored, and dosage adjustments may be necessary when these medications are used together.

It is also important to note that while the systemic absorption of diltiazem from a rectal ointment is expected to be lower than from oral forms, some systemic absorption can still occur. This means that interactions typical of systemic diltiazem could potentially occur with the rectal ointment as well, although the likelihood may be reduced.

Patients should be instructed to inform their healthcare providers of all medications, supplements, and over-the-counter drugs they are taking to avoid potential interactions. Prescribers should review the patient's medication profile for potential interactions before prescribing diltiazem rectal ointment. If you have any questions or require further information regarding drug interactions with diltiazem rectal ointment, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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Diltiazem HCl, the active ingredient in this 2% rectal ointment, is a calcium channel blocker that is commonly used to treat hypertension and angina. However, when formulated as a rectal ointment, it serves a different purpose. The mechanism of action in this application is primarily through its ability to relax smooth muscle tissue. When applied rectally, diltiazem reduces the sphincter muscle tone and provides analgesic effects, which can be beneficial in treating anal fissures—a condition characterized by a small tear in the lining of the anus that can cause pain and bleeding during bowel movements.

The ointment base, which is greasy or oily, serves as a vehicle to deliver the active medication directly to the affected area. This localized delivery system ensures that the medication is concentrated at the site of application, which increases its effectiveness and reduces the likelihood of systemic side effects. The base also provides a protective barrier that can help to soothe irritated tissue and promote healing. The ointment is designed to be applied externally to the perianal area, and it can help to relieve pain, promote relaxation of the anal sphincter, and facilitate the healing of anal fissures.

For patients, it is important to understand that this ointment should be used as directed by a healthcare provider, and it is typically applied two to four times daily. It is also crucial to maintain good hygiene and to apply the ointment gently to avoid further irritation or injury to the affected area. For prescribers, it is essential to consider the patient's overall health and any other medications they may be taking, as diltiazem can interact with certain drugs. Additionally, prescribers should monitor the patient's progress and adjust the treatment regimen as necessary to ensure optimal healing and relief from symptoms.

If you have any questions about the Diltiazem HCl 2% Rectal Ointment or its use in treating anal fissures and associated conditions, please do not hesitate to 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 effectively use this formulation.

Other Uses

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While Diltiazem HCl 2% Rectal Ointment is primarily formulated for the treatment of anal fissures to relax the anal sphincter and improve blood flow, thereby promoting healing and providing pain relief, it is important to recognize that its use might extend beyond this indication due to its pharmacological properties. Diltiazem is chiefly known as a calcium channel blocker and acts to dilate blood vessels, which can be beneficial in other diseases involving spasms or tightness of smooth muscle. However, the effectiveness and safety of diltiazem for indications other than anal fissures when used in a rectal ointment format are not well-established and should be approached with caution.

In practice, patients have occasionally used diltiazem ointment for off-label purposes such as treating chronic anal fissures not responsive to initial treatment, or hemorrhoids, where its vasodilatory effect may help reduce swelling and discomfort. Although there might be anecdotal references to its efficacy, prescribers must decide on a case-by-case basis if the off-label application is rational and justified given the patient's medical history and clinical condition. It is crucial to secure informed consent and to ensure that patients are aware of the nature of off-label use. Similarly, consideration should be given to potential systemic absorption, especially in sensitive areas with mucous membranes, and the associated risk of systemic side effects like hypotension or bradycardia should not be overlooked.

Another possible, albeit uncommon, application could be in the management of vasospastic disorders due to diltiazem's vasodilatory action. For example, patients with Raynaud's phenomenon or certain types of headaches attributable to vasospasm, may theoretically benefit from the localized application of diltiazem. Nevertheless, the rectal ointment form is not specifically designed for these purposes, and efficacy in such conditions has not been established through rigorous clinical studies. The pharmacokinetics and optimal dosing for these potential uses are also not defined, making its utility questionable without further evidence.

In any case, the use of Diltiazem HCl 2% Rectal Ointment outside of its intended purpose should be under the advisement and close supervision of a healthcare professional with an understanding of the patient’s individual needs and response to treatment. If you are considering prescribing or using this preparation for conditions other than anal fissures, or if you have questions about its appropriateness for a particular patient, please do not hesitate to reach out to us at Bayview Pharmacy for additional information and guidance. Our team is committed to supporting clinicians and patients in making informed decisions about compounding medications and their potential applications.

Frequently Asked Questions

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What is Diltiazem HCl 2% Rectal Ointment used for?

Diltiazem HCl 2% Rectal Ointment is a medication used primarily to treat anal fissures and help relieve associated pain, discomfort, and spasm of the anal sphincter. It may also be prescribed for other rectal conditions as deemed appropriate by a healthcare provider.

How should I apply Diltiazem HCl 2% Rectal Ointment?

The ointment should be applied externally to the affected area around the rectum as directed by your healthcare professional. Usually, a small amount is applied with a clean finger or using an applicator if provided. It is important to follow the prescribed dosage and instructions closely.

Can Diltiazem HCl 2% Rectal Ointment be used for internal hemorrhoids?

While Diltiazem ointment is not primarily indicated for internal hemorrhoids, it may be prescribed off-label in certain situations to alleviate symptoms of pain or spasm. It is important to use this medication only as directed by your healthcare provider for the condition they have prescribed it for.

What are the side effects of using Diltiazem HCl 2% Rectal Ointment?

Side effects can include itching, redness, a burning sensation at the application site, or a headache. If you experience any severe reactions or if the side effects do not go away, you should contact your healthcare provider immediately.

How often should Diltiazem HCl 2% Rectal Ointment be applied?

The frequency of application depends on the prescription provided by your healthcare provider. Often, it's applied two to three times a day, but the regimen can vary based on individual needs and the severity of symptoms.

Can I use Diltiazem HCl 2% Rectal Ointment if I am pregnant or breastfeeding?

Prior to using this medication while pregnant or breastfeeding, it is crucial to discuss potential risks and benefits with your healthcare provider. They will be able to advise you on whether this treatment is safe for you based on your specific circumstances.

Will Diltiazem HCl 2% Rectal Ointment interact with other medications I'm taking?

As with all medications, there is potential for interactions. You should inform your healthcare provider about all medications, supplements, and herbs you are currently taking so they can check for any interactions.

How should Diltiazem HCl 2% Rectal Ointment be stored?

Store the ointment at room temperature, away from direct heat and light. Keep the tube tightly closed when not in use, and make sure it is kept out of reach of children and pets.

Is Diltiazem HCl 2% Rectal Ointment suitable for children?

The use of this medication in children has not been well-established. Its usage should be determined by a pediatrician or healthcare provider who can evaluate the potential risks and benefits for the pediatric patient.

What should I do if I miss a dose of Diltiazem HCl 2% Rectal Ointment?

If you miss a dose, apply the ointment 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 apply double the quantity to make up for a missed dose.

Can Diltiazem HCl 2% Rectal Ointment be used for other conditions besides anal fissures?

This medication is specifically formulated for anal fissures and conditions related to rectal pain and muscle spasm. It should not be used for other conditions unless specifically recommended by a 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.