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Formulas

Nifedipine 0.5% Rectal Ointment

Nifedipine 0.5% Rectal Ointment is a specially compounded semi-solid formulation intended for rectal application. This ointment is dispensed in a tube and possesses a greasy or oily base, which facilitates the localized delivery of the active ingredient, nifedipine. Nifedipine is a calcium channel blocker that, when applied rectally, is used to treat anal fissures by promoting blood flow to the area, thereby aiding in the relaxation of the sphincter muscles and facilitating the healing process. This formulation is specifically designed to provide symptomatic relief from pain and to support the healing of anal fissures, contributing to improved patient comfort and outcomes.

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Nifedipine Hydrochloride
Topical Ointment
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Formula Information

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Nifedipine 0.5% Rectal Ointment is a specialized semi-solid formulation that is carefully compounded by our team at Bayview Pharmacy. This ointment is designed for rectal application, where it serves as a topical vasodilator due to the active ingredient, nifedipine. Nifedipine is a calcium channel blocker that, when applied locally, helps to relax and expand blood vessels, improving blood flow to the affected area. This mechanism of action is particularly beneficial in treating anal fissures, which are small tears in the lining of the anus that can cause pain and bleeding. By increasing blood flow, nifedipine promotes healing and provides symptomatic relief from pain and spasms associated with these fissures.

The ointment is dispensed in a tube, providing a convenient and hygienic method of application. The base of the ointment is designed to be greasy or oily, which not only aids in the delivery of the active medication but also provides a protective barrier that can help to soothe and heal the skin. This type of base is particularly useful in rectal formulations as it can help to lubricate the area, reducing discomfort during application and ensuring that the medication is retained at the site of action for optimal effectiveness.

For patients, it is important to follow the application instructions provided by your healthcare provider to ensure the best therapeutic outcomes. The ointment should be applied as directed, typically in a thin layer around the anal area. It is also crucial to maintain good hygiene and avoid any potential irritants that could exacerbate the condition. For prescribers, it is essential to consider the patient's overall health status and any potential interactions with other medications they may be taking. Nifedipine rectal ointment can be a valuable addition to the treatment regimen for patients suffering from anal fissures, providing both symptomatic relief and aiding in the healing process.

If you have any questions or require further information about the Nifedipine 0.5% Rectal Ointment or its compounding process, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing the highest quality of care and is ready to assist with any inquiries you may have.

Drug Interactions

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Nifedipine is a calcium channel blocker that is primarily used to treat hypertension and angina. However, when formulated as a 0.5% rectal ointment, it is typically used off-label for the treatment of anal fissures due to its ability to relax smooth muscle and improve blood flow to the area, promoting healing. While the systemic absorption of nifedipine from a rectal ointment is expected to be lower than oral forms, there is still potential for drug interactions, particularly with medications that may also affect blood pressure and heart function.

Patients using nifedipine rectal ointment should be aware of the potential for interaction with other antihypertensive agents, such as beta-blockers, ACE inhibitors, or diuretics. Concurrent use may enhance the blood pressure-lowering effects of these medications, which could result in hypotension. Careful monitoring of blood pressure is advised when using these medications together. Additionally, nifedipine may interact with other calcium channel blockers, leading to an increased risk of side effects such as edema, headache, or dizziness.

Drugs that induce or inhibit the cytochrome P450 3A4 (CYP3A4) enzyme system can also affect nifedipine levels. CYP3A4 inducers, such as rifampin and St. John's Wort, may decrease the plasma concentration of nifedipine, potentially reducing its efficacy. Conversely, CYP3A4 inhibitors, including certain antifungals (like ketoconazole), macrolide antibiotics (such as erythromycin), and protease inhibitors, may increase nifedipine levels, leading to an increased risk of side effects. Patients should inform their healthcare provider of all medications, including over-the-counter drugs and herbal supplements, they are taking to avoid potential interactions.

Patients taking digoxin should also be cautious, as nifedipine can increase serum digoxin levels, which may necessitate monitoring and possible dose adjustment of digoxin. Similarly, those on quinidine may see altered serum levels of quinidine when used concurrently with nifedipine. Tacrolimus is another medication that could interact with nifedipine, as nifedipine can increase tacrolimus blood levels, potentially requiring dose adjustments.

It is important to note that while nifedipine is used topically in this formulation, systemic effects are still possible, and the potential for drug interactions exists. Patients should be counseled on the signs and symptoms of hypotension, such as dizziness, fainting, and fatigue, and instructed to report these to their healthcare provider. 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 nifedipine 0.5% rectal ointment and its potential drug interactions, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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Nifedipine is a calcium channel blocker that is primarily used to treat high blood pressure and angina. However, when formulated as a 0.5% rectal ointment, it serves a different purpose. The mechanism of action in this semi-solid formulation is based on its ability to relax smooth muscle tissue. When applied rectally, nifedipine ointment can help to reduce the pressure within the anal sphincter, thereby alleviating pain associated with anal fissures and promoting their healing. Anal fissures are small tears in the lining of the anus that can cause severe 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 application ensures that the nifedipine acts where it is needed most, minimizing systemic absorption and potential side effects. The base also provides a protective layer over the skin, which can help to soothe irritation and allow for a more comfortable application. The formulation is designed to be applied externally to the skin around the anal area, and not internally.

By relaxing the anal sphincter muscle, the ointment can help to increase blood flow to the region, which is essential for the healing process. Improved blood flow delivers oxygen and nutrients to the damaged tissue, aiding in the repair of the fissure. Additionally, by reducing the spasm of the sphincter, nifedipine ointment can help to decrease pain and facilitate easier bowel movements, which is crucial for the prevention of further trauma to the area.

It is important for patients and prescribers to understand that while nifedipine rectal ointment can be highly effective for the treatment of anal fissures, it should be used as directed by a healthcare professional. The ointment is typically applied topically to the affected area up to three times daily, or as prescribed. Patients should be instructed on proper application techniques to ensure the best possible outcomes. If there are any questions or concerns regarding the use of nifedipine 0.5% rectal ointment, or if additional guidance is needed, please reach out to us at Bayview Pharmacy for further assistance.

Other Uses

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Nifedipine is primarily recognized as a calcium channel blocker typically used to manage hypertension and angina. However, as a 0.5% rectal ointment, this formulation has been utilized for its off-label use in treating anal fissures due to its ability to induce smooth muscle relaxation and reduce anal sphincter spasm, which improves blood flow to the site of the fissure allowing for faster healing and pain relief. Beyond this application, the ointment may also have potential uses in other conditions involving smooth muscle spasm or where vasodilation could be beneficial. For instance, it may provide symptomatic relief in cases of chronic proctalgia where muscle tension plays a role.

Another potential therapeutic application for this formulation could be in the treatment of Raynaud's phenomenon, which causes some areas of the body, such as the fingers and toes, to feel numb and cold in response to cold temperatures or stress. Although usually administered orally for this condition, topical nifedipine could help by locally dilating the blood vessels and improving blood flow to the affected extremities. Furthermore, patients with other circulatory issues resulting in localized pain or ischemia, such as chilblains, might also benefit from the vasodilatory and smooth muscle relaxing properties of this compound when applied topically.

However, it is crucial to note that the use of Nifedipine 0.5% Rectal Ointment beyond the treatment of anal fissures is considered off-label and should be approached with caution. Healthcare providers should make prescribing decisions based on individual patient needs, existing evidence for the off-label use, and the risk-benefit profile of the treatment. Moreover, patients should be counseled on the appropriate use of this formulation, expected therapeutic outcomes, and adverse effect profile. Due to the aforementioned reasons, if you have any questions or concerns regarding the suitability of this formulation for other uses, or if additional guidance is required for specific patient cases, please feel free to reach out to us at Bayview Pharmacy. We are more than willing to provide support and ensure the safe and effective use of our compounded nifedipine preparation.

Frequently Asked Questions

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What is Nifedipine 0.5% Rectal Ointment used for?

Nifedipine 0.5% Rectal Ointment is typically prescribed for the treatment of chronic anal fissures to improve blood flow and promote healing, as well as to relieve the pain and spasm associated with the condition.

How should Nifedipine 0.5% Rectal Ointment be applied?

The ointment should be applied directly to the affected area. It's important to clean and dry the area before application. Use the applicator tip or a gloved finger to apply the ointment externally as directed by your healthcare provider.

What are the possible side effects of Nifedipine 0.5% Rectal Ointment?

Common side effects may include headaches, dizziness, or a temporary decrease in blood pressure. If used rectally, local irritation can occasionally occur. If you experience any severe symptoms, contact your doctor immediately.

How often should I use Nifedipine 0.5% Rectal Ointment?

The dosing schedule for Nifedipine 0.5% Rectal Ointment should be determined by your healthcare provider. Typically, the ointment is applied two or three times per day.

Can Nifedipine 0.5% Rectal Ointment be used with other medications?

Before using other medications or topical treatments in combination with this ointment, it's crucial to discuss this with your healthcare provider, as there may be potential interactions.

Is Nifedipine 0.5% Rectal Ointment safe during pregnancy?

Always consult your healthcare provider before using Nifedipine 0.5% Rectal Ointment during pregnancy. The risks and benefits of the treatment will need to be evaluated on an individual basis.

How should I store Nifedipine 0.5% Rectal Ointment?

The ointment should be stored at room temperature, away from light and moisture, and out of reach of children and pets. Do not refrigerate or freeze the ointment.

What should I do if I miss a dose of Nifedipine 0.5% Rectal Ointment?

If you miss a dose, apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and proceed with your regular dosing schedule. Do not double up doses to make up for a missed one.

Can I use Nifedipine 0.5% Rectal Ointment if I have a history of heart problems?

Patients with a history of heart problems should consult their healthcare provider before using the ointment, as nifedipine can affect heart function and blood pressure.

What should I avoid while using Nifedipine 0.5% Rectal Ointment?

Avoid using other topical medications on the affected area unless your healthcare provider tells you to. Additionally, avoid activities that require alertness if you experience dizziness or lightheadedness after applying the ointment, as these could be side effects of the medication.

Can Nifedipine 0.5% Rectal Ointment be used long-term?

The duration of treatment with Nifedipine 0.5% Rectal Ointment should be determined by your healthcare provider based on your condition. Long-term use may be necessary for some patients, but regular follow-up with your doctor is important to assess the ongoing need for treatment and manage any side effects.

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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.