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Formulas

Sirolimus 0.1 mg/g Topical Cream

The Sirolimus 0.1 mg/g 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 utilized for its immunosuppressive and antiproliferative properties. This particular concentration and dosage form is commonly used in the management of various dermatological conditions, including but not limited to, facial angiofibromas associated with tuberous sclerosis complex, psoriasis, and atopic dermatitis. The cream's vehicle is formulated to enhance the penetration of sirolimus, ensuring targeted action and minimizing systemic exposure.

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Sirolimus
Topical Cream
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Formula Information

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Sirolimus 0.1 mg/g Topical Cream is a specialized medication formulated by the compounding pharmacists at Bayview Pharmacy to deliver a precise dose of sirolimus, an immunosuppressant drug, directly to the affected skin areas. This cream is compounded in a semisolid form and is dispensed in a pump mechanism container, which ensures a consistent and controlled dose with each application. The pump mechanism is particularly beneficial for maintaining the sterility of the product and avoiding contamination, as well as for patient convenience and adherence to the treatment regimen.

Sirolimus, the active ingredient in this formulation, is traditionally known for its use in preventing organ transplant rejection. However, in a topical cream form at a concentration of 0.1 mg/g, sirolimus has been found to be effective in treating various dermatological conditions. This includes, but is not limited to, tuberous sclerosis complex (TSC)-associated angiofibromas, which are benign skin growths that can cause disfigurement and bleeding. Sirolimus works by inhibiting the mammalian target of rapamycin (mTOR) pathway, which is involved in cell growth and proliferation. By doing so, it can reduce the size and redness of these skin lesions. Additionally, sirolimus has shown promise in treating other skin conditions such as psoriasis and atopic dermatitis, where the mTOR pathway also plays a role in the inflammatory process.

For patients and prescribers considering Sirolimus 0.1 mg/g Topical Cream, it is important to note that the use of this medication should be guided by a healthcare professional with experience in managing dermatological conditions. The cream should be applied as directed, typically to clean, dry skin. Patients should be advised to wash their hands before and after applying the cream unless the hands are the treated area. Side effects can include local reactions such as itching, redness, or irritation at the application site. Systemic absorption is minimal with topical application, but patients should be monitored for any signs of systemic side effects, particularly if they are using the cream over large areas of the body or for extended periods.

As with any compounded medication, Sirolimus 0.1 mg/g Topical Cream is made to order based on a prescription and is not FDA-approved. However, the ingredients used in compounding are typically FDA-approved. It is essential that prescribers provide a comprehensive medical history and discuss the potential benefits and risks with their patients. If you have any questions or require further information about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is committed to providing high-quality, individualized care to meet the specific needs of each patient.

Drug Interactions

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Sirolimus, also known as rapamycin, is an immunosuppressive agent that is primarily used to prevent organ transplant rejection and to treat certain rare lung diseases. When formulated as a 0.1 mg/g topical cream, sirolimus is intended for localized treatment, potentially reducing systemic exposure and associated side effects. However, even when applied topically, sirolimus can be absorbed through the skin and may interact with other medications. It is important for both patients and prescribers to be aware of these potential interactions.

Sirolimus is a substrate of the cytochrome P450 3A4 (CYP3A4) enzyme and the P-glycoprotein (P-gp) efflux transporter. Consequently, concomitant use of drugs that are strong inhibitors of CYP3A4 and/or P-gp, such as ketoconazole, itraconazole, clarithromycin, and ritonavir, may increase the systemic absorption of sirolimus, potentially leading to increased sirolimus blood levels and a higher risk of adverse effects, including immunosuppression and increased susceptibility to infections and malignancies. Conversely, drugs that are strong inducers of CYP3A4 and P-gp, such as rifampin, carbamazepine, and phenytoin, may decrease sirolimus levels, reducing its efficacy.

Additionally, sirolimus has been shown to increase the serum concentrations of certain other drugs, particularly those with narrow therapeutic indices. For example, sirolimus may increase the levels of statins, which could elevate the risk of myopathy or rhabdomyolysis. It is advisable to monitor the patient's lipid profile and for signs of muscle pain or weakness when sirolimus is used in conjunction with statins.

Live vaccines should be avoided during treatment with sirolimus due to the potential for reduced vaccine efficacy and increased risk of infection. Patients should consult with their healthcare provider before receiving any vaccinations.

Grapefruit juice and other foods that inhibit CYP3A4 should also be avoided, as they may increase the systemic absorption of sirolimus from the topical cream. Patients should be advised to maintain a consistent diet and to discuss any dietary supplements or herbal products they are taking, as these may also interact with sirolimus.

It is crucial for patients to inform their healthcare providers of all medications they are currently taking, including over-the-counter drugs, prescription medications, and herbal supplements, to avoid potential drug interactions. Healthcare providers should closely monitor patients for sirolimus blood levels, kidney function, and signs of toxicity, adjusting the dose as necessary.

For any questions or concerns regarding the use of sirolimus 0.1 mg/g topical cream or its 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 safe and effective treatment for our patients.

How Does it Work

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Sirolimus, also known as rapamycin, is an immunosuppressive drug that is commonly used to prevent organ transplant rejection. However, in a topical formulation, such as the Sirolimus 0.1 mg/g Topical Cream, it serves a different purpose. When applied to the skin, sirolimus works by inhibiting the mammalian target of rapamycin (mTOR) pathway, which is a key regulator of cell growth, proliferation, and survival. By doing so, it can reduce the proliferation of certain skin cells and has anti-inflammatory and antiproliferative effects. This makes it useful in treating various dermatological conditions.

The Sirolimus 0.1 mg/g Topical Cream is specifically designed to deliver a controlled dose of sirolimus to affected areas of the skin. The cream is formulated to ensure that sirolimus is adequately absorbed through the skin to exert its local effects. The semisolid preparation is dispensed in a pump mechanism, which allows for precise dosing and helps to prevent contamination of the product. This method of application is not only convenient but also ensures that the medication is applied consistently and evenly.

This topical cream is particularly beneficial in treating disease states such as tuberous sclerosis complex (TSC)-associated skin lesions, which include facial angiofibromas, and other conditions like psoriasis or atopic dermatitis where the mTOR pathway is implicated. In TSC, for example, sirolimus helps to reduce the size and redness of angiofibromas by targeting the overactive mTOR pathway in the skin, leading to an improvement in the appearance and symptoms associated with these lesions.

For patients and prescribers considering the use of Sirolimus 0.1 mg/g Topical Cream, it is important to understand that while the systemic absorption of sirolimus from topical application is minimal, the drug should still be used with caution, especially in patients with a history of systemic exposure to sirolimus or similar drugs. Regular monitoring and follow-up with a healthcare provider are recommended to assess the efficacy and safety of the treatment. Additionally, patients should be instructed on the proper use of the pump mechanism to ensure they are applying the correct dose.

If you have any questions about the Sirolimus 0.1 mg/g Topical Cream or its use in specific disease states, 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 make informed decisions about your treatment options.

Other Uses

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Sirolimus, often recognized for its potent immunosuppressive and antiproliferative properties, is typically used systemically to prevent organ transplant rejection. In the topical formulation at a concentration of 0.1 mg/g, it acts with more localized effect. Beyond its use in immunosuppression, topical sirolimus has shown potential in a variety of dermatological conditions due to its inhibitory action on mTOR (mammalian target of rapamycin) signaling pathway, which plays a role in cell growth, proliferation, and survival. For instance, patients suffering from facial angiofibromas, which are commonly associated with tuberous sclerosis, may benefit from the application of sirolimus cream with improvements in lesion appearance. This may also be relevant for the treatment of other benign tumors such as lymphangioleiomyomatosis, particularly due to its anti-proliferative effects on smooth muscle cells.

Furthermore, the modulation of the mTOR pathway by sirolimus has been explored as a therapeutic option in several cutaneous diseases, including but not limited to psoriasis, atopic dermatitis, and cutaneous lupus erythematosus. In these disease states, sirolimus aids by dampening the overactive immune responses and abnormal cell proliferation. Additionally, initial studies have suggested potential benefits in vascular anomalies such as Kaposi sarcoma, and in certain rare genetic skin diseases like pachyonychia congenita, although more research is warranted for conclusive evidence.

Another intriguing research avenue includes the utilization of topical sirolimus for its anti-aging effects on the skin. Given its action on cellular pathways that are implicated in the aging process, such as the reduction of cellular senescence and promotion of autophagy, sirolimus could potentially be used to address skin aging concerns, although this is a relatively novel use and would require further clinical investigation before being recommended broadly.

We advise prescribers and patients to note that off-label uses of sirolimus topical cream should be approached with consideration of the existing evidence and under the guidance of a healthcare professional experienced in its use. As with any medication, potential risks and benefits should be evaluated on an individual basis. For detailed information about this formulation and potential other uses, professional consultation, or any questions regarding this specialty medication, please reach out to us at Bayview Pharmacy.

Frequently Asked Questions

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What is Sirolimus 0.1 mg/g Topical Cream used for?

Sirolimus 0.1 mg/g Topical Cream is used for the treatment of various skin conditions that may benefit from its immunosuppressive and antiproliferative properties. It's commonly used for specific skin diseases that your physician will determine based on your medical history and current health status.

How should Sirolimus 0.1 mg/g Topical Cream be applied?

This topical cream should be applied directly to the affected area of the skin as prescribed by your healthcare provider. The cream is dispensed from a pump mechanism, allowing for controlled application. It's important to follow your healthcare provider's instructions regarding the amount of cream to apply and the frequency of application.

What is the pump mechanism for, and how do I use it correctly?

The pump mechanism is designed for convenient and controlled dispensing of the cream, ensuring that you get a consistent dose every time. To use it correctly, prime the pump as directed in the instructions, then press down on the pump to dispense the prescribed amount of cream. If you have any difficulty, refer to the instructions provided with the product or consult your pharmacist.

Are there any side effects associated with Sirolimus 0.1 mg/g Topical Cream?

As with any medication, there can be side effects. Common side effects may include irritation, redness, or itching at the site of application. If these persist or worsen, or if you experience any severe reactions, it's important to contact your healthcare provider immediately.

Can I use Sirolimus 0.1 mg/g Topical Cream with other medications?

Before using this cream with other medications, it's crucial to discuss with your healthcare provider or pharmacist. Some medications may interact with sirolimus, potentially altering its effectiveness or causing adverse effects.

How often should I apply Sirolimus 0.1 mg/g Topical Cream?

The frequency of application will be determined by your healthcare provider based on your condition. Always adhere to the prescribed regimen and do not apply more often than instructed.

Should I cover the treated area with a bandage after applying the cream?

Do not cover the treated area with a bandage or any other occlusive dressing unless advised by your healthcare provider, as this may alter the absorption of the active ingredient.

How should the Sirolimus 0.1 mg/g Topical Cream be stored?

Store the cream at room temperature away from direct sunlight and heat. Keep the container tightly closed when not in use. Be sure to refer to the storage instructions on the product label or package insert for any specific requirements.

Can Sirolimus 0.1 mg/g Topical Cream be used on open wounds?

No, it is not recommended to use this cream on open wounds. Sirolimus 0.1 mg/g Topical Cream should only be applied to intact, unbroken skin unless otherwise directed by your healthcare provider.

What should I do if I miss a dose of Sirolimus 0.1 mg/g Topical Cream?

If you miss a dose, 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 double the application to make up for a missed dose.

Is Sirolimus 0.1 mg/g Topical Cream suitable for children?

The suitability of Sirolimus 0.1 mg/g Topical Cream for children depends on specific conditions and should be determined by a healthcare provider. It is important to follow the provider's guidance regarding use in pediatric populations.

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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.