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Formulas

Nifedipine 0.2% Rectal Ointment

The Nifedipine 0.2% Rectal Ointment is a semi-solid formulation that is dispensed in a tube for rectal application. This ointment provides a greasy or oily base, which facilitates the localized delivery of the active ingredient, nifedipine. Nifedipine is a calcium channel blocker that, when formulated for rectal use, is effective in treating anal fissures by promoting smooth muscle relaxation and increasing blood flow to the affected area, thereby aiding in the healing process. This ointment is specifically designed for patients suffering from anal fissures and is applied externally to the perianal skin and within the anal canal to provide symptomatic relief and promote healing of the fissure.

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Nifedipine Hydrochloride
Topical Ointment
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Formula Information

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Nifedipine 0.2% 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 makes it particularly effective for treating anal fissures, which are small tears in the lining of the anus that can cause pain and bleeding during bowel movements. By increasing blood flow, nifedipine promotes healing of these fissures and alleviates symptoms such as pain and spasm of the surrounding muscular sphincter.

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 irritated tissues and promote a more comfortable healing environment. While primarily indicated for anal fissures, the properties of the ointment may also assist in the management of other localized conditions where improved blood flow could be beneficial, although its use in such conditions should be based on the advice of a healthcare professional.

For patients, it is important to follow the application instructions provided by the prescriber to ensure optimal treatment outcomes. The ointment should be applied as directed, usually in a small amount around the anal area. Patients should be advised to clean the area gently before application to prevent infection and to wash their hands thoroughly before and after applying the ointment. For prescribers, it is essential to consider the patient's overall health status and any concurrent medications to avoid potential drug interactions, particularly those that may affect blood pressure or cardiac function, given nifedipine's systemic effects when absorbed.

Our team at Bayview Pharmacy is committed to providing high-quality, customized medications to meet the unique needs of each patient. We are available to answer any questions or concerns regarding the formulation, its use, or its appropriateness for specific patients. We encourage both patients and healthcare providers to reach out to us for further information or clarification on the use of Nifedipine 0.2% Rectal Ointment or any other compounded medication needs.

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 0.2% rectal ointment, it is typically used off-label for the treatment of anal fissures due to its ability to promote blood flow and reduce muscle spasms. It is important to consider potential drug interactions when using nifedipine in any form, including as a rectal ointment.

Patients should be advised that nifedipine can interact with a variety of medications. Concurrent use with other antihypertensive agents or drugs that lower blood pressure, such as beta-blockers, ACE inhibitors, or diuretics, may result in an additive hypotensive effect. This could lead to symptoms such as dizziness, fainting, or an excessive decrease in blood pressure. It is crucial to monitor blood pressure when using nifedipine with these medications.

Additionally, nifedipine is metabolized by the liver enzyme CYP3A4. Drugs that inhibit this enzyme, such as ketoconazole, itraconazole, ritonavir, and certain macrolide antibiotics (e.g., erythromycin), can increase the concentration of nifedipine in the blood, potentially leading to an increased risk of side effects. Conversely, medications that induce CYP3A4, such as rifampin, phenytoin, carbamazepine, and St. John's Wort, may decrease the plasma concentration of nifedipine, reducing its efficacy.

Grapefruit juice is known to inhibit CYP3A4 and should be avoided while using nifedipine, as it can also increase the medication's blood levels and risk of side effects. Patients should be counseled on the importance of maintaining a consistent diet and avoiding grapefruit products.

Patients taking digoxin should be monitored closely, as nifedipine can increase serum digoxin levels, which may necessitate an adjustment in the digoxin dose to avoid toxicity. Similarly, those on tacrolimus or sirolimus could have increased levels of these immunosuppressants when used with nifedipine, requiring dose adjustments and monitoring of drug levels.

It is also important to note that while the systemic absorption of nifedipine from a rectal ointment is expected to be lower than from oral administration, systemic effects are still possible, especially in patients with compromised skin barriers or when applied to mucous membranes. Therefore, all potential drug interactions should be considered.

Patients should be instructed to inform their healthcare provider of all medications they are taking, including over-the-counter drugs, herbal supplements, and vitamins, to ensure safe use of nifedipine rectal ointment. Prescribers should review the patient's medication profile for potential interactions before prescribing this formulation and monitor for any adverse effects during treatment.

If you have any questions or require further information regarding the use of nifedipine 0.2% rectal ointment and potential drug interactions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to ensure the safe and effective use of this medication.

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 (chest pain). However, when formulated as a 0.2% 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 works locally to relax the smooth muscles of the anal sphincter. This relaxation can help to reduce 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 ointment base provides a protective barrier that not only aids in the delivery of the active medication but also helps to soothe the affected area.

The greasy or oily base of the ointment serves as a vehicle for the nifedipine, ensuring that the medication is released slowly and steadily at the site of application. This localized delivery system minimizes systemic absorption, which is particularly important for a medication that is typically used to treat systemic conditions such as hypertension. By applying the ointment directly to the perianal area, the nifedipine can act where it is needed most without significantly affecting blood pressure or causing the side effects that might be seen with oral administration.

For patients and prescribers considering the use of nifedipine 0.2% rectal ointment, it is important to understand that this formulation is specifically designed for topical use and should not be ingested. Patients should be instructed on proper application techniques to ensure the effectiveness of the treatment. The ointment is typically applied to the affected area two to three times daily, or as directed by a healthcare provider. It is also crucial to maintain good hygiene and avoid further irritation to the area being treated. As with any medication, there may be potential side effects, and patients should be advised to report any unusual symptoms to their healthcare provider.

While nifedipine 0.2% rectal ointment is not a cure for underlying conditions such as hypertension, it can provide significant symptomatic relief for those suffering from anal fissures and associated spasms. By improving blood flow and promoting muscle relaxation, this formulation can aid in the healing process and improve the quality of life for patients dealing with these painful conditions. If you have any questions or require further information about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy.

Other Uses

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Nifedipine, while primarily known for its use as an anti-hypertensive medication by causing vasodilation, has been repurposed for topical applications such as in the formulation of a 0.2% rectal ointment. This nifedipine ointment is specially compounded for rectal use to treat conditions such as anal fissures and chronic anal ulcers, which benefit from the vasodilation effect leading to increased blood flow, promoting healing and providing pain relief. However, beyond these common indications, the nifedipine ointment may have other off-label applications which can be explored under the guidance of a healthcare provider.

For instance, this nifedipine ointment may also be used in the management of other localized ischemic conditions where blood flow needs to be increased. In certain cases, such as with Raynaud's phenomenon affecting the nipples, often associated with breastfeeding, the application of a compounded nifedipine ointment has been reported to provide symptomatic relief due to its vasodilatory effects. Moreover, there has been anecdotal evidence that suggests the ointment may be beneficial for individuals with vasospastic disorders or conditions with poor peripheral circulation. However, the use in such conditions should be rigorously evaluated and closely monitored by a healthcare professional.

In some specialized scenarios, the compounding of nifedipine into a rectal ointment may also allow for the therapeutic benefits of topical nifedipine to be leveraged for off-label indications under the discretion of a prescriber. This can include the experimental treatment of other smooth muscle spasms or ailments in localized tissues where vasodilation may be therapeutic. It is crucial to note that such uses would be considered experimental and should be pursued only under professional medical advice and supervision. Additionally, prescribers should carefully consider the concentration of the nifedipine in the formulation to ensure that the dosing is appropriate for such off-label use.

Patients and prescribers interested in exploring these additional uses of nifedipine 0.2% rectal ointment should discuss the potential risks and benefits thoroughly. If there are any questions or the need for further guidance on the application or potential uses of this formulation, feel free to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is poised to provide educational support, share insights on best practices, and assist with any queries regarding the compounding process or the pharmacotherapeutic aspects of the nifedipine ointment.

It is paramount that both patients and prescribers strictly adhere to the prescribed instructions and remain vigilant for any adverse effects when using nifedipine in a topical form, especially when considering it for off-label uses. Monitoring for systemic effects, despite the localized application, is recommended due to the potential absorption through the skin. Always consult a healthcare professional before initiating the use of nifedipine ointment outside of its approved indications. Our pharmacists are ready to provide the necessary support and ensure that the compounded formulation meets the specific needs of the patient. With patient safety as our top priority, we are dedicated to maintaining a high standard of care in the compounding and dispensing of pharmaceutical products.

Frequently Asked Questions

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What is Nifedipine 0.2% Rectal Ointment used for?

Nifedipine 0.2% Rectal Ointment is used for the treatment of anal fissures, which are small tears in the skin around the anus. It helps to reduce pain and facilitate healing by relaxing the blood vessels, thus improving blood flow to the affected area.

How should Nifedipine 0.2% Rectal Ointment be applied?

The ointment should be applied externally to the anus. A small amount of ointment should be placed on the fingertip and gently applied to the affected area, usually twice a day or as directed by a healthcare professional.

Is Nifedipine 0.2% Rectal Ointment safe to use for a prolonged period?

Long-term safety depends on individual circumstances and the advice of a healthcare provider. It is essential to follow the prescribed duration of treatment and attend follow-up appointments to assess the progress of healing.

Can Nifedipine 0.2% Rectal Ointment cause side effects?

As with any medication, side effects can occur, although they may be rare with topical applications. Potential side effects may include mild irritation, itching, or a burning sensation at the application site. Notify your doctor if you experience any persistent or concerning symptoms.

Should the ointment be stored under certain conditions?

The ointment should be stored at room temperature, away from direct light and heat. Keep it out of reach of children and do not freeze the ointment unless specified by the manufacturer.

Can Nifedipine 0.2% Rectal Ointment interact with other medications?

Although unlikely with topical application, interactions can still occur. Always inform your healthcare provider about any other medications or supplements you are taking to avoid potential interactions.

Can pregnant or breastfeeding women use Nifedipine 0.2% Rectal Ointment?

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

What should be done in case of an accidental ingestion of the ointment?

If the ointment is accidentally ingested, seek immediate medical attention or contact a Poison Control Center. Keep the ointment out of reach of children to minimize the risk of accidental ingestion.

Is it possible to use the ointment after the expiration date?

No, using expired medication is not recommended. An expiration date is provided to ensure the effectiveness and safety of the medication. After the expiration date, the potency and safety of the ointment cannot be guaranteed.

Are there any restrictions on activities while using Nifedipine 0.2% Rectal Ointment?

There are typically no specific activity restrictions while using this ointment. However, it may be advisable to avoid activities that could result in the ointment being wiped away or spread to other areas, especially shortly after application. Baths, swimming, or intense physical activity should be timed to allow the ointment to be absorbed fully.

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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.