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Formulas

Ketoconazole 50 mg Oral Capsules

Ketoconazole 50 mg Oral Capsules are a solid dosage form consisting of two halves of either gelatin or vegetarian-based shells that encapsulate the medication. This design ensures the capsules are easy to swallow and provide an accurate dose of the active ingredient, ketoconazole. Ketoconazole is an antifungal agent used to treat a variety of fungal infections, including systemic mycoses such as candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. It is also used in the treatment of skin infections such as athlete's foot, ringworm, and jock itch, as well as dandruff and seborrheic dermatitis of the scalp.

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Ketoconazole
Capsules
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Formula Information

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Ketoconazole 50 mg Oral Capsules are a solid dosage form that consists of two halves of either gelatin or vegetarian-based shells, which are filled with the precise amount of the antifungal medication, ketoconazole. These capsules are designed to be easily swallowed, ensuring patient compliance and convenience. Ketoconazole is a broad-spectrum antifungal agent that works by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes. By disrupting the cell membrane formation, it effectively weakens the fungal cell, leading to its death and the resolution of the infection.

This formulation is particularly used in the treatment of various fungal infections, including but not limited to, systemic candidiasis, chronic mucocutaneous candidiasis, oral thrush, and some dermatophyte infections such as athlete's foot, jock itch, and ringworm. It may also be prescribed for more serious fungal infections when other treatments are not suitable or have failed. The 50 mg strength of the capsule allows for flexible dosing that can be adjusted according to the severity of the infection and the patient's response to the medication.

For prescribers, it is important to note that ketoconazole should be used with caution in patients with liver disease and those taking other medications, as it can cause serious interactions. Regular monitoring of liver function tests is recommended during the course of treatment. Patients should be advised to take the capsules with food to enhance absorption and to follow the prescribed regimen closely to ensure the best possible outcome. It is also crucial for patients to complete the full course of treatment, even if symptoms improve, to prevent the risk of recurrence or resistance.

Bayview Pharmacy is committed to providing high-quality compounded medications tailored to meet individual patient needs. Our team of expert compounding pharmacists is available to answer any questions and provide guidance on the use of Ketoconazole 50 mg Oral Capsules. We ensure that each batch of capsules is prepared with the utmost precision and care, adhering to strict pharmaceutical standards. If you have any questions or require further information about this formulation, please do not hesitate to reach out to us.

Drug Interactions

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Ketoconazole is an antifungal medication that works by interfering with the cell membrane formation of various fungi, thereby inhibiting their growth. It is commonly used to treat a variety of fungal infections, including those affecting the skin, nails, and systemic infections. As with any medication, ketoconazole can interact with a wide range of other drugs, potentially altering their effects or increasing the risk of adverse reactions.

One of the most significant interactions is with drugs that can affect the acidity of the stomach. For example, antacids, H2 blockers, and proton pump inhibitors can decrease the absorption of ketoconazole, leading to reduced efficacy. Therefore, it is recommended to take ketoconazole at least two hours before or one hour after these medications.

Ketoconazole is also known to interact with certain drugs metabolized by the liver enzyme CYP3A4. It can inhibit this enzyme, leading to increased blood levels of drugs such as cyclosporine, tacrolimus, certain statins (like simvastatin and atorvastatin), some benzodiazepines, and calcium channel blockers, among others. This can enhance the effects of these drugs and increase the risk of side effects. Conversely, drugs that induce CYP3A4, such as rifampin and certain anticonvulsants, can decrease the blood levels of ketoconazole, potentially reducing its effectiveness.

Additionally, ketoconazole can interact with blood thinners like warfarin, increasing the risk of bleeding. Close monitoring of prothrombin time or INR is necessary when patients are taking both medications. Ketoconazole can also increase the plasma concentrations of certain drugs that prolong the QT interval, such as certain antipsychotics, antiarrhythmics, and antibiotics, which can lead to an increased risk of serious cardiac events.

It is also important to note that ketoconazole can interact with alcohol, leading to a disulfiram-like reaction, which can cause symptoms such as flushing, rash, nausea, vomiting, and headache. Patients should be advised to avoid alcohol while taking ketoconazole capsules.

Patients should be counseled to inform their healthcare providers of all medications they are taking, including over-the-counter drugs, herbal supplements, and vitamins, to ensure that potential interactions with ketoconazole can be assessed and managed appropriately. Prescribers should review the patient's medication regimen in detail to avoid any harmful interactions and adjust dosages or medications as necessary.

If you have any questions or require further information regarding the interactions of ketoconazole 50 mg oral capsules, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the support and guidance needed to ensure safe and effective treatment.

How Does it Work

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Ketoconazole 50 mg oral capsules are a solid dosage form that consists of two halves of a shell, typically made from gelatin or a vegetarian alternative, which are filled with the precise amount of the active ingredient, ketoconazole. These capsules are designed to be easily swallowed, ensuring that the medication is delivered into the digestive system where it can be absorbed into the bloodstream. Once ingested, the capsule shell dissolves, releasing ketoconazole to exert its therapeutic effects.

Ketoconazole is an antifungal agent that works by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes. By disrupting the production of ergosterol, ketoconazole compromises the structural integrity of the fungal cell membrane, leading to leakage of cellular contents and ultimately the death of the fungal cell. This mechanism of action makes ketoconazole effective in treating a variety of fungal infections, including those affecting the skin, nails, and systemic infections such as candidiasis.

When prescribed as an oral capsule, ketoconazole is absorbed into the bloodstream and distributed throughout the body, reaching the site of infection where it can act directly on the pathogenic fungi. The 50 mg dosage provides a controlled quantity of the active ingredient, which is important for maintaining effective therapeutic levels while minimizing the risk of side effects. It is crucial for patients to adhere to the prescribed dosing schedule and to complete the full course of treatment, even if symptoms improve, to ensure the eradication of the infection and to prevent the development of resistance.

For prescribers, it is important to consider the potential interactions of ketoconazole with other medications, as it can affect the metabolism of certain drugs, potentially leading to increased levels and a higher risk of adverse effects. Additionally, prescribers should be aware of contraindications, such as liver disease or a history of hypersensitivity to ketoconazole, and should monitor patients for signs of liver toxicity or other adverse reactions during treatment.

Patients should be counseled on the importance of taking ketoconazole capsules with food to enhance absorption and to report any unusual symptoms or side effects to their healthcare provider promptly. It is also advisable for patients to avoid alcohol and certain medications that may interact with ketoconazole during treatment.

If you have any questions or require further information about ketoconazole 50 mg oral capsules or their use in treating fungal infections, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the support and guidance you need to ensure safe and effective treatment.

Other Uses

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Ketoconazole 50 mg oral capsules, a solid dosage form using two gelatin or vegetarian shells, are predominantly used in the management of various fungal infections. However, this antifungal agent has also been investigated and utilized for other indications beyond its primary use. For instance, based on its mechanism that interferes with steroid synthesis, ketoconazole capsules have been used as an off-label treatment for endocrine disorders such as Cushing's syndrome. In this condition, the drug helps in reducing the excessive production of cortisol. Moreover, due to its anti-androgenic properties, ketoconazole can be prescribed off-label for conditions like prostate cancer or hirsutism in females, where androgen levels play a significant role.

Another important use of ketoconazole capsules that is not directly related to fungal infections is their potential application in the management of certain skin conditions such as seborrheic dermatitis when other more common treatments are not suitable or have failed. Additionally, there is some evidence to suggest its effectiveness in treating parasitic infections, like leishmaniasis, though such use is not commonly encountered and would be considered experimental.

Given the wide-ranging potential applications of ketoconazole 50 mg oral capsules, it becomes imperative for prescribers to weigh the benefits against the risks, especially considering the possibility of hepatic toxicity which necessitates monitoring liver function tests during treatment with ketoconazole. If there is any uncertainty or specific clinical considerations to take into account, or if patients or prescribers have any questions about the off-label uses or specific aspects of this formulation, they are encouraged to reach out to the compounding pharmacists at Bayview Pharmacy for more detailed information and individualized advice.

Frequently Asked Questions

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What are Ketoconazole 50 mg Oral Capsules?

Ketoconazole 50 mg Oral Capsules are a solid dosage form that contains the antifungal medication ketoconazole. The capsules are made from either gelatin or vegetarian-based shells. These capsules are designed to be swallowed easily while ensuring patients receive the precise amount of active ingredient for their treatment.

How should I take Ketoconazole 50 mg Oral Capsules?

Take Ketoconazole 50 mg Oral Capsules as directed by your healthcare provider. Typically, the capsules should be swallowed whole with a glass of water and can be taken with or without food. However, it is best to follow the specific instructions provided with your prescription.

What are the potential side effects of Ketoconazole 50 mg Oral Capsules?

Common side effects may include nausea, headache, dizziness, stomach pain, and changes in liver enzyme levels. Contact your healthcare provider if you experience severe reactions, such as liver problems, allergic reactions, or severe skin reactions.

Can I open the capsule and sprinkle the contents on food?

It is not recommended to open Ketoconazole 50 mg Oral Capsules. Doing so can affect the medication's effectiveness and may alter its intended absorption profile. Always take the medication as prescribed by your doctor.

Are Ketoconazole Oral Capsules safe to take during pregnancy?

The safety of Ketoconazole 50 mg Oral Capsules during pregnancy has not been fully established. You should only take this medication while pregnant if your doctor considers it essential, and the benefits outweigh the potential risks.

Can I drink alcohol while taking Ketoconazole 50 mg Oral Capsules?

It is usually advised to avoid alcohol while taking Ketoconazole Oral Capsules, as alcohol can increase the risk of liver damage and may intensify side effects like dizziness.

How do I store Ketoconazole 50 mg Oral Capsules?

Store Ketoconazole 50 mg Oral Capsules at room temperature, away from light and moisture. Keep the capsules in their original packaging until it's time to take them, and keep them out of the reach of children and pets.

What should I do if I miss a dose of Ketoconazole 50 mg Oral Capsules?

If you miss a dose of Ketoconazole 50 mg Oral Capsules, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten capsule.

Can Ketoconazole Oral Capsules interact with other medications?

Yes, Ketoconazole Oral Capsules can interact with various medications, which can change how your medications work or increase your risk for serious side effects. Inform your healthcare provider of all medications you are currently taking, including prescriptions, over-the-counter products, and herbal supplements.

Are Ketoconazole 50 mg Oral Capsules available over the counter?

No, Ketoconazole 50 mg Oral Capsules are not available over the counter. This medication requires a prescription from a healthcare provider, as it is important to confirm the diagnosis and appropriate treatment for your condition.

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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.