PHYTORAL 200MG

# Ketoconazole 200 mg ## SHORT DESCRIPTION Ketoconazole 200 mg is an **azole antifungal medicine** used to treat certain serious fungal infections when appropriate alternatives are not suitable. It works by interfering with the production of **ergosterol**, an essential component of fungal cell membranes. **Important:** Oral ketoconazole tablets have significant risks of **serious liver injury, adrenal insufficiency and potentially dangerous drug interactions**. In many settings, oral ketoconazole is reserved for specific situations where other effective antifungal treatments are unavailable or not tolerated. ## KEY BENEFITS * Helps treat certain **serious systemic fungal infections** * Interferes with fungal cell membrane formation * Provides antifungal activity against susceptible fungi * May be considered when alternative antifungal treatments are unsuitable * Oral formulation provides systemic antifungal exposure ## USES / INDICATIONS Ketoconazole 200 mg tablets may be used in selected patients for certain fungal infections when other appropriate treatments are unavailable, not tolerated or unsuitable. Depending on clinical circumstances, it may be considered for: * Certain systemic fungal infections * Certain difficult-to-treat fungal infections * Selected infections caused by susceptible yeasts or fungi **Oral ketoconazole should not routinely be used for common superficial fungal infections when safer topical or systemic alternatives are available.** Ketoconazole 200 mg tablets should be prescribed only after careful consideration of the benefits and risks. ## HOW IT WORKS Ketoconazole inhibits the fungal enzyme **lanosterol 14-alpha-demethylase**, which is involved in the production of ergosterol. Ergosterol is an important component of fungal cell membranes. By reducing ergosterol production, ketoconazole disrupts fungal cell membrane structure and function, inhibiting fungal growth. Ketoconazole also inhibits certain human steroid-producing enzymes, which contributes to some of its clinically important adverse effects and drug interactions. ## DOSAGE & ADMINISTRATION * Take Ketoconazole 200 mg **only as prescribed by your doctor**. * The dose and duration depend on the type and severity of the fungal infection. * Oral ketoconazole dosing must be individualized because of its potential for serious toxicity. * Take the tablet according to the specific product instructions. * Swallow with water. * Do not exceed the prescribed dose. * Do not self-medicate with oral ketoconazole. * Your doctor may require **liver-function tests and other monitoring** before and during treatment. ### Missed Dose Take the missed dose when remembered unless it is nearly time for the next dose. Do not take two doses together. ## SIDE EFFECTS Common or possible side effects include: * Nausea * Vomiting * Abdominal discomfort * Headache * Diarrhea * Dizziness * Itching or skin rash ### Serious Side Effects Seek immediate medical attention if you experience: * **Yellowing of the skin or eyes** * Dark urine * Pale stools * Severe or persistent nausea * Severe abdominal pain * Unusual tiredness or weakness * Loss of appetite * Fainting or severe dizziness * Irregular or rapid heartbeat * Severe allergic reaction * Swelling of the face, lips or throat * Difficulty breathing Oral ketoconazole can rarely cause **serious and potentially fatal liver injury**. ## PRECAUTIONS & WARNINGS * **Serious liver injury:** Oral ketoconazole can cause severe hepatotoxicity, including liver failure and death in rare cases. * Your doctor may check liver function before and during treatment. * Avoid unnecessary alcohol consumption because alcohol can increase the burden on the liver. * Tell your doctor if you have current or previous **liver disease**. * Ketoconazole can inhibit adrenal steroid production and may cause **adrenal insufficiency**. * Symptoms of adrenal insufficiency may include unusual weakness, dizziness, low blood pressure, nausea and vomiting. * Ketoconazole can cause **QT prolongation**, potentially resulting in dangerous heart rhythm abnormalities. * Tell your doctor if you have heart rhythm problems or a history of prolonged QT interval. * Many medicines interact with oral ketoconazole because it strongly inhibits the **CYP3A4 enzyme**. * Tell your doctor about every medicine, supplement and herbal product you take. * Seek medical advice if severe rash or allergic symptoms occur. * Tell your doctor if you are pregnant, planning pregnancy or breastfeeding. * Oral ketoconazole should generally be avoided for minor fungal infections when safer alternatives are available. ## DRUG INTERACTIONS Ketoconazole has **many clinically important drug interactions**. Examples include: * Certain **statins**, such as simvastatin and lovastatin — increased risk of serious muscle toxicity. * Certain **benzodiazepines** — increased sedation and respiratory depression may occur. * Certain medicines affecting **heart rhythm** — increased risk of QT prolongation and dangerous arrhythmias. * Some anticoagulants — anticoagulant effects may be altered. * Certain calcium-channel blockers — concentrations and adverse effects may increase. * Certain immunosuppressants — drug concentrations can rise significantly. * Some oral diabetes medicines — blood glucose effects may be altered. * Certain antipsychotic medicines — increased adverse-effect risk. * Some antiarrhythmic medicines — potentially serious cardiac interactions. * **Rifampicin, rifabutin and certain enzyme-inducing medicines** can substantially reduce ketoconazole concentrations and effectiveness. * Acid-reducing medicines may affect absorption depending on the formulation. Because the interaction list is extensive, **do not start, stop or change another medicine while taking oral ketoconazole without consulting your doctor or pharmacist.** ## STORAGE INFORMATION * Store according to the manufacturer's instructions. * Keep tablets in their original packaging. * Store at the recommended room temperature. * Protect from excessive heat, moisture and direct sunlight. * Keep the medicine out of reach of children. * Do not use after the expiry date. * Do not use tablets if the packaging is damaged. ## PRESCRIPTION STATUS **Prescription medicine.** Ketoconazole 200 mg tablets should be used only under the supervision of a qualified healthcare professional because of the risk of serious liver injury, adrenal effects and potentially dangerous drug interactions. ## GENUINE MEDICINE ASSURANCE For safe and genuine Ketoconazole 200 mg: * Purchase only from a licensed and reputable pharmacy. * Check the medicine name and strength. * Verify the manufacturer's information. * Check the batch number and expiry date. * Ensure the packaging and seal are intact. * Do not use products with damaged or suspicious packaging. * Avoid purchasing prescription medicines from unauthorized sources. * Consult a pharmacist if you have concerns about product authenticity. ## FAQ ### What is Ketoconazole 200 mg used for? Ketoconazole 200 mg tablets may be used for certain **serious fungal infections** when other suitable antifungal treatments are unavailable, unsuitable or not tolerated. ### Is Ketoconazole 200 mg an antifungal medicine? Yes. Ketoconazole is an **azole antifungal medicine**. ### How does Ketoconazole work? Ketoconazole blocks fungal ergosterol production, disrupting the fungal cell membrane and inhibiting fungal growth. ### Is oral Ketoconazole safe? Oral ketoconazole can cause **serious liver injury and potentially dangerous drug interactions**. It should only be used when the expected benefits outweigh the risks and when appropriate alternatives are unsuitable. ### Is Ketoconazole 200 mg used for skin fungal infections? Oral ketoconazole is generally **not the preferred treatment for routine skin fungal infections** because safer alternatives are available. Topical ketoconazole may be used for certain superficial fungal conditions. ### Can Ketoconazole treat ringworm? Topical antifungal treatment is generally preferred for uncomplicated ringworm. Oral ketoconazole should not be self-used for ringworm and is generally avoided when safer alternatives are available. ### Can Ketoconazole treat dandruff? Ketoconazole **shampoo or topical preparations** may be used for dandruff and seborrheic dermatitis. Oral Ketoconazole 200 mg tablets are not routinely used for ordinary dandruff. ### What are the major side effects of oral Ketoconazole? Important adverse effects include **liver injury, nausea, abdominal discomfort, adrenal insufficiency and heart rhythm abnormalities**. ### Can Ketoconazole damage the liver? Yes. Oral ketoconazole can cause serious, potentially life-threatening **liver injury**. Contact your healthcare professional immediately if you develop jaundice, dark urine, severe fatigue or persistent nausea. ### Does Ketoconazole affect the heart? It can. Oral ketoconazole may prolong the **QT interval** and increase the risk of serious abnormal heart rhythms, particularly when combined with certain medicines. ### Can Ketoconazole affect hormones? Yes. Ketoconazole can inhibit steroid production and may affect adrenal and other hormone pathways. This is one reason oral treatment requires medical supervision. ### Can I drink alcohol while taking Ketoconazole 200 mg? It is advisable to avoid alcohol unless your healthcare professional says otherwise because both alcohol and ketoconazole can affect the liver. ### Can Ketoconazole be taken during pregnancy? Do not take oral ketoconazole during pregnancy unless specifically prescribed after your doctor has assessed the benefits and risks. ### Can Ketoconazole be taken while breastfeeding? Discuss breastfeeding with your doctor before using oral ketoconazole. Your healthcare professional will determine whether treatment is appropriate. ### Can Ketoconazole be taken with other medicines? Ketoconazole has **numerous drug interactions**. Always provide your doctor or pharmacist with a complete list of medicines, supplements and herbal products you use. ### Can I take Ketoconazole with antacids? Medicines that reduce stomach acidity can affect the absorption of some oral ketoconazole formulations. Ask your pharmacist or doctor how to take them safely together. ### What should I do if I miss a dose? Take the missed dose when remembered unless it is almost time for the next dose. Do not double the next dose. ### What happens if I take too much Ketoconazole? An overdose can increase the risk of adverse effects. Seek medical advice promptly if you have taken more than the prescribed amount. ### How long does Ketoconazole take to work? The time required depends on the type and severity of the fungal infection. Your healthcare professional will determine the appropriate treatment duration. ### Is Ketoconazole 200 mg available without a prescription? Oral Ketoconazole 200 mg is generally a **prescription medicine** and should only be used under medical supervision. ### How should Ketoconazole 200 mg be stored? Store it according to the manufacturer's instructions, generally at room temperature away from excessive heat and moisture. Keep it in its original packaging and out of reach of children. ## MEDICAL DISCLAIMER This information is provided for educational and informational purposes only and does not replace professional medical advice, diagnosis or treatment. **Oral Ketoconazole 200 mg has significant safety risks and should not be self-medicated.** It can cause serious liver injury, adrenal insufficiency, QT prolongation and potentially dangerous interactions with numerous medicines. Your healthcare professional should determine whether oral ketoconazole is appropriate and may require liver-function and other monitoring during treatment. Seek urgent medical attention for jaundice, severe weakness, fainting, irregular heartbeat, severe allergic reactions or other serious symptoms. Always follow the specific product label and your healthcare professional's instructions.