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Formulas

Sirolimus 1% Topical Cream

The Sirolimus 1% Topical Cream is a semisolid preparation intended for dermatological use. It is dispensed in a pump mechanism, which allows for convenient and controlled application directly to the skin. This formulation is designed for localized treatment and facilitates the absorption of sirolimus, the active ingredient, into the affected area. Sirolimus, a macrolide compound, is known for its immunosuppressive and antiproliferative properties. The cream is commonly used in the treatment of various disease states, including tuberous sclerosis complex-associated skin lesions, facial angiofibromas, and other dermatological conditions where sirolimus has been shown to be beneficial. Its use in these conditions helps to reduce lesion prominence and improve skin appearance.

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Topical Cream
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Formula Information

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Sirolimus 1% Topical Cream is a specialized medication formulated by the compounding pharmacists at Bayview Pharmacy to address specific dermatological conditions. Sirolimus, also known as rapamycin, is an immunosuppressant drug that has been found to have efficacy in treating various skin disorders due to its anti-proliferative and anti-inflammatory properties. This cream is compounded at a 1% concentration, ensuring a potent dose of the active ingredient is delivered directly to the affected area of the skin.

The cream is prepared as a semisolid dosage form, which allows for a smooth and uniform application. It is dispensed in a pump mechanism container, which is designed to provide patients with a convenient, hygienic, and controlled method of application. This packaging helps to prevent contamination of the product and ensures that the correct dose is administered each time, which is crucial for the effectiveness of the treatment and the safety of the patient.

Sirolimus 1% Topical Cream is used in the treatment of various skin conditions, such as psoriasis, atopic dermatitis, and cutaneous lupus erythematosus. It works by inhibiting the activation and proliferation of T-cells and other cells of the immune system that contribute to the inflammatory processes underlying these conditions. By doing so, sirolimus helps to reduce inflammation, itching, and the progression of the disease. Additionally, it has been investigated for its potential use in preventing skin cancer in high-risk patients, due to its ability to inhibit cell growth and proliferation.

Patients and prescribers should be aware that the use of Sirolimus 1% Topical Cream may be associated with certain side effects, such as local irritation, redness, or dryness of the skin. It is important to follow the prescribed regimen and monitor for any adverse reactions. As with any compounded medication, this formulation is tailored to meet the specific needs of individual patients, and it is essential to use it under the guidance of a healthcare professional.

For those interested in Sirolimus 1% Topical Cream or seeking more information about its use and suitability for specific conditions, please reach out to us at Bayview Pharmacy. Our team of expert compounding pharmacists is available to answer any questions and provide guidance on the best treatment options for your unique needs.

Drug Interactions

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Sirolimus, also known as rapamycin, is an immunosuppressive agent that is commonly used systemically to prevent organ transplant rejection and to treat certain rare lung diseases. When formulated as a 1% topical cream, sirolimus is primarily used for its anti-proliferative and immunomodulatory effects, which can be beneficial in treating various skin conditions such as psoriasis, atopic dermatitis, and cutaneous manifestations of tuberous sclerosis complex. However, even when applied topically, sirolimus has the potential to be absorbed systemically, and therefore, drug interactions must be considered to ensure patient safety and efficacy of treatment.

Patients and prescribers should be aware that sirolimus is metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme system and is also a substrate of the drug efflux pump P-glycoprotein (P-gp). Consequently, concomitant use of drugs that are strong inhibitors of CYP3A4 (such as ketoconazole, itraconazole, clarithromycin, and ritonavir) could increase systemic levels of sirolimus, potentially leading to an increased risk of adverse effects, including immunosuppression and increased susceptibility to infections. Conversely, drugs that are strong inducers of CYP3A4 (such as rifampin, carbamazepine, and phenytoin) may decrease systemic levels of sirolimus, potentially reducing its efficacy.

Similarly, drugs that inhibit P-gp, like verapamil and amiodarone, may increase sirolimus absorption and systemic exposure, while P-gp inducers, such as St. John's Wort, may decrease sirolimus levels. Additionally, sirolimus has been shown to increase the serum concentrations of certain other drugs, such as statins and calcium channel blockers, which could enhance or prolong their therapeutic and adverse effects. Therefore, monitoring for signs of toxicity or subtherapeutic effects of these drugs is recommended when used concurrently with sirolimus cream.

It is also important to consider the potential for additive immunosuppression when sirolimus is used with other systemic immunosuppressants, such as corticosteroids, tacrolimus, or cyclosporine. This could increase the risk of infections, including opportunistic infections, and lymphoma. Patients should be monitored closely for signs of infection and advised to report any unusual symptoms to their healthcare provider.

Given the complexity of drug interactions with sirolimus, prescribers are encouraged to review a patient's medication profile for potential interactions before prescribing sirolimus 1% topical cream. Pharmacists can play a key role in identifying and managing these interactions to optimize patient outcomes. If you have any questions or require further information regarding drug interactions with sirolimus 1% topical cream, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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Sirolimus 1% Topical Cream is a specialized medication formulated to deliver sirolimus, an immunosuppressant drug, directly to the affected skin areas. Sirolimus, also known as rapamycin, is a macrolide compound that has both antiproliferative and immunosuppressive properties. This cream is designed to be dispensed from a pump mechanism, which allows for a controlled and consistent dose with each application. The pump also helps to maintain the sterility and stability of the product.

The mechanism of action of sirolimus involves the inhibition of the mammalian target of rapamycin (mTOR), a key regulatory kinase. By inhibiting mTOR, sirolimus effectively blocks the activation of T cells and B cells by reducing their sensitivity to interleukin-2 (IL-2). This action prevents the proliferation of these cells, which is a central process in the immune response. As a result, sirolimus has a potent immunosuppressive effect, which is beneficial in preventing organ rejection in transplant patients and in treating certain autoimmune diseases.

In the context of dermatology, sirolimus 1% Topical Cream is used to treat skin conditions that benefit from its immunosuppressive and antiproliferative effects. For example, it has been used off-label for the treatment of psoriasis, a chronic autoimmune condition characterized by the overproduction of skin cells, leading to thick, scaly patches on the skin. Sirolimus helps to slow down the rapid growth of skin cells and reduce inflammation. Additionally, it has been used in the treatment of atopic dermatitis, tuberous sclerosis complex-associated skin lesions, and other dermatological conditions with an immunological basis.

When applied topically, sirolimus is absorbed into the skin, where it exerts its effects locally. This localized treatment minimizes systemic absorption and reduces the risk of systemic side effects commonly associated with oral or injectable forms of immunosuppressants. The cream base also provides a moisturizing effect, which can be soothing for irritated or inflamed skin.

It is important for patients and prescribers to understand that the use of sirolimus 1% Topical Cream should be guided by a healthcare professional experienced in its application and familiar with the patient's specific condition. The frequency and duration of treatment will vary depending on the severity and type of skin condition being treated. Patients should follow the prescribed regimen and report any adverse effects or concerns to their healthcare provider.

For more detailed information on sirolimus 1% Topical Cream, its application, and its role in treating various dermatological conditions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is ready to assist with any questions or concerns regarding this formulation.

Other Uses

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While Sirolimus 1% Topical Cream is primarily indicated for its immunosuppressive properties and the treatment of specific skin manifestations, such as those found in tuberous sclerosis complex and psoriasis, it is worth noting that research has suggested other potential uses for the active ingredient, sirolimus. Emerging evidence supports the idea that sirolimus, due to its mTOR inhibitory action, may have off-label dermatological applications including but not limited to the management of certain rare genetic skin disorders, cutaneous manifestations of systemic diseases, and complex skin neoplasms. For example, sirolimus has been explored in the context of angiofibromas, lymphangioleiomyomatosis, and Kaposi's sarcoma. It is essential to acknowledge that these uses are not as extensively studied or approved by regulatory agencies, and such off-label use should only occur under the guidance of a healthcare professional knowledgeable in treating skin disorders.

Moreover, sirolimus has anti-proliferative and anti-angiogenic effects that might be beneficial in cases of vascular anomalies and overgrowths, where abnormal cell growth and blood vessel formation are concerns. Researchers are actively examining the possibility of extending its use to other conditions that share pathophysiological pathways, potentially including more common disorders such as acne and rosacea. However, the effectiveness and safety profile for these conditions remain to be established through well-designed clinical trials.

The 1% preparation in a pump mechanism provides a measured dose with each use, ensuring consistency in the amount of the drug applied to the skin. This allows for better patient adherence, precise dosing, and potentially fewer adverse effects due to over-application. It may also facilitate use in a research setting where dosing accuracy is critical. Despite these benefits, it's crucial for prescribers and patients alike to be aware of sirolimus' potential systemic absorption, especially when applied to large surface areas or over damaged skin, which could theoretically lead to undesirable systemic effects typically associated with oral formulations of the drug.

In conclusion, the versatility of Sirolimus 1% Topical Cream stems from its mechanism of action. While not all of its potential uses are fully explored or endorsed in clinical guidelines, the scope of its application could be wider than its current FDA-approved indications. Prescribers should be vigilant about monitoring their patients for both efficacy and safety outcomes when using this cream for both labeled and off-label conditions. Should you have any questions or require further information regarding Sirolimus 1% Topical Cream and its uses, please feel free to reach out to us at Bayview Pharmacy. Our expert compounding pharmacists are ready to assist with patient education and support healthcare providers in optimizing treatment outcomes.

Frequently Asked Questions

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What is Sirolimus 1% Topical Cream used for?

Sirolimus 1% Topical Cream is used to treat various skin conditions that may benefit from its immunosuppressive and antiproliferative effects, such as certain dermatological disorders, tuberous sclerosis complex-associated lesions, and psoriasis. Always consult your healthcare provider for the specific condition it has been prescribed for.

How should I apply Sirolimus 1% Topical Cream?

To use Sirolimus 1% Topical Cream, press the pump to dispense a small amount on your fingertip and apply a thin layer to the affected area of the skin as directed by your healthcare provider. Wash your hands before and after applying the cream unless you are treating the skin on your hands.

Can I use this cream on any part of my body?

Sirolimus 1% Topical Cream is intended for external use only and should be applied as directed by your healthcare provider. Avoid contact with eyes, mouth, or mucous membranes, and do not apply on areas of the skin not specified in your treatment plan.

How often should I use Sirolimus 1% Topical Cream?

The frequency of application depends on your specific condition and the instructions provided by your healthcare provider. Typically, it is applied once or twice daily, but follow the prescribed regimen.

What should I do if I miss a dose?

If you miss a dose of Sirolimus 1% Topical Cream, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not apply extra cream to make up for a missed dose.

Are there any side effects with Sirolimus 1% Topical Cream?

As with any medication, Sirolimus 1% Topical Cream may cause side effects. Common side effects can include skin irritation, redness, itching, or dryness at the application site. If you experience any severe side effects, such as signs of systemic absorption or infection, contact your healthcare provider immediately.

How should I store Sirolimus 1% Topical Cream?

Store Sirolimus 1% Topical Cream at room temperature, away from light and moisture. Keep it out of reach of children and pets, and do not store in the bathroom.

Can I cover the treated area with bandages or dressings?

Do not cover the treated area with occlusive dressings or bandages unless advised by your healthcare provider, as this could alter the absorption of the medication.

How long will it take to see results after starting Sirolimus 1% Topical Cream?

The timeframe to see results may vary depending on your specific condition and how your skin responds to the medication. It is important to follow the treatment plan and have regular follow-up appointments with your healthcare provider to assess the effectiveness and make any necessary adjustments to your therapy.

Is Sirolimus 1% Topical Cream safe to use during pregnancy or breastfeeding?

The safety of Sirolimus 1% Topical Cream during pregnancy or breastfeeding has not been fully established. It is essential to inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding to determine if this medication is appropriate for you.

Can I use cosmetics or other skincare products while using Sirolimus 1% Topical Cream?

You may be able to use cosmetics or other skincare products; however, you should discuss this with your healthcare provider. They may recommend that you wait a certain amount of time after application of Sirolimus 1% Topical Cream before applying any other products to the treated area.

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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.