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Nizoral is an Azole antifungal treatment that works by destroying the cell walls and critical enzymes of yeast and other fungal infectious agents. Nizoral also decreases testosterone levels (making it useful in treating prostate cancer), and reduces production of excessive adrenal corticosteroid hormones (making it useful for Cushing's syndrome.) This treatment may be hard on the liver, and can cause dangerous buildups of certain drugs if used in combination. Use exactly as recommended by your doctor.

This drug is approved to treat the following conditions: Blastomycosis (lung and systemic), Candida (yeast) infections of the skin and digestive tract, Candida infections of the internal organs, Chromomycosis, Coccidioidomycosis (lung and systemic), fungal dandruff (topical form), Histoplasmosis (lung and systemic), Paracoccidioidomycosis, Tinea infections (athlete's foot, jock itch), and Tinea versicolor.

Nizoral may also be used for certain other conditions that physicians have found it useful in treating: Candida (yeast) infections of the vagina and vulva, Cushing's syndrome (excess adrenal hormones), febrile neutropenia, fungal infections in newborns, fungal pneumonia, fungal septicemia, fungal toenail infections, hirsutism, prostate cancer (short-term treatment), ringworm (beard, hand, scalp), systemic sporotrichosis, and visceral leishmaniasis.

Nizoral is only available by prescription.

Nizoral Side Effects

Occasional Side Effects: Headache, mild fatigue, nausea, vomiting.

Rare Side Effects: Breast swelling (men), depression, diarrhea, dizziness, drowsiness, impotence, light-sensitivity, menstrual irregularities.

Serious Side Effects: Allergic reaction (blisters, hives, itching, peeling, rash, reddened skin or mucous membranes), dark or amber urine, fever & chills, severe fatigue or weakness, pale stools, stomach pain, unusual bleeding or bruising, yellow eyes or skin (jaundice). If any of these unusual effects occur, speak to your doctor immediately.

Cautions: Nizoral (ketoconazole) is not suitable for everyone. Speak with your doctor if you have a history of any of the following conditions to make sure that your treatment is safe and effective.

• Alcoholism: If you suffer from untreated alcoholism, you should not use this medication as life-threatening damage to the liver may be sustained when this medication is mixed with acohol.
• Allergy: Allergic reactions to this medication indicate that you should not use it. Rarely, the first dose of Nizoral can cause a life-threatening anaphylactic reaction. If you should have a severe reaction from this treatment, seek emergency care immediately.
• Adrenal Gland Conditions: A history of adrenal insufficiency may affect your treatment regimen, and your doctor will need to make an individual recommendation based on your situation.
• Anemia or Low Platelet Count: This condition could be made worse.
• Liver Disease: Any active liver conditions are a contraindication for treatment with this class of antifungals.
• Low Stomach Acid: You may have difficulty absorbing this medication.
• Other Medications: Do not combine this treatment with Halcion (triazolam), Hismanal (astemizole), Propulsid (cisapride), or Viagra (sildenafil).

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This medication should not be mixed with all prescription or over the counter treatments, or certain adjustments may have to be made to dosage or scheduling to ensure that treatment remains safe and effective. Be sure to ask your doctor or pharmacist before starting any new treatment, and make sure that your prescribing physician always has an updated list of the medications you are currently taking.

• Alcohol - Do not combine. Toxic side effects and liver damage may result.
• Aldomet (Methyldopa) - Increases risk of liver damage.
• Amphotericin B - May be less effective when used with ketoconazole.
• Anabolic steroids or Androgens (male hormones) - Increases risk of liver damage.
• Antabuse (disulfiram) - Increases risk of liver damage.
• Antacids (all types) - Take two hours after ketoconazole, these drugs may interfere with absorption.
• Antibiotics (several) - Speak to your doctor to be sure that no dangerous or undesirable reaction will occur if you should need antibiotic treatment during your ketoconazole therapy.
• Anticonvulsants such as Cerebyx (fosphenytoin), Dilantin (phenytoin), Sinemet (carbidopa, levodopa), or Tegretol (carbamazepine) may have their blood levels altered by ketoconazole. The valproic acid preparations Depakote and Depakene may increase the risk of liver damage.
• Antidiabetic medications (oral) - Extremely low blood sugar may result.
• Antihistamines (minimally sedating) - Medications like Allegra (fexofenadine) and Claritin (loratadine) may build up in the body when taken in combination with antifungal medication. Your doctor may suggest a lowered dose.
• Antihistamines (nonsedating) - Medications like Hismanal (astemizole) and Seldane (terfenadine, no longer available in US) may build up in the body to dangerous levels, possibly resulting in serious heart problems. Never combine these treatments.
• Antithyroid treatments - Increases risk of liver damage.
• Aralen (chloroquine) - Increases risk of liver damage.
• Benzodiazepines (a class of antidepressants, anti-panic agents, sleep medications, and muscle relaxants) such as Ativan (lorazepam), Dalmane (flurazepam), Valium (diazepam), Halcion (triazolam), Librium (chlordiazepoxide), Restoril (temazepam), Xanax (alprazolam), Tranxene-SD (clorazepate), Paxipam (halazepam), ProSom (estazolam), Klonopin (clonazepam), and others, may build up in the body, increasing the chance of oversedation or other undesirable side effects.
• BiCNU (carmustine) - Increases risk of liver damage.
• Bronchodilators of the xanthine (thioxanthine) class (Aminophylline, Dyphylline, Oxtriphylline, Somophyllin, Theo-Dur, etc...) - These medications may be less effective.
• Calcium channel blockers - Medications like Bepadin (bepridil), Calan (verapamil), Cardene (nicardipine), Cardizem (diltiazem), DynaCirc (isradipine), Norvasc (amlodipine), Nimotop (nimodipine), Plendil (felodipine), Procardia (nifedipine), or Sibelium (flunarizine) may build up in the body.
• Carafate (sucralfate) - May reduce the effectiveness of this antifungal.
• Cerubidine (daunorubicin) - Increases risk of liver damage.
• Cordarone (amiodarone) - Increases risk of liver damage.
• Coumadin (warfarin) - May build up and cause bleeding. More frequent INR testing and perhaps altered dosing will be necessary for combined treatment.
• Dantrium (dantrolene) - Increases risk of liver damage.
• Detrol (tolterodine) - Toxicity may result if this medication is mixed with ketoconazole.
• Estrogens (female hormones) - Increases risk of liver damage.
• Flexeril (cyclobenzaprine) - May interfere with absorption of ketoconazole. Take only 2 full hours after taking your antifungal treatment.
• Gold salts - This arthritis treatment increases risk of liver damage in combination with this class of antifungals.
• Histamine blockers like Axid (nizatidine), Pepcid (famotidine), Tagamet (cimetidine), and Zantac (ranitidine) may interfere with ketoconazole absorption. Take only 2 full hours after taking your antifungal treatment.
• HMG-CoA reductase inhibitors (statins) - Drugs like Baycol (cerivastatin), Lescol (fluvastatin), Lipitor (atorvastatin), Mevacor (lovastatin), Pravachol (pravastatin), or Zocor (simvastatin) may build up in the body leading to undesirable side effects.
• Isoniazid - Antifungals may be less effective when mixed.
• Lanoxin (digoxin) - This medication may build up to toxic levels when mixed with ketoconazole.
• Mexate (methotrexate) - Increases risk of liver damage.
• Monistat (miconazole) - Ketoconazole may build up in the body.
• Neutrexin (trimexate) - May have its effects increased with combined treatment.
• Oral Contraceptives - May increase the buildup of the antifungal, and the risk of undesirable side effects on the liver.
• Orap (pimozide) - Increased chance of undesirable side effects.
• Plaquenil (hydroxychloroquine) - Increases risk of liver damage.
• Prograf (tacrolimus) and Rapamune (serolimus) may build up to toxic levels with combined treatment, necessitating more frequent blood level checks and likely dosage adjustments.
• Propulsid (cisapride) - Serious heart toxicity may result. Do not combine these treatments for any reason.
• Protease inhibitors such as Agenerase (amprenavir), Crixivan (indinavir), Invirase (saquinivir), Norvir (ritonavir), and perhaps others, may build up to toxic levels in the body.
• Proton pump inhibitors like Prevacid (lansoprazole), Prilosec (omeprazole), and possibly others, may decrease the effectiveness of ketoconazole. Take only two hours after your antifungal treatment, or as directed by your doctor.
• Purinethol (mercaptopurine) - Increases risk of liver damage.
• Quinaglute (quinidine) - Toxic buildup of this medication may occur, blood levels should be checked and adjusted as needed.
• Rescriptor (delavirdine) - Effects of this medication may be increased.
• Rifadin (rifampin) - Antifungals may be less effective when mixed.
• Ritalin (methylphenidate) - May interfere with absorption of ketoconazole, take no sooner than 2 hours apart, speak to your doctor for further instructions.
• Sandimmune (cyclosporine) - Effects may be increased when mixed with ketoconazole, toxicity may occur.
• Seldane (terfenadine) - Speak with your doctor before combining treatment.
• Seroquel (quetiapine) - Effects of this medication may be increased.
• Tegison (etretinate) - Increases risk of liver damage.
• Tikosyn (dofetilide) - Serious heart toxicity may result. Do not combine these treatments for any reason.
• Tretinoin - May build up to toxic levels when combined with ketoconazole.
• Trexan (naltrexone) - Increases risk of liver damage with long-term use.
• Viagra (sildenafil) - Effects of Viagra may be increased, speak to your doctor about the safety of combining these treatments.
• Videx (didanosine) - May be less effective when combined with ketoconazole.
• Viramune (nevirapine) - May decrease the effectiveness of antifungal treatments.

This medication comes in the following forms:

• Cream - 2% (for external Candida and tinea infections)
• Shampoo - 2%
• Tablets - 200 mg

The following dosage suggestions are general guidelines, and are not meant to replace the dosage recommendation of your physician:

• Fungal Iinfections - 200-400 mg once a day, to a maximum of 800 mg
• Cushing's Syndrom - 600-1,200 mg once a day, to a maximum of 1,200 mg
• Prostate Cancer - 400 mg three times a day, to a maximum of 1,200 mg

Do not increase your dose of Nizoral without instructions from your doctor. If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Skip the missed dose of Nizoral and resume your regular schedule. Do not take double doses of this medication.

Take Nizoral for as long as your doctor prescribes. Do not stop taking it until your doctor advises you to do so, even if you feel better. It may take an additional two to four weeks (perhaps several months for some cases) after the symptoms of infection subside to rid your body of the yeast or fungus completely. A fungal infection may return if you don't take the full prescribed course of the medication.

Store Nizoral away from direct light and heat. Store in a dry location; avoid storing it in the bathroom, near sinks, or other areas where it may become damp. Do not use after the expiration date. Do not allow the liquid form of this medication to freeze.

Keep Nizoral away from children; both when storing it, and when discarding any unused medication.

Nizoral may cause drowsiness or dizziness. Be cautious if you plan to drive or operate heavy machinery, avoid these activities if you find yourself feeling tired or disoriented.

Nizoral and Pregnancy

Nizoral has been demonstrated to cause significant risk of toxicity and birth defects in animal studies, though studies in humans are not available. This treatment should only be used during pregnancy if your doctor determines that the potential benefits outweight the not insignificant risks.

Do not combine this treatment with breastfeeding.

Nizoral and Children

This medication is approved for use in children over 2 years old, and in some cases in newborns. Your pediatrician must determine dosage individually based on body weight and the nature of the infection.

Nizoral and Seniors

This medication does not appear to behave differently in individuals over the age of 60, dosing changes do not seem to be necessary.

However, Nizoral requires an acid environment in the stomach for proper absorption. If you have low stomach acid, speak to your doctor about how to make treatment more effective.

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Nizoral is a trademark of Janssen

Generic Ketoconazole manufactured by Mylan and Taro

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The information contained in this document is provided for educational purposes and information only. It is not a substitute for consultation with a physician or Health professional, either to diagnose symptoms or prescribe treatment. Any dosages mentioned are general guidelines only, please follow the directions of your doctor or pharmacist exactly when taking medication. We have made every effort to ensure that this information is accurate, but only your doctor, physician or Health professional can say if a medication, a drug alternative or drug combination, is safe for you. Information intended for US residents only.