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  • Manufacturer ASPIN PHARMACEUTICALS (PVT.) LTD.
  • Generic Name

    Ketoconazole

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Description

    Ketoconazole, a synthetic antifungal drug, exerts its mechanism of action primarily by inhibiting the synthesis of ergosterol, a crucial component of fungal cell membranes. It selectively binds to fungal cytochrome P450 enzymes, particularly lanosterol 14α-demethylase, which is essential for converting lanosterol to ergosterol. By blocking this enzyme, ketoconazole disrupts the fungal cell membrane structure and function, leading to impaired membrane permeability, inhibition of fungal growth, and ultimately, fungal cell death. This selective inhibition of fungal sterol synthesis makes ketoconazole effective against a range of fungal pathogens while minimizing effects on human cells, which do not produce ergosterol.

  • Ingredients

    Ketoconazole

  • Drug Class

    Antifungal, imidazole derivative.

  • Dosage Form

    Tablet

  • Uses

    The following are the uses of Ketoconazole Tablet:

    • Used for treating fungal infections, especially those affecting the skin, hair, and nails.
    • Used for controlling dandruff and seborrheic dermatitis by reducing the growth of fungi on the scalp.
    • Used for treating pityriasis, a type of skin infection that causes scaly patches.
    • Used for managing fungal infections in the body, such as those affecting the lungs or other internal organs.
    • Used for preventing the recurrence of certain fungal infections in susceptible individuals.
    • Used for treating fungal infections in immunocompromised patients to improve their quality of life.
    • Used for addressing fungal-related hair loss or hair thinning in some cases.
  • In case of Overdose

    In the case of an overdose of Ketoconazole Tablets, it is important to seek medical advice promptly. Symptoms of an overdose may include nausea, vomiting, diarrhea, and dizziness. Do not induce vomiting; instead, contact a healthcare professional or a poison control center for guidance. They will provide specific instructions for managing the overdose, which may include monitoring vital signs and providing supportive care to ensure the individual's well-being.

  • Missed Dose

    In the case of a missed dose of Ketoconazole Tablet, it is important to take the medication as soon as you remember. However, 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 missed one, as this may increase the risk of side effects. If you miss multiple doses, contact your healthcare provider for advice on how to proceed, as they may recommend adjusting your dosage or provide specific instructions for catching up on missed doses safely.

  • How To Use

    To take Ketoconazole Tablets, swallow the tablet whole with a full glass of water, preferably with a meal or as directed by your healthcare professional, ensuring you follow the prescribed dosage and duration provided by your doctor.

  • When Not to Use

    Here are the circumstances when Ketoconazole Tablet should not be used:

    • Avoid using if you have a known allergy to Ketoconazole or other azole antifungal medications.
    • Not suitable for individuals with severe liver disease.
    • Should not be used if you have a history of prolonged QT interval or heart rhythm disorders.
    • Contraindicated in patients with adrenal gland problems, as it can lead to adrenal insufficiency.
    • Do not use if you have a rare hereditary condition known as porphyria.
    • Not recommended for individuals with a history of depression, as it can worsen the symptoms.
    • Avoid using Ketoconazole if you are taking certain medications that interact with it, such as warfarin, phenytoin, or oral hypoglycemic agents.
    • Should not be used during pregnancy or breastfeeding, unless the potential benefits outweigh the risks.
    • Not suitable for children, as the safety and efficacy have not been established in pediatric patients.
    • Avoid using if you have a history of alcohol abuse or liver problems caused by alcohol.
  • Side Effects

    The side effects of Ketoconazole Tablet may include:

    • Nausea and vomiting.
    • Diarrhea or constipation.
    • Abdominal pain.
    • Headache.
    • Dizziness or lightheadedness.
    • Skin rashes or itching.
    • Dark-colored urine.
    • Fatigue or weakness.
  • Precautions & Warnings

    Following are the precautions and warnings for Ketoconazole Tablet:

    • Not suitable for individuals with a known allergy to ketoconazole or related azole medications.
    • Requires caution in patients with liver disease, as it can affect liver function and regular monitoring is necessary.
    • May cause adrenal gland problems, so patients with a history of adrenal insufficiency or those at risk should be monitored closely.
    • Should be used with caution in patients with a history of heart disease, as it may affect heart rhythm.
    • Elderly patients may be more susceptible to side effects, particularly adrenal and liver-related issues.
    • Not recommended for children unless prescribed by a doctor, as safety and efficacy in pediatric patients is not well-established.
    • Pregnant and breastfeeding women should consult their healthcare provider before taking Ketoconazole, as it may have potential risks to the fetus or infant.
  • Drug Interactions

    Following are the drug interactions for Ketoconazole Tablet:

    • Concomitant use with drugs metabolized by CYP3A4 can lead to increased levels of these drugs, such as cisapride, pimozide, quinidine, and ergot alkaloids, which may result in serious adverse effects.
    • The tablet can increase concentrations of HMG-CoA reductase inhibitors (statins), potentially raising the risk of statin-related myopathy/rhabdomyolysis.
    • Anticoagulants like warfarin may have enhanced effects when used with Ketoconazole, requiring close monitoring of coagulation parameters.
    • The risk of QT interval prolongation and arrhythmias is increased when combined with other drugs that prolong the QT interval.
    • Drugs that lower gastric acidity, such as proton pump inhibitors (PPIs), can reduce Ketoconazole absorption, decreasing its effectiveness.
    • Ketoconazole may increase the blood levels of calcium channel blockers, leading to enhanced effects and potential side effects.
    • Caution is advised with other drugs that affect the central nervous system, as Ketoconazole can cause drowsiness and may enhance these effects.
  • Food Interactions

    Following are the food interactions for Ketoconazole Tablet:

    • Grapefruit and grapefruit juice consumption should be avoided as they can increase Ketoconazole levels in the blood, potentially leading to increased side effects.
    • Alcohol intake is not recommended as it may reduce the effectiveness of Ketoconazole and increase the risk of liver-related issues.
    • Avoid high-fat meals as they can decrease the absorption of Ketoconazole, reducing its effectiveness.
    • Ketoconazole may interact with vitamin A, so consult your doctor before taking any supplements.
    • Avoid natural licorice as it can affect the potassium levels in your body, which Ketoconazole may also influence.
    • Limit caffeine intake as Ketoconazole can slow down the metabolism of caffeine, leading to increased side effects like nervousness and rapid heartbeat.
    • Be cautious with foods containing tyramine (aged cheeses, cured meats) as Ketoconazole may interact, causing potential blood pressure issues.
    • Always follow the advice of your healthcare provider regarding dietary restrictions and interactions.
  • Storage/Disposal

    Ketoconazole Tablets should be stored in a cool and dry place, preferably at room temperature, away from direct exposure to sunlight, heat, and moisture. The original container should be used to protect the tablets from contamination and maintain their integrity. It is crucial to keep the medication away from children to prevent accidental ingestion. Always check the expiration date before using the tablets, and do not use them if they have expired. For proper disposal, do not flush the tablets or throw them into the trash. Instead, consult your pharmacist or local waste management guidelines for safe and environmentally friendly disposal methods. Responsible storage and disposal practices help ensure the effectiveness of the medication and minimize potential risks.

  • Quick Tips, if any

    Following are the quick tips for Ketoconazole Tablet:

    • Take the tablet as directed by your doctor, typically with a full meal.
    • Swallow the tablet whole without crushing or chewing for optimal absorption.
    • Avoid grapefruit and grapefruit juice while taking this medication.
    • Maintain a consistent medication schedule for better results.
    • Do not increase or decrease the dosage without medical advice.
    • Inform your doctor about all the medications you are taking to prevent potential drug interactions.
    • Store the tablets in a cool, dry place, away from direct sunlight and moisture.

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